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NCT Number: NCT05206838

Achilles Tendon for the Treatment of Gluteus Medius Insufficiency

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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Key information

Conditions

Arthroplasty Complications Atrophy Cardiovascular Diseases Intermittent Claudication Muscle Atrophy Muscle Tear Muscle Weakness Muscular Atrophy Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Mölndal, 431 80, Sweden

Location status: Recruiting

Location contact

Georgios Tsikandylakis, MD, PhD

CONTACT

[email protected]

+4603121000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical reconstruction of gluteus medius with Achilles tendon allograft

Procedure

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

Other names: Homologous Achilles tendon transplant, Gastrocnemius tendon allograft

Primary outcomes

  1. Oxford Hip Score (OHS)

    Time frame: 12 months

    Patient-reported hip function measured in a scale 0-48

Secondary outcomes

  1. Trendelenburg's sign

    Time frame: 12 months

    Presence or abscence of Trendelenburg's sign as binary outcome (yes/no)

  2. Hip abduction torque

    Time frame: 12 months

    Abduction torque in the frontal plane measured in Nm/Kg with gait analysis

  3. University of California Level of Activity (UCLA)

    Time frame: 12 months

    Patient-reported activity level measured with in a rank scale 0-10

  4. 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

  5. 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

  6. Adverse events

    Time frame: 12 months

    All complications resulting in contact with health care provider within one year.

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Collaborators

  • Göteborg University
  • The Swedish Society of Medicine
  • Vastra Gotaland Region

Registry information

Official study title

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

Acronym: HLS

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Jan 25, 2022
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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