Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001177549
Ethics application status
Approved
Date submitted
7/08/2015
Date registered
2/11/2015
Date last updated
6/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Full randomised controlled trial of Arthroscopic Surgery for Hip Impingement versus best coNventional Care
Scientific title
Full randomised controlled trial to determine efficacy of arthroscopic surgery versus best conventional care for femoroacetabular impingement
Secondary ID [1] 287126 0
ISRCTN64081839
This trial registration is for the FASHIoN study sites in the United Kingdom. The same study is also underway in Australia. The Australian arm of FASHIoN includes the same outcome measures and study protocol as the UK study #ISRCTN64081839. In addition the Australian study includes radiographic (structural) and biomechanical measures.
The Australian sites were assumed to be under the same trial registration ISRCTN64081839 as the parent UK FASHIoN study until very recently the decision was made to register the Australian arm of FASHIoN separately.
Universal Trial Number (UTN)
Trial acronym
FASHIoN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Femoroacetabular Impingement 295663 0
Condition category
Condition code
Musculoskeletal 295941 295941 0 0
Other muscular and skeletal disorders
Surgery 296157 296157 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
140 participants will be recruited from sites in Australia. Participation will be over a 3-year period. Participants will be allocated to either:
1. Hip Arthroscopic Surgery - performed by an experienced trained surgeon will involve viewing and treatment of the hip joint through a minimally invasive arthroscope inserted into the hip joint. Detailed guidelines for acetabular rim trimming, labral repair, labral resection, chondroplasty, microfracture and osteochondroplasty of the femoral head-neck junction will be followed by all surgeons consistent with the FASHIoN trial protocol. This procedure takes approximately 1.5- 2 hours
Pre-operative:
Patients will undergo routine preoperative care, including an anaesthetic consult assessing fitness for surgery and general anaesthesia.
Peri-operative:
Arthroscopic hip surgery will be performed under general anaesthesia in a lateral or supine position. Arthroscopic portals will be established in the central and peripheral compartment under radiographic guidance according to the surgeon’s usual practice. Shape abnormalities and consequent labral and cartilage pathology will be treated. Bony resection at the acetabular rim and at the head-neck junction will be assessed by intraoperative image intensifier radiograph and/or satisfactory impingement free range of movement of the hip. Osteo-integrative anchors will be used during the surgical procedure to avoid any issues with post-op MRI quality and dGEMRIC accuracy.
Post-operative:
Patients will be allowed home when they can walk safely with crutches (usually within 24h hours). On discharge all patients will be referred to outpatient physiotherapy services for a course of rehabilitation as per usual care for that surgeon. We will not specify a protocol for the duration, mode and format of this post-operative physiotherapy. These post-operative physiotherapists will be distinct from those providing PHT to avoid contamination between groups. Patients will also have a post-op MRI done at 12 months.

2. Best Conservative Care - a package of physiotherapy-led therapy entitled 'Personalised Hip Therapy' given over a 12-week period with an option of booster sessions up to 6 months.
Intervention code [1] 292376 0
Treatment: Surgery
Intervention code [2] 292809 0
Rehabilitation
Comparator / control treatment
A course of best conventional care (a structured programme of exercise-based care supervised by a physiotherapist - this has been called personalised hip therapy) aimed at improving the muscle strength and control around the hip joint.
PHT is a package of physiotherapy-led best conventional care for FAI. It was developed during the UK FASHIoN feasibility study and 'road-tested' during the pilot trial. Although the name for this intervention is new, the care being offered represents a consensus of what physiotherapists, physicians and surgeons currently provide, and regard as 'best conventional care' for FAI. PHT will be delivered by at least one qualified physiotherapist at each site, who will be trained in a FASHIoN PHT workshop.
Pre-treatment.
Participants will receive a PHT information pack that describes what to expect during the course of their treatment. The first core component of PHT is an assessment of pain, function and range of hip motion.
Treatment.
PHT has three further core components: (i) an exercise programme that has the key features of individualisation, progression and supervision; (ii) education; and (iii) help with pain relief (which may include an X-ray or ultrasound guided intra-articular steroid injections where pain prevents performance of the exercise programme). The intervention is delivered over a minimum of 12 weeks with a minimum of 6 patient contacts. Some of the patient contacts are permissible using either telephone / email for whom geographical distance prevents all contacts being carried out face-to-face.
It is recommended that initial appointments are between 40 and 60 minutes, and that follow up appointments are 20-30 minutes.
PHT includes a phased exercise programme that begins with muscle control work, and progresses to stretching and strengthening with increasing ROM and resistance. This programme is not a set protocol, rather the physiotherapists are asked to select appropriate exercises from a set of 24 exercises as appropriate for each individual participant.
Participants are provided with a personalised and written exercise prescription that is progressed and revised over treatment sessions, with provision of exercise sheets. Participants are asked to complete their prescribed exercise programme at home, at a frequency and duration deemed appropriate by their treating physiotherapist.
Post-treatment.
Typically, PHT will be delivered over a minimum of 12 weeks. However, in situations where the patient needs additional review, support or guidance, a further four booster sessions with the physiotherapists are permitted between 12 weeks and 6 months.

