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

NCT06288867 | Recruiting

• 1 other identifier: FMASU MD28/2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hip Injuries; Acetabular Labral Tear; Femoro Acetabular Impingement

Keywords

Hip Arthroscopy; Labral Repair; Labral Debridement; Acetabular Labral Tear

Outcome Measures

Primary Outcomes (3)

• Change from baseline in Hip Function, as measured by Hip Outcome Score (HOS)

  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

• Change from baseline in Hip Function, as measured by Harris Hip Score (HHS)

  \<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)

  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

Study Arms (2)

Labral Repair

ACTIVE COMPARATOR

Labral tears will be repaired with suture anchors.

Procedure: Arthroscopic Labral Repair

Labral Debridement

ACTIVE COMPARATOR

Labral Debridement will be done by electrocautery

Procedure: Arthroscopic Labral Debridement

Interventions

Arthroscopic Labral Repair PROCEDURE

Patients with Hip Labral tears will be treated with labral repair

Labral Repair

Arthroscopic Labral Debridement PROCEDURE

Patients with Hip Labral tears will be treated with labral debridement

Labral Debridement

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Hip Injuries; Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karim A Salem, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karim A Salem, MD

CONTACT

1000017388; karimatefsalem@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2024
• First Posted: March 1, 2024
• Study Start: August 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

EG (1)