- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02154620
Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster (70)
Dorsally Displaced Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster - A Prospective Randomized Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Stockholm, Sweden, 11883
- Department of Orthopaedics, Stockholm South Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Plaster cast
The patient will be treated in a dorsal plaster cast for 4 weeks following the injury to the wrist
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Experimental: Volar plate
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.
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An anatomically countoured volar plate is implanted through a Henry's incision.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient related wrist evaluation (PRWE)
Time Frame: 52 weeks
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52 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient related wrist evaluation (PRWE)
Time Frame: 3 years
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3 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anders Enocson, M.D, PhD, Karolinska Institutet
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 70
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Volar plate
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Karolinska InstitutetCompletedDorsally Displaced Intraarticular Distal Radius Fractures | Age 50 - 74 for Females or 60-74 for Males | Low Energy TraumaSweden
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Universidad de La FronteraSOCIEDAD CHILENA DE ORTOPEDIA Y TRAUMATOLOGIAUnknownSurgery | Distal Radius Fracture | Wrist Fracture, | Pronator Quadratus | Volar PlateChile
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Olof SkoldenbergThe Swedish Association for Survivors of Accident and InjuryRecruitingOsteoarthritis | Tendon Injuries | Surgery | Surgery--Complications | Surgical Site Infection | Radius Fracture Distal | Dislocation | CRPS Type I | Tendon Rupture | Treatment Complication | CRPS Type IISweden
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Karolinska InstitutetActive, not recruitingCost-effectiveness, Volar Locking Plate or Non-operative Treatment Distal Radius Fracture (HE-VOCAL)Quality of Life | Postoperative Complications | Wrist Injuries | Radius Fractures | Aged | Health Care Utilization | Cost-Benefit Analysis | Wrist FractureSweden
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Istanbul UniversityCompletedDistal Radius FracturesTurkey
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Norfolk and Norwich University Hospitals NHS Foundation...DePuy International; Global Diagnostics UKCompletedDistal Radial Fractures Treated With a DVR-A Locking PlateUnited Kingdom
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Karolinska InstitutetCompletedDorsally Displaced Intraarticular Distal Radius Fractures | Age 50 - 74 for Females or 60-74 for Males | Low Energy TraumaSweden