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Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 48 - 49
1 Mar 2006
Jolles B Bogoch E Beaton D
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Introduction The purpose of this study was to identify issues of importance to Juvenile Idiopathic Arthritis (JIA) patients before and after total hip arthroplasty (THA) and to determine if these issues are included in widely utilized, standardized outcome measures for THA (Western-Ontario and McMaster Universities Arthritis Index – WOMAC; Patient Specific Index – PASI). Methods JIA patients who underwent THA between 1986 and 1999 in our institution participated in the study (n=31). An independent observer was asked to gather data forms including patient demographics, a postoperative WOMAC questionnaire, postoperative patient-generated items from the PASI, a retrospectively completed preoperative PASI form, and changes in items from pre-operative to postoperative PASI. Descriptive analysis was completed on demographic information and clinical outcomes as well as for the WOMAC and PASI scores. Spearmans rank correlation coefficients were calculated to describe the association between WOMAC and PASI scores. Results Issues deemed important by JIA patients included four symptom areas (pain, joint motion, strength, discomfort) and five activity areas (light household, leisure, clothing, sports, sex); some indicated they had no symptoms or difficulties. Issues relevant to patients shifted from predominantly symptoms before surgery, to recreational and social activities at follow-up. Comparison of postoperative WOMAC questionnaires with preoperative and postoperative PASI questionnaires revealed fundamental differences between items found in the standardized WOMAC and items deemed important by the patient. The WOMAC included less than 10% of the unweighted content deemed important by these patients at follow-up.The shift in the PASI towards more physically demanding activities after surgery indicates that patients improved, which is not reflected in the WOMAC. Correlations between postoperative WOMAC and PASI scores for pain sub-scales were low to moderate (Spearman‘s coefficient rs=0.53) and 63% of JRA patients had higher PASI than WOMAC normalized scores. Conclusion The self-generated, self-reported portion of the PASI questionnaire provided a different perspective on the impact of THA in JIA patients. The WOMAC did not include content deemed to be important by JRA patients and did not correlate well with the patient specific instrument


Orthopaedic Proceedings
Vol. 85-B, Issue SUPP_I | Pages 17 - 17
1 Jan 2003
Whitehouse S Learmonth I Lingard E
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Presently, many instruments exist for assessing both patient - and surgeon-based satisfaction after joint replacement, including both generic (measures of general health status) and disease specific measures. As such, the US PORT study (1995) recommends use of both the WOMAC and SF-36. However, this means that studies need to incorporate at least these two lengthy questionnaires into protocols, which increases the pressure on patients for both time and difficulty, but also introduces some duplication of data. The SF-36 has been successfully reduced and validated to a 12 item questionnaire (SF-12) which can be used as a summarised generic health score. It would be of great benefit if a reduced version of the WOMAC could be derived to give a similar summarised disease-specific measurement tool. To derive and assess the validity of a reduced function scale of the WOMAC for patients with osteoarthritis of the hip and knee. All unilateral data from 12 centres world-wide (UK US Canada and Australia) involved in an international, multi-centre outcome study for patients undergoing TKR were included for analysis. The reduced scale was derived from pre-op and 3 month post op data using a combination of data-driven analysis and purely clinical methods. The reduced WOMAC was then extensively validated in three key areas; validity, reliability and responsiveness using 12 month post-op data from the study and data from the Medicare Hip Replacement Study. Data from 898 patients pre-operatively and 806 patients at 3-months were used for the data driven section of analysis. For the clinical section, 30 members of the orthopaedic community were surveyed as to their opinions of which items should be retained in the reduced version of the scale. These results were then combined to produce a reduced function scale of 7 items to be used in conjunction with the 5-item pain scale. The questions remaining in the scale (and their original number in the scale) were: 2) ascending stairs, 3) rising from sitting, 6) walking on flat, 7) getting in/out of car, 9) putting on socks/stockings, 10) rising from bed and 14) sitting. This reduced scale was then scrutinised to ensure it’s validity (both construct and content), reliability (both internal consistency and reproducibility) and responsiveness (using Standardised Response Means). When examining 12 month data the reduced scale compared favourably with the full scale both overall, and when sub-divided by age, sex and country. It’s construct validity was confirmed by significant positive correlation with the SF-36 physical component score, the knee society function score, the Oxford knee score, and for the hip data, the Harris hip score and SF-12 physical component score. Cronbach’s alpha was consistently high (α> 0.85) with the reduced scale, showing it to be reliable, and the SRM’s indicated that the reduced scale may even be better at detecting change than the full scale. This reduced WOMAC has been successfully derived and validated for use as a summarised and more practical version of the full WOMAC scale


