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The Bone & Joint Journal
Vol. 98-B, Issue 10 | Pages 1376 - 1381
1 Oct 2016
Bucknall V Rutherford D MacDonald D Shalaby H McKinley J Breusch SJ

Aims . This is the first prospective study to report the pre- and post-operative patient reported outcomes and satisfaction scores following excision of interdigital Morton’s neuroma. Patients and Methods. Between May 2006 and April 2013, we prospectively studied 99 consecutive patients (111 feet) who were to undergo excision of a Morton’s neuroma. There were 78 women and 21 men with a mean age at the time of surgery of 56 years (22 to 78). Patients completed the Manchester-Oxford Foot Questionnaire (MOXFQ), Short Form-12 (SF-12) and a supplementary patient satisfaction survey three months pre-operatively and six months post-operatively. Results. Statistically significant differences were found between the mean pre- and post-operative MOXFQ and the physical component of the SF-12 scores (p = 0.00081 and p = 0.00092 respectively). Most patients reported their overall satisfaction as excellent (n = 49, 49.5%) or good (n = 29, 29.3%), but ten patients were dissatisfied, reporting poor (n = 8, 8.1%) or very poor (n = 2, 2.0%) results. Only 63 patients (63%) were pain-free at follow-up: in eight patients (8.1%), the MOXFQ score worsened. There was no statistically significant difference in outcome between surgery on single or multiple sites. However, the MOXFQ scores were significantly worse after revision surgery (p = 0.004). Conclusions. The patient-reported outcomes after resection of a symptomatic Morton’s neuroma are acceptable but may not be as good as earlier studies suggest. Surgery at several sites can be undertaken safely but caution should be exercised when considering revision surgery. Cite this article: Bone Joint J 2016;98-B:1376–81


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 2 | Pages 215 - 221
1 Feb 2012
Dawson J Boller I Doll H Lavis G Sharp R Cooke P Jenkinson C

The responsiveness of the Manchester–Oxford Foot Questionnaire (MOXFQ) was compared with foot/ankle-specific and generic outcome measures used to assess all surgery of the foot and ankle. We recruited 671 consecutive adult patients awaiting foot or ankle surgery, of whom 427 (63.6%) were female, with a mean age of 52.8 years (18 to 89). They independently completed the MOXFQ, Short-Form 36 (SF-36) and EuroQol (EQ-5D) questionnaires pre-operatively and at a mean of nine months (3.8 to 14.4) post-operatively. Foot/ankle surgeons assessed American Orthopaedic Foot and Ankle Society (AOFAS) scores corresponding to four foot/ankle regions. A transition item measured perceived changes in foot/ankle problems post-surgery. Of 628 eligible patients proceeding to surgery, 491 (78%) completed questionnaires and 262 (42%) received clinical assessments both pre- and post-operatively. The regions receiving surgery were: multiple/whole foot in eight (1.3%), ankle/hindfoot in 292 (46.5%), mid-foot in 21 (3.3%), hallux in 196 (31.2%), and lesser toes in 111 (17.7%). Foot/ankle-specific MOXFQ, AOFAS and EQ-5D domains produced larger effect sizes (> 0.8) than any SF-36 domains, suggesting superior responsiveness. In analyses that anchored change in scores and effect sizes to patients’ responses to a transition item about their foot/ankle problems, the MOXFQ performed well. The SF-36 and EQ-5D performed poorly. Similar analyses, conducted within foot-region based sub-groups of patients, found that the responsiveness of the MOXFQ was good compared with the AOFAS.

This evidence supports the MOXFQ’s suitability for assessing all foot and ankle surgery.


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 7 | Pages 928 - 931
1 Jul 2012
Keenan ACM Wood AM Arthur CA Jenkins PJ Brenkel IJ Walmsley PJ

We report the ten-year survival of a cemented total knee replacement (TKR) in patients aged < 55 years at the time of surgery, and compare the functional outcome with that of patients aged > 55 years. The data were collected prospectively and analysed using Kaplan-Meier survival statistics, with revision for any reason, or death, as the endpoint. A total of 203 patients aged < 55 years were identified. Four had moved out of the area and were excluded, leaving a total of 221 TKRs in 199 patients for analysis (101 men and 98 women, mean age 50.6 years (28 to 55)); 171 patients had osteoarthritis and 28 had inflammatory arthritis. Four patients required revision and four died. The ten-year survival using revision as the endpoint was 98.2% (95% confidence interval 94.6 to 99.4). Based on the Oxford knee scores at five and ten years, the rate of dissatisfaction was 18% and 21%, respectively. This was no worse in the patients aged < 55 years than in patients aged > 55 years.

