Arthroscopic Primary Repair of the Anterior Cruciate Ligament (ACL)

NCT03510845 | Completed

• 1 other identifier: 1559
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective cohort study that will be conducted at Sultan Qaboos University Hospital. It aims to determine the outcomes, in terms of, activity level, functional level, subjective knee function, range of motion, stability, and failure, among patients with acute ACL injuries, who undergo arthroscopic primary ACL repair; and to compare these results with patients who undergo arthroscopic ACL reconstruction. To the investigators' knowledge, there is a dearth of studies looking into the outcomes of arthroscopic primary ACL repair and this going to be the first study in the Middle East. The investigators believe that arthroscopic primary ACL repair is superior to arthroscopic ACL reconstruction; and conducting this research project will elucidate the previously abandoned facts about acute ACL repair; and will eventually have a huge impact in the field of orthopedic surgery.

Conditions

Rupture of Anterior Cruciate Ligament

Outcome Measures

Primary Outcomes (1)

• Activity level

  Assessment of activity level by Tegner score. it describes preinjury \& current activity level. The score varies from 0-10: 0 represents sick leave/disability pension because of knee problems while 10 corresponds to participation in national/international elite competitive sports.

  2 years

Secondary Outcomes (1)

• Functional level

  2 years

Other Outcomes (3)

• Subjective knee function

  2 years

• Knee stability

  2 years

• Knee range of motion

  2 years

Study Arms (2)

Repairable ACL tear

EXPERIMENTAL

Patients whose ACL found to be avulsed from its femoral insertion or has a proximal tear, and intra-operatively, found to have a good tissue quality, will undergo arthroscopic ACL primary repair using fiberwires and SwiveLock screw to anchor the ligament into its origin, in the femoral condyle.

Procedure: Arthroscopic ACL Primary Repair

Irreparable ACL tear

OTHER

Patients whose ACL cannot be repaired, will undergo arthroscopic ACL reconstruction using hamstring tendons.

Procedure: Arthroscopic ACL Reconstruction

Interventions

Arthroscopic ACL Primary Repair PROCEDURE

All patients (in both groups) will undergo diagnostic knee arthroscopy at the start of the procedure; those in the experimental arm "repairable ACL tear", whose ACL found to be avulsed from its femoral insertion or has a proximal tear, and intra-operatively, found to have a good tissue quality, will undergo arthroscopic ACL primary repair using fiberwires and SwiveLock screw to anchor the ligament into its origin, in the femoral condyle.

Also known as: Diagnostic knee arthroscopy

Repairable ACL tear

Arthroscopic ACL Reconstruction PROCEDURE

Patients whose ACL cannot be repaired, will undergo arthroscopic ACL reconstruction using hamstring tendons.

Also known as: Diagnostic knee arthroscopy

Irreparable ACL tear

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Acute ACL injuries. i.e., within 3 month.
• ACL rupture from its femoral attachment or a proximal tear close to it
• Concomitant meniscal injuries

You may not qualify if:

• Chronic ACL injuries
• Mid-substance ACL tears
• Previous surgery on the injured knee
• Associated knee pathology (e.g. infection; fractures, osteoarthritis, etc).

Sponsors & Collaborators

• Sultan Qaboos University: lead

Study Sites (1)

Sultan Qaboos University Hospital

Muscat, 123, Oman

Location

Related Publications (25)

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• DiFelice GS, van der List JP. Arthroscopic Primary Repair of Proximal Anterior Cruciate Ligament Tears. Arthrosc Tech. 2016 Sep 19;5(5):e1057-e1061. doi: 10.1016/j.eats.2016.05.009. eCollection 2016 Oct.

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MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: April 27, 2018
• Study Start: February 1, 2017
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: September 1, 2022

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

OM (1)