Hip Abductor Tendon Repair Versus Sham Surgery

Open Surgical Reconstruction Versus Open Sham Surgery in the Treatment of Hip Abductor Tendon Tears; A Double Blinded, Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Rupture of Hip Abductor Tendon (Disorder)
• Intervention / Treatment: Procedure: Surgical reconstruction of hip abductor tendon tear; Procedure: Sham surgery of hip abductor tendon tear

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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeppe Lange, MD, PhD; Email: jepplang@rm.dk
• Study Contact Backup: Name: Mathias Høgsholt, PT, PhD.st.; Phone Number: +45 24205299; Email: mathhg@rm.dk

Study Locations

• Denmark
  • Horsens, Denmark, 8700
    • Recruiting
    • Horsens Regional Hospital
    • Contact: Mathias Høgsholt, PT,PhD.-st.; Phone Number: +45 24205299; Email: mathhg@rm.dk
    • Contact: Jeppe Lange, MD,PhD.; Email: jepplang@rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rHat-group; Surgical reconstruction of hip abductor tendon tear	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.
Sham Comparator: SHAM-group; Sham surgery of hip abductor tendon tear	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in changes in patient-reported symptoms measured with the revised Copenhagen Hip And Groin Outcome Score (HAGOS) (continuous data)	The subscale "symptoms" on HAGOS measures the patients perception of hip and/or groin pain. It consist of seven items. A score from 0 to 100 is calculated, where a higher score is indicating lower symptoms.	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)	The subscale "ADL" on HAGOS measures the patients perception of hip and/or groin pain. It consist of five items. A score from 0 to 100 is calculated, where a higher score is indicating higher function.	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)	The subscale "sport/recreation" on HAGOS measures the patients perception of hip and/or groin pain. It consist of eight items. A score from 0 to 100 is calculated, where a higher score is indicating higher function.	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)	The subscale "PA" on HAGOS measures the patients perception of hip and/or groin pain. It consist of two items. A score from 0 to 100 is calculated, where a higher score is indicating higher ability to participate in physical activity.	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)	The subscale "QOL" on HAGOS measures the patients perception of hip and/or groin pain. It consist of five items. A score from 0 to 100 is calculated, where a higher score is indicating higher quality of life.	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 the patient-reported outcome measure Oxford Hip Score (continuous data)	Oxford Hip Score (OHS), which consists of 12items. OHS is developed and validated for patients undergoing total hip replacements to access pain and function. It is a composite score ranging from 0 (worst) to 48 (best).	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 the patient-reported outcome measure EQ-5D-5L (continuous data)	European Questionnaire-5 Dimensions (EQ-5D-5L and EQ-VAS) consists of five items and a visual analogue score (VAS), a vertical line on which the patients score their perception of their overall health from 0 to 100 (worst to best)	From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Global Rating of Change (GRoC)	GRoC consists of a 11-point scale, where the patient rates the perceived overall change of the hip condition from "very much better" to "very much worse" . Responses on GRoC will be considered successful if patients scored "moderately better" to "very much better". Global improvement will be measured as the percentage of successful reports.	The outcome is conducted at 3- and 6-months post-surgery follow-up.
Differences in changes in lateral hip pain on a numerical pain rating scale (NRS)	Participants rate their pain on a scale from 0 (no pain) to 10 (worst imaginable). Participants will rate their average pain for the past 14 days during rest and activity.	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 the patient-reported outcome measure The Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G) (continuous data)	The Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G) is validated for patients with gluteal tendinopathy and measures the severity of disability related to the condition. VISA-G consist of eight items and appraise the pain in relation to gluteal tendinopathy by a score from 0-100, where a higher score will indicate lower pain and less disability.	From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Differences in changes of maximal isometric hip abduction muscle strength (continuous data)	Maximal isometric hip abduction strength test measures the maximal voluntary isometric contraction in supine position. The strength will be measured using a fixed dynamometer. Strength will be conducted in Newton, but will be normalised according to the lever arm and body weight, and will be reported as Nm/kg bodyweight.	From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.
Differences in changes of the number of repetitions of a 30 second sit to stand test (continuous data)	Number of repetitions (sits to stand) performed during 30 seconds on a chair with a seat height of 46 cm.	From baseline to 6-months post-surgery follow-up. The outcome is also conducted at 3-months post-surgery follow-up.

Collaborators and Investigators

• Sponsor: Horsens Hospital
• Collaborators: University of Aarhus
• Investigators: Study Chair: Kristian Thorborg, PhD, Copenhagen University Hospital, Hvidovre; Principal Investigator: Mathias Høgsholt, PT, PhD.st., Horsens Regional Hospital; Aarhus University; Study Director: Jeppe Lange, MD, PhD, Horsens Regional Hospital; Aarhus University; Study Chair: Signe Kierkegaard-Brøchner, PhD, Horsens Regional Hospital; Study Chair: Marie Bagger Bohn, MD, PhD, Horsens Regional Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: April 30, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: rehabilitation; orthopedics; lateral hip pain; hip injuries; sham surgery; hip abductor tendon tear
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: 1-16-02-128-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

What data will be shared: All quantitative individual participant data collected during the trial, after deidentification, and according to current Danish Data Protection Regulation and GDPR.

With whom will data be shared: Researchers who provide a methodologically sound proposal.

For what types of analyses: To achieve aims in the approved proposal. The abovementioned is based on Data Sharing Statements for Clinical Trial: A Requirement of the ICMJE located at: https://www.icmje.org/news-and-editorials/data_sharing_june_2017.pdf

• IPD Sharing Time Frame: Immediately following publication and ending 5 years following primary article publication.
• IPD Sharing Access Criteria: Proposals should be directed to mathhg@rm.dk. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No