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 360 - 360
1 Sep 2005
Jolles B Bogoch E Beaton D
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Introduction and Aims: In this study, we identify issues of importance to adult Juvenile Rheumatoid Arthritis (JRA) patients before and after total hip arthroplasty (THA) and determine if these issues are included in widely utilised, standardised outcome measures for THA (Western-Ontario and McMaster Universities Arthritis Index – WOMAC; Patient Specific Index – PASI). Method: Adult JRA patients who underwent THA between 1986 and 1999 at our institution participated in the study (n=31). An independent observer gathered data, including patient demographics, a post-operative WOMAC questionnaire, post-operative patient-generated items from the PASI, a retrospectively completed pre-operative PASI form, and changes in items from pre-operative to post-operative PASI. Descriptive analysis was completed on demographic information and clinical outcomes, as well as for the WOMAC and PASI scores. Spearman’s rank correlation coefficients were calculated to describe the association between WOMAC and PASI scores. Results: Issues deemed important by JRA patients included four symptom areas (pain, joint motion, strength, discomfort) and five activity areas (light household, leisure, clothing, sports, sex); some patients indicated they had no symptoms or difficulties. Before surgery, issues identified as relevant by patients were predominantly symptoms, whereas at follow-up, patients primarily identified recreational and social activities as the issues relevant to them. Comparison of post-operative WOMAC questionnaires with pre-operative and post-operative PASI questionnaires revealed fundamental differences between items found in the standardised WOMAC and items deemed important by the patient. The WOMAC included less than 10% of the unweighted content deemed important by these patients at follow-up. The shift in the PASI towards more physically demanding activities after surgery indicates that patients improved, which is not reflected in the WOMAC. Correlations between post-operative WOMAC and PASI scores for pain subscales were low to moderate (Spearman rank correlation coefficient: rs = 0.53) and 63% of JRA patients had higher PASI than WOMAC normalised scores. Conclusion: The self-generated, self-reported portion of the PASI provided a different perspective on the impact of THA in adult JRA patients and more information on issues important to these patients. The WOMAC did not include content deemed to be important by JRA patients and did not correlate well with the PASI


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_II | Pages 339 - 339
1 May 2010
Stevens M Wagenmakers R Van den Akker-Scheek I Groothoff J Zijlstra W Bulstra S
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Introduction: Despite growing awareness of the beneficial effects of physical activity on health, little is known about the amount of physical activity after THA. Although the WOMAC does not give direct information about the amount of physical activity it can be hypothesized that when patients experience limitations this will have an adverse effect on the amount of physical activity they are involved in. In this way the WOMAC can be predictive for the amount of physical activity. The aim of this study is to determine the correlation between the WOMAC and the amount of physical activity and to determine the predictive value of the WOMAC on meeting the (inter-) national guidelines of health -enhancing physical activity. Materials and Methods: 364 patients with a THA (minimal one year postoperative) were included. Self-reported physical functioning was assessed by means of the WOMAC and the amount of physical activity by means of the SQUASH. Correlations between the WOMAC and SQUASH-scores were assessed using Pearson’s correlation coefficient. Binary logistic regression modelling was used to determine to which extent the score on the WOMAC was predictive in meeting the (inter-)national guidelines. Results: A significant, low correlation between the WOMAC and SQUASH-scores (range 0.14 – 0.24) was found. Although the WOMAC was a significant predictor to meet the (inter-) national guidelines of physical activity (p< 0.001), the odds-ratio was low (1.022, 95%CI 1.0121.033). The Nagelkerke R2 was 0.069, implicating that 6.9% of the variance could be explained. Conclusion: The WOMAC is not suitable to predict the amount of physical activity after THA, necessitating the use of additional quantitative outcome measures


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_IV | Pages 469 - 469
1 Apr 2004
Whitehouse S Learmonth I Crawford R
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Introduction The reduced WOMAC function scale has been developed and initial validity performed. However, further validation and recommendations for the treatment of missing values is required. The aim of this study is to further assess the validity of the reduced function scale of the WOMAC and recommend a protocol for the treatment of missing values. Method Further validation of the reduced scale was performed via a cross-over study of 100 pre-operative total joint replacement patients, each being randomised to receive either the full or reduced scale along with the pain scale, and then the alternate version upon admission. Data utilised in the development of the reduced scale was used to develop a missing value protocol, where the number of valid responses for several protocols was examined, as well as comparison of the means and standard deviations. Of the consenting 100 patients, 66 continued onto admission. The median time between administrations of the questionnaires was 14 days (range zero to 72 days). Results There was no significant difference between pain scores for each questionnaire using the paired t-test (p=0.56). Similarly, there was no significant difference between the full and reduced function scales (p=0.65). The standard protocol for the full scale is that if there are four or more missing items, the patient’s response is invalid. But when there are one to three items missing, the average value for the sub-scale is substituted in lieu of these missing values. Examining the frequencies of valid responses, means and standard deviations when using different missing value protocols (none missing, zero or one, up to two and up to three missing), indicated that there was no substantial benefit between the ‘up to two’ missing and ‘up to three’ missing response protocols. However, for this small gain, the supposition that the completed items are representative of the missing ones rises from 29% (two of seven items) to 43% (three of seven items) should be considered unacceptable. Conclusions The reduced WOMAC function scale has been further validated. It is proposed that where three or more responses are missing, the patients response is regarded as invalid. Where there are one or two items missing, the average value for the sub-scale is substituted in lieu of these missing values