Participant are provided with a treatment diary to monitor progress with their exercise program and to encourage compliance however this is not compulsory.
Control group
Active

Outcomes
Primary outcome [1] 295619 0
To compare differences in hip joint structure at 12 months using Gadolinium-enhanced magnetic resonance imaging (dGEMRIC).
Timepoint [1] 295619 0
At baseline and 12 months following recruitment
Secondary outcome [1] 316003 0
To measure the clinical effectiveness of hip arthroscopy compared with best conventional care for patients with femoroacetabular impingement, assessed by patient-reported hip-specific quality of life after one year (Hip Outcome Tool-33 (iHOT-33)).
Timepoint [1] 316003 0
This questionnaire will be completed at baseline, 6 and 12 months following recruitment
Secondary outcome [2] 316004 0
To compare differences in general health status and in health-related quality of life after 12 months between treatment groups using Short Form-12.
Timepoint [2] 316004 0
This questionnaire will be completed at baseline, 6 and 12 months following recruitment
Secondary outcome [3] 316006 0
To compare differences in general health status and in health-related quality of life after 12 months between treatment groups using EuroQol EQ-5D.
Timepoint [3] 316006 0
This questionnaire will be completed at baseline, 6 and 12 months following recruitment.
Secondary outcome [4] 316007 0
To compare, in a longitudinal analysis, the pattern of clinical change over 12 months using the iHOT-33
Timepoint [4] 316007 0
This questionnaire will be completed at baseline, 6 and 12 months following recruitment.
Secondary outcome [5] 316008 0
To compare patient satisfaction patient satisfaction with treatment and outcome after one year using a questionnaire designed specifically for this study
Timepoint [5] 316008 0
This questionnaire will be completed at 12 months following recruitment
Secondary outcome [6] 316009 0
To compare the number and severity of adverse events after treatment as a composite outcome. This data will be recorded using an adverse events form designed for the study. Participants will also be asked to complete a 6 weeks complications questionnaire which will provide information on incidence of DVT's , hospitalizations etc
Timepoint [6] 316009 0
Participants will be asked to complete a 6 week complications questionnaire at 6 weeks following commencement of treatment, all adverse events will be summarized at 12 months following recruitment for each patient.
Secondary outcome [7] 316010 0
To compare the need for further procedures up to three years. Participants will be asked to complete a "need for further procedures" questionnaire: a questionnaire designed specifically for this study
Timepoint [7] 316010 0
These questionnaires will be completed at 2 & 3 years following recruitment
Secondary outcome [8] 316011 0
To compare the cost-effectiveness of hip arthroscopy for FAI with best conventional care, within the trial, and for a patient's lifetime
Timepoint [8] 316011 0
3 years following recruitment
Secondary outcome [9] 316014 0
To develop and report processes to optimise recruitment in an RCT or surgery versus non-operative care. The Integrative Qualitative Research (IQR) team will observe a sample of clinicians and patients in each arm to record how the treatment interventions are delivered. Findings will be fed back to the research team so that practice can be reviewed and any necessary training or changes implemented. Numbers of eligible patients, and the percentages of these that are approached about the RCT, consent to be randomised and immediately accept or reject the allocation will be assessed before the plan of action is implemented, and regularly afterwards to check whether rates are improving.

