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

University of Oslo (UIO)

Status: Active, not recruiting

Conditions: Distal Radius Fractures; Colles' Fracture; Wrist Fracture

Treatments: Procedure: Open reduction and volar locking plate and closed reduction and K-wires.

Study type: Interventional

Funder types: Other

Identifiers

NCT04716309

85724

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

VLP

Active Comparator group

Description:

Open reduction and volar locking plate

Treatment:

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

CRPP

Active Comparator group

Description:

Closed reduction and percutaenous K-wires/pins

Treatment:

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