Achilles Tendon for the Treatment of Gluteus Medius Insufficiency

N/ARecruitingNCT05206838

Sahlgrenska University Hospital44 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Arthroplasty Complications Muscle Weakness Muscle Atrophy

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Oxford Hip Score (OHS)

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

Time frame: 12 months

Secondary Outcomes

Trendelenburg's sign

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

Time frame: 12 months

Hip abduction torque

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

Time frame: 12 months

University of California Level of Activity (UCLA)

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

Time frame: 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

Time frame: 12 months

Euroqol visual analog scale (EQVAS)

Patient-reported health-related quality of life measured with the euroqol visual analog scale 0-100

Time frame: 12 months

Adverse events

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

Time frame: 12 months

Achilles Tendon for the Treatment of Gluteus Medius Insufficiency

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes