Arthroplasty ComplicationsHLSNCT05206838
Achilles Tendon for the Treatment of Gluteus Medius Insufficiency
A study testing Surgical reconstruction of gluteus medius with Achilles tendon allograft in people with Arthroplasty Complications and Muscle Weakness, run by Sahlgrenska University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Arthroplasty Complications, Muscle Weakness, Muscle Atrophy
- What is being tested?
- Surgical reconstruction of gluteus medius with Achilles tendon allograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSweden
- Study dates
- 29 Jun 2022to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- Neuromuscular disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Mölndal, 431 80
Georgios Tsikandylakis, MD, PhD, +4603121000, tsikandylakis@gmail.com
About this study
Official title: Achilles Tendon Homograft for the Treatment of Gluteus Medius Insufficiency After Hip Replacement
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.
- Being tested
- Surgical reconstruction of gluteus medius with Achilles tendon allograft
- Keywords
- Gluteus medius, Limp, Abductor, Trendelenburg
- Medical subject headings
- Muscle Weakness, Muscular Atrophy, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical reconstruction of gluteus medius with Achilles tendon allograftProcedure or surgery
Also called Homologous Achilles tendon transplant, Gastrocnemius tendon allograft
Achilles tendon allograft i fixed between the gluteus medius muscle and the greater trochanter
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Hip Score (OHS)
Patient-reported hip function measured in a scale 0-48
Measured: 12 months
Secondary outcomes (6)
Trendelenburg's sign
Presence or abscence of Trendelenburg's sign as binary outcome (yes/no)
Measured: 12 months
Hip abduction torque
Abduction torque in the frontal plane measured in Nm/Kg with gait analysis
Measured: 12 months
University of California Level of Activity (UCLA)
Patient-reported activity level measured with in a rank scale 0-10
Measured: 12 months
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
Measured: 12 months
Euroqol visual analog scale (EQVAS)
Patient-reported health-related quality of life measured with the euroqol visual analog scale 0-100
Measured: 12 months
Adverse events
All complications resulting in contact with health care provider within one year.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start29 Jun 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty ComplicationsStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with the option of crossover in the control group after a certain period of time.
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University, Vastra Gotaland Region, The Swedish Society of Medicine
- Responsible party
- Principal investigator, Georgios Tsikandylakis, MD PhD, Sahlgrenska University Hospital
- Investigators
- Georgios Tsikandylakis, MD, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206838
- Sponsor's protocol ID
- 276262
- Acronym
- HLS
- Status last verified
- Apr 2025
- First submitted
- 28 Dec 2021
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 31146555Ewen 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 22410129Whiteside 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 21796476Fehm 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 20926725Beard 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achilles Tendon Homograft for the Treatment of Gluteus Medius Insufficiency After Hip Replacement
- ClinicalTrials.gov ID
- NCT05206838
- Acronym / sponsor ID
- HLS / 276262
- Keywords
- Gluteus medius, Limp, Abductor, Trendelenburg
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Göteborg University, Vastra Gotaland Region, The Swedish Society of Medicine
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial with the option of crossover in the control group after a certain period of time.
| Arm | Type | Receives |
|---|---|---|
| Surgical reconstruction | Experimental | Procedure: Surgical reconstruction of gluteus medius with Achilles tendon allograft22 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. |
| Physiotherapy | No intervention | –22 patients receive non-operative treatment for their limp with physiotherapy alone during a 12-month period. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (1 listed)
- Neuromuscular disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical reconstruction of gluteus medius with Achilles tendon allograftAlso: Homologous Achilles tendon transplant, Gastrocnemius tendon allograftAchilles tendon allograft i fixed between the gluteus medius muscle and the greater trochanter | Procedure or surgery | Surgical reconstruction |
Primary outcome
Oxford Hip Score (OHS)
Time frame: 12 months
Patient-reported hip function measured in a scale 0-48
6 secondary outcomes
Trendelenburg's sign
Time frame: 12 months
Hip abduction torque
Time frame: 12 months
University of California Level of Activity (UCLA)
Time frame: 12 months
Euroqol 5 dimension 5 level index (EQ5D-5L)
Time frame: 12 months
Euroqol visual analog scale (EQVAS)
Time frame: 12 months
Adverse events
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Background: PubMed 31146555Whiteside 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.
- Background: PubMed 22410129Ewen 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.
- Background: PubMed 21796476Whiteside 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.
- Background: PubMed 20926725Fehm 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.
- Background: PubMed 25441700Beard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Georgios Tsikandylakis, MD, PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical reconstruction of gluteus medius with Achilles tendon allograft in people with Arthroplasty Complications and Muscle Weakness, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Hip Score (OHS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05206838, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.