Clinical Trial: Assessing Volar Locking Plates in Patients Under 65 With a Distal Radius Fracture

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Are Volar Locking Plates a Cost Effective Strategy for the Treatment of Distal Radius Fractures in Patients <65 Years of Age?

Brief Summary: Patients will be randomized to volar plating with early ROM versus closed reduction with K-wires and 6 weeks of cast immobilization to determine if there is any advantage to volar plating in this subgroup of patients with distal radius fractures.

Detailed Summary:

This study has been designed as a prospective randomized controlled trial examining the cost effectiveness of treating distal radius fractures with open reduction and internal fixation with a volar locking plate (VLP) to closed reduction and k-wire fixation (K-Wires). All patients aged < 65 years with an isolated distal radius fracture (extra-articular or simple intra-articular, AO type A or C1) requiring operative fixation will be included in this study. Patients who have underlying osteoporosis, other injuries or complex intra-articular fractures will be excluded from this study.

Once eligibility is determined, patients will be randomized to one of two treatment arms. They will be treated with either a closed reduction with percutaneous k-wire fixation and 6 weeks of cast immobilization (K-wire) or open reduction internal fixation with a volar locked plate and early range of motion (beginning at 10-14 days) (VLP). All patients will undergo a standardized pre-operative evaluation. This will include classification of their fracture (based on the AO classification), a baseline PRWE and DASH score, a measure of their general health (SF-12) and a general health utility questionnaire (EQ-5d). Patients will be required to report the details of their occupational physical demands and the number of work days missed due to injury.

Patient testing will be incorporated into scheduled clinic visits. Data will be collected at the initial assessment, 2 weeks post-operatively, and then at 6 weeks, 12 weeks, 6 months and 12 months after the fracture. At each visit, AP and lateral wrist radiographs will also be obtained. The investigators will then examine the outcomes of each group based on range of motion, grip strength, and standardized patient rated pain and disability scores (PRWE and DASH). In order to capture differences between
Sponsor: Hand and Upper Limb Clinic, Canada

Current Primary Outcome: Patient Rated Wrist Evaluation [ Time Frame: Prior to randomization and at 3, 6, and 12 months following randomization ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Objective measures [ Time Frame: 3, 6, and 12 months following surgery ]

Original Secondary Outcome: Same as current

Information By: Hand and Upper Limb Clinic, Canada

Dates:
Date Received: April 8, 2011
Date Started: April 2011
Date Completion: March 2014
Last Updated: April 11, 2011
Last Verified: April 2011