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The Bone & Joint Journal
Vol. 106-B, Issue 11 | Pages 1306 - 1311
1 Nov 2024
Watts AC McDaid C Hewitt C

Aims. A review of the literature on elbow replacement found no consistency in the clinical outcome measures which are used to assess the effectiveness of interventions. The aim of this study was to define core outcome domains for elbow replacement. Methods. A real-time Delphi survey was conducted over four weeks using outcomes from a scoping review of 362 studies on elbow replacement published between January 1990 and February 2021. A total of 583 outcome descriptors were rationalized to 139 unique outcomes. The survey consisted of 139 outcomes divided into 18 domains. The readability and clarity of the survey was determined by an advisory group including a patient representative. Participants were able to view aggregated responses from other participants in real time and to revisit their responses as many times as they wished during the study period. Participants were able to propose additional items for inclusion. A Patient and Public Inclusion and Engagement (PPIE) panel considered the consensus findings. Results. A total of 45 respondents completed the survey. Nine core mandatory domains were identified: ‘return to work or normal daily role’; delivery of care was measured in the domains ‘patient satisfaction with the outcome of surgery’ and ‘would the patient have the same operation again’; ‘pain’; ‘revision’; ‘elbow function’; ‘independence in activities of daily living’; ‘health-related quality of life’; and ‘adverse events’. ‘Elbow range of motion’ was identified as important by consensus but was felt to be less relevant by the PPIE panel. The PPIE panel unanimously stated that pain should be used as the primary outcome domain. Conclusion. This study defined core domains for the clinical outcomes of elbow replacement obtained by consensus from patients, carers, and healthcare professionals. Pain may be used as the primary outcome in future studies, where appropriate. Further work is required to define the instruments that should be used. Cite this article: Bone Joint J 2024;106-B(11):xxx–xxx


The Bone & Joint Journal
Vol. 103-B, Issue 12 | Pages 1821 - 1830
1 Dec 2021
Marson BA Manning JC James M Craxford S Deshmukh SR Perry DC Ollivere BJ

Aims. The aim of this study is to develop a core set of outcome domains that should be considered and reported in all future trials of childhood limb fractures. Methods. A four-phase study was conducted to agree a set of core outcome domains. Identification of candidate outcome domains were identified through systematic review of trials, and outcome domains relevant to families were identified through semi-structured interviews with 20 families (parent-child pairing or group). Outcome domains were prioritized using an international three-round Delphi survey with 205 panellists and then condensed into a core outcome set through a consensus workshop with 30 stakeholders. Results. The systematic review and interviews identified 85 outcome domains as relevant to professionals or families. The Delphi survey prioritized 30 upper and 29 lower limb outcome domains at first round, an additional 17 upper and 18 lower limb outcomes at second round, and four additional outcomes for upper and lower limb at the third round as important domains. At the consensus workshop, the core outcome domains were agreed as: 1) pain and discomfort; 2) return to physical and recreational activities; 3) emotional and psychosocial wellbeing; 4) complications from the injury and treatment; 5) rturn to baseline activities daily living; 6) participation in learning; 7) appearance and deformity; and 8) time to union. In addition, 9a) recovery of mobility and 9b) recovery of manual dexterity was recommended as a core outcome for lower and upper limb fractures, respectively. Conclusion. This set of core outcome domains is recommended as a minimum set of outcomes to be reported in all trials. It is not an exhaustive set and further work is required to identify what outcome tools should be used to measure each of these outcomes. Adoption of this outcome set will improve the consistency of research for these children that can be combined for more meaningful meta-analyses and policy development. Cite this article: Bone Joint J 2021;103-B(12):1821–1830


The Bone & Joint Journal
Vol. 103-B, Issue 9 | Pages 1464 - 1471
1 Sep 2021
Barker TP Steele N Swamy G Cook A Rai A Crawford R Lutchman L

Aims. Cauda equina syndrome (CES) can be associated with chronic severe lower back pain and long-term autonomic dysfunction. This study assesses the recently defined core outcome set for CES in a cohort of patients using validated questionnaires. Methods. Between January 2005 and December 2019, 82 patients underwent surgical decompression for acute CES secondary to massive lumbar disc prolapse at our hospital. After review of their records, patients were included if they presented with the clinical and radiological features of CES, then classified as CES incomplete (CESI) or with painless urinary retention (CESR) in accordance with guidelines published by the British Association of Spinal Surgeons. Patients provided written consent and completed a series of questionnaires. Results. In total, 61 of 82 patients returned a completed survey. Their mean age at presentation was 43 years (20 to 77; SD 12.7), and the mean duration of follow-up 58.2 months (11 to 182; SD 45.3). Autonomic dysfunction was frequent: 33% of patients reported bladder dysfunction, and 10% required a urinary catheter. There was a 38% and 53% incidence of bowel and sexual dysfunction, respectively: 47% of patients reported genital numbness. A total of 67% reported significant back pain: 44% required further investigation and 10% further intervention for the management of lower back pain. Quality of life was lower than expected when corrected for age and sex. Half the patients reported moderate or worse depression, and 40% of patients of working age could no longer work due to problems attributable to CES. Urinary and faecal incontinence, catheter use, sexual dysfunction, and genital numbness were significantly more common in patients with CESR. Conclusion. This study reports the long-term outcome of patients with CES and is the first to use validated patient-reported outcome measures to assess the CES Core Outcome Set. Persistent severe back pain and on-going autonomic dysfunction were frequently reported at a mean follow-up of five years. Cite this article: Bone Joint J 2021;103-B(9):1464–1471


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 735 - 743
1 Jul 2024
Gelfer Y Cavanagh SE Bridgens A Ashby E Bouchard M Leo DG Eastwood DM

Aims. There is a lack of high-quality research investigating outcomes of Ponseti-treated idiopathic clubfeet and correlation with relapse. This study assessed clinical and quality of life (QoL) outcomes using a standardized core outcome set (COS), comparing children with and without relapse. Methods. A total of 11 international centres participated in this institutional review board-approved observational study. Data including demographics, information regarding presentation, treatment, and details of subsequent relapse and management were collected between 1 June 2022 and 30 June 2023 from consecutive clinic patients who had a minimum five-year follow-up. The clubfoot COS incorporating 31 parameters was used. A regression model assessed relationships between baseline variables and outcomes (clinical/QoL). Results. Overall, 293 patients (432 feet) with a median age of 89 months (interquartile range 72 to 113) were included. The relapse rate was 37%, with repeated relapse in 14%. Treatment considered a standard part of the Ponseti journey (recasting, repeat tenotomy, and tibialis anterior tendon transfer) was performed in 35% of cases, with soft-tissue release and osteotomies in 5% and 2% of cases, respectively. Predictors of relapse included duration of follow-up, higher initial Pirani score, and poor Evertor muscle activity. Relapse was associated with poorer outcomes. Conclusion. This is the first multicentre study using a standardized COS following clubfoot treatment. It distinguishes patients with and without relapse in terms of clinical outcomes and QoL, with poorer outcomes in the relapse group. This tool allows comparison of treatment methods and outcomes, facilitates information sharing, and sets family expectations. Predictors of relapse encourage us to create appropriate treatment pathways to reduce relapse and improve outcome. Cite this article: Bone Joint J 2024;106-B(7):735–743


The Bone & Joint Journal
Vol. 96-B, Issue 8 | Pages 1016 - 1023
1 Aug 2014
Haywood KL Griffin XL Achten J Costa ML

The lack of a consensus for core health outcomes that should be reported in clinical research has hampered study design and evidence synthesis. We report a United Kingdom consensus for a core outcome set (COS) for clinical trials of patients with a hip fracture. We adopted a modified nominal group technique to derive consensus on 1) which outcome domains should be measured, and 2) methods of assessment. Participants reflected a diversity of perspectives and experience. They received an evidence synthesis and postal questionnaire in advance of the consensus meeting, and ranked the importance of candidate domains and the relevance and suitability of short-listed measures. During the meeting, pre-meeting source data and questionnaire responses were summarised, followed by facilitated discussion and a final plenary session. A COS was determined using a closed voting system: a 70% consensus was required. Consensus supported a five-domain COS: mortality, pain, activities of daily living, mobility, and health-related quality of life (HRQL). Single-item measures of mortality and mobility (indoor/outdoor walking status) and a generic multi-item measure of HRQL - the EuroQoL EQ-5D - were recommended. These measures should be included as a minimum in all hip fracture trials. Other outcome measures should be added depending on the particular interventions being studied. Cite this article: Bone Joint J 2014; 96-B:1016–23


The Bone & Joint Journal
Vol. 102-B, Issue 7 | Pages 890 - 898
1 Jul 2020
Cheung PWH Wong CKH Cheung JPY

Aims. The health-related quality of life (HRQoL) of paediatric patients with orthopaedic conditions and spinal deformity is important, but existing generic tools have their shortcomings. We aim to evaluate the use of Paediatric Quality of Life Inventory (PedsQL) 4.0 generic core scales in the paediatric population with specific comparisons between those with spinal and limb pathologies, and to explore the feasibility of using PedsQL for studying scoliosis patients’ HRQoL. Methods. Paediatric patients attending a speciality outpatient clinic were recruited through consecutive sampling. Two groups of patients were included: idiopathic scoliosis, and paediatric orthopaedic upper and lower limb condition without scoliosis. Patients were asked to complete PedsQL 4.0 generic core scales, Youth version of 5-level EuroQol-5-dimension questionnaire, and Refined Scoliosis Research Society 22-item (SRS-22r) questionnaire. Statistical analyses included scores comparison between scoliosis and limb pathology patients using independent-samples t-test, and correlation tests of PedsQL and SRS-22r. Results. A total of 566 paediatric patients were recruited: 357 (63.0%) having idiopathic scoliosis, and 209 (37.0%) with limb conditions. Patients with limb pathology had lower functioning scale, summary, and total scores of PedsQL than scoliosis patients (p < 0.05 to p < 0.001). No floor or ceiling effects (< 15%) were detected for PedsQL Psychosocial Health Summary and total scores in both groups. PedsQL was sensitive in differentiating patients with/without problems in their daily lives (p < 0.05 to p < 0.01). PedsQL summary and total scores correlated with SRS-22r total score. Conclusion. PedsQL is an effective HRQoL measure for both paediatric orthopaedic groups with minimal ceiling and floor effects, and is capable of detecting worse HRQoL in patients with limb pathology. The multidimensional PedsQL is sensitive in differentiating among those with daily life problems, especially for scoliosis patients. Cite this article: Bone Joint J 2020;102-B(7):890–898


The Bone & Joint Journal
Vol. 103-B, Issue 3 | Pages 589 - 596
1 Mar 2021
Amin N Kraft J Fishlock A White A Holton C Kinsey S Feltbower R James B

