ASSET 2 Study: Long-Term Follow-up of a Randomised Control Trial

NCT04022629 | Completed Phase 2

• 1 other identifier: AC19020
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to measure the long-term efficacy of arthroscopic Bankart repair for first-time anterior shoulder dislocation in terms of recurrent instability and functional outcome.

Conditions

Shoulder Dislocation

Outcome Measures

Primary Outcomes (1)

• Recurrent Dislocation

  Radiographic evidence of recurrent dislocation

  Up to 20 years post-surgery

Secondary Outcomes (2)

• Disabilities of Shoulder, elbow and Hand (DASH) scores

  Up to 20 years post-surgery

• Western Ontario Shoulder Instability (WOSI) Index.

  Up to 20 years post-surgery

Study Arms (2)

Treatment Group 1

ACTIVE COMPARATOR

Patients aged between 18-35 years who have sustained a first-time traumatic anterior dislocation of the shoulder.

Procedure: Arthroscopic Washout Only

Treatment Group 2

ACTIVE COMPARATOR

Patients aged between 18-35 years who have sustained a first-time traumatic anterior dislocation of the shoulder.

Procedure: Arthroscopic Bankart Repair

Interventions

Arthroscopic Washout Only PROCEDURE

To wash out the shoulder joint with a sterile solution through an arthroscope (keyhole surgery) under a general anaesthetic.

Treatment Group 1

Arthroscopic Bankart Repair PROCEDURE

To repair the torn glenoid labrum in the shoulder, using key-hole (arthroscopic) surgery techniques under general anaesthetic. The Bankart technique is well described and will be performed using suture anchors.

Treatment Group 2

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 25 and 55 years.

You may not qualify if:

• Patients will be excluded from this long-term follow-up if no contact details are available or if they no longer retained the capacity to provide consent to participate in the study

Sponsors & Collaborators

• Royal Infirmary of Edinburgh: lead

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Scotland, EH16 4SA, United Kingdom

Location

Related Publications (1)

• Robinson CM, Jenkins PJ, White TO, Ker A, Will E. Primary arthroscopic stabilization for a first-time anterior dislocation of the shoulder. A randomized, double-blind trial. J Bone Joint Surg Am. 2008 Apr;90(4):708-21. doi: 10.2106/JBJS.G.00679.

  PMID: 18381306 BACKGROUND

MeSH Terms

Conditions

Shoulder Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Study Officials

• Liam Z Yapp, MRCSEd

  NHS Lothian

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialty Registrar

Study Record Dates

• First Submitted: July 7, 2019
• First Posted: July 17, 2019
• Study Start: May 1, 2019
• Primary Completion: July 30, 2019
• Study Completion: January 1, 2020
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)