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Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 16 - 16
1 Nov 2021
Frydendal T Christensen R Mechlenburg I Mikkelsen LR Overgaard S Ingwersen KG
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Introduction and Objective. Hip osteoarthritis (OA) is the leading cause for total hip arthroplasty (THA). Although, being considered as the surgery of the century up to 23% of the patients report long-term pain and deficits in physical function and muscle strength may persist after THA. Progressive resistance training (PRT) appear to improve several outcomes moderately in patients with hip OA. Current treatment selection is based on low-level evidence as no randomised controlled trials have compared THA to non-surgical treatment. The primary objective of this trial is to determine the effectiveness of THA followed by standard care compared to 12 weeks of supervised PRT followed by 12 weeks of optional unsupervised PRT, on changes in hip pain and function, in patients with severe hip OA after 6 months. Materials and Methods. This is a protocol for a multicentre, parallel-group, assessor blinded, randomised controlled superiority trial. Patients aged ≥50 years with clinical and radiographic hip OA found eligible for THA by an orthopaedic surgeon will be randomised to THA or PRT (allocation 1:1). The primary outcome will be change in patient-reported hip pain and function, measured using the Oxford Hip Score. Key secondary outcomes will be change in the Hip disability and Osteoarthritis Outcome Score subscales, University of California Los Angeles Activity Score, 40-meter fast-paced walk test, 30-second chair stand test, and number of serious adverse events. Results. The trial has been approved by The Regional Committees on Health Research Ethics for Southern Denmark (Project-ID: S-20180158) in February 2019 and registration was performed at . ClinicalTrials.gov. (NCT04070027) in August 2019. Recruitment was initiated on the 2. nd. of September 2019 and the final deadline will be on the 30. th. of June 2021, or when a sample size of 120 patients has been accomplished. Conclusions. The results of the current trial are expected to enable evidence-based recommendations, which may be used to facilitate the shared-decision making process in the discussion of treatment strategy for the individual patient with severe hip OA. All results will be presented in peer-reviewed scientific journals and international conferences


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_18 | Pages 75 - 75
14 Nov 2024
Khalid T Shlomo YB Bertram W Culliford L enderson E Jepson M Johnson E Palmer S Whitehouse M Wylde V
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Introduction. Approximately 20-25% of patients having joint replacement in the UK have moderate-severe frailty. Frailty is associated with poorer outcomes after joint replacement. Targeting frailty pre-operatively with exercise and protein supplementation could improve post-operative outcomes. Prior to conducting a randomised controlled trial (RCT), a feasibility study was necessary to inform trial design and delivery. Method. We conducted a randomised feasibility study with embedded qualitative work. Patients aged ≥65 years, frail and undergoing THR or TKR were recruited from three UK hospitals. Participants were randomly allocated on a 1:1 ratio to the intervention or usual care group. The intervention group had a 1:1 appointment with a physiotherapist and were provided with a home-based, tailored daily exercise programme and a daily protein supplement for 12 weeks before their operation, supported by six telephone calls from a physiotherapist. Questionnaires were administered at baseline and 12 weeks after randomisation. Interviews were conducted with 19 patients. Feasibility outcomes were eligibility and recruitment rates, intervention adherence, and acceptability of the trial and the intervention. Result. 411 patients were sent a screening pack. Of the 168 patients who returned a screening questionnaire, 79 were eligible and consented to participate, and 64 were randomised. Of the 33 participants randomised to the intervention, 26 attended the intervention appointment. Eighteen participants (69%) received all six intervention follow-up telephone calls. Nineteen participants completed an intervention adherence log; 13 (68%) adhered to the exercise programme and 11 (58%) adhered to the protein supplementation. The overall retention rate was 86% at 12 weeks. The 12-week follow-up questionnaire was returned by 84% of participants who were sent a questionnaire. Interviews found that the trial and intervention were generally acceptable, but areas of potential improvements were identified. Conclusion. This study demonstrated that a larger study is possible and has identified improvements to optimise the design of a RCT


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_18 | Pages 45 - 45
14 Nov 2024
Kjeldsen T Thorgaard Skou S Dalgas U Tønning L Birch S Frydendal T Varnum C Garval M G Ingwersen K Mechlenburg I
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Introduction. Exercise is recommended as first-line treatment for patients with hip osteoarthritis (OA). Interestingly, content and dose of exercise interventions seem to be important for the effect of exercise interventions, but the optimal content and dose is unknown. This warrants randomized controlled trials providing evidence for the optimal exercise program in Hip OA. The aim of this trial was to investigate whether progressive resistance training (PRT) is superior to neuromuscular exercise (NEMEX) for improving functional performance, hip pain and hip-related quality of life in patients with hip OA. Method. This was a multicenter, cluster-randomized, controlled, parallel-group, assessor-blinded, superiority trial. 160 participants with clinically diagnosed hip OA were recruited from hospitals and physiotherapy clinics and randomly assigned to twelve weeks of PRT or NEMEX. The PRT intervention consisted of 5 high-intensity resistance training exercises targeting muscles at the hip and knee joints. The NEMEX intervention included 10 exercises and emphasized sensorimotor control and functional stability. The primary outcome was change in the 30-second chair stand test (30s-CST). Key secondary outcomes were changes in scores on the pain and hip-related quality of life (QoL) subscales of the Hip Disability and Osteoarthritis Outcome Score (HOOS). Result. The mean changes from baseline to 12-week follow-up in the 30s-CST were 1.5 (95% CI, 0.9 to 2.1) chair stands with PRT and 1.5 (CI, 0.9 to 2.1) chair stands with NEMEX (difference, 0.0 [CI, 0.8 to 0.8] chair stands). For the HOOS pain subscale, mean changes were 8.6 (CI, 5.3 to 11.8) points with PRT and 9.3 (CI, 5.9 to 12.6) points with NEMEX. For the HOOS QoL subscale, mean changes were 8.0 (CI, 4.3 to 11.7) points with PRT and 5.7 (CI, 1.9 to 9.5) points with NEMEX. Conclusion. In patients with hip OA, PRT is not superior to NEMEX for improving functional performance, hip pain, or hip-related QoL


