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NCT Number: NCT04716309

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Distal Radius Fractures Arm Injuries Colles' Fracture Fracture Dislocation Fractures, Bone Joint Diseases Joint Dislocations Musculoskeletal Diseases Radius Fractures Wounds and Injuries Wrist Fracture Wrist Fractures Wrist Injuries

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skadelegevakten

Oslo, 0182, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

DVR Anatomic Plate, K-wires

Primary outcomes

  1. Patient-Related Wrist and Hand Evaluation (PRWHE) score

    Time frame: 1 year

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

Secondary outcomes

  1. Quick Dash score

    Time frame: 1 year

    PROM of 11 questions, score ranging from 0 (best) to 100 (worst)

  2. X-ray wrist posterior-anterior and lateral view

    Time frame: 1 year

    Volar tilt (degrees), radial inclination (degrees), ulnar variance (mm), stepp-off (mm)

  3. Range of motion

    Time frame: 1 year

    Flexion, extension, supination and pronation measured in degrees from neutral position, pulpa palm distance in cm

  4. Grip strength

    Time frame: 1 year

    Grip strength with a hand dynamometer

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Sophies Minde Ortopedi

Registry information

Official study title

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.

Important dates

Study start
2021
Primary completion
2024
Study completion
2028
First posted
Jan 20, 2021
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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