First-line Treatment for Femoroacetabular Impingement Syndrome

Study Overview
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Brief Summary
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There is sparse evidence on the effectiveness of first-line treatment in patients with femoroacetabular impingement syndrome (FAIS) regarding clinical- and cost-effectiveness. The goal of this randomized controlled trial is to compare the clinical effectiveness and cost-effectiveness of a supervised strength exercise intervention to usual first-line care in patients with FAIS. The main hypothesis it aims to investigate are: 6-months of supervised strength exercise intervention is superior (i.e., at least 6 points, on a scale from 0-100) to usual care in improving hip related quality of life in patients with FAIS at the end of intervention. 6-months of supervised strength exercise intervention is cost-effective compared to usual first-line care at 12-month follow-up in patients with FAIS. High exercise adherence and dosage will be superior to low exercise adherence and dosage in mediating clinical effectiveness in patients with FAIS.

Detailed Description
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There is sparse evidence on the effectiveness of first-line treatment in patients with femoroacetabular impingement syndrome (FAIS) regarding clinical- and cost-effectiveness. The Better Hip trial is a multicenter, stratified (by hospital site), randomized (allocation 1:1), controlled, assessor blinded, superiority trial conducted in Denmark (Aarhus, Horsens, Aalborg, and Odense) and Australia (Melbourne). Eligible patients will either be randomized to a supervised strength exercise intervention or to usual care. The primary outcome will be hip-related quality of life measured at end of intervention (6 months) with the iHOT-33. A health economic evaluation will assess the difference in cost-effectiveness between groups from baseline to 12 months. Secondary outcomes will be measured at baseline, 3-, 6- and 12- months after initiating the intervention for patient reported outcome measures (PROMs), and at baseline and 6-months for objective outcome measures obtained at clinical assessments. This trial aims to investigate the clinical and cost-effectiveness of a supervised strength exercise intervention compared to usual care as first-line treatment in patients with FAIS. A secondary aim is to explore how exercise adherence and dosage of a supervised strength exercise intervention mediates outcomes. The investigators hypothesis that; 6-months of supervised strength exercise intervention is superior (i.e., at least 6 points, on a scale from 0-100) to usual care in improving hip related quality of life in patients with FAIS at the end of intervention. 6-months of supervised strength exercise intervention is cost-effective compared to usual first-line care at 12-month follow-up in patients with FAIS. High exercise adherence and dosage will be superior to low exercise adherence and dosage in mediating clinical effectiveness in patients with FAIS. A full trial protocol will be published and made publicly available prior to analysis for the primary paper. All primary and secondary outcomes will be analysed with the intention-to-treat principle. Supplementary to the intention-to-treat analysis a per protocol analysis will be conducted. Between-group differences will be analyzed using a linear mixed effect model for continuous outcomes and a logistical mixed effect model for binary outcome variables. Intervention group, recruitment site and time will be included as fixed effects and patients will be included as a random effect. Incremental cost-effectiveness ratios (ICER) will be calculated by dividing the difference in costs by the difference in effects (quality-adjusted life years for cost-utility and iHOT-33 for cost-effectiveness)

Official Title
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First-line Treatment for Femoroacetabular Impingement Syndrome: a Multicenter Randomized Controlled Trial Comparing a Supervised Strength Exercise Intervention to Usual Care on Hip-related Quality of Life. (Better Hip Trial)

Conditions
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Femoroacetabular Impingement Syndrome

Intervention / Treatment
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* Other: Supervised strength exercise intervention
* Other: Minimal educational intervention (usual care)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Activity- or position-related pain lasting ≥ 3 months Positive Flexion-Adduction-Internal rotation (FADIR) test Cam-type FAIS; x-ray alpha angle > 60 degrees OR crossover-sign Motivated to exercise 2 times a week for 6 months 18-50 years old Body Mass Index (BMI) score < 35 Exclusion Criteria: Physiotherapist-led strengthening exercises targeting the hip for at least 3 months for ≥ 6 sessions prior to inclusion Previous hip surgery or other major hip injury in index hip (i.e., hip arthroscopy, fracture, calves perthes, necrosis or luxation). Evidence of pre-existing osteoarthritis, defined as Tönnis grade ≥ 2 or Kellgreen-Lawrence ≥ 2 Evidence of pre-existing osteoarthritis, defined as lateral joint space width ≥ 3 mm (measured at the lateral sourcil). Hip dysplasia, defined as a Center-Edge-angle (CE-angle) ≤ 25° and an acetabular index > 10° Comorbidities or other problems considered to affect hip function and participation in exercise Unable to perform baseline testing procedures (1 RM unilateral leg press, One Leg Rise Test and Single Leg Hop for Distance) Unable to communicate in the respective languages of the participating countries