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_7 | Pages 94 - 94
4 Apr 2023
Çil E Subaşı F Şaylı U
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Plantar fasciitis (PF) is one of the widespread conditions causing hindfoot pain. The most common presenting symptoms are functional limitation and pain (first step and activity) on plantar surface of the foot. The non-operative treatments provide complete resolution of pain in 90% of patients, but functional limitation still remains as a risk factor for recurrency of PF. Although the number of non-operative treatment options showing efficacy on pain and functional limitation are excessive, the evidences are limited for functional limitation. Additionally, Mulligan mobilization with movement (MMWM) in Chronic Plantar Fasciitis has been poorly studied in the literature. According to these findings, the study was aimed to determine effectiveness of Mulligan mobilization with movement on Chronic Plantar Fasciitis. A total of 25 patients (40 feet) with chronic PF were included in the study. The patients were randomly divided into Mulligan concept rehabilitation group (PF-M, n=20 feet) and Home Rehabilitation group (PF-H, n=20 feet). (MMWM), Foot and ankle exercises program were applied to PF-M, twice a week totally 8 week (16 sessions) and foot- ankle exercises as a home program were given for PF-H, 8 weeks. The range of motion (ROM) for dorsiflexion and plantar flexion was measured by using a manual goniometer. Pain, disability and activity restriction were assessed by Foot Function Index (FFI) . The first step morning pain was evaluated by Visual Analogue Scale (VAS) and Kinesiophobia was also reported by using Tampa Scale (TSK). Patients were evaluated at baseline and 8 weeks. FFI, VAS, TSK, ROM values improved in all groups (intragroup variability) at 8th week (P < .05). The other result indicated that ROM values for DF and PF and TSK scores in PF-M had more significant improvement than PF-H (p<.05). To the best of our knowledge this is the first randomised controlled trial for investigating Mulligan Concept efficiancy on chronic PF. Both Mulligan mobilization with movement (MMWM) and exercise protocols are effective for chronic PF. Furthermore, The Mulligan concept seems more effective treatment option in reducing kinesiophobia and improving functional capacity


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_8 | Pages 83 - 83
11 Apr 2023
Khojaly R Rowan F Nagle M Shahab M Shah V Dollard M Ahmed A Taylor C Cleary M Niocaill R
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Is Non-Weight-Bearing Necessary? (INWN) is a pragmatic multicentre randomised controlled trial comparing immediate protected weight-bearing (IWB) with non-weight-bearing cast immobilisation (NWB) following ankle fracture fixation (ORIF). This trial compares; functional outcomes, complication rates and performs an economic analysis to estimate cost-utility. IWB within 24hrs was compared to NWB, following ORIF of all types of unstable ankle fractures. Skeletally immature patients and tibial plafond fractures were excluded. Functional outcomes were assessed by the Olerud-Molander Ankle Score (OMAS) and RAND-36 Item Short Form Survey (SF-36) taken at regular follow-up intervals up to one year. A cost-utility analysis via decision tree modelling was performed to derive an incremental cost effectiveness ratio (ICER). A standard gamble health state valuation model utilising SF-36 scores was used to calculate Quality Adjusted Life Years (QALYs) for each arm. We recruited 160 patients (80 per arm), aged 15 to 94 years (M = 45.5), 54% female. Complication rates were similar in both groups. IWB demonstrated a consistently higher OMAS score, with significant values at 6 weeks (MD=10.4, p=0.005) and 3 months (MD 12.0, p=0.003). Standard gamble utility values demonstrated consistently higher values (a score of 1 equals perfect health) with IWB, significant at 3 months (Ẋ = 0.75 [IWB] / 0.69 [NWB], p=0.018). Cost-utility analysis demonstrated NWB is €798.02 more expensive and results in 0.04 fewer QALYs over 1 year. This results in an ICER of −€21,682.42/QALY. This negative ICER indicates cost savings of €21,682.42 for every QALY (25 patients = 1 QALY gain) gained implementing an IWB regime. IWB demonstrates a superior functional outcome, greater cost savings and similar complication rates, compared to NWB following ankle fracture fixation


