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

NCT ID: NCT04022629

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2020-01-01

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.

Conditions

Shoulder Dislocation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment Group 1

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

Group Type: ACTIVE_COMPARATOR

Arthroscopic Washout Only

Intervention Type: PROCEDURE

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

Treatment Group 2

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

Group Type: ACTIVE_COMPARATOR

Arthroscopic Bankart Repair

Intervention Type: 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.

Interventions

Arthroscopic Washout Only

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Infirmary of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Liam Yapp

Specialty Registrar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liam Z Yapp, MRCSEd

Role: PRINCIPAL_INVESTIGATOR

NHS Lothian

Locations

Royal Infirmary of Edinburgh

Edinburgh, Scotland, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 18381306 (View on PubMed)

Other Identifiers

AC19020

Identifier Type: -

Identifier Source: org_study_id