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

Not Applicable

Active, not recruiting

• Conditions: Distal Radius Fractures; Colles' Fracture; Wrist Fracture
• Interventions: Procedure: Open reduction and volar locking plate and closed reduction and K-wires.

• Registration Number: NCT04716309
• Lead Sponsor: Oslo University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-16
• Study First Posted: 2021-01-20
• Study Start: 2021-02-16
• Status Verified: 2024-02
• Primary Completion: 2024-02-08
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-21
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VLP	Open reduction and volar locking plate and closed reduction and K-wires.	Open reduction and volar locking plate
CRPP	Open reduction and volar locking plate and closed reduction and K-wires.	Closed reduction and percutaenous K-wires/pins

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Skadelegevakten; 🇳🇴 Oslo, Norway