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 181 - 181
1 Mar 2006
Pospischill M Knahr K
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Background: There are many clinical and radiographic long term results of Total Hip Arthroplasties reported in literature but very few attend to the subjective quality of life of patients living with an implant. In the last few years different quality of life assessment scores were developed. In this study the subjective SF-36 and the WOMAC score were evaluated and the results were compared to the commonly used clinical Harris Hip Score. Patients and methods: From a total number of 152 cement-less Total Hip Arthroplasties (Alloclassic®) performed between October 1987 and December 1988 at our clinic, 103 hips in 99 patients were available for a clinical and radiographic evaluation with an average follow-up of 14.3 years. For clinical evaluation the Harris Hip Score was used. Additionally all patients got SF-36 and WOMAC questionnaires. 78 questionnaires were returned fully completed and could be evaluated. The overall results and the results in the domain “pain” and “function” which occur in all three scores were compared statistically. Results: The mean Harris Hip Score was 88.2 (range 24 – 100), pain score 41.9 and function score 48.4. The mean WOMAC Score was 10.6 in total, pain 2.8 and function 3.9. The SF-36 domain “Bodily Pain” was 56.6 and “physical function” 48.2. Concerning the domain “function” a significant correlation was found in all of the three scores (p < 0.01). A significant “pain” correlation was seen comparing the SF-36 to the WOMAC score (p < 0.01). No significant correlation was found comparing the clinical Harris Pain Score to the SF-36 domain “Bodily Pain” and to the WOMAC pain score. Conclusion: In this study the subjective assessment questionnaires SF-36 and WOMAC show significant similar results to the clinical Harris Hip Score concerning the domain “function”. Concerning “Pain” comparable results were found between the SF-36 and the WOMAC with no significant correlation to the HHS. These data suggest that the quality of life assessment questionnaires can not replace the clinical evaluation using a clinical score


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_IV | Pages 469 - 469
1 Apr 2004
Whitehouse S Learmonth I Lingard E
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Introduction Presently, many instruments exist for assessing both patient and surgeon-based satisfaction after joint replacement, including both generic and disease specific measures. Our aim was to derive and assess the validity of a reduced function scale of the WOMAC for patients with osteoarthritis of the hip and knee. Methods All unilateral data from 12 centres world-wide (UK, US, Canada and Australia) involved in an international, multi-centre outcome study for patients undergoing TKR were included for analysis. The reduced scale was derived from pre-operative and three month postoperative data using a combination of data-driven analysis and purely clinical methods. The reduced WOMAC was then extensively validated in three key areas; validity, reliability and responsiveness using 12 month post-operative data from the study and data from the Medicare Hip Replacement Study. Data from 898 patients pre-operatively and 806 patients at three months was used for the data driven section of analysis. For the clinical section, 30 members of the orthopaedic community were surveyed as to their opinions of which items should be retained in the reduced version of the scale. These results were then combined to produce a reduced function scale of seven items to be used in conjunction with the five item pain scale. This reduced scale was then scrutinised to ensure it’s validity (both construct and content), reliability (both internal consistency and reproducibility) and responsiveness (using Standardised Response Means). Results The items retained were: ascending stairs, rising from sitting, getting in/out of car, going shopping, rising from bed, taking off socks and sitting. The scales’s construct validity was confirmed by significant positive correlation with the SF-36 physical component score, the knee society function score, the Oxford knee score, and for the hip data, the Harris Hip Score and SF-12 physical component score. Cronbach’s alpha was consistently high (a> 0.85) with the reduced scale, showing it to be reliable. Conclusions The SRM’s indicated that the reduced scale may even be better at detecting change than the full scale