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised strength exercise intervention<br>Group 1 | Other: Supervised strength exercise intervention<br>* A 6 months exercise intervention of training 2 times a week. Patients will be instructed by a physiotherapist during the first session, in order to be able to perform the exercises at home or in a local gymnasium based on personal preference. Subsequently, there are supervised sessions once every second week (12 sessions in total). The intervention will consist of 6 exercises. 4 targeting planes of hip movement (i.e., flexion, extension, abduction and adduction), a general lower extremity- and a trunk exercise. Progression is made when an exercise is performed with the designated number of sets and repetitions, with good performance quality and tolerable pain. Progression is provided by 3 levels of difficulty and secondly by the number of repetitions or where possible by increasing the external load. In addition, patient information and education is identical to what is delivered in the usual care group.<br>|
| Active Comparator: Usual care<br>Group 2 | Other: Minimal educational intervention (usual care)<br>* Usual care varies slightly across regions in Denmark and between Denmark and Australia. The consensus is that the patient should be advised to remain physically active and reduce symptom provoking activities. Therefore, minimal educational intervention is provided as usual care. Patients allocated to the usual care group will receive written information in a leaflet on self-management of hip symptoms including advice about staying physically active in accordance with the World Health Organization guidelines on physical activity and sedentary behavior. Moreover, self-management of hip symptoms will include advice to reduce symptoms by focusing on symptom-lowering activities and sports. The content of the information provided as usual care will be identical to the information provided to the patients in the intervention group. Patients in the usual care group can continue to seek any additional treatment they would like and won't be prohibited from doing this.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hip-related quality of life measured by the International Hip and Outcome Tool 33 (iHOT-33) at end of intervention. | The iHOT-33 is a 33-item self-administered valid and reliable outcome measure based on a Visual Analogue Scale response format designed for young and active population with hip pathology. The total score ranges from 0 to 100, with higher scores indicating better hip-related quality of life. | Measured at baseline, 3, 6 and 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle strength measured by the unilateral one-repetition-maximum (1 RM) leg press test at end of intervention. | Maximal lower extremity strength is measured by a 1 RM test in a leg press resistance training machine. | Measured at baseline and 6 months. | 
| Change in functional performance measured by the One-Leg Rise Test (number of repetitions) at end of intervention. | The One-Leg Rise Test is a reliable global measure of lower limb strength and endurance. | Measured at baseline and 6 months. | 
| Change in functional performance measured by the Single leg hop for distance test at end of intervention. | The single-leg hop for distance test is a reliable functional performance test evaluating power generation and absorption. | Measured at baseline and 6 months. | 
| Adherence to the 6 month to the supervised strength exercise intervention measured by a training diary and the Exercise Adherence Rating Scale (EARS). | The total score ranges from 0-24, higher scores indicating higher adherence. | Registered throughout the 6 months intervention by patients and at 6 months follow-up using the Exercise Adherence Rating Scale (EARS). | 
| The highest level of symptoms beyond which patients considers themselves well measured by the Patient Acceptable Symptom State (PASS) | Patient Acceptable Symptom State (PASS), defined as the value beyond which patients consider themselves well is evaluated using a single question. The scale is binary (yes/no). | Measured at baseline, 6 and 12 months. | 
| Global Perceived Effect (GPE) | The GPE will be used as a measure of patient-rated recovery and will be assessed for three domains; pain, activities of daily living, and quality of life rated on a 7-point Likert scale ranging from 'Worse, an important worsening' (worst) to 'Better, an important improvement' (best) | Measured at 6 and 12 months. | 
| AE (Adverse Events) & Serious Adverse Events (SAE) | Continuous registration of health issues and injuries. The events will be monitored by the physiotherapists supervising the exercise sessions. Further, patients will be asked at 6- and 12-month follow-ups about potential AE and SAE using open-probe questions. | Registered throughout the 12-month study period. | 
| Drop-outs | Number of drop-out from the intervention groups. | Registered throughout the 12-month study period. | 
| Hip surgery | Number of hip surgeries within the follow-up period. | Measured at baseline, 3, 6 and 12 months. | 
| Exercise level | Exercise level (1-3), higher level indicating higher level of difficulty in exercises. | Registered throughout the 6 month intervention in the supervised strength exercise intervention. | 
| Number of sets | Number of sets (0-3), higher indicating completion of more sets in each exercise sessions. Number of sets will be used to calculate exercise dosage. | Registered throughout the 6 month intervention in the supervised strength exercise intervention. | 
| Number of repetitions | Number of repetitions, higher indication completion of more repetitions in each exercise session. Number of repetitions will be used to calculate exercise dosage. | Registered throughout the 6 month intervention in the supervised strength exercise intervention. | 
| External load | External load will be used to calculate exercise dosage. | Registered throughout the 6 month intervention in the supervised strength exercise intervention. | 
| Rate of perceived exertion | Rate of perceived exertion (0-10), higher scores indicating larger perceived effort. | Registered throughout the 6 month intervention in the supervised strength exercise intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Femoroacetabular Impingement Syndrome, FAI, Hip, Usual care, Exercise Therapy, Health economic evaluation, Effectiveness