Aims. Osteonecrosis (ON) can cause considerable morbidity in young people who undergo treatment for acute lymphoblastic leukaemia (ALL). The aims of this study were to determine the operations undertaken for ON in this population in the UK, along with the timing of these operations and any sequential procedures that are used in different joints. We also explored the outcomes of those patients treated by core decompression (CD), and compared this with conservative management, in both the pre- or post-collapse stages of ON. Methods. UK treatment centres were contacted to obtain details regarding surgical interventions and long-term outcomes for patients who were treated for ALL and who developed ON in UKALL 2003 (the national leukaemia study which recruited patients aged 1 to 24 years at diagnosis of ALL between 2003 and 2011). Imaging of patients with ON affecting the femoral head was requested and was used to score all lesions, with subsequent imaging used to determine the final grade. Kaplan-Meier failure time plots were used to compare the use of CD with non surgical management. Results. Detailed information was received for 85 patients who had developed ON during the course of their ALL treatment. A total of 206 joints were affected by ON. Of all joints affected by ON, 21% required arthroplasty, and 43% of all hips affected went on to be replaced. CD was performed in 30% of hips affected by ON. The majority of the hips were grade 4 or 5 at initial diagnosis of ON. There was no significant difference in time to joint collapse between those joints in which CD was performed, compared with no joint-preserving surgical intervention. Conclusion. There is a high incidence of surgery in young people who have received treatment for ALL and who have developed ON. Our results suggest that CD of the femoral head in this group of patients does not delay or improve the rates of femoral head survival. Cite this article: Bone Joint J 2021;103-B(3):589–596


The Journal of Bone & Joint Surgery British Volume
Vol. 72-B, Issue 3 | Pages 387 - 390
1 May 1990
Learmonth I Maloon S Dall G

We performed 41 core decompressions in 32 patients for stage I or stage II osteonecrosis of the femoral head. The intra-osseous pressure at the intertrochanteric level was raised in 28 (68%) and there was histological confirmation of necrosis in 36 hips (88%). After a follow-up of 10 to 84 months (mean 31) nine of the 12 stage I hips (75%) showed significant clinical or radiological deterioration; no evidence of necrosis had been found in the core specimens of the other three hips. Of the 29 hips in stage II, 25 (86%) showed significant radiological deterioration, and only five (17%) had improved clinically. We believe that once necrosis has occurred, core decompression will not significantly influence the subsequent course of the disease


The Journal of Bone & Joint Surgery British Volume
Vol. 78-B, Issue 5 | Pages 827 - 830
1 Sep 1996
Mont MA Schon LC Hungerford MW Hungerford DS

We reviewed 11 patients (17 ankles) who had had core decompression for symptomatic avascular necrosis of the talus before collapse. The Mazur grading system was used to assess function preoperatively and at final follow-up, and radiographs were graded according to the Ficat and Arlet (1980) classification modified for the ankle. At a mean follow-up of seven years (2 to 14) 14 ankles (82%) had an excellent or good outcome (Mazur scores > 80 points; pain scores > 40 points (41 to 50)). The other three ankles required tibiotalar fusion at a mean of 13 months (5 to 20) after core decompression. We conclude that core decompression is a viable method of treatment for symptomatic avascular necrosis of the talus before collapse


The Bone & Joint Journal
Vol. 98-B, Issue 9 | Pages 1175 - 1179
1 Sep 2016
Olsen M Lewis PM Morrison Z McKee MD Waddell JP Schemitsch EH

Aims. One method of femoral head preservation following avascular necrosis (AVN) is core decompression and insertion of a tantalum rod. However, there may be a high failure rate associated with this procedure. The purpose of this study was to document the clinical and radiological outcomes following total hip arthroplasty (THA) subsequent to failed tantalum rod insertion. Patients and Methods. A total of 37 failed tantalum rods requiring total hip arthroplasty were identified from a prospective database. There were 21 hips in 21 patients (12 men and nine women, mean age 37 years, 18 to 53) meeting minimum two year clinical and radiographic follow-up whose THAs were carried out between November 2002 and April 2013 (mean time between tantalum rod implantation and conversion to a THA was 26 months, 6 to 72). These were matched by age and gender to individuals (12 men, nine women, mean age 40 years, 18 to 58) receiving THA for AVN without prior tantalum rod insertion. Results. There were no functional outcome differences between the two groups. Tantalum residue was identified on all post-operative radiographs in the tantalum group. Linear wear rates were comparable between groups with no evidence of catastrophic wear in either group. Conclusion. In the short term, tantalum rod implantation does not demonstrate an adverse effect on subsequent total joint replacement surgery. There is however, a high rate of retained tantalum debris on post-operative radiographs and thus there is an unknown risk of accelerated articular wear necessitating longer term study. Cite this article: Bone Joint J 2016;98-B:1175–9


