Achilles Tendon for the Treatment of Gluteus Medius Insufficiency

Muscle Weakness Clinical Trial

— HLS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05206838
• Other study ID #: 276262
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2022
• Est. completion date: December 2026

Study information

• Verified date: November 2023
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty Complications
• Muscle Atrophy
• Muscle Tear
• Muscle Weakness
• Muscular Atrophy

Intervention

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

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Mölndal

Sponsors (4)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	Göteborg University, The Gothenburg Society of Medicine, Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxford Hip Score (OHS)	Patient-reported hip function measured in a scale 0-48	12 months
Secondary	Trendelenburg's sign	Presence or abscence of Trendelenburg's sign as binary outcome (yes/no)	12 months
Secondary	Hip abduction torque	Abduction torque in the frontal plane measured in Nm/Kg with gait analysis	12 months
Secondary	University of California Level of Activity (UCLA)	Patient-reported activity level measured with in a rank scale 0-10	12 months
Secondary	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	12 months
Secondary	Euroqol visual analog scale (EQVAS)	Patient-reported health-related quality of life measured with the euroqol visual analog scale 0-100	12 months
Secondary	Adverse events	All complications resulting in contact with health care provider within one year.	12 months