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Completed

NCT Number: NCT04022629

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.

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Key information

Conditions

Shoulder Dislocation Joint Diseases Joint Dislocations Musculoskeletal Diseases Shoulder Injuries Wounds and Injuries

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Royal Infirmary of Edinburgh

Edinburgh, Scotland, EH16 4SA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroscopic Washout Only

Procedure

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

Arthroscopic Bankart repair

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.

Primary outcomes

  1. Recurrent Dislocation

    Time frame: Up to 20 years post-surgery

    Radiographic evidence of recurrent dislocation

Secondary outcomes

  1. Disabilities of Shoulder, elbow and Hand (DASH) scores

    Time frame: Up to 20 years post-surgery

    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.

  2. Western Ontario Shoulder Instability (WOSI) Index.

    Time frame: Up to 20 years post-surgery

    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.

Sponsors and collaborators

Lead sponsor

Royal Infirmary of Edinburgh

Other

Registry information

Official study title

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

Acronym: ASSET 2

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jul 17, 2019
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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