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Arthroscopic Treatment of Anterior Shoulder Dislocation Using Knotted and Knotless Anchors

NCT02535585 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2021-04-06

No results posted yet for this study

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.

Conditions

  • Shoulder Dislocation

Interventions

DEVICE

knotted anchors (SutureTak biocomposite 3.0 mm)

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

DEVICE

knotless anchors (PushLock biocomposite 2.9 mm knotless)

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

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-27
Primary Completion
2020-03-23
Completion
2021-01-16

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02535585 on ClinicalTrials.gov