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Arthroscopic Bankart Repair With and Without Remplissage in Anterior Shoulder Instability

NCT01324531 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-04-02

No results posted yet for this study

Summary

The purpose of this prospective, randomized, controlled trial is to compare subjective patient-reported outcomes and objective clinical results between arthroscopic Bankart repair with and without arthroscopic infraspinatus remplissage in patients with anterior shoulder instability with a Hill-Sachs Defect.

Conditions

  • Other Instability, Shoulder
  • Hill-Sachs Lesion

Interventions

PROCEDURE

Bankart repair and remplissage

Bankart repair may be completed before or after remplissage. While maintaining camera in anterior-superior portal drill guide and anchor cannula is placed through the posterior portal into remplissage site. Anchor cannula with obturator is passed through infraspinatus tendon and posterior capsule via pre-existing portal, and first anchor is placed in inferior aspect of Hill-Sachs lesion.Once anchor is inserted, penetrating grasper is passed through tendon and posterior capsule, 1 cm inferior to the initial portal entry site, to grasp and pull 1 suture limb.Second anchor is placed in superior aspect of Hill-Sachs lesion and grasper penetrator is used in same fashion to pass 1 suture limb 1 cm superior to initial portal entry site. The inferior suture is tied first with knots remaining extraarticular in the subdeltoid space. The superior suture is tied to complete remplissage.

PROCEDURE

Bankart repair

Bankart repair based on surgeon's preference

Sponsors & Collaborators

  • University of Ottawa

    collaborator OTHER

  • Western University, Canada

    collaborator OTHER

  • University of British Columbia

    collaborator OTHER

  • Panam Clinic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2019-06-30
Completion
2024-08-31

Countries

  • Canada

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 NCT01324531 on ClinicalTrials.gov