Clinical trial NCT06398015: Hip Abductor Tendon Repair Versus Sham Surgery
Official title: Open Surgical Reconstruction Versus Open Sham Surgery in the Treatment of Hip Abductor Tendon Tears; A Double Blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rupture of Hip Abductor Tendon (Disorder)
Keywords: orthopedics
hip injuries
rehabilitation
sham surgery
lateral hip pain
hip abductor tendon tear
Lead sponsor: Horsens Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2024-05-03
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Differences in changes in patient-reported pain measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
timeFrame: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Secondary outcomes:
measure: Differences in changes in patient-reported symptoms measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
timeFrame: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
measure: 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)
timeFrame: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
measure: 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)
timeFrame: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
measure: Differences in changes in patient-reported participation in physical activities (PA) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
timeFrame: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
measure: Differences in changes in patient-reported quality of life (QOL) measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)
timeFrame: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
measure: Differences in changes in the patient-reported outcome measure Oxford Hip Score (continuous data)
timeFrame: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
measure: Differences in changes in the patient-reported outcome measure EQ-5D-5L (continuous data)
timeFrame: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
measure: Global Rating of Change (GRoC)
timeFrame: The outcome is conducted at 3- and 6-months post-surgery follow-up.
measure: Differences in changes in lateral hip pain on a numerical pain rating scale (NRS)
timeFrame: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
measure: Differences in changes in the patient-reported outcome measure The Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G) (continuous data)
timeFrame: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
measure: Differences in changes of maximal isometric hip abduction muscle strength (continuous data)
timeFrame: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
measure: Differences in changes of the number of repetitions of a 30 second sit to stand test (continuous data)
timeFrame: From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Other outcomes:
Locations:
city: Horsens
country: Denmark
facility: Horsens Regional Hospital
Study officials:
affiliation: Horsens Regional Hospital; Aarhus University
name: Mathias Høgsholt, PT, PhD.st.
role: PRINCIPAL_INVESTIGATOR
affiliation: Horsens Regional Hospital; Aarhus University
name: Jeppe Lange, MD, PhD
role: STUDY_DIRECTOR
affiliation: Regionshospitalet Horsens
name: Signe Kierkegaard-Brøchner, PhD
role: STUDY_CHAIR
affiliation: Copenhagen University Hospital, Hvidovre
name: Kristian Thorborg, PhD
role: STUDY_CHAIR
affiliation: Regionshospitalet Horsens
name: Marie Bagger Bohn, MD, PhD
role: STUDY_CHAIR
References: