None of the screened potential participants were interested in participating.
Open Surgical Reconstruction Versus Open Sham Surgery in the Treatment of Hip Abductor Tendon Tears; A Double Blinded, Randomized Controlled Trial
Sponsor study identifier
interventional
0
1 country
1
Study Start
May 1, 2024
Actual (reported)Primary Completion
June 26, 2026
Actual (reported)Study Completion
June 26, 2026
Actual (reported)This study will examine the effectiveness of open surgical reconstruction in the treatment of patients with hip abductor tendon tears. Patients will be randomly allocated to either the open surgical reconstruction or to a open surgical sham procedure. The primary outcome is patient reported pain measured by the revised Copenhagen Hip And Groin Outcome Score (HAGOS), which will be conducted pre-surgery and at three and six months post-surgery. The six-month follow-up is the primary endpoint.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 26, 2026
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 30, 2024
Actual (reported)May 1, 2024
Actual (reported)May 3, 2024
Actual (reported)June 26, 2026
Actual (reported)June 26, 2026
Actual (reported)Differences in changes in patient-reported pain measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
The subscale "pain" on HAGOS measures the patients perception of hip and/or groin pain. It consist of ten items. A score from 0 to 100 is calculated, where a higher score is indicating lower pain.
From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Differences in changes in patient-reported symptoms measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Differences in changes in patient-reported physical function in daily living (ADL) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Differences in changes in patient-reported physical function in sport and recreational activities (sport/recreation) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Differences in changes in patient-reported participation in physical activities (PA) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Differences in changes in patient-reported quality of life (QOL) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
Surgical reconstruction of hip abductor tendon tear
Sham surgery of hip abductor tendon tear
If the patient is allocated to surgical reconstruction, the incision from the sham surgery is continued into the iliotibial band (ITB) and down to the hip abductor tendon complex/greater trochanter. A standardized reconstruction of the HAT with bone anchors is then performed. This standardized procedure has been used by the surgeons for the last 6 years. The ITB is then closed with looped suture, the subcutaneous tissue sutured with standard resorbable single sutures, the skin stapled and a standard wound dressing is applied.
Horsens Regional Hospital
Horsens, 8700, Denmark
Mathias Høgsholt, PT, PhD.st.
Horsens Regional Hospital; Aarhus University
Jeppe Lange, MD, PhD
Horsens Regional Hospital; Aarhus University
Signe Kierkegaard-Brøchner, PhD
Regionshospitalet Horsens
Kristian Thorborg, PhD
Copenhagen University Hospital, Hvidovre
0 participants (actual enrollment reported by the registry).
First Submitted
April 30, 2024
First Posted
May 3, 2024
From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
If the patient is allocated to sham surgery, the incision will only include the skin and subcutaneous tissue. Subsequently, the subcutaneous tissue will be sutured with standard resorbable single sutures, the skin stapled and a standard wound dressing applied. The patient will be kept in general anesthesia for 10 minutes after the procedure is finalized to mimic a true intervention (to hinder staff or relatives to comment on the duration of the procedure). The normal standard procedure takes approximately 40 minutes.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Marie Bagger Bohn, MD, PhD
Regionshospitalet Horsens
Study Start
May 1, 2024
Actual (reported)Primary Completion
June 26, 2026
Actual (reported)Study Completion
June 26, 2026
Actual (reported)Last Updated
June 30, 2026
Record last verified: 2026-06
What data will be shared: All quantitative individual participant data collected during the trial, after deidentification, and according to current Danish Data Protection Regulation and GDPR. With whom will data be shared: Researchers who provide a methodologically sound proposal. For what types of analyses: To achieve aims in the approved proposal. The abovementioned is based on Data Sharing Statements for Clinical Trial: A Requirement of the ICMJE located at: https://www.icmje.org/news-and-editorials/data\_sharing\_june\_2017.pdf
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Source: ClinicalTrials.gov.
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