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXIII | Pages 37 - 37
1 May 2012
Osborne R Bucknill A De Steiger R Brand C Graves S
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As there is currently no evidenced-based and systematic way of prioritising people requiring JRS we aimed to develop a clinically relevant system to improve prioritisation of people who may require JRS. An important challenge in this area is to accurately assign a queue position and improve list management. To identify priority criteria areas eight workshops were held with surgeons and patients. Domains derived were pain, activity limitations, psychosocial wellbeing, economic impact and deterioration. Draft questions were developed and refined through structured interviews with patients and consultation with consultants. 38 items survived critical appraisal and were mailed to 600 patients. Eleven items survived clinimetric and statistical item reduction. Validation then included co-administration with standardised questionnaires (960 patients), verification of patient MAPT scores through clinical interview, examination of concordance with surgeon global ratings and test-retest. Ninety-six Victorian surgeons weighted items using Discrete Choice Experiments (DCEs). The DCE scaling generated a scale, which clearly ranked patients across the disease continuum. The MAPT differentiated people on or not on waiting lists (p<0.001), and was highly correlated with other questionnaires, e.g., unweighted-MAPT vs WOMAC (r=0.78), Oxford Hip/Knee (r=0.86/0.75), Quality of Life (r=0.78), Depression (r=0.64), Anxiety (r=0.60), p<0.001 for all. Test-retest was excellent (ICC=0.89, n=90). Cronbachs reliability was also high 0.85. The MAPT is now routinely administered across all Victorian hospitals undertaking arthroplasty where the response rate is generally above 90%. In the hands of clinicians the MAPT has been used to facilitate fast-tracking of patients with the greatest need, monitoring for deterioration in those waiting for surgery or having a trial of non-operative treatment and deferment of surgery for those that may benefit from further non-operative treatments. The MAPT is short, easy to complete and clinically relevant. It is a specific measure of severity of hip/knee arthritis and assigns priority for surgery. It has excellent psychometric and clinimetric properties evidenced by concordance with standard disease-specific and generic scales and widespread use and endorsement across health services


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_2 | Pages 116 - 116
10 Feb 2023
Sundaraj K Russsell V Salmon L Pinczewski L
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The aim of this study was to determine the long term 20 year survival and outcomes of high tibial osteotomy (HTO). 100 consecutive subjects underwent HTO under the care of a single surgeon between 2000 and 2002, consented to participation in a prospective study and completed preoperative WOMAC scores. Subjects were reviewed at 10 years, and again at a minimum of 20 years after surgery. PROMS included further surgery, WOMAC scores, Oxford Knee Score (OHS), KOOS, and EQ-5D, and satisfaction with surgery. 20 year survival was assessed with Kaplan-Meir analysis, and failure defined as proceeding to subsequent knee arthroplasty. The mean age at HTO was 50 years (range 26-66), and 72% were males. The 5, 10, and 20 year survival of the HTO was 88%, 76%, 43% respectively. On multiple regression analysis HTO failure was associated with poor preoperative WOMAC score of 45 or less (HR 3.2, 95% CI 1.7-6.0, p=0.001), age at surgery of 55 or more (HR 2.3, 95% CI 1.3-4.0, p=0.004), and obesity (HR 1.9, 95% CI 1.1-3.4, p=0.023). In patients who met all criteria of preoperative WOMAC score of 45 or less, age <55 years and body mass index of <30 HTO survival was 100%, 94%, and 59% at 5, 10 and 20 years respectively. Of those who had not proceeded to TKA the mean Oxford Score was 40, KOOS Pain score was 91 and KOOS function score was 97. 97% reported they were satisfied with the surgery and 88% would have the same surgery again under the same circumstances. At 20 years after HTO 43% had not proceeded to knee arthroplasty, and were continuing to demonstrate high subjective scores and satisfaction with surgery. HTO survival was higher in those under 55 years, with BMI <30 and baseline WOMAC score of >45 at 59% HTO survival over 20 years. HTO may be considered a viable procedure to delay premature knee arthroplasty in carefully selected subjects


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 73 - 73
1 Dec 2022
Woolfrey M Bolton C Woolfrey K Warchuk D
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Despite total knee arthroplasty demonstrating high levels of success, 20% of patients report dissatisfaction with their result. Wellness Stasis Socks are embedded with a proprietary pattern of neuro-receptor activation points that have been proven to activate a precise neuro-response, as according to the pattern theory of haptic perception, which stimulates improvements in pain and function. Technologies that manipulate this sensory environment, such as textured insoles, have proven to be effective in improving gait patterns in patients with knee osteoarthritis. In regard to patients undergoing TKA using this new technology may prove beneficial as an adjunct to recovery as many patients suffer from further deficits to their proprioceptive system caused by ligamentous damage and alterations to mechanoreceptors during procedure. We hypothesized that the Wellness Stasis Socks are a safe, cost-effective and easily scalable strategy to support TKA patients through their recovery. Double-blinded, placebo-controlled randomized trial. Randomization using a computer-generated program . All study coordinators, healthcare personel and patients were blinded to patient groups. All surgical procedures were conducted by the same technique and orthopaedic surgeon. Intervention group: Wellness Stasis socks containing receptor point-activation technology. Control group: indentical appearing Wellness Stasis socks without receptor point-activation technology. Sock use during the waking hours . All additional post-operative protocols remained consistent between groups including same facility physiotherapy . Additional modalities (ice machines, soft-tissue massages, acupuncture) were prohibited. WOMAC questionnaire completed at baseline, 2 weeks, and 6 weeks to assess pain, stiffness and physical function. G. *. Power software to determine minimum sample of 50 in each group. No patients were lost to follow up and all followed study protocol. Data analysis using SPSS software. P-values, effect sizes, and confidence intervals are reported to assess clinical relevance of the finding. Physical status classifications were compared using t-test. Within-subject and between-subject differences in the mean WOMAC were analyzed by ANOVA. Cramer's V statistical analysis noted that other variables of Sex, BMI, ASA classification and Age were not statistically different between the control and intervention groups. No statistical difference between groups in Preop Womac scores. The data showed a consistent improvement in Womac scores for pain and stiffness at 2 weeks post op in the interventional group over the control group. The womac scores assessing physical function showed a consistent improvement at both 2 and 6 weeks post op in the intervention group compared to the control group. There were no complications in either group associated the sock use. The intervention proved to be a low cost and safe additional intervention post operatively from TKA to help patients improve with regard to pain, stiffness and physical function. This study suggests this modality can be added to the list of other commonly used post op interventions such as cryocuffs, physiotherapy, and relaxation techniques as safe post op interventions to help patients improve post op TKA and can act as an adjunct in providing non narcotic pain control


