A comparison of conservative management with external rotation bracing versus arthroscopic surgical treatment for shoulder dislocation in young people

Modified conservative management with external rotation bracing versus early arthroscopic surgical intervention amongst 16 to 30 year olds with primary anterior shoulder dislocation: a randomised controlled trial to compare shoulder stability, clinical efficacy and quality of life

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000442808

Enrollment

Registered

2012-04-18

Start date

2012-05-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of the study is to determine the clinical outcomes and effectiveness of two randomly allocated treatments used to manage acute anterior shoulder dislocations: six weeks of external rotation bracing versus early arthroscopic shoulder stabilisation intervention. It is hypothesised that the arthroscopic shoulder stabilisation surgery may lead to better patient outcomes compared with the external rotation bracing on the basis that evidence for external rotation bracing is still emerging and (although promising) has not yet been established with as much rigor as arthroscopic shoulder stabilisation surgery. However, in the absence of substantial differences in patient outcomes, external rotation bracing may be demonstrated to be more cost-effective than surgery. Outcomes from this study will inform clinical decision making about management for young people with shoulder dislocation. This study will not only impact clinical practice for this high demand patient group in Queensland, but nationally and internationally due to widespread uncertainty to the effectiveness (and cost-effectiveness) of the (cheaper and more conservative) external rotation bracing in comparison to arthroscopic shoulder stabilisation surgery amongst young patients (16-30 years) who have dislocated their shoulder for the first time.

Interventions

Two interventions will be compared. Group A will receive external rotation bracing (using a Don Joy external Rotation Brace) full time for 6 weeks + routine post immobilization physical therapy. Group B will receive arthroscopic stabilisation surgery (approximately 90-180 minutes) + routine post operative physical therapy.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

16 Years to 30 Years

Healthy volunteers

Inclusion criteria

islolated shoulder injury with a typical history for anterior dislocaton patient presenting within 7 days of injury

Exclusion criteria

History of previous instability prior to index injury. Significant acute associated fracture of scapula or humerus. Significant acute ipsilateral no capsulo-labral soft tissue injury (cuff tear, vessel injury, nerve injury). Previous surgery to ipsilateral shoulder. Previous injury or condition in ipsilateral shoulder. History of contralateral shoulder instability symptoms. Associated significant injuries increasing risk of surgery or preventing compliance with bracing. Medical/anaesthetic contraindication to surgery. Unable to comply with rehabilitation or attend follow up appointments. Currently pregnant.

Outcome results