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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28257
Enrollment
30
Registered
2018-11-12
Start date
2018-11-12
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Short term pain experience Functional shoulder movement Open surgery / arthroscopic surgery Distal clavicle excision

Interventions

Arthrocopic surgery and open surgery in distal clavicle excision

Sponsors

Flevoziekenhuis Almere
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All participants must have an indication for distal clavicle excision based on AC osteolysis, post-traumatic injury or arthrosis/arthritis confirmed by ultrasound, x-ray and physical examination. Indication is determined by the orthopaedic surgeon when conservative treatment (physical therapy, rest, corticosteroid injections) fails to improve the shoulder function and pain. Age: at least 18 years 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 arthrosis, rotator cuff/biceps tears, labrum tears confirmed by ultrasound, MRI or x-ray. -Frozen shoulder or local infection at the time of physical examination -AC instability Rockwood >1

Design outcomes

Primary

MeasureTime frame
The primary objective is to examine the difference in daily pain experience between open and arthroscopic surgery in distal clavicle excision for patients with acromioclavicular pathology measured with the NRS (in rest and movement) in the first 6 weeks after surgery

Secondary

MeasureTime frame
• Daily shoulder function measured with the DASH (pre-operatively, 6 weeks, 3 months, 6 months, 12 months) • Pain measured with the NRS (pre-operatively, 6 weeks, 3 months, 6 months, 12 months) • Adverse events (frozen shoulder) diagnosed by physical examination • Number of wound infections • Time until return to work • Total costs of surgery • Total costs of the revalidation process

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)