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Cast OFF-2: One week of plaster cast immobilization for non-reduced distal radius fractures. An implementation study.

Cast OFF-2: One week of plaster cast immobilization for non-reduced distal radius fractures. An implementation study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26972
Enrollment
440
Registered
2021-02-17
Start date
2021-09-01
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

Distal radius fractures

Interventions

The study will be performed using a stepped wedge design. All hospitals will start with their usual treatment (Condition A), often plaster cast immobilization for three to five weeks. When the cluster

Sponsors

International Grant form the Orthopaedic Trauma Association.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • age between 18 and 85 years • isolated acute distal radius fracture; intra and extra articular • closed reduction is not performed • non-operative treatment with cast immobilisation • ability to perform Activities of Daily Living independently • ability to give informed consent

Exclusion criteria

Exclusion criteria: • multiple injured patient • reduction is indicated/performed • operative treatment • no understanding of Dutch language • a patient with extra care at home; in need of a caregiver or professional for Activities of Daily Living • open fractures • history of surgically treated wrist fracture on the currently injured side • estimated high risk of secondary displacement by surgeon due to comorbidities, high risk of falling or life circumstances

Design outcomes

Primary

MeasureTime frame
The main study parameter is the acceptability of the study (number of protocol violations).

Secondary

MeasureTime frame
The following study parameters are gathered: - Functional outcome using PRWE, Short Form - 36, Promis Pain Interference after six weeks and three-, six- and twelve months. - Return to activity using productivity costs questionnaire (iCPQ) - Cost-effectiveness using a selection of questions of the medical consumption questionnaire (iMCQ) and the productivity costs questionnaire (iCPQ) - The number of complications such as secondary displacement and Complex Regional Pain Syndrome

Contacts

Public ContactEmily Boersma

Radboudumc

emily.boersma@radboudumc.nl(024) 36 199 08

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)