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Completed
NCT05927935
First-line Treatment for Femoroacetabular Impingement Syndrome
Conditions: Femoroacetabular Impingement Syndrome
Sex: All
Ages: 18 Years – 50 Years
Healthy volunteers: No
Phase: NA
Enrollment: 120
Sponsor: University of Aarhus
Location: La Trobe University Melbourne
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.
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
Source: ClinicalTrials.gov (NCT05927935). StuddyBuddy aggregates publicly available trial information.