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_9 | Pages 4 - 4
17 Apr 2023
Frederik P Ostwald C Hailer N Giddins G Vedung T Muder D
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Metacarpal fractures represent up to 33% of all hand fractures; of which the majority can be treated non-operatively. Previous research has shown excellent putcomes with non-operative treatment yet surgical stabilisation is recommended to avoid malrotation and symptomatic shortening. It is unknown whether operative is superior to non-operative treatment in oblique or spiral metacarpal shaft fractures. The aim of the study was to compare non-operative treatment of mobilisation with open surgical stabilisation. 42 adults (≥ 18 years) with a single displaced oblique or spiral metacarpal shaft fractures were randomly assigned in a 1:1 pattern to either non-operative treatment with free mobilisation or operative treatment with open reduction and fixation with lag screws in a prospective study. The primary outcome measure was grip-strength in the injured hand in comparison to the uninjured hand at 1-year follow-up. The Disabilities of the Arm, Shoulder and Hand Score, ranges of motion, metacarpal shortening, complications, time off work, patient satisfaction and costs were secondary outcomes. All 42 patients attended final follow-up after 1 year. The mean grip strength in the non-operative group was 104% (range 73–250%) of the contralateral hand and 96% (range 58–121%) in the operatively treated patients. Mean metacarpal shortening was 5.0 (range 0–9) mm in the non-operative group and 0.6 (range 0–7) mm in the operative group. There were five minor complications and three revision operations, all in the operative group. The costs for non-operative treatment were estimated at 1,347 USD compared to 3,834USD for operative treatment; sick leave was significantly longer in the operative group (35 days, range 0–147) than in the non-operative group (12 days, range 0–62) (p=0.008). When treated with immediate free mobilization single, patients with displaced spiral or oblique metacarpal shaft fractures have outcomes that are comparable to those after operative treatment, despite some metacarpal shortening. Complication rates, costs and sick leave are higher with operative treatment. Early mobilisation of spiral or long oblique single metacarpal fractures is the preferred treatment. Trial registration number: ClinicalTrials.gov NCT03067454


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 8 - 8
1 Nov 2021
Khojaly R Rowan FE Nagle M Shahab M Ahmed AS Dollard M Taylor C Cleary M Niocaill RM
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Introduction and Objective. Ankle fractures are common and affect young adults as well as the elderly. An unstable ankle fracture treatment typically involves surgical fixation, immobilisation, and modified weight-bearing for six weeks. Non-weight bearing (NWB) cast immobilisation periods were used to protect the soft tissue envelope and osteosynthesis. This can have implications on patient function and may reduce independence, mobility and return to work. Newer trends in earlier mobilisation compete with traditional NWB doctrine, and weak consensus exists as to the best postoperative strategy. The purpose of this trial is to investigate the safety and efficacy of immediate weight-bearing (IWB) and range of motion (ROM) exercise regimes following ORIF of unstable ankle fractures with a particular focus on functional outcomes and complication rates. Materials and Methods. A pragmatic randomised controlled multicentre trial, comparing IWB in a walking boot and ROM within 24 hours versus non-weight-bearing (NWB) and immobilisation in a cast for six weeks, following ORIF of all types of unstable adult ankle fractures (lateral malleolar, bimalleolar, trimalleolar with or without syndesmotic injury). The exclusion criteria are skeletal immaturity and tibial plafond fractures. The primary outcome measure is the functional Olerud-Molander Ankle Score (OMAS). Secondary outcomes include wound infection (deep and superficial), displacement of osteosynthesis, the full arc of ankle motion (plantar flexion and dorsal flection), RAND-36 Item Short Form Survey (SF-36) scoring, time to return to work and postoperative hospital length of stay. Results. We recruited 160 patients with an unstable ankle fracture. Participants’ ages ranged from 15 to 94 years (M = 45.5, SD = 17.2), with 54% identified as female. The mean time from injury to surgical fixation was 1.3 days (0 to 17 days). Patients in the immediate weight-bearing group had a 9.5-point higher mean OMAS at six weeks postoperatively (95% CI 1.48, 17.52) P = 0.021. The complications rate was similar in both groups. The rate of surgical site infection was 4.3%. One patient had DVT, and another patient had a pulmonary embolism; both were randomised to NWB. Length of hospital stay (LOS) was 1 ± 1.5 (0, 12) for the IWB group vs 1.5 ± 2.5 (0, 19) for the NWB group. Conclusions. There is a paucity of quality evidence supporting the postoperative management regimes used most commonly in clinical practice. To our knowledge, immediate weight-bearing (IWB) following ORIF of all types of unstable ankle fractures has not been investigated in a controlled prospective manner in recent decades. In this large multicentre, randomised controlled trial, we investigated immediate weight-bearing following ORIF of all ankle fracture patterns in the usual care condition using standard fixation methods. Our result suggests that IWB following ankle fracture fixation is safe and resulted in a better functional outcome. Once anatomical reduction and stable internal fixation is achieved, we recommend IWB in all types of ankle fractures in a compliant patient


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_16 | Pages 8 - 8
1 Dec 2021
Khojaly R Rowan F Nagle M Shahab M Ahmed AS Taylor C Cleary M Mac Niocaill R
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Abstract. Objectives. The purpose of this trial is to investigate the safety and efficacy of immediate weight-bearing (IWB) and range of motion exercise regimes following ORIF of unstable ankle fractures with a particular focus on functional outcomes and complication rates. Methods. A pragmatic randomised controlled multicentre trial, comparing IWB in a walking boot and ROM within 24 hours versus NWB and immobilisation in a cast for six weeks, following ORIF of all types of unstable adult ankle fractures. The exclusion criteria are skeletal immaturity and tibial plafond fractures. The primary outcome measure is the functional Olerud-Molander Ankle Score (OMAS). Secondary outcomes include wound infection, displacement of osteosynthesis, the full arc of ankle motion, RAND-36 Item Short Form Survey (SF-36) scoring, time to return to work and postoperative hospital length of stay. Results. We recruited 160 patients with an unstable ankle fracture. Participants’ ages ranged from 15 to 94 years (M = 45.5, SD = 17.2), with 54% identified as female. The mean time from injury to surgical fixation was 1.3 days (0 to 17 days). Patients in the IWB group had a 9.5-point higher mean OMAS at six weeks postoperatively (95% CI 1.48, 17.52) P = 0.021 with a similar result at three months. The complications rate was similar in both groups. The rate of surgical site infection was 4.3%. One patient had DVT, and another patient had a PE, both were randomised to NWB. Length of hospital stay was 1 ± 1.5 (0, 12) for the IWB group vs 1.5 ± 2.5 (0, 19) for the NWB group. Conclusion. In this large multicentre RCT, we investigated WB following ORIF of all ankle fracture patterns in the usual care condition using standard fixation methods. Our result suggests that IWB following ankle fracture fixation is safe and resulted in a better functional outcome


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_18 | Pages 129 - 129
14 Nov 2024
Larsen JB Skou ST Laursen M Bruun NH Bandholm T Arendt-Nielsen L Madeleine P
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Introduction. There is a lack of evidence-based treatments for patients with chronic pain after total knee arthroplasty (TKA). It is well-established that knee extensor and flexor muscle strength are markedly impaired following TKA, but no studies have examined muscle strength and power in patients with chronic pain after TKA. Therefore, the aim was to investigate if neuromuscular exercises and pain neuroscience education (PNE) were superior to PNE alone for improvement of muscle strength and power in patients with chronic pain after TKA. Method. This report presents the exploratory analysis of a randomized controlled trial (NCT03886259). Participants with chronic moderate-to-severe average daily pain intensity and no signs of prosthesis failure at least one year after primary TKA were included. Participants were randomized to receive either supervised neuromuscular exercise and PNE or the same PNE sessions alone. The outcomes were changes from baseline to 12-months for peak leg extension power and maximum muscle strength, measured during maximal voluntary isometric contractions, for the knee extensors and flexors. Result. Sixty-nine participants (age 62.2±7.2, 40 females) were included. No between-group differences were observed for peak leg extension power (difference 13.6 Watts, 95% CI -22.2 to 49.3), maximum knee extensor muscle strength (difference -20.9 Newtons, 95% CI -65.8 to 24.0) or maximum knee flexor muscle strength (difference 8.6 Newtons, 95% CI -11.9 to 29.1). Peak leg extension power (26.3 Watts, 95% CI 4.3 to 48.3) and maximum knee flexor muscle strength (19.7 Newtons, 95% CI 7.6 to 31.9) improved significantly in the neuromuscular exercise and PNE group with no significant improvements observed in the PNE alone group. Conclusion. Neuromuscular exercise and PNE did not improve muscle strength and power compared to PNE alone in patients with chronic pain after TKA. Acknowledgements. This study was funded by the Danish Rheumatism Association, the Svend Andersen Foundation and Lions Club Denmark


Bone & Joint Research
Vol. 6, Issue 10 | Pages 590 - 599
1 Oct 2017
Jefferson L Brealey S Handoll H Keding A Kottam L Sbizzera I Rangan A