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_13 | Pages 81 - 81
7 Aug 2023
Bliddal H Beier J Hartkopp A Conaghan P Henriksen M
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Abstract. Introduction. The effectiveness of single intra-articular injections of polyacrylamide hydrogel (iPAAG) and hyaluronic acid (HA) was compared in subgroups of participants from an RCT based on baseline age, BMI or Kellgren-Lawrence (KL) grade. Methodology. 239 participants were randomised to 6 mL iPAAG (Arthrosamid; n=119) or 6 mL HA (Synvisc-One; n=120). Participants continued analgesics (except 48 hours prior to visits) and non-pharmacological therapy. Topical therapies and intra-articular corticosteroids were not allowed. Pre-specified subgroup analyses (age: <70 years, ≥70 years; BMI: normal, overweight, obese; KL grade: 2, 3, 4, 2–3) of change from baseline in WOMAC pain subscale at 52 weeks were based on the least squares means for the treatment-by-week interaction effect using a mixed model for repeated measurement with a restricted maximum likelihood-based approach. Results. Across all patients, change from baseline in WOMAC pain subscale in the iPAAG group was non-inferior to HA at 26 weeks and approached superiority (p=0.0572) at 52 weeks. Treatment differences for change from baseline in WOMAC pain subscale in favour of iPAAG over HA were statistically significant for the age <70 years (p=0.019), BMI normal (p=0.011) and KL grade 2–3 (p=0.033) subgroups. Treatment differences for all other subgroups favoured iPAAG, except for KL grade 4 which favoured HA, without reaching statistical significance. Conclusion. iPAAG approached superiority to HA across all participants at 52weeks, but demonstrated statistical superiority in participants with normal BMI, participants <70 years old or participants with KL score 2–3. iPAAG represents a useful alternative to HA for the treatment of knee OA


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_8 | Pages 58 - 58
11 Apr 2023
Jansen M Salzlechner C Barnes E DiFranco M Custers R Watt F Vincent T Lafeber F Mastbergen S
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Knee joint distraction (KJD) has been associated with clinical and structural improvement and synovial fluid (SF) marker changes. However, structural changes have not yet been shown satisfactorily in regular care, since radiographic acquisition was not fully standardized. AI-based modules have shown great potential to reduce reading time, increase inter-reader agreement and therefore function as a tool for treatment outcome assessment. The objective was to analyse structural changes after KJD in patients using this AI-based measurement method, and relate these changes to clinical outcome and SF markers. 20 knee OA patients (<65 years old) were included in this study. KJD treatment was performed using an external fixation device, providing 5 mm distraction for 6 weeks. SF was aspirated before, during and immediately after treatment. Weight-bearing antero-posterior knee radiographs and WOMAC questionnaires were collected before and ~one year after treatment. Radiographs were analysed with the Knee Osteoarthritis Labelling Assistant (KOALA, IB Lab GmbH, Vienna, Austria), and 10 pre-defined biomarker levels in SF were measured by immunoassay. Radiographic one-year changes were analysed and linear regression was used to calculate associations between changes in standardized joint space width (JSW) and WOMAC, and changes in JSW and SF markers. After treatment, radiographs showed an improvement in Kellgren-Lawrence grade in 7 of 16 patients that could be evaluated; 3 showed a worsening. Joint space narrowing scores and continuous JSW measures improved especially medially. A greater improvement in JSW was significantly associated with a greater improvement in WOMAC pain (β=0.64;p=0.020). A greater increase in MCP1 (β=0.67;p=0.033) and lower increase in TGFβ1 (β=-0.787;p=0.007) were associated with JSW improvement. Despite the small number of patients, also in regular care KJD treatment shows joint repair as measured automatically on radiographs, significantly associated with certain SF marker change and even with clinical outcome


