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

Acute Shoulder Stabilisation Using Endoscopic Techniques (ASSET) 2 Study: Long-Term Follow-up of a Randomised Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Dislocation
• Intervention / Treatment: Procedure: Arthroscopic Washout Only; Procedure: Arthroscopic Bankart Repair

Detailed Description

Approximately half of patients who experience a dislocation of their shoulder will go on to experience further problems with their shoulder. Some people will suffer persisting instability, and notice an uncomfortable feeling of their shoulder wanting to give way. This can occur commonly during active movements such as playing sports or lifting heavy objects. Some patients experience recurrent dislocations, and find that their shoulder is so weak that it slips out of joint with little provocation.

Previous research suggested that this high rate of subsequent shoulder problems can be greatly reduced (although not abolished completely) by surgery performed soon after the first dislocation. Ten years ago, there were two different methods which had been popularised:

1. Arthroscopic Wash-Out: The first is to wash out the shoulder joint with a sterile solution through an arthroscope (keyhole surgery) under a general anaesthetic.
2. Arthroscopic Repair: The second is to repair the torn tissues in the shoulder, again using key-hole surgery techniques under general anaesthetic.

A previous clinical trial was undertaken in our unit (2001-2005) which randomised young patients aged under 35 years to one of the two possible treatments (described above). These procedures were not new or experimental. The same Arthroscopic Repair technique continues to be routinely used in NHS Lothian to treat patients who have late problems following a dislocated shoulder. We do not routinely perform wash-outs of the shoulder joint because this is only effective in treating problems that occur at an early stage.This new study intends to build on these findings by asking each of the patient groups to complete a short questionnaire which uses validated outcomes to measure their shoulder function. The aim of the study is to identify if there is a long-term clinical and functional benefit of early arthroscopic shoulder stabilisation in high-risk patients.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United Kingdom
  • Scotland
    • Edinburgh, Scotland, United Kingdom, EH16 4SA
      • Royal Infirmary of Edinburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients who had previously enrolled in the previous study shall be considered eligible for inclusion.
• Aged between 25 and 55 years.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment Group 1; Patients aged between 18-35 years who have sustained a first-time traumatic anterior dislocation of the shoulder.	Procedure: Arthroscopic Washout Only; To wash out the shoulder joint with a sterile solution through an arthroscope (keyhole surgery) under a general anaesthetic.
Active Comparator: Treatment Group 2; Patients aged between 18-35 years who have sustained a first-time traumatic anterior dislocation of the shoulder.	Procedure: Arthroscopic Bankart Repair; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent Dislocation	Radiographic evidence of recurrent dislocation	Up to 20 years post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disabilities of Shoulder, elbow and Hand (DASH) scores	Objective validated measure of general upper limb function. Comparison between pre-operative, 2 year post-operative and long-term (10-20 year) post-operative total score of each cohort. Score calculated to give a total out of 100. The lower the score, the better the function.	Up to 20 years post-surgery
Western Ontario Shoulder Instability (WOSI) Index.	Objective validated measure of instability-specific shoulder function. Comparison between pre-operative, 2 year post-operative and long-term (10-20 year) post-operative total score of each cohort. Total score is out of 2100.	Up to 20 years post-surgery

Collaborators and Investigators

• Sponsor: Royal Infirmary of Edinburgh
• Investigators: Principal Investigator: Liam Z Yapp, MRCSEd, NHS Lothian

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): July 30, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: July 7, 2019
• First Submitted That Met QC Criteria: July 13, 2019
• First Posted (Actual): July 17, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 21, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Shoulder Dislocation
• Other Study ID Numbers: AC19020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No patient identifiable data shall be available to anyone other than the study researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No