CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 45 enrolled
Drug / intervention
Arthroscopic ACL Primary Repair +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03510845
NCT03510845N/ACompleted

Arthroscopic Primary Repair of the Anterior Cruciate Ligament (ACL)

Sultan Qaboos University·interventional·Posted Apr 27, 2018·Updated Sep 1, 2022

In Brief

A clinical study evaluating Arthroscopic ACL Primary Repair and Arthroscopic ACL Reconstruction for Rupture of Anterior Cruciate Ligament. Completed, enrolled 45 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesOman
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedApr 27, 2018
Enrollment StartFeb 1, 2017
Primary CompletionSep 15, 2020
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 8.2 years ago

Interventions

Arthroscopic ACL Primary Repairprocedure

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.

Arthroscopic ACL Reconstructionprocedure

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