These results demonstrate that the cemented PFC Sigma knee has an excellent survival rate in patients aged < 55 ten years post-operatively, with clinical outcomes similar to those of an older group. We conclude that TKR should not be withheld from patients on the basis of age.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_8 | Pages 12 - 12
10 May 2024
Sevic A Patel C Tomlinson M
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Introduction. Comparative studies examining Fixed-Bearing (FB) and Mobile-Bearing (MB) Total Ankle Replacement (TAR) designs have demonstrated similar results and successful long-term outcomes for both. To date there has been no study directly comparing FB and MB designs of the same prosthesis. We present the first prospective randomised trial comparing patient satisfaction, functional outcomes and radiographic results of the Salto Talaris Fixed-Bearing and the Salto Mobile-Bearing Total Ankle Replacement in the treatment of end-stage ankle arthritis. Methods. A total of 108 adult patients with end-stage ankle arthritis were enrolled in the study between November 2014 and October 2021 with similar demographic comparison. Prospective patient-reported outcomes and standardised weightbearing ankle radiographs were performed preoperatively, at 6 weeks, 6 months and 12 months post-operatively, followed by yearly intervals. All surgeries were performed by a single non-design orthopaedic foot and ankle specialist with experience in over 200 Salto and Salto Talaris TAR prior to the study. Radiographs were examined independently by two clinicians. Complete patient data and radiographs were available for 103 patients with an average follow up of 2 years. Results. Both groups demonstrated statistically significant improvement from preoperative evaluation to most recent follow up with no statistically significant difference between the two groups in all outcome measures. Radiographic incidence of subchondral cyst formation was 8.9% and 38.2% for FB and MB, respectively. Talar subsidence occurred in 2.2% and 5.5% of FB and MB, respectively. Discussion. Our study demonstrates a higher than previously reported rate of cyst formation in the MB TAR and comparatively higher talar subsidence in the MB TAR vs FB however this did not correlate with clinical outcome measures which were favourable for both groups. Conclusion. Fixed-Bearing and Mobile-Bearing Total Ankle Replacement demonstrate comparable favourable


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_14 | Pages 9 - 9
10 Oct 2023
Aithie J Robinson P Butcher R Denton M Simpson A Messner J
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Patellofemoral instability (PFI) is a common cause of knee pain and disability in the paediatric population. Patella alta, lateralised tibial tubercle, medial patellofemoral ligament (MPFL) deficiency, genu valgum and trochlear dysplasia are well known risk factors. A prospective database was created including patients referred through our physiotherapy pathway following first-time patella dislocation. Patella alta and lateralisation of the tibial tuberosity was treated with a Fulkerson-type tibial tubercle osteotomy(TTO). Medial patellofemoral ligament was reconstructed using quads tendon autograft pull-down technique. A modified Sheffield protocol was used postoperatively allowing weightbearing in a hinged knee brace. Forty patients were identified with 8 patients having bilateral presentations. Male to female ratio was 12:28 with an age range of 4–17 years. Eight patients had congenital PFI, five patients acquired PFI through traumatic patella dislocation and twenty-seven patients developed PFI from recurrent dislocations. Structural abnormalities were found in 38(95%) of patients. Patella alta (Caton-Deschamps index >1.2) was identified in 19(47%) patients, genu valgum in 12(30%) patients, increased tibial tubercle-trochlear groove distance(TT-TG>20mm) was present in 9(22.5%) patients and persistent femoral anteversion(> 20 deg) in 7(17%) patients. Eight patients were treated with TTO and MPFL reconstruction, three patients with MPFL reconstruction alone and five patients had guided growth for genu valgum correction. Ten patients are awaiting surgery. No postoperative patients had recurrence of PFI at their latest follow up. PFI is a common problem in the adolescent paediatric population with identifiable structural abnormalities. Correcting structural pathology with surgery leads to predictable and safe outcomes


