Achilles Tendon for the Treatment of Gluteus Medius Insufficiency

Not Applicable

Recruiting

• Conditions: Muscle Tear; Arthroplasty Complications; Muscle Weakness; Muscle Atrophy
• Interventions: Procedure: Surgical reconstruction of gluteus medius with Achilles tendon allograft

• Registration Number: NCT05206838
• Lead Sponsor: Sahlgrenska University Hospital

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 Timeline

• Study First Submitted: 2021-12-28
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-25
• Study Start: 2022-06-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-05
• Last Update Posted: 2025-04-08
• Primary Completion: 2027-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical reconstruction	Surgical reconstruction of gluteus medius with Achilles tendon allograft	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.

Primary Outcome Measures

Name	Time	Method
Oxford Hip Score (OHS)	12 months	Patient-reported hip function measured in a scale 0-48

Secondary Outcome Measures

Name	Time	Method
University of California Level of Activity (UCLA)	12 months	Patient-reported activity level measured with in a rank scale 0-10
Euroqol 5 dimension 5 level index (EQ5D-5L)	12 months	Patient-reported health-related quality of life measured with swedish version of the euroqol 5 dimension 5 level index in a scale 0-1
Euroqol visual analog scale (EQVAS)	12 months	Patient-reported health-related quality of life measured with the euroqol visual analog scale 0-100
Adverse events	12 months	All complications resulting in contact with health care provider within one year.
Trendelenburg's sign	12 months	Presence or abscence of Trendelenburg's sign as binary outcome (yes/no)
Hip abduction torque	12 months	Abduction torque in the frontal plane measured in Nm/Kg with gait analysis

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Mölndal, Sweden