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Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_6 | Pages 57 - 57
2 May 2024
Martin A Alsousou J Chou D Costa M Carrothers A
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Current treatment options for displaced acetabular fractures in elderly patients include non-surgical management, surgical fixation and surgical fixation with simultaneous hip replacement, the so-called “fix-and-replace”™. There remains a paucity of evidence to guide surgeons in decision making for these difficult injuries. The aim of this study was to assess the feasibility of performing an appropriately powered RCT between treatment options for acetabular fractures in older patients. This was an NIHR funded feasibility triple-arm RCT with participation from 7 NHS MTCs. Patients older than 60 were recruited if they had an acetabular fracture deemed sufficiently displaced for the treating surgeon to consider surgical fixation. Randomisation was performed on a 1:1:1 basis. The three treatment arms were non-surgical management, surgical fixation and fix-and-replace. Feasibility was assessed by willingness of patients to participate and clinicians to recruit, drop out rate, estimates of standard deviation to inform the sample size calculation for the full trial and completion rates to inform design of a future definitive trial. EQ-5D was the primary outcome measure at 6 months, OHS and Disability Rating Index were secondary outcome measures. Of 117 eligible patients, 60 were randomised whilst 50 declined study participation. Nine patients did not receive their allocated intervention. Analysis was performed on an intention to treat basis. During the study period 4 patients withdrew before final review, 4 patients died and 1 was lost to follow-up. The estimated sample size for a full scale study was calculated to be 1474 participants for an EQ-5D MCID of 0.06 with a power of 0.8. This feasibility study suggests a full scale trial would require international collaboration. This study also has provided observed safety data regarding mortality and morbidity for the fix-and-replace procedure to aid surgeons in the decision-making process when considering treatment options


Displaced acetabular fractures in the older patient present significant treatment challenges. There is evidence the morbidity and mortality associated is similar to the fractured neck of femur cohort. Despite growing literature, there remains significant controversy regarding treatment algorithms; varying between conservative management, to fracture fixation and finally surgical fixation and simultaneous THA to allow immediate full weight bearing.

£250k NIHR, Research for Patient Benefit (Ref: PB-PG-0815-20054). Trial ethical approval (17/EE/0271). After national consultation, 3 arms included; conservative management, fracture fixation and simultaneous fracture fixation with THA. Statistical analysis required minimum 12 patients/3 arms to show feasibility, with an optimum 20/arm. Inclusion criteria; patients >60 years & displaced acetabular fracture. Exclusion criteria: open fracture, THA in situ, pre-injury immobility, polytrauma. Primary outcome measure - ability recruit & EQ-5D-5L at 6 months. Secondary outcome measures (9 months); OHS, Disability Rating Index, radiographs, perioperative physiological variables including surgery duration, blood loss, complications and health economics.

11 UK level 1 major trauma centres enrolled into the trial, commenced December 2017. Failure surgical equipoise was identified as an issue regarding recruitment. Full trial recruitment (60 patients) achieved; 333 patients screened. 66% male, median age 76 (range 63–93), median BMI 25 (range 18–37), 87% full mental capacity, 77% admitted from own home. 75% fall from standing height. 60% fractures; anterior column posterior hemi-transverse. Trial feasibility confirmed December 2020. Presented data- secondary outcomes that are statistically significant in improvement from baseline for only the fix and replace arm, with acceptable trial complications. Issues are highlighted with conservative management in this patient cohort.

Our unique RCT informs design and sample size calculation for a future RCT. It represents the first opportunity to understand the intricacies of these treatment modalities. This RCT provides clinicians with information on how best to provide management for this medically complex patient cohort.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_11 | Pages 34 - 34
7 Jun 2023
Board T Powell R Davies A Coffey T Wylde V Taylor T Hickey H Gornall M Jackson R Dalal G Eden M Wilson M Divecha H
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Studies have shown that 10–30% patients do not achieve optimal function outcomes after total hip replacement (THR). High quality randomised controlled trials (RCTs) evaluating the clinical and cost-effectiveness of techniques to improve functional outcomes after THR are lacking. We performed this study to evaluate the feasibility of a RCT comparing patient-reported functional outcomes after hybrid or fully cemented THR (ISRCTN11097021).

