Back to resultsDistal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster (70)
Primary Purpose
Distal Radius Fracture
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Volar plate
Synthes TCP volar plate
Sponsored by
About this trial
This is an interventional treatment trial for Distal Radius Fracture focused on measuring Distal radius fracture, wrist fracture, volar plate, surgical treatment, plaster immobilisation
Eligibility Criteria
Inclusion Criteria:
- Dorsally displaced, 20 degrees or from a plane perpendicular do the diaphyseal axis, fracture.
- Low energy injury
- Patient 70 years old or older
- 72 hours or less since injury at time of diagnosis
- Patient registered in the Stockholm region
- Patient understands spoken and written swedish
Exclusion Criteria:
- Intraarticular displacement in radiocarpal joint of more than 1 mm
- Ulna fractured proximal to the base of the styloid process of ulna
- Earlier unilateral functional impairment of hand/wrist
- Injury to tendon, nerve or skin besides the fracture
- Rheumatoid arthritis or other severe systemic joint disease
- Severe psychiatric disorder, ongoing drug abuse or dementia (Pfeiffer score 5 points or less)
- Besides the wrist fracture also other big injuries, for example fracture of hip, shoulder or ankle
- Medical illness that makes general anesthesia impossible
Sites / Locations
- Department of Orthopaedics, Stockholm South Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Plaster cast
Volar plate
Arm Description
The patient will be treated in a dorsal plaster cast for 4 weeks following the injury to the wrist
The patient will undergo surgery to the injured wrist with a Synthes Two-column plate (TCP) with a volar approach. Cast will be worn 2 weeks after surgery.
Outcomes
Primary Outcome Measures
Patient related wrist evaluation (PRWE)
Secondary Outcome Measures
Patient related wrist evaluation (PRWE)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02154620
Brief Title
Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster
Acronym
70
Official Title
Dorsally Displaced Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster - A Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Distal radius fractures with dorsal dislocation among patients 70 years or older are randomized to conservative treatment with plaster or internal fixation with a volar plate. Thereafter they are followed at 2 weeks, 5 weeks, 3 months and 12 months with x-ray, functional scores and clinical examination.
An additional follow up at three years with X-ray, functional scores and clinical outcome will be conducted after a new written consent of continued participation in the study.
A health economy analysis will be preformed at 1, and 3 years for the participants with complete EQ5D.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture
Keywords
Distal radius fracture, wrist fracture, volar plate, surgical treatment, plaster immobilisation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plaster cast
Arm Type
No Intervention
Arm Description
The patient will be treated in a dorsal plaster cast for 4 weeks following the injury to the wrist
Arm Title
Volar plate
Arm Type
Experimental
Arm Description
The patient will undergo surgery to the injured wrist with a Synthes Two-column plate (TCP) with a volar approach. Cast will be worn 2 weeks after surgery.
Intervention Type
Procedure
Intervention Name(s)
Volar plate
Other Intervention Name(s)
Synthes TCP volar plate for distal radius
Intervention Description
An anatomically countoured volar plate is implanted through a Henry's incision.
Intervention Type
Device
Intervention Name(s)
Synthes TCP volar plate
Primary Outcome Measure Information:
Title
Patient related wrist evaluation (PRWE)
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Patient related wrist evaluation (PRWE)
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Dorsally displaced, 20 degrees or from a plane perpendicular do the diaphyseal axis, fracture.
Low energy injury
Patient 70 years old or older
72 hours or less since injury at time of diagnosis
Patient registered in the Stockholm region
Patient understands spoken and written swedish
Exclusion Criteria:
Intraarticular displacement in radiocarpal joint of more than 1 mm
Ulna fractured proximal to the base of the styloid process of ulna
Earlier unilateral functional impairment of hand/wrist
Injury to tendon, nerve or skin besides the fracture
Rheumatoid arthritis or other severe systemic joint disease
Severe psychiatric disorder, ongoing drug abuse or dementia (Pfeiffer score 5 points or less)
Besides the wrist fracture also other big injuries, for example fracture of hip, shoulder or ankle
Medical illness that makes general anesthesia impossible
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Enocson, M.D, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopaedics, Stockholm South Hospital
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
35549696
Citation
Sudow H, Severin S, Wilcke M, Saving J, Skoldenberg O, Navarro CM. Non-operative treatment or volar locking plate fixation for dorsally displaced distal radius fractures in patients over 70 years - a three year follow-up of a randomized controlled trial. BMC Musculoskelet Disord. 2022 May 12;23(1):447. doi: 10.1186/s12891-022-05394-7.
Results Reference
derived
Learn more about this trial
Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster
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