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Achilles Tendon for the Treatment of Gluteus Medius Insufficiency (HLS)

Primary Purpose

Arthroplasty Complications, Muscle Weakness, Muscle Atrophy

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Surgical reconstruction of gluteus medius with Achilles tendon allograft
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthroplasty Complications focused on measuring Gluteus medius, Limp, Abductor, Trendelenburg

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sahlgrenska University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Surgical reconstruction

Physiotherapy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Oxford Hip Score (OHS)
Patient-reported hip function measured in a scale 0-48

Secondary Outcome Measures

Trendelenburg's sign
Presence or abscence of Trendelenburg's sign as binary outcome (yes/no)
Hip abduction torque
Abduction torque in the frontal plane measured in Nm/Kg with gait analysis
University of California Level of Activity (UCLA)
Patient-reported activity level measured with in a rank scale 0-10
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
Euroqol visual analog scale (EQVAS)
Patient-reported health-related quality of life measured with the euroqol visual analog scale 0-100
Adverse events
All complications resulting in contact with health care provider within one year.

Full Information

First Posted
December 28, 2021
Last Updated
October 24, 2022
Sponsor
Sahlgrenska University Hospital, Sweden
Collaborators
Göteborg University, Vastra Gotaland Region, The Gothenburg Society of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05206838
Brief Title
Achilles Tendon for the Treatment of Gluteus Medius Insufficiency
Acronym
HLS
Official Title
Achilles Tendon Homograft for the Treatment of Gluteus Medius Insufficiency After Hip Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2022 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
Collaborators
Göteborg University, Vastra Gotaland Region, The Gothenburg Society of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroplasty Complications, Muscle Weakness, Muscle Atrophy, Muscle Tear
Keywords
Gluteus medius, Limp, Abductor, Trendelenburg

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with the option of crossover in the control group after a certain period of time.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical reconstruction
Arm Type
Experimental
Arm Description
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.
Arm Title
Physiotherapy
Arm Type
No Intervention
Arm Description
22 patients receive non-operative treatment for their limp with physiotherapy alone during a 12-month period.
Intervention Type
Procedure
Intervention Name(s)
Surgical reconstruction of gluteus medius with Achilles tendon allograft
Other Intervention Name(s)
Homologous Achilles tendon transplant, Gastrocnemius tendon allograft
Intervention Description
Achilles tendon allograft i fixed between the gluteus medius muscle and the greater trochanter
Primary Outcome Measure Information:
Title
Oxford Hip Score (OHS)
Description
Patient-reported hip function measured in a scale 0-48
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Trendelenburg's sign
Description
Presence or abscence of Trendelenburg's sign as binary outcome (yes/no)
Time Frame
12 months
Title
Hip abduction torque
Description
Abduction torque in the frontal plane measured in Nm/Kg with gait analysis
Time Frame
12 months
Title
University of California Level of Activity (UCLA)
Description
Patient-reported activity level measured with in a rank scale 0-10
Time Frame
12 months
Title
Euroqol 5 dimension 5 level index (EQ5D-5L)
Description
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
Title
Euroqol visual analog scale (EQVAS)
Description
Patient-reported health-related quality of life measured with the euroqol visual analog scale 0-100
Time Frame
12 months
Title
Adverse events
Description
All complications resulting in contact with health care provider within one year.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georgios Tsikandylakis, MD, PhD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Mölndal
ZIP/Postal Code
431 80
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georgios Tsikandylakis, MD, PhD
Phone
+4603121000
Email
tsikandylakis@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31146555
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.
Results Reference
background
PubMed Identifier
22410129
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.
Results Reference
background
PubMed Identifier
21796476
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.
Results Reference
background
PubMed Identifier
20926725
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.
Results Reference
background
PubMed Identifier
25441700
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.
Results Reference
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Achilles Tendon for the Treatment of Gluteus Medius Insufficiency

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