Shoulder DislocationPhase 2/3ASSET 2NCT04022629
ASSET 2 Study: Long-Term Follow-up of a Randomised Control Trial
A Phase 2/3 study testing Arthroscopic Washout Only and Arthroscopic Bankart Repair in people with Shoulder Dislocation, run by Royal Infirmary of Edinburgh at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Shoulder Dislocation
- What is being tested?
- Arthroscopic Washout Only and Arthroscopic Bankart Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2019to 1 Jan 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All patients who had previously enrolled in the previous study shall be considered eligible for inclusion.
- Aged between 25 and 55 years.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Infirmary of Edinburgh
Edinburgh, Scotland, EH16 4SA
About this study
Official title: 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.
Read the 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.
- Conditions
- Shoulder Dislocation
- Being tested
- Arthroscopic Washout Only, Arthroscopic Bankart Repair
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic Washout OnlyProcedure or surgery
To wash out the shoulder joint with a sterile solution through an arthroscope (keyhole surgery) under a general anaesthetic.
Arthroscopic Bankart RepairProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Active comparator | Patients aged between 18-35 years who have sustained a first-time traumatic anterior dislocation of the shoulder. Receives: Procedure: Arthroscopic Washout Only |
| Treatment Group 2 | Active comparator | Patients aged between 18-35 years who have sustained a first-time traumatic anterior dislocation of the shoulder. Receives: Procedure: Arthroscopic Bankart Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent Dislocation
Radiographic evidence of recurrent dislocation
Measured: Up to 20 years post-surgery
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 20 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start1 May 2019
- Primary completion30 Jul 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder DislocationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Infirmary of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liam Yapp, Royal Infirmary of Edinburgh
- Investigators
- Liam Z Yapp, MRCSEd, Principal investigator, NHS Lothian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022629
- Sponsor's protocol ID
- AC19020
- Acronym
- ASSET 2
- Status last verified
- Jan 2020
- First submitted
- 7 Jul 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No patient identifiable data shall be available to anyone other than the study researchers.
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.
PubMed 18381306
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Shoulder Stabilisation Using Endoscopic Techniques (ASSET) 2 Study: Long-Term Follow-up of a Randomised Control Trial
- ClinicalTrials.gov ID
- NCT04022629
- Acronym / sponsor ID
- ASSET 2 / AC19020
- Conditions
- Shoulder Dislocation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Royal Infirmary of EdinburghUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 17 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 | Active comparator | Procedure: Arthroscopic Washout OnlyPatients aged between 18-35 years who have sustained a first-time traumatic anterior dislocation of the shoulder. |
| Treatment Group 2 | Active comparator | Procedure: Arthroscopic Bankart RepairPatients aged between 18-35 years who have sustained a first-time traumatic anterior dislocation of the shoulder. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- All patients who had previously enrolled in the previous study shall be considered eligible for inclusion.
- Aged between 25 and 55 years.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic Washout OnlyTo wash out the shoulder joint with a sterile solution through an arthroscope (keyhole surgery) under a general anaesthetic. | Procedure or surgery | Treatment Group 1 |
| Arthroscopic Bankart RepairTo 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. | Procedure or surgery | Treatment Group 2 |
Primary outcome
Recurrent Dislocation
Time frame: Up to 20 years post-surgery
Radiographic evidence of recurrent dislocation
2 secondary outcomes
Disabilities of Shoulder, elbow and Hand (DASH) scores
Time frame: Up to 20 years post-surgery
Western Ontario Shoulder Instability (WOSI) Index.
Time frame: Up to 20 years post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Background: PubMed 18381306Robinson 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.
- Individual participant dataSharing planned: No. No patient identifiable data shall be available to anyone other than the study researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liam Z Yapp, MRCSEd principal investigator
NHS Lothian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Arthroscopic Washout Only and Arthroscopic Bankart Repair in people with Shoulder Dislocation, run by Royal Infirmary of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent Dislocation (time frame: Up to 20 years post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04022629, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.