Timepoint [9] 316014 0
3 years following commencement of trial
Secondary outcome [10] 316016 0
To measure fidelity of delivery of interventions. This will be assessed by self-reporting of study surgeons and physiotherapists using surgical and physiotherapy case report forms.
Timepoint [10] 316016 0
At trial close-out
Secondary outcome [11] 316018 0
To compare differences in hip joint structure at 12 months using Hip Osteoarthritis MRI Scoring System (HOAMS) and "HiptoNorm" software analysis for Xrays).
Timepoint [11] 316018 0
At baseline and 12 months following recruitment
Secondary outcome [12] 316019 0
To compare differences in hip joint 3D stress during walking and various functional tasks as related to hip joint structure. Gait analysis software will be used for this purpose.
Timepoint [12] 316019 0
At baseline and 12 months following recruitment
Secondary outcome [13] 316673 0
To compare differences in hip joint structure as related to symptomatic improvements. Hip joint structure will be assessed using dGEMRIC, MRI and Xray outcome scores and symptomatic improvements: iHOT data.
Timepoint [13] 316673 0
At baseline and 12 months following recruitment
Secondary outcome [14] 316674 0
To compare differences in hip muscle activation patterns using EMG
Timepoint [14] 316674 0
At baseline and 12 months following recruitment
Secondary outcome [15] 316676 0
To compare differences in hip joint motion using gait software analysis
Timepoint [15] 316676 0
At baseline and 12 months following recruitment
Secondary outcome [16] 317389 0
To compare hip muscle strength using isometric muscle testing in the gait lab
Timepoint [16] 317389 0
At baseline and 12 months following recruitment
Secondary outcome [17] 318353 0
To compare differences in hip muscle co-contraction patterns using EMG
Timepoint [17] 318353 0
At baseline and 12 months following recruitment
Secondary outcome [18] 318510 0
To compare hip joint contact forces in gait using gait analysis software.
Timepoint [18] 318510 0
At baseline and 12 months following recruitment
Secondary outcome [19] 318511 0
To compare hip joint moments in gait using gait analysis software
Timepoint [19] 318511 0
At baseline and 12 months following recruitment

Eligibility
Key inclusion criteria
1. Age: 16 years or over (no upper age limit)
2. Symptoms of hip pain - patients may also have symptoms of clicking, catching or giving way
3. Radiographic signs, demonstrated on cross sectional imaging following a plain radiograph, of either:
* Cam morphology: Defined as an alpha angle over 55 degrees and/or
* Pincer morphology: Defined as a lateral centre edge angle over 40 degrees or other radiographic signs of pincer; including positive cross over sign
4. The treating surgeon believes the patient would benefit from arthroscopic FAI surgery
5. The patient is able to give written informed consent and to participate fully in the interventions and follow-up procedures
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Evidence of pre-existing osteoarthritis, defined as Tonnis grade >1, or more than 2 mm loss of superior joint space width on AP pelvic radiograph
2. Previous significant hip pathology such as Perthes' disease, slipped upper femoral epiphysis, or avascular necrosis
3. Previous hip injury such as acetabular fracture, hip dislocation or femoral neck fracture
4. Previous shape changing surgery (open or arthroscopic) in the hip being considered for treatment
5. Renal impairment precluding use of contrast injection with MRI
6. Pregnant or breast-feeding patients

