To find out whether surgical treatment of acute Rockwood type 3 AC dislocations, by anatomic reconstruction using the arthroscopic TightRope technique, will give a better functional outcome then conservative treatment.
ID
Source
Brief title
Condition
- Fractures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Visual Analoge Scale (VAS) score for pain and activity level
Constant-Murley shoulder score
Disabilities of Arm Shoulder and Hand score (DASH)
Nederlandse Simpele Schouder Test (NSST)
Secondary outcome
-
Background summary
AC dislocations are often caused by a fall on the shoulder in young active
males. The treatment of acute AC dislocations Rockwood type 1 and 2 is
conservative. In Rockwood type 4,5 and 6 AC dislocations treatment is surgical.
In the case of Rockwood type 3 AC dislocations there's still no evidence based
consensus regarding treatment.
Study objective
To find out whether surgical treatment of acute Rockwood type 3 AC
dislocations, by anatomic reconstruction using the arthroscopic TightRope
technique, will give a better functional outcome then conservative treatment.
Study design
In the study protocol patients with acute AC dislocations of Rockwood type 3
will be prospectively randomised to either conservative treatment or surgical
treatment using the arthroscopic TightRope technique.
Intervention
Patients in the intervention group will be treated surgical with the
arthroscopic TightRope system.
Study burden and risks
Because the arthroscopic TightRope system is already being used in Rockwood
type 4, 5 and 6 AC dislocations, no extra specific operative risks are
expected. The generaql operative risks are wound infection, haematoma
formation, nerve injury and redislocation.
Lijnbaan 32
2501 CK Den Haag
Nederland
Lijnbaan 32
2501 CK Den Haag
Nederland
Listed location countries
Age
Inclusion criteria
AC dislocation Rockwood type III
acute trauma within 6 weeks
age 18 or older
informed consent
Exclusion criteria
age under 18
gleno-humeral instability
fracture
frozen shoulder
previous AC surgery
non compliant by mental state or language barrier
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL24443.098.09 |