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

NCT ID: NCT06288867

Last Updated: 2024-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-12-01

Brief Summary

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

Detailed Description

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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).

Conditions

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Hip Injuries Acetabular Labral Tear Femoro Acetabular Impingement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Labral Repair

Labral tears will be repaired with suture anchors.

Group Type ACTIVE_COMPARATOR

Arthroscopic Labral Repair

Intervention Type PROCEDURE

Patients with Hip Labral tears will be treated with labral repair

Labral Debridement

Labral Debridement will be done by electrocautery

Group Type ACTIVE_COMPARATOR

Arthroscopic Labral Debridement

Intervention Type PROCEDURE

Patients with Hip Labral tears will be treated with labral debridement

Interventions

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Arthroscopic Labral Repair

Patients with Hip Labral tears will be treated with labral repair

Intervention Type PROCEDURE

Arthroscopic Labral Debridement

Patients with Hip Labral tears will be treated with labral debridement

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Karim Atef Salem

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karim A Salem, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Ain Shams University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Karim A Salem, MD

Role: CONTACT

1000017388 ext. +20

Facility Contacts

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Karim A Salem, MD

Role: primary

1000017388 ext. +20

Other Identifiers

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FMASU MD28/2024

Identifier Type: -

Identifier Source: org_study_id

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