Cast-OFF trial: One versus four-five weeks cast immobilization for non reduced distal radius fractures. A randomized clinical trial. A feasibility study.

Cast-OFF trial: One versus four-five weeks cast immobilization for non reduced distal radius fractures. A randomized clinical trial. A feasibility study. - Cast-OFF trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45589

Enrollment

Registered

2017-07-26

Start date

2020-01-31

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 fracture

Interventions

Patients will be included at emergency room. After one week they will be randomized for the intervention or control group. The patients in the intervention group follow the same protocol as the conv

distal radius fracture

early mobilisation

functional outcome

non-operative treatment

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 75 years. Isolated acute distal radius fracture Closed reduction is not performed Non-operative treatment with cast immobilisation Understanding of Dutch language

Exclusion criteria

Exclusion criteria: under the age of 18 or older than 75 years multiple injured patient reduction is indicated/performed operative treatment cognitive disorder

Design outcomes

Primary

Measure	Time frame
The main study parameter in this study will be the patient reported outcome (PRO) measured with the patient reported wrist evaluation (PRWE) questionnaire.	—

Secondary

Measure	Time frame
1. In addition to the PRWE, we will use the DASH questionnaire for upper extremity functioning. The two questionnaires will be measured after six weeks and three, six and twelve months. Comprehensive PRO measures will also be measured. This a more generic instrument that captures aspects of health status and quality of life beyond hand functioning. The Short Form * 36 (SF-36) will be used to measure this. 2. Complications. The complication checklist for DRF from McKay will be used for scoring the complications after a DRF. The clinical record, questions by interview and questionnaires will be used to complete the checklist. The Budapest diagnostic criteria will be used to score CRPS, a complication which can occur after a DRF. In addition, pain and post traumatic pain will be scored. The visual analogue scale (VAS) will be asked and the PROMIS pain interference questionnaire will be used for pain interference and diagnosing post traumatic pain. 3. Process evaluation. The evaluation will be focused on: - Willingness of participants. Every patient who can be included in the study will be analyzed. Patients who did not want to be included are asked what their reasons are. - Acceptability of the study. Participants will be asked to give feedback on study design and give their reaction to the intervention. This will be asked at 12 months* follow-up. - Process evaluation. The study design will be evaluated afterwards. This includes, evaluation of inclusion process, the intervention and follow-up with questionnaires (response rates, adherence/compliance rates, etc) [Arain, 2010].	—

Measure

Time frame

1. In addition to the PRWE, we will use the DASH questionnaire for upper extremity functioning. The two questionnaires will be measured after six weeks and three, six and twelve months. Comprehensive PRO measures will also be measured. This a more generic instrument that captures aspects of health status and quality of life beyond hand functioning. The Short Form * 36 (SF-36) will be used to measure this. 2. Complications. The complication checklist for DRF from McKay will be used for scoring the complications after a DRF. The clinical record, questions by interview and questionnaires will be used to complete the checklist. The Budapest diagnostic criteria will be used to score CRPS, a complication which can occur after a DRF. In addition, pain and post traumatic pain will be scored. The visual analogue scale (VAS) will be asked and the PROMIS pain interference questionnaire will be used for pain interference and diagnosing post traumatic pain. 3. Process evaluation. The evaluation will be focused on: - Willingness of participants. Every patient who can be included in the study will be analyzed. Patients who did not want to be included are asked what their reasons are. - Acceptability of the study. Participants will be asked to give feedback on study design and give their reaction to the intervention. This will be asked at 12 months* follow-up. - Process evaluation. The study design will be evaluated afterwards. This includes, evaluation of inclusion process, the intervention and follow-up with questionnaires (response rates, adherence/compliance rates, etc) [Arain, 2010].

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)