First-line Treatment for Femoroacetabular Impingement Syndrome

NCT05927935 | Active Not Recruiting

• 1 other identifier: BetterHip
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 5

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

Conditions

Femoroacetabular Impingement Syndrome

Keywords

Femoroacetabular Impingement Syndrome; FAI; Hip; Usual care; Exercise Therapy; Health economic evaluation; Effectiveness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Change in muscle strength measured by the unilateral one-repetition-maximum (1 RM) leg press test at end of intervention.

  Measured at baseline and 6 months.

• Change in functional performance measured by the One-Leg Rise Test (number of repetitions) at end of intervention.

  Measured at baseline and 6 months.

• Change in functional performance measured by the Single leg hop for distance test at end of intervention.

  Measured at baseline and 6 months.

• Exercise level

  Registered throughout the 6 month intervention in the supervised strength exercise intervention.

• Number of sets

  Registered throughout the 6 month intervention in the supervised strength exercise intervention.

Other Outcomes (15)

• Change in symptoms measured by the International Hip and Outcome Tool 33 (iHOT-33) Symptoms subscale.

  Measured at baseline 3, 6 and 12 months.

• Change in sport and recreational activities measured by the International Hip and Outcome Tool 33 (iHOT-33) Sports and Recreational activities subscale.

  Measured at baseline 3, 6 and 12 months.

• Change in job related concerns measured by the International Hip and Outcome Tool 33 (iHOT-33) Job related concerns subscale.

  Measured at baseline 3, 6 and 12 months.

Study Arms (2)

Supervised strength exercise intervention

EXPERIMENTAL

Group 1

Other: Supervised strength exercise intervention

Usual care

ACTIVE COMPARATOR

Group 2

Other: Minimal educational intervention (usual care)

Interventions

Supervised strength exercise intervention OTHER

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.

Supervised strength exercise intervention

Minimal educational intervention (usual care) OTHER

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, patients will receive a referral for physiotherapy and supplementary a minimal educational intervention is provided as usual care. Patients allocated to the usual care group will receive written information 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.

Usual care

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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 communicate in the respective languages of the participating countries

Sponsors & Collaborators

• University of Aarhus: lead
• Horsens Hospital: collaborator
• Aalborg University Hospital: collaborator
• Aarhus University Hospital: collaborator
• Odense University Hospital: collaborator
• La Trobe University: collaborator
• Hvidovre University Hospital: collaborator

Study Sites (5)

La Trobe University

Melbourne, Australia

Location

Orthopaedic Center, Alborg sygehus, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Horsens Regional Hospital

Horsens, 8700, Denmark

Location

Hvidovre Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (1)

• Foldager FN, Kierkegaard-Brochner S, Kemp JL, van Tulder MW, Lund B, Mygind-Klavsen B, Bibby BM, Dalgas U, Mechlenburg I. First-line treatment for femoroacetabular impingement syndrome and hip-related quality of life: study protocol for a multicentre randomised controlled trial comparing a 6-month supervised strength exercise intervention to usual care (the Better Hip Trial). BMJ Open. 2024 Jun 21;14(6):e078726. doi: 10.1136/bmjopen-2023-078726.

  PMID: 38908842 DERIVED

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frederik Foldager, MSc

  Aarhus University Hospital and Aarhus University

  PRINCIPAL INVESTIGATOR

• Inger Mechlenburg, Prof.

  Aarhus University Hospital and Aarhus University

  STUDY DIRECTOR

• Signe Kierkegaard-Brøchner, Postdoc

  Horsens Regional Hospital and Aarhus University

  STUDY DIRECTOR

• Joanne Kemp, Ass. Prof.

  Latrobe Sports Exercise Medicine Research Centre, School of Allied Health, La Trobe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masking is single-blinded to the outcome assessor, whom is unaware of the participant's treatment group. The outcome assessor is blinded to the allocation of the participant´s and participant's are asked not to disclose their allocation during test.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: July 3, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 22, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: When will data be available: Immediately following publication. The data set will be kept for at least 5 years after the last publication of new results in Denmark and 7 years in Australia as per standards in accordance with the Responsible Research Practice at Aarhus University in Denmark and Ethical Standards at Human Research Ethics Committee at Latrobe University in Australia.
• Access Criteria: Researchers who provide a methodologically sound proposal. Data access will be reviewed by the author group. By what mechanism will data be made available: The data will be available via the Aarhus University Institutional Data Access to researchers who meet the criteria for access to confidential data. Restrictions may apply according to EU data transfer legislation. Proposals should be directed to Inger.mechlenburg@clin.au.dk and Frederikfoldager@clin.au.dk. To gain access, data requestors will need to sign a data access agreement. Requesters will be required to sign a Data Access Agreement.

Locations

DK (4); AU (1)