Objectives. To explore whether orthopaedic surgeons have adopted the Proximal Fracture of the Humerus: Evaluation by Randomisation (PROFHER) trial results routinely into clinical practice. Methods. A questionnaire was piloted with six orthopaedic surgeons using a ‘think aloud’ process. The final questionnaire contained 29 items and was distributed online to surgeon members of the British Orthopaedic Association and British Elbow and Shoulder Society. Descriptive statistics summarised the sample characteristics and fracture treatment of respondents overall, and grouped them by whether they changed practice based on PROFHER trial findings. Free-text responses were analysed qualitatively for emerging themes using Framework Analysis principles. Results. There were complete responses from 265 orthopaedic and trauma surgeons who treat patients with proximal humeral fractures. Around half (137) had changed practice to various extents because of PROFHER, by operating on fewer PROFHER-eligible fractures. A third (43) of the 128 respondents who had not changed practice were already managing patients non-operatively. Those who changed practice were more likely to be younger, work in a trauma unit rather than a major trauma centre, be specialist shoulder surgeons and treat fewer PROFHER-eligible fractures surgically. This group gave higher scores when assessing validity and applicability of PROFHER. In contrast, a quarter of the non-changers were critical, sometimes emphatically, of PROFHER. The strongest theme that emerged overall was the endorsement of evidence-based practice. Conclusion. PROFHER has had an impact on surgeons’ clinical practice, both through changing it, and through underpinning existing non-operative practice. Although some respondents expressed reservations about the trial, evidence from such trials was found to be the most important influence on surgeons’ decisions to change practice. Cite this article: L. Jefferson, S. Brealey, H. Handoll, A. Keding, L. Kottam, I. Sbizzera, A. Rangan. Impact of the PROFHER trial findings on surgeons’ clinical practice: An online questionnaire survey. Bone Joint Res 2017;6:590–599. DOI: 10.1302/2046-3758.610.BJR-2017-0170


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_2 | Pages 90 - 90
1 Mar 2021
Mahatma M Jayasuriya R Gossiel F Gallagher O Hughes D Buckley S Gordon A Hamer A Tomouk M Wilkinson JM
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Abstract. Objective. In this phase 2 clinical trial (EudraCT 2011-000541-20) we examined the effect of denosumab versus placebo on osteolytic lesion activity in patients undergoing revision surgery after THA. Methods. Men and women ≥ 30 years old scheduled for revision surgery for symptomatic, radiologically-confirmed osteolysis were randomised (1:1) to receive either denosumab 60mg or placebo subcutaneously eight weeks prior to operation. At surgery, biopsies from the osteolytic membrane-bone interface were taken for histomorphometric analysis of osteoclast number, the primary outcome measure. Secondary outcome measures included other static histomorphometric indices and systemic bone turnover markers. Adverse events and patient-reported clinical outcome scores were recorded as safety endpoints. Results. Of the 24 subjects enrolled, 22 completed the study (10 denosumab) and comprise the per-protocol analysis. There were no differences in baseline characteristics and bone turnover markers between groups (p>0.05). The denosumab group had 78% fewer osteoclasts at osteolytic lesion sites (95% CI −61 to −95, P=0.011), 81% lower osteoclast surface (−70 to −95, P=0.009), and 73% lower eroded surface (−54 to −92, P=0.020) compared to the placebo group. Number of osteoblasts and osteoblast surface were also reduced by 81% (−62 to −100, p=0.021) and 82% (−64 to −101, p=0.017), respectively. Immunocytochemistry for cell proliferation (Ki67) and apoptosis (Caspase 3) identified no differences between the groups (p>0.05). At surgery, serum CTX-I in the denosumab group was 80% lower (−65 to −95, p<0.001), TRAP5b −65% (−40 to −90, p<0.001), PINP −53% (−41 to −65, p<0.001). Patient-reported outcome measures and the rate of adverse events (denosumab 6, placebo 7) were similar between groups (P>0.05). Conclusion. A single dose of denosumab reduced osteoclast activity within osteolytic lesions and was safe to administer. These data provide a biological basis for a phase 3 trial using clinical outcomes of pain, function and prosthesis survival as the study endpoints. Declaration of Interest. (a) fully declare any financial or other potential conflict of interest


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_3 | Pages 50 - 50
1 Apr 2018
Wylde V Artz N Dixon S Marques E Lenguerrand E Blom A Gooberman-Hill R
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Background. Inpatient physiotherapy is routinely provided after total knee replacement (TKR) surgery to enhance recovery prior to discharge. However, the provision of outpatient physiotherapy is variable in the UK, and the longer-term benefits of outpatient physiotherapy are unclear. This study aimed to evaluate the feasibility of conducting a randomised controlled trial (RCT) to assess the effectiveness and cost-effectiveness of group-based outpatient physiotherapy after TKR. Methods. Patients listed for primary TKR were recruited prior to surgery. Patients who decided not to participate were asked about their reasons for non-participation. Patients were randomised to attend a newly developed post-operative physiotherapy class plus usual care or usual care alone. Patients allocated to the intervention group were invited to attend a weekly one-hour physiotherapy class, starting at 6 weeks after surgery and running over 6 consecutive weeks. The group classes were run by two physiotherapists within an outpatient gym, and involved task-orientated and individualised exercises. Classes ran on a rolling system, allowing new patients to join each week. Participants completed an evaluation questionnaire after the final class. Outcomes assessment was by questionnaire prior to surgery and 2 weeks, 3 months and 6 months after surgery. Outcomes related to function, pain, balance, self-efficacy, participation, quality of life and resource use. Results. 46/124 patients consented to participate (37% recruitment rate). Frequent reasons for non-participation were related to travelling distance, transportation, and time commitments. 17/23 patients randomised to the intervention group attended the exercise classes. Most (15) patients were very satisfied with the range of exercises on offer. The task-orientated and individual exercises were given average usefulness ratings of 9.6/10 and 9.5/10, respectively. Retention of participants was acceptable; 2 patients were withdrawn from the intervention group and 2 patients from the usual care group. Questionnaire return rates were high in the intervention group (91% at 6 months post-operative) but lower in the usual care group (65% at 6 months post-operative). Conclusion. This study highlights the importance of conducting feasibility work for a RCT. Collecting data on reasons for non-participation provided valuable information on barriers to participation in a trial with this population. The intervention was well attended, and feedback was positive. Questionnaire completion was lower in the usual care group, highlighting the need for additional strategies to improve data collection. Findings from this feasibility study have informed the design of a multi-centre RCT to evaluate the clinical and cost-effectiveness of a group-based outpatient physiotherapy intervention following TKR


