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Cast OFF-2: One versus four-five weeks of plaster cast immobilization for non-reduced distal radius fractures. A randomized stepped wedge design.

Cast OFF-2: One versus four-five weeks of plaster cast immobilization for non-reduced distal radius fractures. A randomized stepped wedge design. - Cast OFF-2

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48442
Enrollment
440
Registered
2020-06-04
Start date
Unknown
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

distal radius fractures wrist fractures

Interventions

The patients in the intervention group will be treated with plaster cast for one week.

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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 (ADL) independently - written 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 ADL - open fractures - history of surgically treated wrist fracture on the currently injured side - estimated high risk of secondary displacement by surgeon

Design outcomes

Primary

MeasureTime frame
The main parameters for this study are the following: - Patient reported outcome using the Patient Rated Wrist Evaluation (PRWE) score and for analysing quality of life we will use the ShortForm-36 - Return to activity will be meassured using a five minute short questionnaire - A cost-effectiveness analysis will be performed along-side the underlying stepped wedge trial.

Secondary

MeasureTime frame
The following secondary parameters will be measured: - The complication checklist for DRF from McKay will be used for scoring the complications after a DRF - Pain catastrophizing scale (PCS-4) will be used to measures patients fear for movement and the influence of psychological problems - Patient satisfaction will be additionally measured by using a 10 point ordinary scale - A budget impact analysis will be performed from various perspectives with the budgetary framework for the care as the base case perspective

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)