NCT06398015

Hip Abductor Tendon Repair Versus Sham Surgery

Open Surgical Reconstruction Versus Open Sham Surgery in the Treatment of Hip Abductor Tendon Tears; A Double Blinded, Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Horsens Hospital · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a study protocol for a Good Clinical Practice-monitored, double-blinded, randomized, controlled superiority trial with two groups, where the primary endpoint is differences in changes in lateral hip pain 6 months post-surgery. If included in the study, patients will be randomly allocated to one of the two arms: 1. Open surgical reconstruction of the hip abductor tear (rHAT-group) 2. Sham surgery (SHAM-group) Patients will be allocated with a 1:1 ratio using permuted blocks with random varying sizes of 4, 6, and 8. An interim analysis will be performed when 8 patients in each group have completed the primary outcome assessment at 6 months. Post-surgery, the patients in both groups will be guided and instructed in exercises according to their pain levels and functional capacity by an experienced physiotherapist blinded to the allocation. The first 6 post-surgery weeks, rehabilitation is home-based. After the 6-week follow-up, the patients will be referred to further rehabilitation in their home municipality (current standard practice). The patients will be assessed pre-surgery, at 3 months post-surgery, and at the final follow-up at 6 months post-surgery. A physiotherapist blinded to the allocation will test the patients at the abovementioned timepoints. In the trial paper all outcomes conducted will be published. That is, the primary outcome and the following secondary outcomes: The remaining five subscales of the revised HAGOS questionnaire (symptoms, function in daily living, function in sport and recreation, participation in physical activity, quality of life), Oxford Hip Score (OHS), European Questionnaire-5 Dimension (EQ-5D-5L and EQ-VAS), Global Rating of Change (GroC), Lateral hip pain on a numerical rating scale (NRS), The Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G), isometric hip abduction muscle strength, functional capacity by a 30 second Chair Stand Test (30s-CST). The primary aim is to evaluate between-group changes on hip pain based on the subscale "pain" from the patient-reported outcome measure the revised Copenhagen Hip And Groin Outcome Score (HAGOS) from pre-surgery to 6 months post-surgery. Primarily The primary hypothesis: The score in the subscale "pain" on the revised HAGOS will increase more in the intervention group compared to the control group, 6 months post-surgery. A full study protocol will be published and made available.

Conditions

• Rupture of Hip Abductor Tendon (Disorder)

Interventions

Type	Name	Description
PROCEDURE	Surgical reconstruction 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.
PROCEDURE	Sham surgery of hip abductor tendon tear	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.

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-07-01
• Completion: 2027-02-01
• First posted: 2024-05-03
• Last updated: 2024-05-03

Locations

1 site across 1 country: Denmark