Clinical trial NCT05206838: Achilles Tendon for the Treatment of Gluteus Medius Insufficiency
Official title: Achilles Tendon Homograft for the Treatment of Gluteus Medius Insufficiency After Hip Replacement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthroplasty Complications
Muscle Weakness
Muscle Atrophy
Muscle Tear
Keywords: Gluteus medius
Limp
Abductor
Trendelenburg
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Göteborg University
name: Vastra Gotaland Region
name: The Swedish Society of Medicine
First posted: 2022-01-25
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with the option of crossover in the control group after a certain period of time.
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Oxford Hip Score (OHS)
timeFrame: 12 months
Secondary outcomes:
measure: Trendelenburg's sign
timeFrame: 12 months
measure: Hip abduction torque
timeFrame: 12 months
measure: University of California Level of Activity (UCLA)
timeFrame: 12 months
measure: Euroqol 5 dimension 5 level index (EQ5D-5L)
timeFrame: 12 months
measure: Euroqol visual analog scale (EQVAS)
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Mölndal
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Georgios Tsikandylakis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: 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.