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Open vs arthroscopic distal clavicle excision: a randomized controlled pilot trial

Open vs arthroscopic distal clavicle excision: a randomized controlled pilot trial - AC Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON52803
Enrollment
30
Registered
2019-08-23
Start date
2022-02-14
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

AC joint arthritis acromioclavicular pathology

Interventions

intervention group: open surgery, control group: arthroscopic surgery.

Sponsors

Flevoziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Daily shoulder pain (NRS)

Secondary

MeasureTime frame
Daily shoulder function (DASH) Complications (N=) Costs (euro)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)