Hip Abductor Tendon Repair Versus Sham Surgery

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)

Interventions

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.

Sponsors & Collaborators

• University of Aarhus

  collaborator OTHER

• Horsens Hospital

  lead OTHER

Principal Investigators

• 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

• Marie Bagger Bohn, MD, PhD · Regionshospitalet Horsens

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-01

Primary Completion

2026-07-31

Completion

2027-02-28

Countries

• Denmark

Study Locations