Patients were recruited from two centres and randomised to receive either a fully cemented or hybrid THR. Data collection included Patient Reported Outcome Measures (PROMs), non-serious adverse events of special interest (AESI), serious adverse device effects (SADE) and NHS resource use. Qualitative interviews were undertaken to understand a) patient experiences of study processes and their reasons for taking part or not, and b) to understand surgeons’ perceptions of the study, factors affecting willingness to participate, and barriers to implementation of the future RCT findings.

The target of 40 patients were successfully recruited for the feasibility RCT; the ratio of successful recruitment to eligible patients was 0.61 across both sites. Treatment crossovers occurred in four patients, all related to bone quality. Four patients were withdrawn due to not undergoing surgery within the study window because of the pandemic. Follow-up was 100% and PROMs were completed by all patients at all time points. The feasibility of conducting a within-trial cost-utility analysis was demonstrated. Interviews were conducted with 27 patients and 16 surgeons. Patients and surgeons generally found the study procedures acceptable and workable. Some declined participation because they did not want treatment allocated at random, or because blinding was off-putting. Surgeons’ perceptions of equipoise varied, and implementation of findings from the future RCT would need to recognise the ‘craft’ nature of surgery and the issue of training.

We conclude that a full RCT with economic analysis will be both feasible and practicable, although mechanisms to safely implement potential changes to practice because of RCT findings may need consideration by the wider arthroplasty community.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_14 | Pages 45 - 45
1 Nov 2021
Sugano N Hamada H Takao M Ando W Uemura K Nakamura N
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The purposes of this study were to evaluate the accuracy and feasibility of a robotic preparation for acetabular metal augments in patients with developmental dysplasia of the hip (DDH). Mako robotic arm reaming was used in 7 DDH to prepare the bony cavities for both Trident PSL cups and Tritanium acetabular wedge augments in six hips with Crowe 2 or 3 DDH. In CT-based planning, a properly sized cup was placed in the original acetabulum, and the same sized cup was also placed to fit the superolateral acetabular defect. The coordinates of the planned positions of cup and augment were recorded to manage the robotic arm reaming. After registration of the patient's pelvis, robotic reaming was performed first for the augment, then, for the cup by changing the target position of reaming as planned. The accuracy of the cup and augment placement was assessed on postoperative CT. To evaluate the feasibility of the robotic procedure, the OR time and blood loss were compared with those of 13 patients who received the same cup and augment systems with a conventional technique. All procedures were done without fracture or fixation failure. There were no differences in OR time or blood loss between the two procedures. Postoperative CT measurements of the distance between the cup center and the augment sphere center showed less than 2mm difference from the Mako preoperative planning.

Although a longer time of follow up evaluation is mandatory, our robotic acetabular augment preparation technique is accurate and feasible.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_4 | Pages 6 - 6
1 Apr 2022
Mayne A Cassidy R Magill P Mockford B Acton D McAlinden G
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Waiting times for arthroplasty surgery in Northern Ireland are among the longest in the National Health Service, which have been further lengthened by the onset of the SARS-CoV-19 global pandemic in March 2020. The Department of Health (DoH) in Northern Ireland has announced a new Elective Care Framework (ECF), with the framework proposing that by March 2026 no patient will wait more than 52 weeks for inpatient/day case treatment. We aimed to assess the feasibility of achieving this with reference to Total Hip Arthroplasty (THA).

Waiting list information was obtained via a Freedom of Information request to the DoH (May 2021) and National Joint Registry data was used to determine baseline operative numbers. Mathematical modelling was undertaken to calculate the time taken to meet the ECF target and also to determine the time to clear the waiting lists for THA using the number of patients currently on the waiting list and percentage operating capacity relative to pre-Covid-19 capacity to determine future projections.

As of May 2021, there were 3,757 patients awaiting primary THA in Northern Ireland. Prior to April 2020, there were a mean 2,346 patients/annum added to the waiting list for primary THA and there were a mean 1,624 primary THAs performed per annum.

The ECF targets for THA will only be achieved in 2026 if operating capacity is 200% of pre COVID-19 pandemic capacity and will be achieved in 2030 if capacity is 170%. Surgical capacity must exceed pre-Covid capacity by at least 30% to meet ongoing demand.

THA capacity was significantly reduced following resumption of elective orthopaedics post-COVID-19 (22% of pre-COVID-19 capacity – 355 THAs/annum post-COVID-19 versus 1,624/annum pre-COVID-19).

