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

NCT ID: NCT04716309

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-16
• Study Completion Date: 2028-12-31

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.

Conditions

Distal Radius Fractures; Wrist Fracture; Colles' Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VLP

Open reduction and volar locking plate

Group Type: ACTIVE_COMPARATOR

Open reduction and volar locking plate and closed reduction and K-wires.

Intervention Type: PROCEDURE

DVR Anatomic Plate, K-wires

CRPP

Closed reduction and percutaenous K-wires/pins

Group Type: ACTIVE_COMPARATOR

Open reduction and volar locking plate and closed reduction and K-wires.

Intervention Type: PROCEDURE

DVR Anatomic Plate, K-wires

Interventions

Open reduction and volar locking plate and closed reduction and K-wires.

DVR Anatomic Plate, K-wires

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sophies Minde Ortopedi

INDUSTRY

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Børge Olsen

MD Børge Olsen

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Williksen, MD

Role: STUDY_DIRECTOR

Oslo University Hospital

Locations

Skadelegevakten

Oslo, , Norway

Countries

Norway

Other Identifiers

85724

Identifier Type: -

Identifier Source: org_study_id