Wrist fractures treated with plaster cast or operation: what leads to the best outcome in patients older than 50 years?

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29311

Enrollment

200

Registered

2008-04-17

Start date

2008-06-01

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 plate fixation plaster cast immobilization

Interventions

Open reduction and internal fixation using locking-plate and angular stable screw fixation versus plaster cast immobilization

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age > 50 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 > 1mm, or the ulnar variance is more than 3mm. 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

Measure	Time frame
Main study parameter/endpoint Functional outcome parameters: Disability of Arm, Shoulder and Hand (DASH) score, Musculoskeletal Function Assessment (MFA)	—

Secondary

Measure	Time frame
Secondary study parameters/endpoints Functional outcome parameters: Short Form 36 (SF-36) health survey questionnaire, Patient Related Wrist Evaluation (PRWE), Range of motion, Pain level (VAS), Cost-effectiveness analysis Radiographic analysis: Lidstrom score Complications: complex regional pain syndrome type-I, infection, re-operation, arthrodesis, general surgical complications (pneumonia, myocardial infarction, etc).	—

Measure

Time frame

Secondary study parameters/endpoints Functional outcome parameters: Short Form 36 (SF-36) health survey questionnaire, Patient Related Wrist Evaluation (PRWE), Range of motion, Pain level (VAS), Cost-effectiveness analysis Radiographic analysis: Lidstrom score Complications: complex regional pain syndrome type-I, infection, re-operation, arthrodesis, general surgical complications (pneumonia, myocardial infarction, etc).

—

Contacts

Public ContactM. Poeze

Department of Surgery University Medical Center Maastricht PO Box 5800

m.poeze@surgery.azm.nl+31 (0)43 3876543

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)