Achilles Tendon for the Treatment of Gluteus Medius Insufficiency

NCT05206838 | Recruiting

• 1 other identifier: 276262
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthroplasty Complications; Muscle Weakness; Muscle Atrophy; Muscle Tear

Keywords

Gluteus medius; Limp; Abductor; Trendelenburg

Outcome Measures

Primary Outcomes (1)

• Oxford Hip Score (OHS)

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

  12 months

Secondary Outcomes (6)

• Trendelenburg's sign

  12 months

• Hip abduction torque

  12 months

• University of California Level of Activity (UCLA)

  12 months

• Euroqol 5 dimension 5 level index (EQ5D-5L)

  12 months

• Euroqol visual analog scale (EQVAS)

  12 months

Study Arms (2)

Surgical reconstruction

EXPERIMENTAL

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

Physiotherapy

NO INTERVENTION

22 patients receive non-operative treatment for their limp with physiotherapy alone during a 12-month period.

Interventions

Surgical reconstruction of gluteus medius with Achilles tendon allograft PROCEDURE

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

Also known as: Homologous Achilles tendon transplant, Gastrocnemius tendon allograft

Surgical reconstruction

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• Neuromuscular disorders

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Göteborg University: collaborator
• Vastra Gotaland Region: collaborator
• The Swedish Society of Medicine: collaborator

Study Sites (1)

Sahlgrenska University Hospital

Mölndal, 431 80, Sweden

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Muscle Weakness; Muscular Atrophy; Intermittent Claudication

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Atrophy; Pathological Conditions, Anatomical; Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Georgios Tsikandylakis, MD, PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant in orthopaedic surgery

Model Details: Randomized controlled trial with the option of crossover in the control group after a certain period of time.

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: January 25, 2022
• Study Start: June 29, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)