Achilles Tendon for the Treatment of Gluteus Medius Insufficiency (HLS)

November 20, 2023 updated by: Georgios Tsikandylakis, MD PhD, Sahlgrenska University Hospital, Sweden

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Mölndal, Sweden, 431 80
        • Recruiting
        • Sahlgrenska University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Collaborators

Göteborg University
Vastra Gotaland Region
The Gothenburg Society of Medicine

Investigators

  • Principal Investigator: Georgios Tsikandylakis, MD, PhD, Sahlgrenska University Hospital, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 28, 2021

First Submitted That Met QC Criteria

January 11, 2022

First Posted (Actual)

January 25, 2022

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 276262

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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