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Comparison of the results of operative versus non-operative management of acute grade III and IV acromioclavicular joint disruption

A multicentre prospective randomised controlled trial to compare the results of AcromioClavicular Open Reduction versus Nonoperative treatment for the management of acute grade III and IV acromioclavicular joint disruption

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN47376242
Enrollment
80
Registered
2013-11-07
Start date
2011-02-01
Completion date
Unknown
Last updated
2020-10-26

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

Conditions

Orthopaedic trauma Injury, Occupational Diseases, Poisoning Dislocation of acromioclavicular joint

Interventions

A total of 80 participants will be randomised using the closed envelope technique into a control (non-operative management) group or treatment (operative management) group each containing 40 participa

Sponsors

Royal Infirmary of Edinburgh (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Grade III or IV acromioclavicular joint disruption 2. Acute injury (within last 2 weeks) 3. Age 16-35 years inclusive

Exclusion criteria

Exclusion criteria: 1. Grade I or II acromioclavicular joint disruptions 2. Patients who are not local residents and unable to attend for follow-up 3. Coexisting clavicle or proximal humeral fractures 4. Multiple medical co-morbidities

Design outcomes

Primary

MeasureTime frame
Functional assessment with use of the short-form health survey (SF-12), Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and Oxford score will be carried out for all patients preoperatively, at 6 weeks and at 12 months postoperatively. In addition SF-12 and DASH scores will be assessed at 3 and 6 months.

Secondary

MeasureTime frame
1. Shoulder ROM will be assessed at 6 months and 12 months postoperatively. The contralateral shoulder will be assessed for comparison 2. Any complications occurring in patients in either group will be documented at the time of procedure and throughout follow-up 3. Radiographic evidence of recurrent dislocation

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026