Ignite Creation Date:
2024-05-05 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 9:41 AM
Study NCT ID:
NCT00594841
Status:
COMPLETED
Last Update Posted:
2020-04-24
First Post:
2008-01-07
Brief Title:
Non-operative Versus Operative Treatment of Acute Acromioclavicular Joint Dislocation
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
A Multicenter Randomized Clinical Trial of Non-operative Versus Operative Treatment of Acute Acromioclavicular Joint Dislocation
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACJoint
Brief Summary:
The purpose of this study is to compare non-operative treatment versus operative treatment in patients who suffer a complete acute acromioclavicular AC joint dislocation This study will show if one method is superior to the other and will also show advantages and disadvantages associated with each treatment method
Detailed Description:
All patients presenting to the hospital with a Type III IV or V acute acromioclavicular AC joint dislocation and meeting the eligibility criteria will be approached and asked to enter this prospective randomized clinical trial After obtaining consent the subject will be managed in accordance with one of the two randomized treatment strategies The first treatment strategy will involve conservative nonoperative management of the AC joint dislocation The second treatment strategy will involve operative fixation ie ORIF of the dislocation with a hook plate and screws
The subjects in both treatment groups will receive post-operative care according to the same standards and protocol The surgeon and research staff will be responsible for study follow-up clinical and radiological assessment of the patient on admission baseline on discharge from the hospital and at post-operative intervals of six weeks three months six months one year and two years Primary and secondary outcomes will be monitored at these post-operative intervals
The subjects in both treatment groups will receive post-operative care according to the same standards and protocol The surgeon and research staff will be responsible for study follow-up clinical and radiological assessment of the patient on admission baseline on discharge from the hospital and at post-operative intervals of six weeks three months six months one year and two years Primary and secondary outcomes will be monitored at these post-operative intervals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MMES 2008 | None | None | None |