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

Primary Purpose

Shoulder Dislocation

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Arthroscopic Washout Only
Arthroscopic Bankart Repair
Sponsored by
Royal Infirmary of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Dislocation

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Infirmary of Edinburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Treatment Group 1

Treatment Group 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Recurrent Dislocation
Radiographic evidence of recurrent dislocation

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 7, 2019
Last Updated
January 21, 2020
Sponsor
Royal Infirmary of Edinburgh
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1. Study Identification

Unique Protocol Identification Number
NCT04022629
Brief Title
ASSET 2 Study: Long-Term Follow-up of a Randomised Control Trial
Acronym
ASSET 2
Official Title
Acute Shoulder Stabilisation Using Endoscopic Techniques (ASSET) 2 Study: Long-Term Follow-up of a Randomised Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Royal Infirmary of Edinburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Dislocation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group 1
Arm Type
Active Comparator
Arm Description
Patients aged between 18-35 years who have sustained a first-time traumatic anterior dislocation of the shoulder.
Arm Title
Treatment Group 2
Arm Type
Active Comparator
Arm Description
Patients aged between 18-35 years who have sustained a first-time traumatic anterior dislocation of the shoulder.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic Washout Only
Intervention Description
To wash out the shoulder joint with a sterile solution through an arthroscope (keyhole surgery) under a general anaesthetic.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic Bankart Repair
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recurrent Dislocation
Description
Radiographic evidence of recurrent dislocation
Time Frame
Up to 20 years post-surgery
Secondary Outcome Measure Information:
Title
Disabilities of Shoulder, elbow and Hand (DASH) scores
Description
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.
Time Frame
Up to 20 years post-surgery
Title
Western Ontario Shoulder Instability (WOSI) Index.
Description
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.
Time Frame
Up to 20 years post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liam Z Yapp, MRCSEd
Organizational Affiliation
NHS Lothian
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH16 4SA
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No patient identifiable data shall be available to anyone other than the study researchers.
Citations:
PubMed Identifier
18381306
Citation
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.
Results Reference
background

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

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