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_13 | Pages 9 - 9
1 Dec 2022
Glaris Z Okamoto T Goetz T
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SARS-CoV-2 emerged in Wuhan, China in December 2019 causing pneumonia and resulting in a pandemic, commonly known as COVID-19. This pandemic led to significant changes to our daily lives due to restrictions, such as social distancing, quarantining, stay at home orders and closure of restaurants and shops among other things. The psychological effects of this uncertainty as well as of these changes to our lives have been shown to be significant. This study is a prospective study investigating the mental effects of the pandemic on hand and wrist patients seen in our clinic during this pandemic. A prospective database on wrist pain was used to identify patients seen in our hand clinic from January 1, 2018 to December 10, 2021. All participants had been diagnosed with either radial sided wrist pain or ulnar side wrist pain. The Center for Epidemiological Studies Depression (CES-D) Scale was used to assess the mental health of our participants before and during this pandemic. An independent samples t-test was used to compare the scores of the 2 groups. A total of 437 CES-D questionnaires were collected during this period. 118 of them belonging to the pandemic group and 319 to the pre-pandemic group. A difference (p < 0 .05) in the CES-D score was observed between the pre-pandemic and during pandemic groups. The mean score for the pre-pandemic group was found to be 9.23 (8.94) and 12.81 (11.45) for the pandemic group. However, despite the increase in score, it didn't exceed the cut off score of 16 or greater used to assess depression. Our results indicate that there was a slight increase in score for depression in hand and wrist patients, but not above the cut off level of 16 to be of a significant risk for depression. Other global studies have shown an increase in depression in the general public. Our mild results might be attributed to the fact that British Columbia did not implement severe restrictions compared to other countries or regions, i.e no stay at home orders. Additionally, our study population was skewed and included more middle age and older patients compared to younger ones and age might be a factor in keeping the score down


Bone & Joint Open
Vol. 3, Issue 1 | Pages 61 - 67
18 Jan 2022
van Lingen CP Ettema HB Bosker BH Verheyen CCPM

Aims. Large-diameter metal-on-metal (MoM) total hip arthroplasty (THA) has demonstrated unexpected high failure rates and pseudotumour formation. The purpose of this prospective cohort study is to report ten-year results in order to establish revision rate, prevalence of pseudotumour formation, and relation with whole blood cobalt levels. Methods. All patients were recalled according to the guidelines of the Dutch Orthopaedic Association. They underwent clinical and radiographical assessments (radiograph and CT scan) of the hip prosthesis and whole blood cobalt ion measurements. Overall, 94 patients (95 hips) fulfilled our requirements for a minimum ten-year follow-up. Results. Mean follow-up was 10.9 years (10 to 12), with a cumulative survival rate of 82.4%. Reason for revision was predominantly pseudotumour formation (68%), apart from loosening, pain, infection, and osteolysis. The prevalence of pseudotumour formation around the prostheses was 41%, while our previous report of this cohort (with a mean follow-up of 3.6 years) revealed a 39% prevalence. The ten-year revision-free survival with pseudotumour was 66.7% and without pseudotumour 92.4% (p < 0.05). There was poor discriminatory ability for cobalt for pseudotumour formation. Conclusion. This prospective study reports a minimum ten-year follow-up of large-head MoM THA. Revision rates are high, with the main reason being the sequelae of pseudotumour formation, which were rarely observed after five years of implantation. Blood ion measurements show limited discriminatory capacity in diagnosing pseudotumour formation. Our results evidence that an early comprehensive follow-up strategy is essential for MoM THA to promptly identify and manage early complications and revise on time. After ten years follow-up, we do not recommend continuing routine CT scanning or whole cobalt blood measurements, but instead enrolling these patients in routine follow-up protocols for THA. Cite this article: Bone Jt Open 2022;3(1):61–67


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_15 | Pages 44 - 44
7 Nov 2023
Crawford H Recordon J Stott S Halanski M Mcnair P Boocock M
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In 2010, we published results of Ponseti versus primary posteromedial release (PMR) for congenital talipes equinovarus (CTEV) in 51 prospective patients. This study reports outcomes at a median of 15 years from original treatment. We followed 51 patients at a median of 15 years (range 13–17 years) following treatment of CTEV with either Ponseti method (25 patients; 38 feet) or PMR (26 patients; 42 feet). Thirty-eight patientsd were contacted and 33 participated in clinical review (65%), comprising patient reported outcomes, clinical examination, 3-D gait analysis and plantar pressures. Sixteen of 38 Ponseti treated feet (42%) and 20 of 42 PMR treated feet (48%) had undergone further surgery. The PMR treated feet were more likely to have osteotomies and intra- articular surgeries (16 vs 5 feet, p<0.05). Of the 33 patients reviewed with multimodal assessment, the Ponseti group demonstrated better scores on the Dimeglio (5.8 vs 7.0, p<0.05), the Disease Specific Instrument (80 vs 65.6, p<0.05), the Functional Disability Inventory (1.1 vs 5.0, p<0.05) and the AAOS Foot & Ankle Questionnaire (52.2 vs. 46.6, p < 0.05), as well as improved total sagittal ankle range of motion in gait, ankle plantarflexion range at toe off and calf power generation. The primary PMR group displayed higher lateral midfoot and forefoot pressures. Whilst numbers of repeat surgical interventions following Ponseti treatment and primary PMR were similar, the PMR treated feet had greater numbers of osteotomies and intra-articular surgeries. Outcomes were improved at a median of 15 years for functional data for the Ponseti method versus PMR, with advantages seen in the Ponseti group over several domains. This study provides the most comprehensive evaluation of outcomes close to skeletal maturity in prospective cohorts, reinforcing the Ponseti Method as the initial treatment of choice for idiopathic clubfeet


