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RecruitingNCT05206838HLSUpdated Apr 8, 2025

Achilles Tendon for the Treatment of Gluteus Medius Insufficiency

An interventional study of Surgical reconstruction of gluteus medius with Achilles tendon allograft in Arthroplasty Complications, Muscle Weakness and Muscle Atrophy, sponsored by Sahlgrenska University Hospital. Recruiting at 1 site in Sweden. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-08.

Sponsored by Sahlgrenska University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2022; still recruiting 4 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

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

Keywords

  • Gluteus medius
  • Limp
  • Abductor
  • Trendelenburg
03

In context

Muscle Weakness

477 studies on the registry are indexed under Muscle Weakness; 73 are open to participants now.

This study's planned enrollment of 44 is close to the median of 44 across 362 interventional studies indexed under Muscle Weakness.

Browse Muscle Weakness studies →

Lead sponsor

Sahlgrenska University Hospital is the lead sponsor of 263 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Neuromuscular disorders
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    Surgical reconstruction

    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

  • No intervention
    Physiotherapy

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

Interventions

  • ProcedureSurgical reconstruction of gluteus medius with Achilles tendon allograft

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

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

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What researchers measure

Primary outcomes

  1. Oxford Hip Score (OHS)

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

    Time frame: 12 months

Secondary outcomes

  1. Trendelenburg's sign

    Presence or abscence of Trendelenburg's sign as binary outcome (yes/no)

    Time frame: 12 months

  2. Hip abduction torque

    Abduction torque in the frontal plane measured in Nm/Kg with gait analysis

    Time frame: 12 months

  3. University of California Level of Activity (UCLA)

    Patient-reported activity level measured with in a rank scale 0-10

    Time frame: 12 months

  4. 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

    Time frame: 12 months

  5. Euroqol visual analog scale (EQVAS)

    Patient-reported health-related quality of life measured with the euroqol visual analog scale 0-100

    Time frame: 12 months

  6. Adverse events

    All complications resulting in contact with health care provider within one year.

    Time frame: 12 months

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Study locations

1 of 1 sites recruiting
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 25441700 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2022 (actual). Primary completion is estimated for Dec 2027, 66 months after the start.

Of 200 non-industry interventional studies with no phase under Muscle Weakness, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's planned 66 months is above that.

Counting every sponsor, half of 212 studies reached it within 12 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 28, 2021
First posted
Jan 25, 2022
StartActual
Jun 29, 2022
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2028
Last update
Apr 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05206838
Collaborators
Göteborg University, Vastra Gotaland Region, The Swedish Society of Medicine
Responsible party
Georgios Tsikandylakis, MD PhD (Senior consultant in orthopaedic surgery, Sahlgrenska University Hospital) — Principal investigator
First posted
Jan 25, 2022
Start date
Jun 29, 2022
Primary completion
Dec 2027 (estimated)
Completion
Dec 2028 (estimated)
Last update
Apr 8, 2025

Study contacts

Georgios Tsikandylakis, MD, PhD
principal investigator · Sahlgrenska University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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