main: to examine the difference in daily shoulder pain (NRS) between the two surgery groups in the first 7 weeks after surgery. Second: to examine the difference in shoulder function (DASH) and the chance of complications (frozen shoulder/wound…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Daily shoulder pain (NRS)
Secondary outcome
Daily shoulder function (DASH)
Complications (N=)
Costs (euro)
Background summary
Distal clavicle excision is a frequently used surgery to treat
acromioclavicular pain (+/- 6-8 surgeries per month at the Flevohospital in
Almere). Lack of sufficient scientific evidence in recent literature makes it
difficult to make a decision whether to perform arthroscopic or open surgery.
Hypothesis: there is no difference in shoulder pain experience in the first
seven weeks after surgery between the AS and OS group.
Studies examining the short-term outcomes of OS and AS in patients with distal
clavicle excision were not performed, as far as we know. The primary aim of
this pilot RCT is to examine the difference in daily post-operative pain
experience between the OS and AS group in the first seven weeks after surgery
Study objective
main: to examine the difference in daily shoulder pain (NRS) between the two
surgery groups in the first 7 weeks after surgery.
Second: to examine the difference in shoulder function (DASH) and the chance of
complications (frozen shoulder/wound infections) between both groups.
Study design
Randomised Controlled Pilot Trial
Intervention
intervention group: open surgery, control group: arthroscopic surgery.
Study burden and risks
Both techniques are standard care. Inclusion in the study will not change the
risk of complications
Hospitaalweg 1
Almere 1315 RA
NL
Hospitaalweg 1
Almere 1315 RA
NL
Listed location countries
Age
Inclusion criteria
Indication for distal clavicle excision based on symptomatic AC arthritis,
post-traumatic injury or osteolysis. Indication is determined by the
orthopaedic surgeon when conservative treatment (physical therapy, rest, pain
medication, corticosteroid injections) fails to improve the shoulder function
and pain.
18 yr old
Exclusion criteria
- Not able to read and speak Dutch language sufficiently to complete the
questionnaires
- Distal clavicle excision in the past
- Glenohumeral arthritis, rotator cuff/biceps tears, labral tears
- Frozen shoulder or local infection at the time of physical examination
- AC instability Rockwood >1
- Pregnancy
Design
Recruitment
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 | NL67394.018.19 |