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

Sponsor

Oslo University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04716309

Collaborator

Sophies Minde (Other)

120

Enrollment

Location

Arms

93.5

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Distal Radius Fractures Wrist Fracture Colles' Fracture	Procedure: Open reduction and volar locking plate and closed reduction and K-wires.	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Feb 16, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: VLP Open reduction and volar locking plate	Procedure: Open reduction and volar locking plate and closed reduction and K-wires. DVR Anatomic Plate, K-wires
Active Comparator: CRPP Closed reduction and percutaenous K-wires/pins	Procedure: Open reduction and volar locking plate and closed reduction and K-wires. DVR Anatomic Plate, K-wires

Arm

Intervention/Treatment

Active Comparator: VLP

Open reduction and volar locking plate

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

DVR Anatomic Plate, K-wires

Active Comparator: CRPP

Closed reduction and percutaenous K-wires/pins

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

DVR Anatomic Plate, K-wires

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Skadelegevakten	Oslo		Norway	0182

Sponsors and Collaborators

Oslo University Hospital
Sophies Minde

Investigators

Study Director: John Williksen, MD, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Børge Olsen, MD Børge Olsen, Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT04716309

Other Study ID Numbers:

85724

First Posted:

Jan 20, 2021

Last Update Posted:

Apr 27, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colles' Fracture

Fractures, Bone

Radius Fractures

Study Results

No Results Posted as of Apr 27, 2022