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A randomized trial comparing plaster cast immobilization versus operation in elderly patients with distal radius fractures

A randomized trial comparing plaster cast immobilization versus operation in elderly patients with distal radius fractures - RADIUS

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35514
Enrollment
200
Registered
2009-03-12
Start date
2010-01-01
Completion date
Unknown
Last updated
2024-06-18

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

Conditions

wrist fracture

Interventions

Plaster cast immobilization is compared to open reduction and internal fixation.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age > 55 years 2. Primary displaced unilateral fracture of distal radius (open fractures are included) a. AO (Arbeitsgemeinschaft fur Osteosynthesefragen) type A2 b. AO type A3 c. AO type B1 d. AO type C1 e. AO type C2 3. Independent for activities of daily living (yes/no question) 4. Inadequate reduction of distal radius fracture at emergency department (For specific criteria see below) and/or 5. Inadequate reduction of distal radius at 1 week follow-up at the outpatient department: Therapeutic failure is defined as fracture displacement when the dorsal or volar angulations are more than 10º, intra-articular step-off > 2mm, or the ulnar variance is more than 5mm. This failure accounts for both redisplacement after initial adequate alignment during conservative treatment (including manipulative reduction) on the emergency department) and for secondary failure after surgical reduction.

Exclusion criteria

Exclusion criteria: 1. Fracture of contralateral arm 2. Other fractures at the ipsilateral arm (excluded carpal fractures) 3. Pre-existent abnormalities fractured distal radius 4. Primary unilateral fracture distal radius AO type A1, B2, B3 and C3 5. Pathological fractures (due to metastasis, secondary osteoporosis)

Design outcomes

Primary

MeasureTime frame
Primary outcome parameters: Disability of Arm, Shoulder and Hand (DASH) score, Musculoskeletal Function Assessment (MFA)

Secondary

MeasureTime frame
General and functional outcome parameters: Short Form 12 (SF-12) health survey questionnaire, and Patient Related Wrist Evaluation (PRWE), Range of motion, Pain level (VAS), Cost-effectiveness analysis, Radiographic analysis using Lidstrom score Complication rate.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)