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Possible FAI patients (younger adults with hip pain) will be identified by collaborating surgeons from referral letters.
Diagnostic consultation:
Surgeons will assess patients as usual, taking a history, examining the patient, and performing appropriate imaging investigations. Patients in whom a diagnosis of FAI is made, and who meet the eligibility criteria, will receive a description of the condition from their surgeon and an explanation that there are two possible treatments: an operation or a package of personalised hip therapy. They will be given patient information about FAI and the trial. Patients will be invited to a trial information consultation to discuss what action they would like to take.
Trial information consultation:
Patients will attend a Trial Information Consultation with a trained clinical researcher. Information will again be provided about FAI and its possible treatments, and about the trial. Patients will be given an opportunity to ask questions. Patients will then be invited to give their consent to become participants in the trial. Patients who wish to take more time to consider will be given an opportunity to do so. Patients who agree to take part will complete baseline questionnaires at this consultation.
Treatment allocation:
Concealed allocation procedures will involve central randomisation by computer.
Participants will be randomly allocated to arthroscopic surgery or personalised hip therapy by 1:1 secure online randomisation provided by Warwick University Clinical Trials Unit (CTU).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The recruiting centre and FAI type will be used as stratifying factors when randomising. Each time a participant is randomised these factors will be entered into the computer randomisation program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Consecutive consented FASHION participants from Melbourne will be approached for consent for the fine wire EMG substudy: In a subgroup of 20 participants, fine wire electrodes will also be used to assess muscle activation patterns of four deep hip muscles: posterior gluteus medius, piriformis, obturator internus, and quadratus femoris. The use of fine wire electrodes is necessary to reach these small deeper muscles surrounding the hip joint that play a critical role in its function and which cannot be accessed using surface EMG. The insertions into the aforementioned muscles will be performed, under real-time ultrasound guidance, by Professor Paul Hodges who has extensive expertise in the use of this technique. Standard sterile procedures will be used.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The FASHIoN study sites in the UK have based their sample size to provide adequate power for the analysis of the primary outcome (iHOT-33) which was necessary to satisfy the needs of their funding body. The Australian data will be pooled with the UK data to provide greater applicability of the results of the study.
Sample size calculations for the Australian FASHIoN sites are based on those necessary for the primary structural outcomes that will only be investigated at the Australian FASHIoN sites (dGEMRIC imaging indices for hip cartilage). This was based on a statistical power of 90%, and two-sided significance of 5%. With a sample size of 54 patients in each group, we expect to detect a difference of at least 50ms between two study groups at 12 months based on a standard deviation (SD) of 80ms for the dGEMRIC index. 50ms was chosen as clinically significant based upon increased risk of subsequent total hip replacement. Previous research identified an R2 0.2-0.3 between indirect external measures of hip joint loading and hip neck bone density in people with hip OA, when two covariates (weight and height) were included, indicating a moderate relationship between biomechanical and structural measures. We expect higher R2 values, given that we have direct estimates of cartilage stress and strain. Being conservative, however, in order to achieve an R2 > 0.2 between cartilage loading stimulus and dGEMRIC scores (with three covariates), a power of 90%, and two-sided significance level of 5% we require a total of 56 patients at each site. We will therefore aim to recruit a total of 140 participants (70 in Melbourne, 70 in Sydney) for the study in order to allow for a drop-out rate of 20%, including 5% cross over to the surgical group.

The primary analysis will be of differences in baseline and 12 month dGEMRIC indices between the two treatment groups, on an intention-to-treat basis, presented as the mean difference between the trial groups with a 95% confidence interval. The dGEMRIC data will be assumed to be normally distributed; possibly after appropriate variance-stabilising transformation. The stratified randomization procedure should ensure treatment group balance across recruiting centres. We have no reason to expect that clustering effects will be important for this study, but the possibility of such effects will be explored as part of the analysis. We plan to account for clustering by generalizing a conventional linear (fixed-effects) regression approach to a mixed-effects modeling approach; where patients are naturally grouped by recruiting centers (random-effects) and, if amenable to analysis, also by therapist and surgeon. This model will formally incorporate terms that allow for possible heterogeneity in responses for patients due to the recruiting centre, in addition to the fixed effects of the treatment groups, and patient characteristics that may prove to be important moderators of the treatment effect such as age, gender and FAI type. This analysis will be conducted using specialist mixed-effects modeling functions available in the software package R (http://www.r-project.org/). Secondary analyses will be performed using the above strategy for other approximately normally distributed outcome measures including plain radiography, MRI, muscle strength, Full 3D gait analyses, EMG-informed NMS and FEM models, and the symptomatic outcomes (iHOT-33, EuroQoL EQ-5D, and Short-Form-12). Differences in dichotomous outcome variables such as adverse events, complications related to the trial interventions and the need for further procedures will be compared between groups using chi-squared tests (or Fisher’s exact test) and mixed effects logistic regression analysis will be undertaken, adjusting for the stratifying variables, with differences between trial intervention groups quantified as odds ratios (and 95% confidence intervals). The temporal patterns of any complications will be presented graphically and if appropriate a time-to-event analysis (Kaplan-Meier survival analysis) will be used to assess the overall risk and risk within individual classes of complications. Ordinal scores for patient satisfaction will be compared between intervention groups using proportional odds logistic regression analysis, assuming that the estimated intervention effect between any pair of categories is equivalent. Although our inferences will be drawn from the intention-to-treat analysis, we will perform per protocol analyses to place these in context. We plan to perform a subgroup analysis by FAI type because it is likely that treatment effect is moderated by type. We do not anticipate that crossovers will be a major issue for this study. We therefore expect the main analyses to provide definitive results. If not completing (adhering to) or following (complying with) the PHT proves to be more problematic than we expect, we will augment the planned analysis with a complier average causal effect (CACE) analysis.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
17/02/2015
Date of last participant enrolment
Anticipated
30/06/2018
Actual
30/01/2018
Date of last data collection
Anticipated
30/01/2021
Actual
Sample size
Target
140
Accrual to date
Final
99
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
Recruitment hospital [1] 4067 0
Mater Sydney - North Sydney
Recruitment hospital [2] 4068 0
St Vincents & Mercy Private Hospital - Mercy campus - East Melbourne
Recruitment hospital [3] 4069 0
Maroondah Hospital - Ringwood East
Recruitment hospital [4] 4070 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [5] 4495 0
St Luke's Hospital - Potts Point
Recruitment hospital [6] 4524 0
The Sutherland Hospital - Caringbah
Recruitment hospital [7] 4525 0
Calvary Public Hospital ACT - Bruce
Recruitment hospital [8] 4526 0
Norwest Private Hospital - Bella Vista
Recruitment hospital [9] 4527 0
Macquarie University Hospital - Macquarie Park
Recruitment postcode(s) [1] 10015 0
2060 - North Sydney
Recruitment postcode(s) [2] 10016 0
3002 - East Melbourne
Recruitment postcode(s) [3] 10017 0
3135 - Ringwood East
Recruitment postcode(s) [4] 10018 0
2076 - Wahroonga
Recruitment postcode(s) [5] 10688 0
2011 - Potts Point
Recruitment postcode(s) [6] 12133 0
2232 - Sutherland
Recruitment postcode(s) [7] 12134 0
2617 - Bruce
Recruitment postcode(s) [8] 12135 0
2153 - Bella Vista
Recruitment postcode(s) [9] 12137 0
2109 - Macquarie University