This modelling demonstrates that, in the absence of major funding and reorganisation of elective orthopaedic care, the targets set out in the ECF will not be achieved with regards to hip arthroplasty. Waiting times for THA surgery in the NHS in Northern Ireland are likely to remain greater than 52 weeks for most of this decade.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_13 | Pages 68 - 68
1 Oct 2018
Lombardi AV Berend KR Morris MJ Crawford DA Adams JB
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Total hip arthroplasty (THA) continues moving to the outpatient arena, and may be feasible for some conversion and revision scenarios. Controversy surrounds appropriate patient selection. The purpose of this study is to report complications associated with outpatient revision and conversion THA, and to determine if comorbidities are associated with complications or overnight stay.

From June 2013 through March 2018, 43 patients (44 hips) underwent conversion (n=9) or revision (n=35) THA at a free-standing ambulatory surgery center. Mean patient age was 58.4 years, and 52% of patients were male. Conversion procedures were failed fracture fixation with retained hardware and all involved both femoral and acetabular replacement. Revision procedures involved head only in one, head and liner in 20, cup and head in 8, stem only in one, stem and liner in 4, and full revision in one.

Forty-one (93%) were discharged same day without incident, none required transfer to acute facility, and 3 required overnight stay with 2 of these for convenience and only one for a medical reason, urinary retention. Three patients with early superficial infection, including 2 diagnosed by positive intraoperative cultures, were successfully treated with oral antibiotics. There were no major complications, readmissions, or subsequent surgeries within 90 days. One or more major comorbidities were present in 15 patients (34%) including 1 valvular disease, 7 arrhythmia, 2 thromboembolism history, 3 obstructive sleep apnea, 3 chronic obstructive pulmonary disease, 2 asthma, 4 frequent urination, and 1 renal disease. The single patient who stayed overnight for a medical reason had no major medical comorbidities.

Outpatient arthroplasty, including revision THA in some scenarios, is safe for many patients. Presence of medical comorbidities was not associated with risk of complications. The paradigm change of patient education, medical optimization, and a multimodal program to mitigate risk of blood loss and reduce need for narcotics facilitates performing arthroplasty safely in an outpatient setting.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_11 | Pages 17 - 17
1 Aug 2018
Lombardi A Berend K Morris M Crawford D Adams J
Full Access

Total hip arthroplasty (THA) continues moving to the outpatient arena, and may be feasible for some conversion and revision scenarios. Controversy surrounds appropriate patient selection. The purpose of this study is to report complications associated with outpatient revision and conversion THA, and to determine if comorbidities are associated with complications or overnight stay.

From June 2013 through March 2018, 43 patients (44 hips) underwent conversion (n=12) or revision (n=32) THA at a free-standing ambulatory surgery center. Mean patient age was 58.4 years, and 52% of patients were male. Conversion procedures were for failed resurfacing in two, failed hemiarthroplasty in one, and failed fracture fixation with retained hardware in 9. Revision procedures involved head only in one, head and liner in 20, cup and head in 7, stem only in 2, and stem and liner in 2.

Forty-four (93%) were discharged same day without incident, none required transfer to acute facility, and 3 required overnight stay with 2 of these for convenience and only one for a medical reason, urinary retention. Three patients with early superficial infection were successfully treated with oral antibiotics. There were no major complications, readmissions, or subsequent surgeries within 90 days. One or more major comorbidities were present in 17 patients (39%) including 1 valvular disease, 8 arrhythmia, 2 thromboembolism history, 3 obstructive sleep apnea, 6 chronic obstructive pulmonary disease, 2 asthma, 4 frequent urination, and 1 renal disease. The single patient who stayed overnight for a medical reason had no major medical comorbidities.

Outpatient arthroplasty, including revision THA in some scenarios, is safe for many patients. Presence of medical comorbidities was not associated with risk of complications. The paradigm change of patient education, medical optimization, and a multimodal program to mitigate risk of blood loss and reduce need for narcotics facilitates performing arthroplasty safely in an outpatient setting.


Bone & Joint Research
Vol. 2, Issue 2 | Pages 33 - 40
1 Feb 2013
Palmer AJR Thomas GER Pollard TCB Rombach I Taylor A Arden N Beard DJ Andrade AJ Carr AJ Glyn-Jones S

Objectives

The number of surgical procedures performed each year to treat femoroacetabular impingement (FAI) continues to rise. Although there is evidence that surgery can improve symptoms in the short-term, there is no evidence that it slows the development of osteoarthritis (OA). We performed a feasibility study to determine whether patient and surgeon opinion was permissive for a Randomised Controlled Trial (RCT) comparing operative with non-operative treatment for FAI.

Methods

Surgeon opinion was obtained using validated questionnaires at a Specialist Hip Meeting (n = 61, 30 of whom stated that they routinely performed FAI surgery) and patient opinion was obtained from clinical patients with a new diagnosis of FAI (n = 31).


Bone & Joint Open
Vol. 5, Issue 9 | Pages 776 - 784
19 Sep 2024
Gao J Chai N Wang T Han Z Chen J Lin G Wu Y Bi L

Aims

In order to release the contracture band completely without damaging normal tissues (such as the sciatic nerve) in the surgical treatment of gluteal muscle contracture (GMC), we tried to display the relationship between normal tissue and contracture bands by magnetic resonance neurography (MRN) images, and to predesign a minimally invasive surgery based on the MRN images in advance.

Methods

A total of 30 patients (60 hips) were included in this study. MRN scans of the pelvis were performed before surgery. The contracture band shape and external rotation angle (ERA) of the proximal femur were also analyzed. Then, the minimally invasive GMC releasing surgery was performed based on the images and measurements, and during the operation, incision lengths, surgery duration, intraoperative bleeding, and complications were recorded; the time of the first postoperative off-bed activity was also recorded. Furthermore, the patients’ clinical functions were evaluated by means of Hip Outcome Score (HOS) and Ye et al’s objective assessments, respectively.


Bone & Joint Open
Vol. 2, Issue 11 | Pages 909 - 920
10 Nov 2021
Smith T Clark L Khoury R Man M Hanson S Welsh A Clark A Hopewell S Pfeiffer K Logan P Crotty M Costa M Lamb SE

Aims

This study aims to assess the feasibility of conducting a pragmatic, multicentre randomized controlled trial (RCT) to test the clinical and cost-effectiveness of an informal caregiver training programme to support the recovery of people following hip fracture surgery.

Methods

This will be a mixed-methods feasibility RCT, recruiting 60 patients following hip fracture surgery and their informal caregivers. Patients will be randomized to usual NHS care, versus usual NHS care plus a caregiver-patient dyad training programme (HIP HELPER). This programme will comprise of three, one-hour, one-to-one training sessions for the patient and caregiver, delivered by a nurse, physiotherapist, or occupational therapist. Training will be delivered in the hospital setting pre-patient discharge. It will include practical skills for rehabilitation such as: transfers and walking; recovery goal setting and expectations; pacing and stress management techniques; and introduction to the HIP HELPER Caregiver Workbook, which provides information on recovery, exercises, worksheets, and goal-setting plans to facilitate a ‘good’ recovery. After discharge, patients and caregivers will be supported in delivering rehabilitation through three telephone coaching sessions. Data, collected at baseline and four months post-randomization, will include: screening logs, intervention logs, fidelity checklists, quality assurance monitoring visit data, and clinical outcomes assessing quality of life, physical, emotional, adverse events, and resource use outcomes. The acceptability of the study intervention and RCT design will be explored through qualitative methods with 20 participants (patients and informal caregivers) and 12 health professionals.


Bone & Joint Open
Vol. 1, Issue 9 | Pages 594 - 604
24 Sep 2020
James HK Pattison GTR Griffin J Fisher JD Griffin DR

Aims

To develop a core outcome set of measurements from postoperative radiographs that can be used to assess technical skill in performing dynamic hip screw (DHS) and hemiarthroplasty, and to validate these against Van der Vleuten’s criteria for effective assessment.

Methods

A Delphi exercise was undertaken at a regional major trauma centre to identify candidate measurement items. The feasibility of taking these measurements was tested by two of the authors (HKJ, GTRP). Validity and reliability were examined using the radiographs of operations performed by orthopaedic resident participants (n = 28) of a multicentre randomized controlled educational trial (ISRCTN20431944). Trainees were divided into novice and intermediate groups, defined as having performed < ten or ≥ ten cases each for DHS and hemiarthroplasty at baseline. The procedure-based assessment (PBA) global rating score was assumed as the gold standard assessment for the purposes of concurrent validity. Intra- and inter-rater reliability testing were performed on a random subset of 25 cases.


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.