Bone & Joint Open
Vol. 4, Issue 10 | Pages 808 - 816
24 Oct 2023
Scott CEH Snowden GT Cawley W Bell KR MacDonald DJ Macpherson GJ Yapp LZ Clement ND

Aims. This prospective study reports longitudinal, within-patient, patient-reported outcome measures (PROMs) over a 15-year period following cemented single radius total knee arthroplasty (TKA). Secondary aims included reporting PROMs trajectory, 15-year implant survival, and patient attrition from follow-up. Methods. From 2006 to 2007, 462 consecutive cemented cruciate-retaining Triathlon TKAs were implanted in 426 patients (mean age 69 years (21 to 89); 290 (62.7%) female). PROMs (12-item Short Form Survey (SF-12), Oxford Knee Score (OKS), and satisfaction) were assessed preoperatively and at one, five, ten, and 15 years. Kaplan-Meier survival and univariate analysis were performed. Results. At 15 years, 28 patients were lost to follow-up (6.1%) and 221 patients (51.9%) had died, with the mean age of the remaining cohort reducing by four years. PROMs response rates among surviving patients were: one-year 63%; five-year 72%; ten-year 94%; and 15-year 59%. OKS and SF-12 scores changed significantly over 15 years (p < 0.001). The mean improvement in OKS was 18.8 (95% confidence (CI) 16.7 to 19.0) at one year. OKS peaked at five years (median 43 years) declining thereafter (p < 0.001), though at 15 years it remained 17.5 better than preoperatively. Age and sex did not alter this trajectory. A quarter of patients experienced a clinically significant decline (≥ 7) in OKS from five to ten years and from ten to 15 years. The SF-12 physical component score displayed a similar trajectory, peaking at one year (p < 0.001). Patient satisfaction was 88% at one, five, and ten years, and 94% at 15 years. In all, 15-year Kaplan-Meier survival was 97.6% (95% CI 96.0% to 99.2%) for any revision, and 98.9% (95% CI 97.9% to 99.9%) for aseptic revision. Conclusion. Improvements in PROMs were significant and maintained following single radius TKA, with OKS peaking at five years, and generic physical health peaking at one year. Patient satisfaction remained high at 15 years, at which point 2.4% had been revised. Cite this article: Bone Jt Open 2023;4(10):808–816


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 35 - 35
1 Dec 2022
Verhaegen J Innmann MM Batista NA Merle C Grammatopoulos G
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Adverse spinopelvic characteristics (ASC) have been associated with increased dislocation risk following primary total hip arthroplasty (THA). A stiff lumbar spine, a large posterior standing tilt when standing and severe sagittal spinal deformity have been identified as key risk factors for instability. It has been reported that the rate of dislocation in patients with such ASC may be increased and some authors have recommended the use of dual mobility bearings or robotics to reduce instability to within acceptable rates (<2%). The aims of the prospective study were to 1: Describe the true incidence of ASC in patients presenting for a THA 2. Assess whether such characteristics are associated with greater symptoms pre-THA due to the concomitant dual pathology of hip and spine and 3. Describe the early term dislocation rate with the use of ≤36mm bearings. This is an IRB-approved, two-center, multi-surgeon, prospective, consecutive, cohort study of 220 patients undergoing THA through anterolateral- (n=103; 46.8%), direct anterior- (n=104; 27.3%) or posterior- approaches (n=13; 5.9%). The mean age was 63.8±12.0 years (range: 27.7-89.0 years) and the mean BMI 28.0±5.0 kg/m. 2. (range: 19.4-44.4 kg/m. 2. ). There were 44 males (47.8%) and 48 females (52.2%). The mean follow-up was 1.6±0.5 years. Overall, 54% of femoral heads was 32 mm, and 46% was 36mm. All participants underwent lateral spinopelvic radiographs in the standing and deep-flexed seated positions were taken to determine lumbar lordosis (LL), sacral slope (SS), pelvic tilt (PT), pelvic-femoral angle (PFA) and pelvic incidence (PI) in both positions. Spinal stiffness was defined as lumbar flexion <20° when transitioning between the standing and deep-seated position; adverse standing PT was defined as >19° and adverse sagittal lumbar balance was defined as mismatch between standing PI and LL >10°. Pre-operative patient reported outcomes was measured using the Oxford Hip Score (OHS) and EuroQol Five-Dimension questionnaire (EQ-5D). Dislocation rates were prospectively recorded. Non-parametric tests were used, significance was set at p<0.05. The prevalence of PI-LL mismatch was 22.1% (43/195) and 30.4% had increased standing PT (59/194). The prevalence of lumbar stiffness was 3.5% (5/142) and these patients had all three adverse spinopelvic characteristics (5/142; 3.5%). There was no significant difference in the pre-operative OHS between patients with (20.7±7.6) and patients without adverse spinopelvic characteristics (21.6±8.7; p=0.721), nor was there for pre-operative EQ5D (0.651±0.081 vs. 0.563±0.190; p=0.295). Two patients sustained a dislocation (0.9%): One in the lateral (no ASC) and one in the posterior approaches, who also exhibited ASC pre-operatively. Sagittal lumbar imbalance, increased standing spinal tilt and spinal stiffness are not uncommon among patients undergoing THA. The presence of such characteristics is not associated with inferior pre-operative PROMs. However, when all characteristics are present, the risk of instability is increased. Patients with ASC treated with posterior approach THA may benefit from the use of advanced technology due to a high risk of dislocation. The use of such technology with the anterior or lateral approach to improve instability is to date unjustified as the rate of instability is low even amongst patients with ASCs