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_18 | Pages 106 - 106
14 Nov 2024
Bliddal H Beier J Hartkopp A Conaghan P Henriksen M
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Introduction. Polyacrylamide hydrogel (iPAAG. 1. ), is CE marked for treating symptomatic knee osteoarthritis (OA), meeting the need for an effective, long-lasting, and safe non-surgical option. This study evaluates the efficacy and safety of a single 6 ml intra-articular injection of iPAAG in participants with moderate to severe knee OA over a 5-year post-treatment period, presenting data from the 4-year follow up. Method. This prospective multicentre study (3 sites in Denmark) involved 49 participants (31 females) with an average age of 70 (range 44 – 86 years). They received a single 6 mL iPAAG injection. All participants provided informed consent and re-consented to continue after 1 year. The study followed GCP principles and was approved by Danish health authorities and local Health Research Ethics committees. Twenty-seven participants completed the 4-year follow-up. The study evaluated WOMAC pain, stiffness, function, and Patient Global Assessment (PGA) of disease impact. Changes from baseline were analysed using a mixed model for repeated measurement (MMRM). Sensitivity analyses were applied on the extension data, where the MMRM analysis was repeated only including patients in the extension phase and an ANCOVA model was used, replacing missing values at 4-years with baseline values (BOCF). Results. The planned MMRM analysis (n=49) revealed a statistically significant decrease in WOMAC pain subscale scores (-22.0; 95%CI: -29.5; -14.4) from baseline to 4-years. Analysis of the extension phase (n=27) showed similar results (-21.8; 95%CI: -29.0; -14.6) compared to the initial analysis. Furthermore, BOCF analysis indicated a statistically significant reduction in WOMAC pain subscale scores from baseline (-13.0 units). Four new adverse events were reported between the 3-year and 4-year visits; none were related to treatment. Conclusions. This study shows that single injections of 6 ml intra-articular iPAAG were well tolerated and continued to provide clinically important effectiveness at 4-years after treatment. Acknowledgements. The study was sponsored by Contura International A/S


Bone & Joint Open
Vol. 4, Issue 5 | Pages 370 - 377
19 May 2023
Comeau-Gauthier M Bzovsky S Axelrod D Poolman RW Frihagen F Bhandari M Schemitsch E Sprague S

Aims. Using data from the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemiarthroplasty (HEALTH) trial, we sought to determine if a difference in functional outcomes exists between monopolar and bipolar hemiarthroplasty (HA). Methods. This study is a secondary analysis of patients aged 50 years or older with a displaced femoral neck fracture who were enrolled in the HEALTH trial and underwent monopolar and bipolar HA. Scores from the Western Ontario and McMaster University Arthritis Index (WOMAC) and 12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS) and (MCS) were compared between the two HA groups using a propensity score-weighted analysis. Results. Of 746 HAs performed in the HEALTH trial, 404 were bipolar prostheses and 342 were unipolar. After propensity score weighting, adequate balance between the bipolar and unipolar groups was obtained as shown by standardized mean differences less than 0.1 for each covariable. A total of 24 months after HA, the total WOMAC score and its subcomponents showed no statistically significant difference between the unipolar and bipolar groups. Similarly, no statistically significant difference was found in the PCS and MCS scores of the SF-12 questionnaire. In participants aged 70 years and younger, no difference was found in any of the functional outcomes. Conclusion. From the results of this study, the use of bipolar HA over unipolar design does not provide superior functional outcomes at 24 months postoperatively. The theoretical advantage of reduced acetabular wear with bipolar designs does not appear to influence functional outcomes in the first two years postoperatively. Cite this article: Bone Jt Open 2023;4(5):370–377


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 15 - 15
1 Nov 2021
Ponds N Landman E Lenguerrand E Whitehouse M Blom A Grimm B Bolink S
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Introduction and Objective. An important subset of patients is dissatisfied after total joint arthroplasty (TJA) due to residual functional impairment. This study investigated the assessment of objectively measured step-up performance following TJA, to identify patients with poor functional improvement after surgery, and to predict residual functional impairment during early postoperative rehabilitation. Secondary, longitudinal changes of block step-up (BS) transfers were compared with functional changes of subjective patient reported outcome measures (PROMs) following TJA. Materials and Methods. Patients with end stage hip or knee osteoarthritis (n = 76, m/f = 44/32; mean age = 64.4 standard deviation 9.4 years) were measured preoperatively and 3 and 12 months postoperatively. PROMs were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscore. BS transfers were assessed by wearable-derived measures of time. In our cohort, subgroups were formed based on either 1) WOMAC function score or 2) BS performance, isolating the worst performing quartile (impaired) of each measure from the better performing others (non-impaired). Subgroup comparisons were performed with the Man-Whitney-U test and Wilcoxon Signed rank test resp. Responsiveness was calculated by the effect size, correlations with Pearson's correlation coefficient. A regression analysis was conducted to investigate predictors of poor functional outcome. Results. WOMAC function scores were strongly correlated to WOMAC pain scores (Pearson's r=0.67–0.84) and moderately correlated to BS performance (Pearson's r = 0.31–0.54). Prior to surgery, no significant differences for WOMAC function scores and BS performance were found between the impaired and non-impaired subgroups. One year after TJA, our cohort performed significantly better at WOMAC and BS with largest effect size for the non-impaired subgroups (0.62 and 0.43 resp.) At 12 months postop, 56% of patients allocated to the impaired subgroup defined by WOMAC, represented the impaired subgroup defined by BS. Allocation to the impaired subgroup at 3 months postop, raised the odds for belonging to the impaired subgroup at 12 months for WOMAC with an odds ratio=19.14 (67%) and for BS with an odds ratio=4.41 (42%). Conclusions. Assessment of BS performance following TJA reveals residual functional impairment that is not captured by pain-dominated PROMs. Its additional use may help to early identify those patients at risk for a poor outcome


