A 12 Months Prospective Study Comparing Functional Outcome Scores in Hip Arthroscopic Labral Repair Versus Debridement

August 26, 2024 updated by: Karim Atef Salem, Ain Shams University

Arthroscopic Labral Repair Versus Debridement In Hip Labral Tears: A Prospective Comparative Study

This study aims to address hip labral tears and compare between arthroscopic labral repair versus debridement.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Hip arthroscopy will be performed with the patient under general anesthesia. The patient will be placed in supine position, and traction and joint access will be controlled by fluoroscopy. An anterolateral portal and an inferior mid-anterior portal will be used. Any labral, chondral, and/or bony pathology (cam or pincer) will be treated. Labral tears may be debrided or repaired. Labral repairs will be secured with suture anchors.

Patient's functions will be evaluated preoperatively and postoperatively at 1, 3 and 6 months and 1 year and at the last follow-up using the Harris Hip Score (HHS), visual analog score (VAS), Hip Outcome Score Activities-Daily Living Subscale (HOS-ADL), and Sport-Specific Subscale (HOS-SSS).

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Sex: both sexes.
  • Age: 18 years - 60 years.
  • Femoroacetabular impingement (FAI) including all types (cam, pincer, and combined).
  • Traumatic Labral tears

Exclusion Criteria:

  • Previous hip surgery.
  • Hip joint dysplasia, defined by both center edge (CE) angles <25 degrees and Acetabular Index angle >10 degrees.
  • Osteoarthritis grade >2 according to Tönnis classification.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Labral Repair
Labral tears will be repaired with suture anchors.
Procedure: Arthroscopic Labral Repair
Patients with Hip Labral tears will be treated with labral repair
Active Comparator: Labral Debridement
Labral Debridement will be done by electrocautery
Procedure: Arthroscopic Labral Debridement
Patients with Hip Labral tears will be treated with labral debridement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Hip Function, as measured by Harris Hip Score (HHS)
Time Frame: Baseline, 1 year
<70 (poor result), 70-79 (fair result), 80-89 (good result) and >90 (excellent result)
Baseline, 1 year
Change from baseline in Pain, as measured by the Visual Analogue Scale (VAS)
Time Frame: Baseline, 1 year
Scores are measured on a 100 mm VAS. The VAS ranges from 0 to 100 with 0 indicating no pain, and higher scores indicating greater pain
Baseline, 1 year
Change from baseline in Hip Function, as measured by Hip Outcome Score (HOS)
Time Frame: Baseline, 1 year
The HOS is a patient-completed measure that consists of an "Activities of Daily Living" subscale (17 scored items) and a "Sports" subscale (9 scored items) in which the response options are presented as 5-point Likert scales (Scores 0-4). Scores for each subscale range from 0% (least function) to 100% (most function).The highest potential score is 68, a higher score represents a higher level of physical function for both the ADL and sports subscales
Baseline, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Karim A Salem, MD, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 24, 2024

First Submitted That Met QC Criteria

February 24, 2024

First Posted (Actual)

March 1, 2024

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 26, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MD28/2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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