CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 58 enrolled
Drug / intervention
knotted anchors (SutureTak biocomposite 3.0 mm) +1 moredevice
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/NCT02535585
NCT02535585N/ACompleted

Arthroscopic Treatment of Anterior Shoulder Dislocation Using Knotted and Knotless Anchors

University of Sao Paulo·interventional·Posted Aug 28, 2015·Updated Apr 6, 2021

In Brief

A clinical study evaluating knotted anchors (SutureTak biocomposite 3.0 mm) and knotless anchors (PushLock biocomposite 2.9 mm knotless) for Shoulder Dislocation. Completed, enrolled 58 participants across 1 site.

Detailed Summary

The shoulder is the joint that most commonly suffers dislocation, and anterior instability is the most frequent form. Arthroscopic repair is the gold standard for the treatment of recurrent shoulder dislocation. The most commonly used technique is the attachment of glenoid labrum-ligament complex (GLLC) with knotted anchors. In 2001, Thal introduced the concept of tissue fixation using knotless anchors and its applicability for GLLC lesions. Some researchers have published studies using knotless anchors and have compared this technique to the use of knotted anchors, demonstrating similar reconstruction of labral height and functional outcomes, while the recurrence rate is still contradictory. To date, there are no prospective randomized controlled clinical trial comparing these two techniques of GLLC repairs. The researchers aims to compare clinical outcomes and imaging evaluation of patients undergoing GLLC repair arthroscopically with the use of absorbable knotless and knotted anchors.

Study Details

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

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 28, 2015
Enrollment StartFeb 27, 2017
Primary CompletionMar 23, 2020
Study CompletionJan 16, 2021
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 10.8 years ago

Interventions

knotted anchors (SutureTak biocomposite 3.0 mm)device

Arthroscopic repair of the labral lesion with knotted anchors (SutureTak biocomposite 3.0 mm).

knotless anchors (PushLock biocomposite 2.9 mm knotless)device

Arthroscopic repair of the labral lesion with knotless anchors (PushLock biocomposite 2.9 mm knotless)