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 92 - 92
1 Dec 2022
Thibault J Grammatopoulos G Horton I Harris N Dodd-Moher M Papp S
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In patients admitted to hospital with a hip fracture, urinary issues are common. Despite guidelines that recommend avoiding foley catheter usage when possible, it remains a common part of perioperative care. To date, there is no prospective data on the safety and satisfaction associated with catheter use in such cohort. The aim of this study was to evaluate the satisfaction of patients when using a foley catheter while they await surgery for their fractured hip and the safety associated with catheter use. In our prospectively collected database, 587 patients were admitted to our tertiary care center over a 1 year period. Most patients (328) were catheterized within the first 24h of admission, primarily inserted in ED. Of these patients, 119 patients (61 catheterized and 58 noncatheterized) completed a questionnaire about their perioperative management with foley catheter usage administered on day 1 of admission. This was used to determine satisfaction of catheter use (if catheterized) and pain levels (associated with catheterized or associated with transferring/voiding if not catheterized). Adverse effects related with catheter use included urinary tract infection (UTI) and post-operative urinary retention (POUR). Ninety-five percent of patients found the catheter to be convenient. Only 5% of patients reported any pain with catheter use. On the contrary, 47.5% of non-catheterized patients found it difficult to move to the bathroom and 30.4% found it difficult to urinate. Catheterized patients had significative less pain than uncatheterized patients (0.62/10 vs 2.45/10 respectively, p < 0 .001). The use of nerve block reduced pain levels amongst catheterized patients but was not associated with reduced pain levels or satisfaction amongst non-catheterized patients. The use of catheter was not associated with increased risk of UTI(17.5% in the catheterized vs 13.3% in the non-catheterized, p = 0.541) or POUR (6.8% in the catheterized vs 11.1% in the non-catheterized, p = 0.406). This study illustrates the benefits and safety associated with the use of urinary catheters in the pre-operative period amongst hip fractures. The use of catheters was associated with reduced pain and satisfaction without increasing post-operative UTI or POUR. These findings suggest that pre-operative catheter use is associated with less pain and more satisfaction for patients awaiting hip surgery and whom other measures, such as nerve blocks, are unlikely to reduce the discomfort associated with the mobility required to void. A prospective randomized control study could lead to a more evidence based approach for perioperative foley catheter usage in hip fracture patients