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_14 | Pages 43 - 43
1 Nov 2018
Beswick AD Strange S Mallon C Lenguerrand E Moore AJ Kunutsor SK Whitehouse MR Porteous A Toms A Blom AW
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Patients with knee prosthetic joint infection (PJI) frequently receive one- or two-stage revision. To explore the feasibility of a randomised controlled trial (RCT) comparing methods, we analysed a UK registry, interviewed patients and surgeons, systematically reviewed literature, held a consensus meeting, and assessed progress of an RCT in hip PJI. In 2014, in England and Wales, knee PJI was treated with one- or two-stage procedures in 19% and 71% of patients respectively. Between 2007 and 2014, use of one-stage procedures doubled and, in major centres, up to 42% of treatments were one-stage. We conducted in-depth interviews with 16 patients with knee PJI and 11 surgeons performing one- or two-stage revision. Patients considered randomisation acceptable with appropriate counselling and, depending on infecting organisms and health status, surgeons would randomise treatments. In meta-analysis, two-year re-infection rates in 10 one-stage series (423 patients) and 108 two-stage series (5,129 patients) were 7.6% (95%CI 3.4,13.1) and 8.8% (7.2,10.6) respectively. In a series of patients with knee PJI, surgeons from 2 major centres considered 6/15 patients eligible for either treatment, with 4 more potentially eligible after treatment of soft tissue infection. In an ongoing RCT of surgical treatment of hip PJI, 116 patients have been randomised at 14 centres in 3 years. Randomising patients with PJI is feasible but, as knee PJI is uncommon, a multicentre RCT would be required. Based on WOMAC score outcome and appropriate assumptions on eligibility and acceptability, 170 patients would need to be randomised over 4 years at 14 major centres


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_7 | Pages 104 - 104
4 Apr 2023
Edwards T Khan S Patel A Gupta S Soussi D Liddle A Cobb J Logishetty K
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Evidence supporting the use of virtual reality (VR) training in orthopaedic procedures is rapidly growing. However, the impact of the timing of delivery of this training is yet to be tested. We aimed to investigate whether spaced VR training is more effective than massed VR training.

24 medical students with no hip arthroplasty experience were randomised to learning the direct anterior approach total hip arthroplasty using the same VR simulation, training either once-weekly or once-daily for four sessions. Participants underwent a baseline physical world assessment on a saw bone pelvis. The VR program recorded procedural errors, time, assistive prompts required and hand path length across four sessions. The VR and physical world assessments were repeated at one-week, one-month, and 3 months after the last training session.

Baseline characteristics between the groups were comparable (p > 0.05). The daily group demonstrated faster skills acquisition, reducing the median ± IQR number of procedural errors from 68 ± 67.05 (session one) to 7 ± 9.75 (session four), compared to the weekly group's improvement from 63 ± 27 (session one) to 13 ± 15.75 (session four), p < 0.001. The weekly group error count plateaued remaining at 14 ± 6.75 at one-week, 16.50 ± 16.25 at one-month and 26.45 ± 22 at 3-months, p < 0.05. However, the daily group showed poorer retention with error counts rising to 16 ± 12.25 at one-week, 17.50 ± 23 at one-month and 41.45 ± 26 at 3-months, p<0.01. A similar effect was noted for the number of assistive prompts required, procedural time and hand path length. In the real-world assessment, both groups significantly improved their acetabular component positioning accuracy, and these improvements were equally maintained (p<0.01).

Daily VR training facilitates faster skills acquisition; however weekly practice has superior skills retention.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_8 | Pages 13 - 13
11 Apr 2023
Edwards T Gupta S Soussi D Patel A Khan S Liddle A Cobb J Logishetty K
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Current evidence suggests that superior surgical team performance is linked to fewer intra-operative errors, reductions in mortality and even improved patient outcomes. Virtual reality has demonstrated excellent efficacy in training surgeons and scrub nurses individually, however its impact on training teams is currently unknown. This study aimed to assess if training together (scrub nurse and surgeon) in an innovative multiplayer virtual reality program was superior to single player training for novices learning anterior approach total hip arthroplasty (AA-THA).

