Non- or minimally displaced distal radius fractures in adult patients <50 years of age: Three weeks of cast immobilisation versus one week of brace immobilisation, a Multicenter Randomised Controlled Trial.

Non- or minimally displaced distal radius fractures in adult patients <50 years of age: Three weeks of cast immobilisation versus one week of brace immobilisation, a Multicenter Randomised Controlled Trial. - DR PIP Study - Distal Radius Plaster Immobilisation Period Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56114

Enrollment

Registered

2023-10-18

Start date

2024-01-01

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

distal radius fracture forearm fracture Wrist Fracture

Interventions

Intervention group: one week of brace immobilization control group: three weeks of cast immobilization (general care)

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. 18-50 years (to eliminate osteoporosis); 2. Primary non- or minimally gedisplaced DRF; 3. Independent for activities of daily living.

Exclusion criteria

Exclusion criteria: 1. Fracture of the contralateral wrist; 2. Ipsilateral fractures, proximal of the DRF; 3. Pre-existent abnormalities or functional deficits of the fractured wrist; 4. Open fractures; 5. Poly trauma patiënten 6. Language ability to understand the Dutch patient information and questionnaires.

Design outcomes

Primary

Measure	Time frame
patient-reported outcome after six months measured by PRWE (Patient Related Wrist Evaluation) score. The PRWE is a validated 15-item (scored 1-10) self-reported questionnaire and is the best questionnaire for evaluating the patient reported outcome in case of DRFs. Patients rate their outcome on a 0-10 scale on pain and functional outcome, and scores will be transformed to a 0-100 score. A higher score indicates greater disability.	—

Measure

Time frame

patient-reported outcome after six months measured by PRWE (Patient Related Wrist Evaluation) score. The PRWE is a validated 15-item (scored 1-10) self-reported questionnaire and is the best questionnaire for evaluating the patient reported outcome in case of DRFs. Patients rate their outcome on a 0-10 scale on pain and functional outcome, and scores will be transformed to a 0-100 score. A higher score indicates greater disability.

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Secondary

Measure	Time frame
1. The qDASH (Quick Disabilities of the Arm, Shoulder and Hand) score after 6 weeks, and 6 months 2. PRWE after 6 weeks 3. Range of motion after 6 weeks, and 6 months 4. Pain (VAS-score) at arrival at ED, after cast/brace is applied, in the first week after brace/cast removal, 6 weeks, and 6 months 5. Radiological outcome at 6 weeks, and 6 months 6. Complications 7. Cost-effectiveness (measured by EQ-5D, iMCQ and iPCQ questionnaires) The DASH Outcome Measure is a validated 30-item self-reported questionnaire for patients with disorders of the arm, shoulder and hand. The QuickDASH (qDASH) is the shortened version of the DASH Outcome Measure, using 11 items instead of 30 (scored 1-5) to measure pain and functional outcome. At least 10 of the 11 items must be completed to calculate a score. The scores will be transformed to a 0-100. A higher score indicates greater disability. The range of motion will be measured by using a goniometer: volar/dorsal flexion, radial/ulnar deviation, and pronation/supination, will be determined. The pain will be measured by using the VAS-score. VAS-score is a widely used method for pain assessments. Patients score their pain on a scale of 1-10. A higher score indicated a higher level of pain. The VAS-score will be measured on the ED at arrival and after application of the brace of cast. Patients will also receive a dairy after cast removal to record their pain score. Radiological outcome will be measured; dorsal and volar tilt in degrees, radial height in millimetres and ulnar variance in millimetres will be calculated directly after trauma, and after six weeks and six months. Complications contain secondary displacement (radial shortening >3mm, dorsal tilt >10° or intra-articular step-off >2mm), delayed/non-union, re-interventions, complex regional pain syndrome (CRPS), tendon injuries (ruptures and tendinitis), nerve injuries (carpal tunnel syndrome and lesions), and distal radial ulnar joint disability. C	—

Measure

Time frame

1. The qDASH (Quick Disabilities of the Arm, Shoulder and Hand) score after 6 weeks, and 6 months 2. PRWE after 6 weeks 3. Range of motion after 6 weeks, and 6 months 4. Pain (VAS-score) at arrival at ED, after cast/brace is applied, in the first week after brace/cast removal, 6 weeks, and 6 months 5. Radiological outcome at 6 weeks, and 6 months 6. Complications 7. Cost-effectiveness (measured by EQ-5D, iMCQ and iPCQ questionnaires) The DASH Outcome Measure is a validated 30-item self-reported questionnaire for patients with disorders of the arm, shoulder and hand. The QuickDASH (qDASH) is the shortened version of the DASH Outcome Measure, using 11 items instead of 30 (scored 1-5) to measure pain and functional outcome. At least 10 of the 11 items must be completed to calculate a score. The scores will be transformed to a 0-100. A higher score indicates greater disability. The range of motion will be measured by using a goniometer: volar/dorsal flexion, radial/ulnar deviation, and pronation/supination, will be determined. The pain will be measured by using the VAS-score. VAS-score is a widely used method for pain assessments. Patients score their pain on a scale of 1-10. A higher score indicated a higher level of pain. The VAS-score will be measured on the ED at arrival and after application of the brace of cast. Patients will also receive a dairy after cast removal to record their pain score. Radiological outcome will be measured; dorsal and volar tilt in degrees, radial height in millimetres and ulnar variance in millimetres will be calculated directly after trauma, and after six weeks and six months. Complications contain secondary displacement (radial shortening >3mm, dorsal tilt >10° or intra-articular step-off >2mm), delayed/non-union, re-interventions, complex regional pain syndrome (CRPS), tendon injuries (ruptures and tendinitis), nerve injuries (carpal tunnel syndrome and lesions), and distal radial ulnar joint disability. C

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)