Hip Abductor Tendon Repair Versus Sham Surgery

Last updated: April 30, 2024
Sponsor: Horsens Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Surgical reconstruction of hip abductor tendon tear

Sham surgery of hip abductor tendon tear

Clinical Study ID

NCT06398015
1-16-02-128-24
  • Ages > 30
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Previous hip joint replacement, pelvic osteomies, hip abductor tendon surgery, femoralnailing 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

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: Surgical reconstruction of hip abductor tendon tear
Phase:
Study Start date:
May 01, 2024
Estimated Completion Date:
February 28, 2027

Study 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.

Connect with a study center

  • Horsens Regional Hospital

    Horsens, 8700
    Denmark

    Active - Recruiting

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