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

Hip Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06288867
• Other study ID #: FMASU MD28/2024
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2024
• Source: Ain Shams University
• Contact: Karim A Salem, MD
• Phone: 1000017388
• Email: karimatefsalem[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acetabular Labral Tear
• Femoracetabular Impingement
• Femoro Acetabular Impingement
• Hip Injuries

Intervention

Procedure:
• Arthroscopic Labral Repair
Patients with Hip Labral tears will be treated with labral repair
• Arthroscopic Labral Debridement
Patients with Hip Labral tears will be treated with labral debridement

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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