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

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.

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04716309

Enrollment

120

Registered

2021-01-20

Start date

2021-02-16

Completion date

2028-12-31

Last updated

2024-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colles' Fracture, Distal Radius Fractures, Wrist Fracture

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.

Interventions

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

DVR Anatomic Plate, K-wires

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Range of motion	1 year	Flexion, extension, supination and pronation measured in degrees from neutral position, pulpa palm distance in cm
Grip strength	1 year	Grip strength with a hand dynamometer
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)

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026