Health TrialsbyHealthPanel

Achilles Tendon for the Treatment of Gluteus Medius Insufficiency

ConditionsArthroplasty ComplicationsMuscle WeaknessMuscle AtrophyMuscle Tear
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorSahlgrenska University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%

Disqualifiers

Neuromuscular disorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • Surgical reconstruction of gluteus medius with Achilles tendon allograft

    Procedure/Surgery

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

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Surgical reconstructionExperimental treatment 1 intervention
Group B: PhysiotherapyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Oxford Hip Score (OHS)

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

Time frame
12 months

Secondary outcomes

1

Trendelenburg's sign

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

Time frame
12 months
2

Hip abduction torque

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

Time frame
12 months
3

University of California Level of Activity (UCLA)

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

Time frame
12 months
4

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

Other outcomes

Sponsors and contacts

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Sahlgrenska University Hospital

Lead sponsor

Göteborg University

Collaborator

Vastra Gotaland Region

Collaborator

The Swedish Society of Medicine

Collaborator

Source ClinicalTrials.gov
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