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

Distal Radius Fractures Clinical Trial

Official 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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04716309
• Other study ID #: 85724
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 16, 2021
• Est. completion date: December 2028

Study information

• Verified date: February 2024
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 2028
• Est. primary completion date: February 8, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Colles' Fracture
• Distal Radius Fractures
• Fractures, Bone
• Radius Fractures
• Wrist Fracture
• Wrist Fractures

Intervention

Procedure:
• Open reduction and volar locking plate and closed reduction and K-wires.
DVR Anatomic Plate, K-wires

Locations

Country	Name	City	State
Norway	Skadelegevakten	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Sophies Minde

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-Related Wrist and Hand Evaluation (PRWHE) score	PROM of 15 questions, score ranging from 0 (best) to 100 (worst)	1 year
Secondary	Quick Dash score	PROM of 11 questions, score ranging from 0 (best) to 100 (worst)	1 year
Secondary	X-ray wrist posterior-anterior and lateral view	Volar tilt (degrees), radial inclination (degrees), ulnar variance (mm), stepp-off (mm)	1 year
Secondary	Range of motion	Flexion, extension, supination and pronation measured in degrees from neutral position, pulpa palm distance in cm	1 year
Secondary	Grip strength	Grip strength with a hand dynamometer	1 year