Unstable Distal Radius Fractures With Dorsal Dislocation in Patients Aged 18-64 Years. Volar Locking Plate (VLP) vs Closed Reduction and Percutaenous Pinning (CRPP).

Unstable Distal Radius Fractures AO-type A2, A3 and C1 With Dorsal Dislocation in Patients Aged 18-64 Years. Open Reduction and Volar Locking Plate Versus Closed Reduction and Percutaenous Pinning. A Randomized Controlled Trial.

120 patients age 18-64 years with dorsally displaced distal radius fractures AO-type A2, A3 and C1 are recruited from Oslo Casualty Medical Centre (Oslo Skadelegevakt). Patients are randomized to surgery with closed reduction and pins (CRPP) or open reduction and volar locking plate (VLP). The hypotheses is that CRPP will give equal function and satisfaction to VLP. Patients are followed by current practice of follow-ups until 5 weeks postoperatively, and in addition due to the study with functional tests after 2, 3, 6 and 12 months. These follow-ups will be performed by hand therapist. Scores are also recorded from Patient-Reported Wrist and Hand Evaluation (PRWHE), Quick-Dash (Q-d) and EuroQol Questionnaire (EQ-5D) questionnaires. The main efficacy measure in the study is PRWHE scores after 12 months. There will be X-ray initially, postoperatively and after 12 months. Sub-objectives in the study are analyses of cost-effectiveness (measured by EQ 5D, personnel use, use of additional healthcare service and absence from work), and differences in complications between the two methods.

Study Overview

• Status: Active, not recruiting
• Conditions: Colles' Fracture; Distal Radius Fractures; Wrist Fracture
• Intervention / Treatment: Procedure: Open reduction and volar locking plate and closed reduction and K-wires.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Børge Olsen, MD; Phone Number: +4799263657; Email: borge.ols1@gmail.com
• Study Contact Backup: Name: John Williksen, MD; Phone Number: +4792285918; Email: uxwilj@ous_hf.com

Study Locations

• Norway
  • Oslo, Norway, 0182
    • Skadelegevakten

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• distal radius fractures of AO- A2, A3 and C1 which should be operated on in accordance with Norwegian guidelines
• >18 years and <65 years
• address in Oslo municipality

Exclusion Criteria:

• multitrauma
• previous fracture same wrist
• multiple injuries on the same side
• not competent to consent
• dementia / nursing home patient
• substance abuse
• foreign / tourists
• median nerve compression requiring emergency surgery
• pathological fracture
• open fracture
• congenital malformations that make it difficult to interpret data
• patient does not want surgical treatment
• not operable due to comorbidity (ASA 4, some ASA 3 after assessment by anesthesiologist)
• more than 10 days after injury

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: VLP; Open reduction and volar locking plate	Procedure: Open reduction and volar locking plate and closed reduction and K-wires.; DVR Anatomic Plate, K-wires
Active Comparator: CRPP; Closed reduction and percutaenous K-wires/pins	Procedure: Open reduction and volar locking plate and closed reduction and K-wires.; DVR Anatomic Plate, K-wires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Related Wrist and Hand Evaluation (PRWHE) score	PROM of 15 questions, score ranging from 0 (best) to 100 (worst)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quick Dash score	PROM of 11 questions, score ranging from 0 (best) to 100 (worst)	1 year
X-ray wrist posterior-anterior and lateral view	Volar tilt (degrees), radial inclination (degrees), ulnar variance (mm), stepp-off (mm)	1 year
Range of motion	Flexion, extension, supination and pronation measured in degrees from neutral position, pulpa palm distance in cm	1 year
Grip strength	Grip strength with a hand dynamometer	1 year

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Sophies Minde
• Investigators: Study Director: John Williksen, MD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2021
• Primary Completion (Actual): February 8, 2024
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 16, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations; Arm Injuries; Forearm Injuries; Fracture Dislocation; Wrist Injuries; Fractures, Bone; Radius Fractures; Colles' Fracture; Wrist Fractures
• Other Study ID Numbers: 85724

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No