Achilles Tendon for the Treatment of Gluteus Medius Insufficiency

Study Overview
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Brief Summary
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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
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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.

Official Title
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Achilles Tendon Homograft for the Treatment of Gluteus Medius Insufficiency After Hip Replacement

Conditions
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Arthroplasty Complications, Muscle Weakness, Muscle Tear, Muscle Atrophy

Intervention / Treatment
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* Procedure: Surgical reconstruction of gluteus medius with Achilles tendon allograft


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial with the option of crossover in the control group after a certain period of time.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgical reconstruction<br>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. | Procedure: Surgical reconstruction of gluteus medius with Achilles tendon allograft<br>* Achilles tendon allograft i fixed between the gluteus medius muscle and the greater trochanter<br>* Other names: Gastrocnemius tendon allograft;|
| No Intervention: Physiotherapy<br>22 patients receive non-operative treatment for their limp with physiotherapy alone during a 12-month period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Hip Score (OHS) | Patient-reported hip function measured in a scale 0-48 | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gluteus medius, Limp, Abductor, Trendelenburg