Hip Abductor Tendon Repair Versus Sham Surgery

NCT06398015 | Recruiting

• 1 other identifier: 1-16-02-128-24
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Rupture of Hip Abductor Tendon (Disorder)

Keywords

orthopedics; hip injuries; rehabilitation; sham surgery; lateral hip pain; hip abductor tendon tear

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (12)

• 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)

  From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.

Study Arms (2)

rHat-group

EXPERIMENTAL

Surgical reconstruction of hip abductor tendon tear

Procedure: Surgical reconstruction of hip abductor tendon tear

SHAM-group

SHAM COMPARATOR

Sham surgery of hip abductor tendon tear

Procedure: Sham surgery of hip abductor tendon tear

Interventions

Surgical reconstruction of hip abductor tendon tear 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.

rHat-group

Sham surgery of hip abductor tendon tear 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.

SHAM-group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Horsens Hospital: lead
• University of Aarhus: collaborator

Study Sites (1)

Horsens Regional Hospital

Horsens, 8700, Denmark

RECRUITING

MeSH Terms

Conditions

Hip Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Mathias Høgsholt, PT, PhD.st.

  Horsens Regional Hospital; Aarhus University

  PRINCIPAL INVESTIGATOR

• Jeppe Lange, MD, PhD

  Horsens Regional Hospital; Aarhus University

  STUDY DIRECTOR

• Signe Kierkegaard-Brøchner, PhD

  Regionshospitalet Horsens

  STUDY CHAIR

• Kristian Thorborg, PhD

  Copenhagen University Hospital, Hvidovre

  STUDY CHAIR

• Marie Bagger Bohn, MD, PhD

  Regionshospitalet Horsens

  STUDY CHAIR

Central Study Contacts

Mathias Høgsholt, PT, PhD.st.

CONTACT

+45 24205299; mathhg@rm.dk

Jeppe Lange, MD, PhD

CONTACT

jepplang@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients are allocated when in full general anesthesia. Treatment allocation will be blinded in the electronic patient journal, as the surgeon will insert a general description of the surgery. Unblinding at 6 months at the final consultation with the orthopedic surgeon. At the day of the unblinding the patient will be tested in the Department of Physio- and Occupational Therapy before the consultation with the orthopedic surgeon.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 3, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication and ending 5 years following primary article publication.
• Access Criteria: Proposals should be directed to mathhg@rm.dk. To gain access, data requestors will need to sign a data access agreement.

Locations

DK (1)