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_13 | Pages 8 - 8
1 Dec 2022
Okamoto T Glaris Z Goetz T
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Pathologies such as Scapho-Lunate Advanced Collapse (SLAC), Scaphoid Non-union Advanced Collapse (SNAC) and Kienbock's disease can lead to arthritis in the wrist. Depending on the articular surfaces that are involved, motion preserving surgical procedures can be performed. Proximal Row Carpectomy (PRC) and Four Corner Fusion (4CF) are tried and tested surgical options. However, prospective studies comparing the two methods looking at sufficient sample sizes are limited in the literature. The purpose of this study was to prospectively compare the early results of PRC vs 4CF performed in a single centre. Patients with wrist arthritis were prospectively enrolled (2015 to 2021) in a single centre in Vancouver, Canada. Thirty-six patients and a total of 39 wrists underwent either a PRC (n=18) or 4CF (n=21) according to pre-operative clinical, radiographical, and intra-operative assessment. Patient-Rated Wrist Evaluation (PRWE) scores were obtained preoperatively, as well as at six months and one year post operatively. Secondary outcomes were range of motion (ROM) of the wrist, grip strength, reoperation and complication rates. Statistical significance was set at p=0.05. Respectively for PRC and 4CF, the average PRWE scores at baseline were 61.64 (SD=19.62) and 63.67 (SD=20.85). There was significant improvement at the six-month mark to 38.81 (SD=22.95) (p=0.031) and 41.33 (SD=26.61) (p=0.007), then further improvement at the 12month mark to 33.11 (SD=23.42) (p=0.007) and 36.29 (SD=27.25) (p=0.002). There was no statistical difference between the two groups at any time point. Regarding ROM, statistical difference was seen in pronation for the PRC group at the 6month mark from an average of 72.18 deg to 61.56 deg and in flexion at the 12 month mark from 47.89 deg to 33.50 deg. All other parameters did not show statistically significant difference post operatively. For ROM of the 4CF group, only flexion at the 12month mark showed statistically significant change from an average of 48.81 deg to 38.03 deg. There was no statistical difference in pre-operative ROM between the two groups. One patient in the 4CF group required a revision for delayed union, and three patients ended up with ulnar sided wrist pain. Patients undergoing PRC and 4CF showed significant improvement in post operative PRWE scores, this reflects existing literature. For 4CF care must be taken to minimise ulnar sided wrist pain by relatively shortening the unar sided carpal column mass. ROM analysis showed that patients lost some wrist flexion ROM post-operatively at the 12month mark with both PRC and 4CF. However, other ROM parameters were unchanged


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. 3, Issue 8 | Pages 656 - 665
23 Aug 2022
Tran T McEwen P Peng Y Trivett A Steele R Donnelly W Clark G

Aims. The mid-term results of kinematic alignment (KA) for total knee arthroplasty (TKA) using image derived instrumentation (IDI) have not been reported in detail, and questions remain regarding ligamentous stability and revisions. This paper aims to address the following: 1) what is the distribution of alignment of KA TKAs using IDI; 2) is a TKA alignment category associated with increased risk of failure or poor patient outcomes; 3) does extending limb alignment lead to changes in soft-tissue laxity; and 4) what is the five-year survivorship and outcomes of KA TKA using IDI?. Methods. A prospective, multicentre, trial enrolled 100 patients undergoing KA TKA using IDI, with follow-up to five years. Alignment measures were conducted pre- and postoperatively to assess constitutional alignment and final implant position. Patient-reported outcome measures (PROMs) of pain and function were also included. The Australian Orthopaedic Association National Joint Arthroplasty Registry was used to assess survivorship. Results. The postoperative HKA distribution varied from 9° varus to 11° valgus. All PROMs showed statistical improvements at one year (p < 0.001), with further improvements at five years for Knee Osteoarthritis Outcome Score symptoms (p = 0.041) and Forgotten Joint Score (p = 0.011). Correlation analysis showed no difference (p = 0.610) between the hip-knee-ankle and joint line congruence angle at one and five years. Sub-group analysis showed no difference in PROMs for patients placed within 3° of neutral compared to those placed > 3°. There were no revisions for tibial loosening; however, there were reports of a higher incidence of poor patella tracking and patellofemoral stiffness. Conclusion. PROMs were not impacted by postoperative alignment category. Ligamentous stability was maintained at five years with joint line obliquity. There were no revisions for tibial loosening despite a significant portion of tibiae placed in varus; however, KA executed with IDI resulted in a higher than anticipated rate of patella complications. Cite this article: Bone Jt Open 2022;3(8):656–665


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_16 | Pages 41 - 41
19 Aug 2024
Cobb J Maslivec A Clarke S Halewood C Wozencroft R
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A ceramic-on-ceramic hip resurfacing implant (cHRA) was developed and introduced in an MHRA-approved clinical investigation to provide a non metallic alternative hip resurfacing product. This study aimed to examine function and physical activity levels of patients with a cHRA implant using subjective and objective measures both before and 12 months following surgery in comparison with age and gender matched healthy controls. Eighty-two unilateral cHRA patients consented to this study as part of a larger prospective, non-randomised, clinical investigation. In addition to their patient reported outcome measures (PROMs), self- reported measures of physical activity levels and gait analysis were undertaken both pre- operatively (1.5 weeks) and post operatively (52 weeks). This data was then compared to data from a group of 43 age gender and BMI matched group of healthy controls. Kinetics and kinematics were recorded using an instrumented treadmill and 3D Motion Capture. Statistical parametric mapping was used for analysis. cHRA improved the median Harris Hip Score from 63 to 100, Oxford Hip score from 27 to 48 and the MET from 5.7 to 10.3. cHRA improved top walking speed (5.75km vs 7.27km/hr), achieved a more symmetrical ground reaction force profile, (Symmetry Index value: 10.6% vs 0.9%) and increased hip range of motion (ROM) (31.7° vs 45.9°). Postoperative data was not statistically distinguishable from the healthy controls in any domain. This gait study sought to document the function of a novel ceramic hip resurfacing, using those features of gait commonly used to describe the shortcomings of hip arthroplasty. These features were captured before and 12 months following surgery. Preoperatively the gait patterns were typical for OA patients, while at 1 year postoperatively, this selected group of patients had gait patterns that were hard to distinguish from healthy controls despite an extended posterior approach. Applications for regulatory approval have been submitted


