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Recruiting NCT05206838

Achilles Tendon for the Treatment of Gluteus Medius Insufficiency

No phase Interventional Arthroplasty Complications Muscle Weakness Muscle Atrophy Muscle Tear

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surgical reconstruction of gluteus medius with Achilles tendon allograft.
Who it may be relevant to
Registry conditions: Arthroplasty Complications, Muscle Weakness, Muscle Atrophy, Muscle Tear. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

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.

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.

Interventions

  • Procedure Surgical reconstruction of gluteus medius with Achilles tendon allograft
    Achilles tendon allograft i fixed between the gluteus medius muscle and the greater trochanter

Primary outcome measures

  • Oxford Hip Score (OHS) [Time frame: 12 months]
Secondary outcome measures (6)
  • Trendelenburg's sign [Time frame: 12 months]
  • Hip abduction torque [Time frame: 12 months]
  • University of California Level of Activity (UCLA) [Time frame: 12 months]
  • Euroqol 5 dimension 5 level index (EQ5D-5L) [Time frame: 12 months]
  • Euroqol visual analog scale (EQVAS) [Time frame: 12 months]
  • Adverse events [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Sweden · 1 center
  • Sahlgrenska University Hospital — Mölndal

Publications

  • Whiteside LA, Roy ME. Incidence and treatment of abductor deficiency during total hip arthroplasty using the posterior approach: repair with direct suture technique and gluteus maximus flap transfer. Bone Joint J. 2019 Jun;101-B(6_Supple_B):116-122. doi: 10.1302/0301-620X.101B6.BJJ-2018-1511.R1. PMID 31146555
  • Ewen AM, Stewart S, St Clair Gibson A, Kashyap SN, Caplan N. Post-operative gait analysis in total hip replacement patients-a review of current literature and meta-analysis. Gait Posture. 2012 May;36(1):1-6. doi: 10.1016/j.gaitpost.2011.12.024. Epub 2012 Mar 10. PMID 22410129
  • Whiteside LA. Surgical technique: Transfer of the anterior portion of the gluteus maximus muscle for abductor deficiency of the hip. Clin Orthop Relat Res. 2012 Feb;470(2):503-10. doi: 10.1007/s11999-011-1975-y. PMID 21796476
  • Fehm MN, Huddleston JI, Burke DW, Geller JA, Malchau H. Repair of a deficient abductor mechanism with Achilles tendon allograft after total hip replacement. J Bone Joint Surg Am. 2010 Oct 6;92(13):2305-11. doi: 10.2106/JBJS.I.01011. PMID 20926725
  • Beard DJ, Harris K, Dawson J, Doll H, Murray DW, Carr AJ, Price AJ. Meaningful changes for the Oxford hip and knee scores after joint replacement surgery. J Clin Epidemiol. 2015 Jan;68(1):73-9. doi: 10.1016/j.jclinepi.2014.08.009. Epub 2014 Oct 31. PMID 25441700

Identifiers

NCT: NCT05206838 · 276262

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