Funding & Sponsors
Funding source category [1] 291684 0
Government body
Name [1] 291684 0
National health and Medical Research Council
Country [1] 291684 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 290466 0
None
Name [1] 290466 0
Address [1] 290466 0
Country [1] 290466 0
Other collaborator category [1] 278533 0
University
Name [1] 278533 0
University of Warwick
Address [1] 278533 0
Warwick Clinical Trials Unit
Division of Health Sciences
Warwick Medical School
University of Warwick
Clinical Sciences Research Laboratories
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Country [1] 278533 0
United Kingdom
Other collaborator category [2] 278575 0
University
Name [2] 278575 0
University of Melbourne
Address [2] 278575 0
Parkville VIC 3010
Country [2] 278575 0
Australia
Other collaborator category [3] 278576 0
University
Name [3] 278576 0
Griffith University
Address [3] 278576 0
170 Kessels Road, Nathan QLD 4111
Country [3] 278576 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293213 0
St Vincent's Hospital Sydney HREC
Ethics committee address [1] 293213 0
Ethics committee country [1] 293213 0
Australia
Date submitted for ethics approval [1] 293213 0
Approval date [1] 293213 0
17/11/2014
Ethics approval number [1] 293213 0
HREC/14/SVH/343

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58926 0
Prof David Hunter
Address 58926 0
Rheumatology Department
Royal North Shore Hospital
Pacific Highway, St Leonards,
NSW, 2065
Country 58926 0
Australia
Phone 58926 0
+61 2 94631887
Fax 58926 0
Email 58926 0
david.hunter@sydney.edu.au
Contact person for public queries
Name 58927 0
Jillian Eyles
Address 58927 0
Rheumatology Department
Royal North Shore Hospital
Pacific Highway, St Leonards,
NSW 2065
Country 58927 0
Australia
Phone 58927 0
+61 2 94631773
Fax 58927 0
Email 58927 0
jillian.eyles@sydney.edu.au
Contact person for scientific queries
Name 58928 0
David Hunter
Address 58928 0
Rheumatology Department
Royal North Shore Hospital
Pacific Highway, St Leonards,
NSW, 2065
Country 58928 0
Australia
Phone 58928 0
+61 2 94631887
Fax 58928 0
Email 58928 0
david.hunter@sydney.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProtocol for a multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapy-led care for femoroacetabular impingement (FAI): The Australian FASHIoN trial.2017https://dx.doi.org/10.1186/s12891-017-1767-y
EmbaseMulti-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapist-led care for femoroacetabular impingement (FAI) syndrome on hip cartilage metabolism: the Australian FASHIoN trial.2021https://dx.doi.org/10.1186/s12891-021-04576-z
EmbaseCombined femoral and acetabular version and synovitis are associated with dGEMRIC scores in people with femoroacetabular impingement (FAI) syndrome.2023https://dx.doi.org/10.1002/jor.25568
N.B. These documents automatically identified may not have been verified by the study sponsor.