The Journal of Bone & Joint Surgery British Volume
Vol. 77-B, Issue 1 | Pages 42 - 49
1 Jan 1995
Fairbank A Bhatia D Jinnah R Hungerford D

We have studied the long-term results of core decompression as the sole treatment for Ficat stages I, II and III ischaemic necrosis of 128 femoral heads in 90 patients. The 5-, 10- and 15-year survival rates for the three stages were respectively: stage I 100%, 96% and 90%; stage II 85%, 74% and 66%; and stage III 58%, 35% and 23%. At a mean follow-up of 11 years (4.5 to 19), 55 hips had failed (43%). No further surgery had been needed for 88% of stage-I, 72% of stage-II and 26% of stage-III hips; but despite the generally satisfactory clinical results, 56% of the hips had progressed radiographically by at least one Ficat stage. Complications of the core procedure included four fractures, all from postoperative falls, and one head perforation due to technical error. We conclude that core decompression delays the need for total hip replacement in young patients with ischaemic necrosis


The Journal of Bone & Joint Surgery British Volume
Vol. 75-B, Issue 5 | Pages 785 - 788
1 Sep 1993
Mont M Maar D Urquhart M Lennox D Hungerford D

Thirty shoulders, in 20 patients, which had undergone core decompression for symptomatic avascular necrosis of the humeral head were reviewed 2 to 14 years later (average 5.6). Twenty-two showed good or excellent clinical results; the other eight shoulders had required arthroplasty. All 14 shoulders with stage I or II radiological changes (Ficat and Arlet 1980) at operation had good or excellent results. We advocate early core decompression for symptomatic avascular necrosis of the humeral head


The Journal of Bone & Joint Surgery British Volume
Vol. 75-B, Issue 2 | Pages 210 - 216
1 Mar 1993
Hofmann S Engel A Neuhold A Leder K Kramer J Plenk H

Bone-marrow oedema syndrome (BMOS) of the hip gives a characteristic MRI pattern, in association with severe pain, non-specific focal loss of radiological density and a positive bone scan. In our MRI-controlled study, nine patients with non-traumatic BMOS in ten hips all had core decompression. Bone-marrow pressure measurements and intraosseous venography in five cases showed pathological values. All patients had immediate relief of pain, with return of MRI signals to normal after three months. Regular review was continued for at least 24 months with serial clinical radiological and MRI assessment. At a mean follow-up of 33 months all patients remained free of pain with normal radiographs and MR scans. The histological evaluation of undecalcified sections obtained from eight core decompressions confirmed the presence of bone-marrow oedema, with necrotic and reparative processes involving bone and marrow similar to those of early avascular necrosis but with no evidence of 'osteoporosis'. These findings support the assumption that BMOS may be the initial phase of non-traumatic avascular necrosis. In most patients BMOS will have a self-limiting course, but the duration of symptoms may be reduced by core decompression treatment


The Journal of Bone & Joint Surgery British Volume
Vol. 70-B, Issue 1 | Pages 78 - 84
1 Jan 1988
Saito S Ohzono K Ono K

We have reviewed 54 hips in 46 patients from 2 to 14 years after a joint-preserving operation for idiopathic avascular necrosis of the femoral head. The choice between core decompression (17 hips), bone grafting (18), rotation osteotomy (15) or varus osteotomy (4) was determined by the stage and location of the area of necrosis. The overall success rate was unexpectedly low at 60%. Core decompression and bone grafting by our techniques gave poor long-term results, but those of rotation or varus osteotomies, performed with care for the correct indications, were better. The indications for each procedure are discussed: osteotomy is best when the area of necrosis is shallow and localised in the medial or anterior portion of the femoral head


