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

NCT04716309 | Active Not Recruiting

• 1 other identifier: 85724
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Patient-Related Wrist and Hand Evaluation (PRWHE) score

  PROM of 15 questions, score ranging from 0 (best) to 100 (worst)

  1 year

Secondary Outcomes (4)

• Quick Dash score

  1 year

• X-ray wrist posterior-anterior and lateral view

  1 year

• Range of motion

  1 year

• Grip strength

  1 year

Study Arms (2)

VLP

ACTIVE COMPARATOR

Open reduction and volar locking plate

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

CRPP

ACTIVE COMPARATOR

Closed reduction and percutaenous K-wires/pins

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

Interventions

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

DVR Anatomic Plate, K-wires

CRPP; VLP

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Sophies Minde Ortopedi: collaborator

Study Sites (1)

Skadelegevakten

Oslo, 0182, Norway

Location

MeSH Terms

Conditions

Wrist Fractures; Colles' Fracture

Interventions

Open Fracture Reduction; Bone Wires

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Fracture Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Radius Fractures

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative; Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Study Officials

• John Williksen, MD

  Oslo University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Børge Olsen

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 20, 2021
• Study Start: February 16, 2021
• Primary Completion: February 8, 2024
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)