NCT03009890

Surgery vs. Casting for Displaced Articular Radius Fractures in Elderly

The Effectiveness of Surgery Versus Casting for Elderly Patients With Displaced Distal Intra-Articular Radius Fractures: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: JointResearch · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

Objective: to compare the functional outcome after open reduction and internal fixation with non-operative cast treatment for elderly patients with displaced intra-articular distal radius fractures.

Detailed description

Rationale: there is no consensus about the optimal treatment of displaced intra-articular distal radius fractures in elderly patients. To ensure optimal functional outcome there is a tendency to operate. However, there is no evidence that supports the surgical treatment of patients aged 65 years or older and in the absence of clinical trials it stays unclear how elderly patients with intra-articular fractures should be treated. Study design: multi-center randomized controlled trial with a non-inferiority design. Economic evaluation alongside a randomized controlled multi-center trial. Study population: all consecutive patients aged between 65 years and older with displaced intra-articular (AO Type C) distal radius fractures, with a not acceptable reduction within 3 weeks following trauma. Intervention: patients will be randomized between open reduction and internal fixation (intervention group) and plaster immobilization (control group). Main study parameters: the primary outcome will be evaluated after 1 year with the Patient-Rated Wrist Evaluation score (PRWE). Secondary outcomes comprise other patient reported outcome measures (PROM) including the Disability of the Arm, Shoulder and Hand (DASH), Quality of life (EQ-5D) and Pain Catastrophizing Scale (PCS). Further outcome measurements comprise a costs evaluation questionnaire, range of motion (ROM), grip strength, radiographic parameters and Complications.

Conditions

• Radius Distal Fracture

Interventions

Type	Name	Description
PROCEDURE	Surgery (Open Reduction Internal Fixation)	Either volar of dorsal plating or both
PROCEDURE	Cast treatment	Hospitals may use their preferred protocol

Timeline

• Start date: 2017-02-01
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2017-01-04
• Last updated: 2023-01-18

Locations

1 site across 1 country: Netherlands