40 participants (20 novice surgeons (CT1-ST3 level) and 20 novice scrub nurses) were enrolled in this study and randomised to individual or team virtual reality training. Individually-trained participants played with virtual avatar counterparts, whilst teams trained live in pairs (surgeon and scrub nurse). Both groups underwent 5 VR training sessions over 6 weeks. Subsequently, they underwent a real-life assessment in which they performed AA-THA on a high-fidelity model with real equipment in a simulated operating theatre. Teams performed together and individually-trained participants were randomly paired up with a solo player of the opposite role. Videos of the assessment were marked by two blinded expert assessors. The primary outcome was team performance as graded by the validated NOTECHs II score. Secondary outcomes were procedure time and number of technical errors from an expert pre-defined protocol.

Teams outperformed individually-trained participants for non-technical skills in the real-world assessment (NOTECHS-II score 50.3 ± 6.04 vs 43.90 ± 5.90, p=0.0275). They completed the assessment 28.1% faster (31.22 minutes ±2.02 vs 43.43 ±2.71, p=0.01), and made close to half the number of technical errors when compared to the individual group (12.9 ± 8.3 vs 25.6 ± 6.1, p=0.001).

Multiplayer, team training appears to lead to faster surgery with fewer technical errors and the development of superior non-technical skills.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_9 | Pages 58 - 58
1 May 2017
Akimau P Dakin W Cawthron K Chadwick C Blundell C Davies M
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Background. Avulsion fractures of the base of the fifth metatarsal are some of the commonest foot injuries. The robust scientific evidence on the optimal non-operative treatment of these fractures is scant. We designed and conducted a prospective randomised non-inferiority controlled trial of symptomatic treatment versus cast immobilisation with the null hypothesis that cast immobilisation gave substantial benefit over the symptomatic treatment in terms of patient reported outcome measures(PROMs). The alternative hypothesis was that symptomatic treatment was not inferior. Methods. The primary outcome was the validated Visual Analogue Scale Foot and Ankle (VAS FA) score ranging from 0 to 100. The non-inferiority boundary was set at −10 points. Power sizing determined a minimum of 12 patients per group. Anticipating a significant loss to follow up, 60 patients of 16 years of age or older were randomised to receive either below knee walking cast immobilisation (n = 24) or symptomatic double- elasticated bandage (n = 36) for 4 weeks. Secondary outcome measures were EuroQol-5D, and American Orthopaedic Foot and Ankle Society scores. Data was analysed at the baseline, 4 weeks, 3 months and 6 months post injury by a clinician blinded to a treatment arm. Results. Symptomatic treatment proved to be non-inferior to cast immobilisation treatment in terms of VAS FA at baseline, 4 weeks and 6 months. Secondary outcomes showed similar comparative values between two treatment groups. Loss to follow up reached 43% at 6 months. The imputation of missing data was done and confirmed the non-inferiority of symptomatic treatment. Conclusions. Cast immobilisation does not appear to give benefits over symptomatic treatment of these injuries in terms of validated PROMs in adults. A significant loss to follow up should be expected with these fractures in medium term. Level of Evidence. II. Approval. NRES Yorkshire and the Humber reference: 11/YH/0297. Disclosure. This study was supported with a small research grant from a British Orthopaedic Foot and Ankle Society


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_4 | Pages 26 - 26
1 Jan 2013
Tilbrook H Cox H Hewitt C Chuang L Jayakody S Kanǵombe A Aplin J Semlyen A Trewhela A Watt I Torgerson D
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Purposes of the study and background. Smaller studies indicate that yoga may be an effective treatment for chronic low back pain. We conducted a randomised trial to evaluate if yoga compared to usual care improves back function in patients with chronic or recurrent low back pain. Summary of the methods used and the results. Outcomes were assessed by postal questionnaires. The setting was 13 non-National Health Service premises. We recruited 313 adults with chronic or recurrent low back pain from primary care. 157 were randomised to usual care. 156 were randomised to a 12-class, gradually-progressing programme of yoga delivered by 12 teachers over three months. All received The Back Book. Primary outcome was back function (Roland Morris Disability Score) at three months. Secondary outcomes: back function at six and 12 months, back pain, pain self-efficacy and general health. Back function improved more in the yoga group: mean difference in changes from baseline at three (−2.17, 95% CI −3.31 to −1.03, p<0.001), six (−1.48, 95% CI −2.62 to −0.33, p=0.011) and 12 months (−1.57, −2.71 to −0.42, p=0.007). Improvement in pain self-efficacy at three and six months in the yoga group. No differences in general health and pain reduction. Two adverse events were reported by controls and 12 by the yoga group – 8 out of 12 reported pain which may have been due to yoga. 63 (40%) were not fully compliant with treatment and 23 (15%) did not attend any yoga classes. Conclusion. At all time points Yoga was more effective than usual care at improving back function. Conflicts of Interest. AT, AS and JDA are self-employed yoga practitioners and may benefit if there is a demand for the yoga programme. AT, AS, the funders and the University of York would share any royalties from the future sale of the yoga manuals and CD.” AT, AS AND JDA had no involvement in the collection of data and in the analysis of the trial. Source of funding. Arthritis Research UK


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_1 | Pages 4 - 4
2 Jan 2024
Kucko N Sage K Delawi D Hoebink E Kempen D Van Susante J de Bruijn J Kruyt M
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Pseudoarthrosis after spinal fusion is an important complication leading to revision spine surgeries. Iliac Crest Bone Graft is considered the gold standard, but with limited availability and associated co-morbidities, spine surgeons often utilize alternative bone grafts.

