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

NCT ID: NCT01333371

Last Updated: 2011-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2014-03-31

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 Description

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 the 2 groups in the early phases of recovery - the investigators will administer 2 additional assessments at 4 and 9 weeks by either phone or email. These telephone assessments will include an assessment of patient rated pain and disability (DASH, PRWE) and patients will be asked to provide details on whether they have returned to work or their usual activities.

The primary outcome, patient rated pain and disability, will be quantified with the Patient Rated Wrist Evaluation (PRWE) a tool which has been shown to be valid, reliable and highly responsive in the distal radius fracture population. Secondary outcomes will include range of motion, strength, Disabilities of Arm Shoulder and Hand Score (DASH) and time to return to work. The cost analysis will include both direct and indirect costs, and will include: OR time, anesthesia time, surgeon fees, cost of outpatient visits, equipment costs (volar locked plates and k-wires), x-rays, casting, splints, number of work days missed and work disability costs. The investigators will also use the health utility score (EQ-5d) to determine the cost per quality adjusted life year (QALY) associated with each intervention.

Based on our sample size calculations, the investigators will need 28 patients in each treatment arm (power 80%, p = 0.05). Allowing for a 10-15% drop-out rate, 64 patients are required for enrollment. The secondary outcomes will include ROM, grip strength, union rate, mean time to union (weeks) and DASH score.

Conditions

Distal Radius Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

closed reduction with percutaneous k-wire fixation and casted

Group Type: ACTIVE_COMPARATOR

Surgical Repair of Distal Radius Fracture

Intervention Type: PROCEDURE

2 surgical methods to treat Distal Radius Fracture

open reduction internal fixation with a volar locked plate

Group Type: ACTIVE_COMPARATOR

Surgical Repair of Distal Radius Fracture

Intervention Type: PROCEDURE

2 surgical methods to treat Distal Radius Fracture

Interventions

Surgical Repair of Distal Radius Fracture

2 surgical methods to treat Distal Radius Fracture

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Distal radius fracture - AO type A or C1
• Skeletally mature
• Age 18-65 years old
• Isolated injury

Exclusion Criteria

• AO Type B or C2,3
• Other injuries involving affected or unaffected arm
• Skeletally immature

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Orthopaedic Foundation

OTHER

Sponsor Role: collaborator

Hand and Upper Limb Clinic, Canada

NETWORK

Sponsor Role: lead

Responsible Party

Hand and Upper limb Clinic

Principal Investigators

Ruby Grewal, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Hand and Upper Limb Clinic, St. Joseph's Health Care

Locations

Hand and Upper Limb Clinic, St Joseph's Health Care

London, Ontario, Canada

Countries

Canada

Central Contacts

Ruby Grewal, MD, FRCSC

Role: CONTACT

ruby.greal@sjhc.london.on.ca

519-646-6286

Chris A Young, B.A

Role: CONTACT

chris.young@sjhc.london.on.ca

519-646-6100 ext. 64875

Facility Contacts

James H Roth, MD, FRCSC, FACS

Role: primary

james.roth@sjhc.london.on.ca

519-646-6050

Joy C MacDermid, MScPT, PhD

Role: backup

joy.macdermid@sjhc.london.on.ca

519-646-6100 ext. 64636

Other Identifiers

17545

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HULC drf-Volar Plate

Identifier Type: -

Identifier Source: org_study_id