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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Hand and Upper Limb Clinic, Canada.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Canadian Orthopaedic Foundation
Information provided by:
Hand and Upper Limb Clinic, Canada
ClinicalTrials.gov Identifier:
NCT01333371
First received: April 8, 2011
Last updated: April 11, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Distal Radius Fracture
Procedure: Surgical Repair of Distal Radius Fracture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Are Volar Locking Plates a Cost Effective Strategy for the Treatment of Distal Radius Fractures in Patients <65 Years of Age?

Resource links provided by NLM:


Further study details as provided by Hand and Upper Limb Clinic, Canada:

Primary Outcome Measures:
  • Patient Rated Wrist Evaluation [ Time Frame: Prior to randomization and at 3, 6, and 12 months following randomization ] [ Designated as safety issue: No ]
    Questionnaire administered to assess subjective levels of pain and function


Secondary Outcome Measures:
  • Objective measures [ Time Frame: 3, 6, and 12 months following surgery ] [ Designated as safety issue: No ]
    ROM, Strength and Dexterity will be assessed


Estimated Enrollment: 64
Study Start Date: April 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: closed reduction with percutaneous k-wire fixation and casted Procedure: Surgical Repair of Distal Radius Fracture
2 surgical methods to treat Distal Radius Fracture
Active Comparator: open reduction internal fixation with a volar locked plate Procedure: Surgical Repair of Distal Radius Fracture
2 surgical methods to treat Distal Radius Fracture

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333371

Contacts
Contact: Ruby Grewal, MD, FRCSC 519-646-6286 ruby.greal@sjhc.london.on.ca
Contact: Chris A Young, B.A 519-646-6100 ext 64875 chris.young@sjhc.london.on.ca

Locations
Canada, Ontario
Hand and Upper Limb Clinic, St Joseph's Health Care Not yet recruiting
London, Ontario, Canada, N6A4L6
Contact: James H Roth, MD, FRCSC, FACS    519-646-6050    james.roth@sjhc.london.on.ca   
Contact: Joy C MacDermid, MScPT, PhD    519-646-6100 ext 64636    joy.macdermid@sjhc.london.on.ca   
Principal Investigator: Ruby Grewal, MD, FRCSC         
Sponsors and Collaborators
Hand and Upper Limb Clinic, Canada
Canadian Orthopaedic Foundation
Investigators
Principal Investigator: Ruby Grewal, MD, FRCSC Hand and Upper Limb Clinic, St. Joseph's Health Care
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Ruby Grewal, Hand and Upper limb Clinic
ClinicalTrials.gov Identifier: NCT01333371     History of Changes
Other Study ID Numbers: HULC drf-Volar Plate, 17545
Study First Received: April 8, 2011
Last Updated: April 11, 2011
Health Authority: Canada: Office of Research Ethics, University of Western Ontario

Keywords provided by Hand and Upper Limb Clinic, Canada:
Distal Radius
Volar locked plating
Cost Effectiveness
Randomization
Outcomes

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries

ClinicalTrials.gov processed this record on August 27, 2014