Clinical trial NCT05927935: First-line Treatment for Femoroacetabular Impingement Syndrome
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Femoroacetabular Impingement Syndrome
Keywords: Femoroacetabular Impingement Syndrome
FAI
Hip
Usual care
Exercise Therapy
Health economic evaluation
Effectiveness
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Horsens Hospital
name: Aalborg University Hospital
name: Aarhus University Hospital
name: Odense University Hospital
name: La Trobe University
name: Hvidovre University Hospital
First posted: 2023-07-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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:

1. 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.
2. 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.
3. High exercise adherence and dosage will be superior to low exercise adherence and dosage in mediating clinical effectiveness in patients with FAIS.

Detailed description: 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;

1. 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.
2. 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.
3. 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)

Eligibility criteria: Inclusion Criteria:

1. Activity- or position-related pain lasting ≥ 3 months
2. Positive Flexion-Adduction-Internal rotation (FADIR) test
3. Cam-type FAIS; x-ray alpha angle =\> 60 degrees
4. Pincer-type FAIS; lateral center edge angle \> 39 degrees or crossover-sign
5. Mixed-type FAIS; a combination of cam- and pincer-type impingement
6. Motivated to exercise 2 times a week for 6 months
7. 18-50 years old
8. Body Mass Index (BMI) score \< 35

Exclusion Criteria:

1. Physiotherapist-led strengthening exercises targeting the hip for at least 3 months for ≥ 6 sessions prior to inclusion
2. Previous hip surgery or other major hip injury in index hip (i.e., hip arthroscopy, fracture, calves perthes, necrosis or luxation).
3. Evidence of pre-existing osteoarthritis, defined as Tönnis grade ≥ 2 or Kellgreen-Lawrence ≥ 2
4. Evidence of pre-existing osteoarthritis, defined as lateral joint space width ≥ 3 mm (measured at the lateral sourcil).
5. Hip dysplasia, defined as a Center-Edge-angle (CE-angle) ≤ 25° and an acetabular index \> 10°
6. Comorbidities or other problems considered to affect hip function and participation in exercise
7. Unable to communicate in the respective languages of the participating countries

Primary outcomes:
measure: Change in hip-related quality of life measured by the International Hip and Outcome Tool 33 (iHOT-33) at end of intervention.
timeFrame: Measured at baseline, 3, 6 and 12 months.
Secondary outcomes:
measure: Change in muscle strength measured by the unilateral one-repetition-maximum (1 RM) leg press test at end of intervention.
timeFrame: Measured at baseline and 6 months.
measure: Change in functional performance measured by the One-Leg Rise Test (number of repetitions) at end of intervention.
timeFrame: Measured at baseline and 6 months.
measure: Change in functional performance measured by the Single leg hop for distance test at end of intervention.
timeFrame: Measured at baseline and 6 months.
measure: Exercise level
timeFrame: Registered throughout the 6 month intervention in the supervised strength exercise intervention.
measure: Number of sets
timeFrame: Registered throughout the 6 month intervention in the supervised strength exercise intervention.
measure: Number of repetitions
timeFrame: Registered throughout the 6 month intervention in the supervised strength exercise intervention.
measure: External load
timeFrame: Registered throughout the 6 month intervention in the supervised strength exercise intervention.
measure: Rate of perceived exertion
timeFrame: Registered throughout the 6 month intervention in the supervised strength exercise intervention.
measure: The highest level of symptoms beyond which patients considers themselves well measured by the Patient Acceptable Symptom State (PASS)
timeFrame: Measured at baseline, 6 and 12 months.
measure: Global Perceived Effect (GPE)
timeFrame: Measured at 6 and 12 months.
measure: Hip surgery
timeFrame: Measured at baseline, 3, 6 and 12 months.
measure: AE (Adverse Events) & Serious Adverse Events (SAE)
timeFrame: Registered throughout the 12-month study period.
measure: Drop-outs
timeFrame: Registered throughout the 12-month study period.
Other outcomes:
measure: Change in symptoms measured by the International Hip and Outcome Tool 33 (iHOT-33) Symptoms subscale.
timeFrame: Measured at baseline 3, 6 and 12 months.
measure: Change in sport and recreational activities measured by the International Hip and Outcome Tool 33 (iHOT-33) Sports and Recreational activities subscale.
timeFrame: Measured at baseline 3, 6 and 12 months.
measure: Change in job related concerns measured by the International Hip and Outcome Tool 33 (iHOT-33) Job related concerns subscale.
timeFrame: Measured at baseline 3, 6 and 12 months.
measure: Change in social, emotional and lifestyle concerns measured by the International Hip and Outcome Tool 33 (iHOT-33) Social, Emotional and Lifestyle concerns subscale.
timeFrame: Measured at baseline 3, 6 and 12 months.
measure: Change in pain measured by the The Copenhagen Hip and Groin Outcome Score (HAGOS) Pain subscale.
timeFrame: Measured at baseline and 6 months.
measure: Change Quality of Life measured by the HAGOS Quality of Life subscale.
timeFrame: Measured at baseline and 6 months.
measure: Change in physical function measured by the HAGOS Physical function in Sport and Recreation subscale
timeFrame: Measured at baseline and 6 months.
measure: Sports participation measured by The Hip Sports Activity Scale (HSAS).
timeFrame: Measured at baseline, 6 and 12 months.
measure: Sports participation measured by Return to Sport (RTS) question.
timeFrame: Measured at 6 and 12 months.
measure: Physical activity measured by The short questionnaire to assess health-enhancing physical activity (SQUASH).
timeFrame: Measured at baseline, 6 and 12 months.
measure: Pain catastrophizing measured by the Tampa Scale of Kinesiophobia 17 items (TSK-17).
timeFrame: Measured at baseline, 6 and 12 months.
measure: Change in health outcome measured by the EuroQol Group 5-dimension 5 Level (EQ-5D-5L).
timeFrame: Measured at baseline, 3, 6 and 12 months.
measure: Change in health outcome measured by the EuroQol Group VAS (EQ-VAS)
timeFrame: Measured at baseline, 3, 6 and 12 months.
measure: Productivity losses measured by the Productivity Costs Questionnaire (IPCQ)
timeFrame: Measured at baseline, 3, 6 and 12 months.
measure: Healthcare and medicine usage measured by the Healthcare Utilization Questionnaire (HUQ)
timeFrame: Measured at baseline, 3, 6 and 12 months.
Locations:
city: Melbourne
country: Australia
facility: La Trobe University
city: Odense
country: Denmark
facility: Odense University Hospital
state: Region of Southern Denmark
city: Aalborg
country: Denmark
facility: Orthopaedic Center, Alborg sygehus, Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Horsens
country: Denmark
facility: Horsens Regional Hospital
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
Study officials:
affiliation: Aarhus University Hospital and Aarhus University
name: Frederik Foldager, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital and Aarhus University
name: Inger Mechlenburg, Prof.
role: STUDY_DIRECTOR
affiliation: Horsens Regional Hospital and Aarhus University
name: Signe Kierkegaard-Brøchner, Postdoc
role: STUDY_DIRECTOR
affiliation: Latrobe Sports Exercise Medicine Research Centre, School of Allied Health, La Trobe University
name: Joanne Kemp, Ass. Prof.
role: STUDY_DIRECTOR
References: