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

Recruiting

• Conditions: wrist fracture; 10017322

• Registration Number: NL-OMON35514
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 200

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome parameters: Disability of Arm, Shoulder and Hand (DASH) score,<br /><br>Musculoskeletal Function Assessment (MFA)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>General and functional outcome parameters: Short Form 12 (SF-12) health survey<br /><br>questionnaire, and Patient Related Wrist Evaluation (PRWE),<br /><br>Range of motion,<br /><br>Pain level (VAS),<br /><br>Cost-effectiveness analysis,<br /><br>Radiographic analysis using Lidstrom score<br /><br>Complication rate. </p><br>