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_4 | Pages 8 - 8
3 Mar 2023
Agarwal R Mohanty K Gibby M
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Background. Prospective study to compare patient reported outcome measures (PROM) for sacroiliac joint (SIJ) fusion using HA-coated screw (HACS) vs triangular titanium dowel (TTD). First study of its kind in English literature. Methods. 40 patients underwent percutaneous SIJ stabilisation using HACS and TTD was used in 70 patients. Patients were followed up closely and outcome scores were collected prospectively. PROMs were collected preoperatively and 12 months after surgery. Short Form (SF)-36, Oswestry Disability Index, EuroQol-5D-5L and Majeed Pelvic Scores were collected. Shapiro-wilk test was used to determine normality of data. Mann-whitney U test was used to compared non-parametric data and Independent sample T test for parametric data. Results. 33 patients in HACS group and 61 in TTD group completed follow-up. There was no significant difference in all preoperative PROMs in both groups hence the data was considered comparable. All postoperative PROMs were significantly higher in the TTD group. In the HACS group, 21 patients (63%) had lysis around the screw and a sub-group analysis showed that improvement in PROMs was significantly less in patients with lysis around the screw. 4 patients with lysis around the screw were offered revision due to ongoing pain. Revision was successful in only 1 patient. In TTD group only 5 patients (8.2 %) patients had radiological evidence of lysis. Relative risk of developing lysis was 6.7 times higher in HACS group. Conclusion. Percutaneous SIJ fixation procedure has been shown to have good clinical outcomes and TTD leads to significantly better patient reported outcomes compared to HACS. There is a 6.7 time higher risk of lysis with use of HACS and lysis is a risk factor for poor outcomes


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_13 | Pages 41 - 41
7 Aug 2023
Al-Jabri T Bentley G McCulloch R Miles J Carrington R Shearman A Donaldson J Jayadev C
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Abstract. Background. Autologous chondrocyte implantation is a NICE approved intervention however it involves the morbidity of two operations, a prolonged rehabilitation and substantial healthcare costs. This study describes a novel, one-step, bone marrow (BM) derived mesenchymal stem cell (MSC) transplantation technique for treating knee osteochondral lesions and presents our prospective clinical study investigating the success of this technique in 206 lesions over a 5 year period. Methodology. The surgical technique involves harvesting BM from patients’ anterior superior iliac spines, centrifugation to isolate MSCs and seeding into a type 1 collagen scaffold (SyngenitTM Biomatrix). Autologous fibrin glue is used to secure the scaffold into the defect. Inclusion criteria included patients aged 15 – 55 years old with symptomatic osteochondral lesions >1cm2. Exclusion criteria included patients with ligament instability, uncorrected alignment, inflammatory arthropathy and a Body Mass Index >35 kg/m2. Outcome measures included the Modified Cincinnati Knee Rating System (MCKRS), complications and reoperations. Results. Mean MCKR scores showed statistically significant improvements compared to pre-operative scores at 6 months 58.79 ± 3.5 and 1 year postoperatively 63.82 ± 3.93 with further improvements at 2 years and 5 years which did not reach statistical significance. Survival rates were 97.9%, 94% and 93.2% at 1, 2 and 5 years. Multiple regression analysis identified previous cartilage surgery, microfracture and age as factors affecting MCKRS scores (p < 0.029, 0.001 and 0.030, respectively). Conclusions. One-step BM derived stem cell transplantation demonstrates satisfactory outcomes over a 5 year period


