Achilles Tendon Homograft for the Treatment of Gluteus Medius Insufficiency After Hip Replacement
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Oxford Hip Score (OHS)
Study Overview
Brief Summary
Residual limping after total hip arthroplasty is a serious complication that lacks effective treatment. The purpose of this study is to evaluate a surgical treatment for residual limping and compare its results with non-surgical treatment. Our hypothesis is that surgical treatment followed by physiotherapy increases hip function and reduces limping compared with non-surgical treatment with physiotherapy alone.
Detailed Description
Residual limping due to gluteus medius insufficiency after total hip arthroplasty is a serious complication that lacks effective treatment. The purpose of this study is to evaluate surgical reconstruction of gluteus medius using Achilles tendon allograft and compare its results and adverse events with non-surgical treatment. Our hypothesis is that surgical reconstruction followed by physiotherapy increases hip function and reduces limping compared with non-surgical treatment with physiotherapy alone.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Persisting limping with positive Trendelenburg's sign for at least 12 months after total hip arthroplasty
- •Rupture/avulsion of the gluteus medius tendon verified with ultrasound or MRI
- •Leg length discrepancy of less than 1 cm
- •Femoral offset discrepancy of less than 25%
Exclusion Criteria
- •Neuromuscular disorders
Arms & Interventions
Surgical reconstruction
22 patients undergo surgical reconstruction of gluteus medius with allograft consisting of Achilles tendon with calcaneus block. The calcaneus block is fixed into the greater trochanter and the Achilles tendon i passed through the gluteus medius muscle, tensioned and sutured into the muscle. Postoperatively, partial weight bearing for 2 months followed by physiotherapy for 10 months.
Intervention: Surgical reconstruction of gluteus medius with Achilles tendon allograft (Procedure)
Physiotherapy
22 patients receive non-operative treatment for their limp with physiotherapy alone during a 12-month period.
Outcomes
Primary Outcomes
Oxford Hip Score (OHS)
Time Frame: 12 months
Patient-reported hip function measured in a scale 0-48
Secondary Outcomes
- Hip abduction torque(12 months)
- University of California Level of Activity (UCLA)(12 months)
- Euroqol 5 dimension 5 level index (EQ5D-5L)(12 months)
- Euroqol visual analog scale (EQVAS)(12 months)
- Adverse events(12 months)
- Trendelenburg's sign(12 months)
Investigators
Georgios Tsikandylakis, MD PhD
Senior consultant in orthopaedic surgery
Sahlgrenska University Hospital