Introduction. The first VRAS TKA was performed in New Zealand in November 2020 using a Patient Specific Balanced Technique whereby VRAS enables very accurate collection of the bony anatomy and soft tissue envelope of the knee to plan and execute the optimal positioning for a balanced TKA. Method. The first 45 VRAS patients with idiopathic osteoarthritis of the knee was compared with 45 sequential patients who underwent the same TKA surgical technique using Brainlab 3 which the author has used exclusively in over 1500 patients. One and two year outcome data will be presented. Results. One year outcome dataVely Brainlab Significance Oxford 43.4 40.5 P=0.01 WOMAC 8.4 14.1P=0.02 Forgotten Joint Score 72.2 58.3 P=0.01 KOOS ADL91.3 85.8 P=0.04 Normal 83.3 74.2P =0.048 Activity Pain 8.6 18.4 P=0.009 ROM 127 124 P=0.01 Patient Satisfaction 98% 95% P=0.62 Operation again 100% 91% P=0.055 The two year data will be available for the ASM Conclusion: The one year outcome data shows a significantly better Oxford, WOMAC, Forgotten Joint score, KOOS ADL, Normal score and ROM scores and the activity pain is less compared to the authors extensive experience with Brainlab 3


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_16 | Pages 65 - 65
19 Aug 2024
Walter W Lin D Weinrauch P de Smet K Beaule P Young D Xu J Manktelow A
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Hip resurfacing arthroplasty (HRA) is a bone conserving alternative to total hip arthroplasty. We present the early 2-year clinical and radiographic follow-up of a novel ceramic-on-ceramic (CoC) HRA in an international multi-centric cohort. Patients undergoing HRA between September 2018 and January 2021 were prospectively included. Patient-reported outcome measures (PROMS) in the form of the Forgotten Joint Score (FJS), HOOS Jr, WOMAC, Oxford Hip Score (OHS) and UCLA Activity Score were collected preoperatively and at 1- and 2-years post-operation. Serial radiographs were assessed for migration, component alignment, evidence of osteolysis/loosening and heterotopic ossification formation. 200 patients were identified to have reached 2-year follow-up. Of these, 185 completed PROMS follow-up at 2 years. There was significant improvement in HOOS (p< 0.001) and OHS (p< 0.001) and FJS (p< 0.001) between the pre-operative and 2-year outcomes. Patients reported improved pain (p<0.001), function (p<0.001) and reduced stiffness (p<0.001) as measured by the WOMAC score. Patients had improved activity scores on the UCLA Active Score (P<0.001) with 53% reporting return to impact activity at 2 years. There was no osteolysis and the mean acetabular cup inclination angle was 41deg and the femoral component shaft angle was 137deg. No fractures were reported over but there was one sciatic nerve palsy with partial recovery. Two patients were revised; one at 3 months for pain due to a misdiagnosed back problem and another at 33 months for loosening of the acetabular component with delamination of the titanium ingrowth surface. CoC resurfacing at 2-years post-operation demonstrate promising results with satisfactory PROMS


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_2 | Pages 106 - 106
10 Feb 2023
Lin D Xu J Weinrauch P Yates P Young D Walter W
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Hip resurfacing arthroplasty (HRA) is a bone conserving alternative to total hip arthroplasty. We present the early 1 and 2-year clinical and radiographical follow-up of a novel ceramic-on-ceramic (CoC) HRA in a multi-centric Australian cohort. Patient undergoing HRA between September 2018 and April 2021 were prospectively included. Patient-reported outcome measures (PROMS) in the form of the Forgotten Joint Score (FJS), HOOS Jr, WOMAC, Oxford Hip Score (OHS) and UCLA Activity Score were collected preoperatively and at 1- and 2-years post-operation. Serial radiographs were assessed for migration, component alignment, evidence of osteolysis/loosening and heterotopic ossification formation. 209 patients were identified of which 106 reached 2-year follow-up. Of these, 187 completed PROMS at 1 year and 90 at 2 years. There was significant improvement in HOOS (p< 0.001) and OHS (p< 0.001) between the pre-operative, 1-year and 2-years outcomes. Patients also reported improved pain (p<0.001), function (p<0.001) and reduced stiffness (p<0.001) as measured by the WOMAC score. Patients had improved activity scores on the UCLA Active Score (p<0.001) with 53% reporting return to impact activity at 2 years. FJS at 1 and 2-years were not significantly different (p=0.38). There was no migration, osteolysis or loosening of any of the implants. The mean acetabular cup inclination angle was 41.3° and the femoral component shaft angle was 137°. No fractures were reported over the 2-year follow-up with only 1 patient reporting a sciatic nerve palsy. There was early return to impact activities in more than half our patients at 2 years with no early clinical or radiological complications related to the implant. Longer term follow-up with increased patient numbers are required to restore surgeon confidence in HRA and expand the use of this novel product. In conclusion, CoC resurfacing at 2-years post-operation demonstrate promising results with satisfactory outcomes in all recorded PROMS


Bone & Joint Open
Vol. 3, Issue 9 | Pages 692 - 700
2 Sep 2022
Clement ND Smith KM Baron YJ McColm H Deehan DJ Holland J

Aims. The primary aim of our study was to assess the influence of age on hip-specific outcome following total hip arthroplasty (THA). Secondary aims were to assess health-related quality of life (HRQoL) and level of activity according to age. Methods. A prospective cohort study was conducted. All patients were fitted with an Exeter stem with a 32 mm head on highly cross-linked polyethylene (X3RimFit) cemented acetabulum. Patients were recruited into three age groups: < 65 years, 65 to 74 years, and ≥ 75 years, and assessed preoperatively and at three, 12, 24, and 60 months postoperatively. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Harris Hip Score (HHS), and Hip disability and Osteoarthritis Outcome Score (HOOS), were used to assess hip-specific outcome. EuroQol five-dimension five-level questionnaire (EQ-5D-5L) and 36-Item Short Form Survey (SF-36) scores were used to assess HRQoL. The Lower Extremity Activity Scale (LEAS) and Timed Up and Go (TUG) were used to assess level of activity. Results. There were no significant (p > 0.05) differences in the WOMAC scores, HSS, HOOS, or EQ-5D-5L at any postoperative timepoint between the age groups. Patients aged ≥ 75 years had significantly lower physical function (p ≤ 0.010) and physical role (p ≤ 0.047) SF-36 scores at 12, 24, and 60 months, but were equal to that expect of an age-matched population. No differences according to age were observed for the other six domains of the SF-36 (p > 0.060). The ≥ 75 years group had a lower LEAS (p < 0.001) and longer TUG test times (p ≤ 0.032) compared to the < 65 years group, but older age groups had significant (p < 0.001) improvement relative to their preoperative baseline measures. Conclusion. Age did not influence postoperative hip-specific outcome or HRQoL (according to the EQ-5D) following THA. Despite a significant improvement, older patients had lower postoperative activity levels compared to younger patients, but this may be reflective of the overall physical effect of ageing. Cite this article: Bone Jt Open 2022;3(9):692–700


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_12 | Pages 38 - 38
23 Jun 2023
Karachalios T Varitimidis S Komnos G Koutalos A Malizos KN
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Local anatomical abnormalities vary in congenital hip disease patients. Authors often present early to mid-term total hip arthroplasty clinical outcomes using different techniques and implants randomly on patients with different types of the disease, making same conclusions difficult. We report long term outcomes (13 to 23 years) of the treatment of low and high dislocation cases (separately) with total hip arthroplasty using TM technology acetabular cups (Implex initially and then Zimmer) and short fluted conical (Zimmer) femoral stems. From 2000 to 2010, 418 congenital hip disease hip joints were treated in our department with total hip arthroplasty. According to Hartofilakidis et al's classification, 230 hips had dysplasia, 101 low dislocation, (group A) and 87 high dislocation (group B). Pre-operative and post-operative values, at regular intervals, of HHS, SF-12, WOMAC, OHS and HOOS were available for all patients. Patient, surgeon and implant related failures and complications were recorded for all patients. In all cases an attempt was made to restore hip center of rotation. In group A the average lengthening was 2.8 cm (range: 1 to 4.2) and in group B 5.7 cm (range: 4.2 to 11). In both groups, no hips were revised due to aseptic loosening of either the acetabular cup or the femoral stem. In group A, a cumulative success rate of 95.6% (95% confidence interval, 92.7% – 97.4%) and in group B a cumulative success rate of 94.8% (95% confidence interval, 92.6%–96.9%) was recorded, at 20 years, with revision for any reason as an end point. No s.s. differences were found between groups when mean values of HHS, SF-12, WOMAC and OKS were compared. Satisfactory long-term clinical outcomes can be achieved in treating different types of congenital hip disease when appropriate surgical techniques combined with “game changing” implants are used