Clinical study of comfort, pain and time to return to previous activities with conservative treatment of clavicle fractures with a 2 point-sling or broad arm sling

Clinical study of comfort, pain and time to return to previous activities with conservative treatment of clavicle fractures with a 2 point-sling or broad arm sling - COSTA study (Clavicula cOnservative Sling miTellA)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52753

Enrollment

Registered

2020-03-19

Start date

2020-08-03

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

clavicle fracture collar bone fracture

Interventions

One group will receive a broad arm sling (Merk: BSN Medical, REF: 72139-12, CE-nummer: 607662) the other group will receive a 2 point-sling (Merk: Klinion, REF: 132590, CE-nummer: 607662).

Eligibility

Age

16 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age from 16 years - Competent and adequate understanding of the Dutch language - Conservative treatment of the fracture - Acute fracture (

Exclusion criteria

Exclusion criteria: - Surgical treatment - Fracture> 4 days old - Pathological fracture - Neuro-vascular abnormalities - Multitrauma - Familiar with shoulder complaints / condition with shoulders (eg rheumatism) - Recurrent fracture - Known pain syndrome or under treatment at outpatient pain clinic - Epiphyse / metaphysis fracture

Design outcomes

Primary

Measure	Time frame
Comfort of the immobilisation method is measured with the D-QUEST	—

Secondary

Measure	Time frame
Pain is measured with a visual analogue scale (VAS) Recovery of function is measured with the DASH questionnaire	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)