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

April 8, 2011
April 11, 2011
April 2011
March 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01333371 on ClinicalTrials.gov Archive Site
Objective measures [ Time Frame: 3, 6, and 12 months following surgery ] [ Designated as safety issue: No ]
ROM, Strength and Dexterity will be assessed
Same as current
Not Provided
Not Provided
 
Assessing Volar Locking Plates in Patients Under 65 With a Distal Radius Fracture
Are Volar Locking Plates a Cost Effective Strategy for the Treatment of Distal Radius Fractures in Patients <65 Years of Age?

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Distal Radius Fracture
Procedure: Surgical Repair of Distal Radius Fracture
2 surgical methods to treat Distal Radius Fracture
  • Active Comparator: closed reduction with percutaneous k-wire fixation and casted
    Intervention: Procedure: Surgical Repair of Distal Radius Fracture
  • Active Comparator: open reduction internal fixation with a volar locked plate
    Intervention: Procedure: Surgical Repair of Distal Radius Fracture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
64
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
No
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
Canada
 
NCT01333371
HULC drf-Volar Plate, 17545
No
Dr. Ruby Grewal, Hand and Upper limb Clinic
Hand and Upper Limb Clinic, Canada
Canadian Orthopaedic Foundation
Principal Investigator: Ruby Grewal, MD, FRCSC Hand and Upper Limb Clinic, St. Joseph's Health Care
Hand and Upper Limb Clinic, Canada
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP