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

Shoulder Dislocation Clinical Trial

— ASSET 2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04022629
• Other study ID #: AC19020
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 1, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: January 2020
• Source: Royal Infirmary of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: January 1, 2020
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Dislocation

Intervention

Procedure:
• Arthroscopic Washout Only
To wash out the shoulder joint with a sterile solution through an arthroscope (keyhole surgery) under a general anaesthetic.
• 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.

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
Royal Infirmary of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent Dislocation	Radiographic evidence of recurrent dislocation	Up to 20 years post-surgery
Secondary	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
Secondary	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