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_17 | Pages 5 - 5
11 Oct 2024
Rankin C Stephen L Phin C McCloskey K Syed T Drampalos E
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This prospective study explores the outcomes of the Forth Valley Protocol (FVP) for the management of acute Achilles tendon ruptures. The protocol uses ultrasound as the primary mechanism to guide treatment. All patients presenting with acute tendoachilles rupture over a three-year period were included. Patients under 18 years of age, chronic ruptures, or prior surgery to the Achilles tendon were excluded. Patients with a gap ≤2cm had conservative management following an Early Rehabilitation Protocol (ERP) and >2cm underwent surgery (if an appropriate surgical candidate). Achilles Tendon Rupture Scores (ATRS) were obtained retrospectively. Fischer's exact test was used to determine statistical significance. 158 patients were included with a mean age of 53 (range 20–89). Ultrasound scans were obtained for 121 patients (76.5%), demonstrating a mean tendon gap of 1.61cm. 143 patients managed conservatively and 15 surgically. The overall re-rupture rate was 3.8% (n=6). All the re-ruptures occurred in patients treated conservatively, but this was not found to be statistically significant (n=6, P=1.0). The overall complication rate (excluding re-ruptures) was 1.9%. ATRS was comparable between both treatment modalities (P=0.382, 0.422), with a mean score of 86.6 in the conservative group and 81.4 in the surgical group. The FVP demonstrates low re-rupture and complication rates in line with other published studies. Patients with gaps ≤2.0cm on the ultrasound can be successfully treated conservatively with an ERP. This has potential benefits in terms improved patient outcomes, satisfaction, and preservation of resources


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_13 | Pages 89 - 89
7 Aug 2023
Ahmed I Dhaif F Bowes M Parsons N Hutchinson C Staniszewska S Price A Metcalfe A
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Abstract. Introduction. Previous research has demonstrated no clinically significant benefit of arthroscopic meniscectomy in patients with a meniscal tear, however, patients included in these studies would not meet current treatment recommendations. Prior to further randomised controlled trials (RCTs) research is needed to understand a younger population in more detail. Aim. To describe the baseline characteristics of patients with a meniscal tear and explore any association between baseline characteristics and outcome. Methodology. A prospective, national multicentre cohort study was performed recruiting patients aged 18 to 55 presenting to secondary care. MRI analysis of arthritis was performed using Whole Organ Magnetic Resonance Imaging Score (WORMS) and bone shape analysis. Outcomes included the Western Ontario Meniscal Evaluation Tool (WOMET) and Knee Injury and Osteoarthritis Outcome Score (KOOS4) at 12 months. Results. 150 participants were recruited across eight sites with a mean age of 43.47 (SD 9.63). MRI analysis using WORMS score and bone shape analysis revealed no or early osteoarthritis. At 12 months, 67 (44.67%) of participants were managed non-operatively and 68 (45.33%) were operatively. Participants in the operative group were significantly younger with a lower BMI (p<0.05). A stepwise logistic regression model including 17 characteristics revealed that only baseline score and surgery significantly affected 12-month WOMET and KOOS4. Conclusion. This study in contrast to previous trials demonstrated a benefit of surgery for patients with a meniscal tear. The METRO study demonstrates that it is feasible to recruit younger patients and a future RCT is required using the study population included in this cohort


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_13 | Pages 54 - 54
7 Aug 2023
Kraus M Bingham J Kekic A Erickson C Grilli C Seamans D Upjohn D Hentz J Clarke H Spangehl M
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Abstract. Introduction. Adverse reactions to pain medication and pain can delay discharge after outpatient knee arthroplasty (TKA). Pharmacogenomics is an emerging tool that might help reduce adverse events by tailoring medication use based on known genetic variations in the CYP genes determining drug metabolism. This study was undertaken to evaluate whether pre-operative pharmacogenomic testing could optimize peri-operative pain management in patients undergoing total knee arthroplasty (TKA). Methods. This prospective, randomized study was performed in adults undergoing primary TKA. Patients in the experimental group underwent pre-operative pharmacogenomic evaluation and medication adjustments. Medications were not optimized for control patients. The Overall Benefit of Analgesic Score (OBAS) at 24 hours post-op was the primary outcome. Postoperative pain scores (VAS scale), total opioid use, time in recovery, and time to discharge were also compared. Results. 76 patients enrolled. 93% of patients had a poor-intermediate phenotype for at least one of four CYP genes. OBAS did not differ significantly between the two groups (4.2 control vs. 4.7 experimental; 95% CI −1.1 to 2.1) and was below the minimum clinically important difference of 2.0 points. Furthermore, there were no differences in any OBAS subscale including pain, satisfaction, or nausea. There were no differences in time in the recovery area or to discharge from hospital, or narcotic use. Conclusions. Despite many patients having a poor-intermediate phenotype for a CYP gene, pharmacogenomic testing prior to TKA and medication adjustment did not improve anesthesia or pain management outcomes, time to discharge or mean total opioid use after surgery