Clinical trial NCT04022629: ASSET 2 Study: Long-Term Follow-up of a Randomised Control Trial
Official title: Acute Shoulder Stabilisation Using Endoscopic Techniques (ASSET) 2 Study: Long-Term Follow-up of a Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Shoulder Dislocation
Lead sponsor: Royal Infirmary of Edinburgh
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 88
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Recurrent Dislocation
timeFrame: Up to 20 years post-surgery
Secondary outcomes:
measure: Disabilities of Shoulder, elbow and Hand (DASH) scores
timeFrame: Up to 20 years post-surgery
measure: Western Ontario Shoulder Instability (WOSI) Index.
timeFrame: Up to 20 years post-surgery
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
state: Scotland
Study officials:
affiliation: NHS Lothian
name: Liam Z Yapp, MRCSEd
role: PRINCIPAL_INVESTIGATOR
References:
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.