The Journal of Bone & Joint Surgery British Volume
Vol. 71-B, Issue 4 | Pages 583 - 587
1 Aug 1989
Jacobs M Loeb P Hungerford D

From 1974 to 1981, we performed 28 core decompressions of the distal femur for pathologically confirmed avascular necrosis. At a mean follow-up of 54 months (range 20 to 140 months) and using the Ficat stages, all seven cases in stage I and stage II had good results. Of 21 cases in stage III, 11 cases had good results, four had poor results, and six needed total knee replacement. There were no significant orthopaedic complications. The procedure is worthwhile and will be more accurate with new methods of imaging


The Bone & Joint Journal
Vol. 103-B, Issue 9 | Pages 1462 - 1463
1 Sep 2021
Barker TP Steele N Swamy G Cook A Rai A Crawford R Lutchman L


The Journal of Bone & Joint Surgery British Volume
Vol. 77-B, Issue 6 | Pages 870 - 874
1 Nov 1995
Koo K Kim R Ko G Song H Jeong S Cho S

We performed a randomised trial on 37 hips (33 patients) with early-stage osteonecrosis (ON). After the initial clinical evaluation, including plain radiography and MRI, 18 hips were randomly assigned to a core-decompression group and 19 to a conservatively-treated group. All the patients were regularly followed up by clinical evaluation, plain radiography and MRI at intervals of three months. Hip pain was relieved in nine out of ten initially symptomatic hips in the core-decompression group but persisted in three out of four initially painful hips in the conservatively-treated group at the second assessment (p < 0.05). At a minimum follow-up of 24 months, 14 of the 18 core-decompressed hips (78%) and 15 of the 19 non-operated hips (79%) developed collapse of the femoral head. By survival analysis, there was no significant difference in the time to collapse between the two groups (log-rank test p = 0.79). Core decompression may be effective tin symptomatic relief, but is of no greater value than conservative management in preventing collapse in early osteonecrosis of the femoral head


The Bone & Joint Journal
Vol. 101-B, Issue 10 | Pages 1238 - 1247
1 Oct 2019
Soreide E Denbeigh JM Lewallen EA Thaler R Xu W Berglund L Yao JJ Martinez A Nordsletten L van Wijnen AJ Kakar S

Aims

Options for the treatment of intra-articular ligament injuries are limited, and insufficient ligament reconstruction can cause painful joint instability, loss of function, and progressive development of degenerative arthritis. This study aimed to assess the capability of a biologically enhanced matrix material for ligament reconstruction to withstand tensile forces within the joint and enhance ligament regeneration needed to regain joint function.

Materials and Methods

A total of 18 New Zealand rabbits underwent bilateral anterior cruciate ligament reconstruction by autograft, FiberTape, or FiberTape-augmented autograft. Primary outcomes were biomechanical assessment (n = 17), microCT (µCT) assessment (n = 12), histological evaluation (n = 12), and quantitative polymerase chain reaction (qPCR) analysis (n = 6).


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 12 | Pages 1618 - 1622
1 Dec 2009
Wadey VMR Dev P Buckley R Walker D Hedden D

We have developed a list of 281 competencies deemed to be of importance in the training of orthopaedic surgeons. A stratified, randomised selection of non-university orthopaedic surgeons rated each individual item on a scale 1 to 4 of increasing importance. Summary statistics across all respondents were given. The mean scores and sds were computed. Secondary analyses were computed in general orthopaedics, paediatrics, trauma and adult reconstruction. Of the 156 orthopaedic surgeons approached 131 (84%) responded to the questionnaire. They rated 240 of the 281 items greater than 3.0 suggesting that competence in these was necessary by completion of training.

Complex procedures were rated to be less important. The structure, delivery and implementation of the curriculum needs further study. Learning activities are ‘driven’ by the evaluation of competencies and thus competency-based learning may soon be in the forefront of training programmes.


The Bone & Joint Journal
Vol. 95-B, Issue 7 | Pages 865 - 865
1 Jul 2013
Haddad FS