Arthroscopic Bankart Repair With and Without Remplissage in Anterior Shoulder Instability

NCT01324531 | Active Not Recruiting Phase 2

• 1 other identifier: REMP 01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Bankart repair; remplissage; Hill-Sachs defect; shoulder instability; anterior shoulder instability

Outcome Measures

Primary Outcomes (1)

• Western Ontario Shoulder Instability (WOSI) score

  WOSI score questionnaire is a tool designed for self-assessment of shoulder function for patients with instability problems. Difference between study arm outcomes will be assessed using pre-op WOSI score as a covariate

  24 months post-surgery

Secondary Outcomes (3)

• Simple Shoulder Test

  24 months post-surgery

• American Shoulder and Elbow Society assessment (ASES)

  24 months post-surgery

• Ultrasound imaging

  24 months post-surgery

Study Arms (2)

Bankart repair

ACTIVE COMPARATOR

Procedure: Bankart repair

Bankart repair and remplissage

ACTIVE COMPARATOR

Procedure: Bankart repair and remplissage

Interventions

Bankart repair and remplissage PROCEDURE

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.

Bankart repair and remplissage

Bankart repair PROCEDURE

Bankart repair based on surgeon's preference

Bankart repair

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• must have anterior shoulder instability and Hill-Sachs defect
• must have anterior instability with any engaging Hill Sachs Lesion on CT scan, MRI or ultrasound and no more than 15% glenoid bone loss

You may not qualify if:

• Glenoid defect \>15% of AP diameter of glenoid
• significant shoulder comorbidities (i.e, OA, previous surgery other than previous instability)
• active joint or systemic infection
• significant muscle paralysis
• rotator cuff or Charcot's arthropathy
• significant medical comorbidity that may alter effectiveness of surgical intervention
• major medical illness
• unable to speak French or English
• psychiatric illness that precludes informed consent
• unwilling to be followed for 2 years

Sponsors & Collaborators

• Panam Clinic: lead
• University of Ottawa: collaborator
• Western University, Canada: collaborator
• University of British Columbia: collaborator

Study Sites (2)

Pan Am Clinic

Winnipeg, Manitoba, R3M 3E4, Canada

Location

University of Ottawa/Ottawa Hospital

Ottawa, Ontario, Canada

Location

Related Publications (4)

• Burkhart SS, De Beer JF. Traumatic glenohumeral bone defects and their relationship to failure of arthroscopic Bankart repairs: significance of the inverted-pear glenoid and the humeral engaging Hill-Sachs lesion. Arthroscopy. 2000 Oct;16(7):677-94. doi: 10.1053/jars.2000.17715.

  PMID: 11027751 BACKGROUND

• Burkhart SS, Danaceau SM. Articular arc length mismatch as a cause of failed bankart repair. Arthroscopy. 2000 Oct;16(7):740-4. doi: 10.1053/jars.2000.7794.

  PMID: 11027759 BACKGROUND

• Kropf EJ, Tjoumakaris FP, Sekiya JK. Arthroscopic shoulder stabilization: is there ever a need to open? Arthroscopy. 2007 Jul;23(7):779-84. doi: 10.1016/j.arthro.2007.03.004.

  PMID: 17637415 BACKGROUND

• Woodmass JM, McRae S, Lapner P, Kamikovski I, Jong B, Old J, Marsh J, Dubberley J, Stranges G, Sasyniuk TM, MacDonald PB. Arthroscopic Bankart Repair With Remplissage in Anterior Shoulder Instability Results in Fewer Redislocations Than Bankart Repair Alone at Medium-term Follow-up of a Randomized Controlled Trial. Am J Sports Med. 2024 Jul;52(8):2055-2062. doi: 10.1177/03635465241254063. Epub 2024 Jun 14.

  PMID: 38874505 DERIVED

MeSH Terms

Conditions

Bankart Lesions

Condition Hierarchy (Ancestors)

Shoulder Fractures; Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Head, Orthopaedic Surgery

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: March 29, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2019
• Study Completion: August 1, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-04

Locations

CA (2)