Hip Abductor Tendon Repair Versus Sham Surgery

NCT ID: NCT06398015

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2027-02-28

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

rHat-group

Surgical reconstruction of hip abductor tendon tear

Group Type: EXPERIMENTAL

Surgical reconstruction of hip abductor tendon tear

Intervention Type: PROCEDURE

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.

SHAM-group

Sham surgery of hip abductor tendon tear

Group Type: SHAM_COMPARATOR

Sham surgery of hip abductor tendon tear

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with an MRI verified hip abductor tendon pathology
• Age 30 years or above
• Lateral hip pain for more than 12 months
• Ability to understand written and verbal Danish

Exclusion Criteria

• Previous hip joint replacement, pelvic osteomies, hip abductor tendon surgery, femoral nailing or iliotibial band surgery
• Pregnancy
• Osteoarthritis of the hip joint on the affected side (Kellgren Lawrence grade +2)
• Rheumatoid disorders
• Inability to attend planned follow-up visits
• Having an ongoing occupational injury insurance case
• Expected lack of compliance due to cognitive issues, alcohol, or drug abuse

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: collaborator

Horsens Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeppe Lange

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mathias Høgsholt, PT, PhD.st.

Role: PRINCIPAL_INVESTIGATOR

Horsens Regional Hospital; Aarhus University

Jeppe Lange, MD, PhD

Role: STUDY_DIRECTOR

Horsens Regional Hospital; Aarhus University

Signe Kierkegaard-Brøchner, PhD

Role: STUDY_CHAIR

Regionshospitalet Horsens

Kristian Thorborg, PhD

Role: STUDY_CHAIR

Copenhagen University Hospital, Hvidovre

Marie Bagger Bohn, MD, PhD

Role: STUDY_CHAIR

Regionshospitalet Horsens

Locations

Horsens Regional Hospital

Horsens, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Mathias Høgsholt, PT, PhD.st.

Role: CONTACT

mathhg@rm.dk

+45 24205299

Jeppe Lange, MD, PhD

Role: CONTACT

jepplang@rm.dk

Facility Contacts

Mathias Høgsholt, PT,PhD.-st.

Role: primary

mathhg@rm.dk

+45 24205299

Jeppe Lange, MD,PhD.

Role: backup

jepplang@rm.dk

Other Identifiers

1-16-02-128-24

Identifier Type: -

Identifier Source: org_study_id