Achilles Tendon for the Treatment of Gluteus Medius Insufficiency

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-29

Study Completion Date

2028-12-31

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.

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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.

Conditions

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Arthroplasty Complications Muscle Weakness Muscle Atrophy Muscle Tear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial with the option of crossover in the control group after a certain period of time.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Surgical reconstruction of gluteus medius with Achilles tendon allograft

Intervention Type PROCEDURE

Achilles tendon allograft i fixed between the gluteus medius muscle and the greater trochanter

Physiotherapy

22 patients receive non-operative treatment for their limp with physiotherapy alone during a 12-month period.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Surgical reconstruction of gluteus medius with Achilles tendon allograft

Achilles tendon allograft i fixed between the gluteus medius muscle and the greater trochanter

Intervention Type PROCEDURE

Other Intervention Names

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Homologous Achilles tendon transplant Gastrocnemius tendon allograft

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%