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

Phase 2

Completed

• Conditions: Shoulder Dislocation
• Interventions: Procedure: Arthroscopic Washout Only; Procedure: Arthroscopic Bankart Repair

• Registration Number: NCT04022629
• Lead Sponsor: Royal Infirmary of Edinburgh

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.

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 Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2019-07-07
• Study First Submitted QC: 2019-07-13
• Study First Posted: 2019-07-17
• Primary Completion: 2019-07-30
• Status Verified: 2020-01
• Study Completion: 2020-01-01
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group 1	Arthroscopic Washout Only	Patients aged between 18-35 years who have sustained a first-time traumatic anterior dislocation of the shoulder.
Treatment Group 2	Arthroscopic Bankart Repair	Patients aged between 18-35 years who have sustained a first-time traumatic anterior dislocation of the shoulder.

Primary Outcome Measures

Name	Time	Method
Recurrent Dislocation	Up to 20 years post-surgery	Radiographic evidence of recurrent dislocation

Secondary Outcome Measures

Name	Time	Method
Disabilities of Shoulder, elbow and Hand (DASH) scores	Up to 20 years post-surgery	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.
Western Ontario Shoulder Instability (WOSI) Index.	Up to 20 years post-surgery	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.

Trial Locations

Locations (1)

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, Scotland, United Kingdom