Determine the non-inferiority of a novel submicron-sized needle-shaped surface biphasic calcium phosphate (BCP<µm) as compared to autograft in instrumented posterolateral spinal fusion.

Adult patients indicated for instrumented posterolateral spinal fusion of one to six levels from T10-S2 were enrolled at five participating centers. After instrumentation and preparation of the bone bed, the randomized allocation side of the graft type was disclosed. One side was grafted with 10cc of autograft per level containing a minimum of 50% iliac crest bone. The other side was grafted with 10cc of BCP<µm granules standalone (without autograft or bone marrow aspirate). In total, 71 levels were treated. Prospective follow-up included adverse events, Oswestry Disability Index (ODI), and a fine-cut Computerized Tomography (CT) at one year. Fusion was systematically scored as fused or not fused per level per side by two spine surgeons blinded for the procedure.

The first fifty patients enrolled are included in this analysis (mean age: 57 years; 60% female and 40% male). The diagnoses included deformity (56%), structural instability (28%), and instability from decompression (20%). The fusion rate determined by CT for BCP<μm was 76.1%, which compared favorably to the autograft fusion rate of 43.7%. Statistical analysis through binomial modeling showed that the odds of fusion of BCP<μm was 2.54 times higher than that of autograft. 14% of patients experienced a procedure or possible device-related severe adverse event and there were four reoperations. Oswestry Disability Index (ODI) score decreased from a mean of 46.0 (±15.0) to a mean of 31.7 (±16.9), and 52.4% of patients improved with at least 15-point decrease.

This data, aiming to determine non-inferiority of standalone BCP<μm as compared to autograft for posterior spinal fusions, is promising. Ongoing studies to increase the power of the statistics with more patients are forthcoming.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXVIII | Pages 44 - 44
1 Jun 2012
Smith J Hussain S Horey L Patil S Meek R
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Hip resurfacing has generally been used in younger patients with early osteoarthritis of the hip. There has been considerable recent interest in this over the past few years. We conducted a prospective randomised trial comparing 2 hip resurfacing implants, Durom and ASR looking at radiological and clinical outcomes. Forty-nine patients (78% male) with hip osteoarthritis which met the criteria for hip resurfacing were randomised to receive either a Durom or ASR resurfacing implant. These patients have so far been followed up for a minimum of one year. The groups were comparable in age (p=0.124) and gender (p=0.675). The average age in the ASR group was 54.04 years and in the Durom group it was 51.25. Radiological views were scrutinised immediately post op and at final follow up so far to look at cup inclination, stem-shaft angle, and acetabular osseointegration. Clinical outcomes were compared using the Oxford hip scores, WOMAC scores and SF12 scores. At minimum follow up of 1 year the mean post operative Oxford hip score was not significantly different between the Durom (45.32, SD 3.93) and ASR (43.44, SD 8.44). The mean post operative WOMAC score was also not significantly different between the Durom (52.56, SD 6.06) and ASR (49.63, SD 2.23). There was no difference between the groups with regards to signs of osseointegration from radiological assessment (p=0.368). There were 3 periprosthetic femoral neck fractures (5.7%) and one revision for pain. We conclude from this trial that there is no difference in the clinical or radiological findings between the Durom and ASR implants


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_16 | Pages 134 - 134
1 Nov 2018
Murchú SÓ Goel R Sydnor K Rondon A Purtill JJ Austin MS
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The use of a tourniquet during total knee arthroplasty (TKA) is controversial. Return to function and pain are believed to be affected by the use of a tourniquet. The hypothesis of this study was that use of a tourniquet (T) would delay postoperative functional recovery and increase pain as compared to no tourniquet use (NT). 200 patients were recruited for this prospective, double-blinded, randomized controlled trial. All surgeries were performed by one of two fellowship trained arthroplasty surgeons at our institution. Patients were randomized to either undergo TKA with T or NT and blinded to group allocation. An otherwise standardized perioperative protocol was followed. The primary outcome measures were functional assessment testing using the timed up-and-go (TUG) and stair-climb (SC) tests and visual analog scale pain (VAS-P) scores. Secondary outcome measures included blood loss and range-of-motion (ROM). Patients completed outcomes measures preoperatively, in hospital, and postoperatively at 4–6 weeks and 6–8 months. Minimal detectable change (MDC) and Student's T-test, alpha of p < 0.05, were used to determine significance. No significant differences were seen in postoperative TUG, SC, VAS-P, or ROM at any time point. NT patients were seen to have significantly more calculated blood loss (means: T 1,370.04mL, NT 1,743.85mL; p < 0.001), without a significant increase in transfusion events. Tourniquet use during TKA significantly decreases blood loss and does not adversely affect early postoperative outcomes. Tourniquet use during routine TKA is safe and effective and concerns over deleterious effects on function and pain may not be justified