- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00809861
Volar Locking Plate Versus External Fixator/Cast Fixation for the Treatment of Distal Radius Fractures
Volar Locking Plate Versus External Fixator/Cast Fixation for the Treatment of Distal Radius Fractures. A Randomised Controlled Prospective Study
Aim: Osteosynthesis with locking plate/screws has become increasingly popular in recent years. It is the only treatment option which allows immediate postoperative immobilization. However, compared to conservative treatment or treatment with external fixators, locking plates are very expensive and the operation can be very challenging, even for experienced surgeons. The long-term results of all treatment modalities are equal, which has been shown in numerous studies. However, there are no evidence based studies published yet which look at short-term outcomes. The investigators do feel but do not know that patients who do not need postoperative immobilization return to work significantly earlier or are independent faster than patients whose wrists are immobilized for up to 6 weeks. If that is the case, then the higher costs and risks of the operation are justified, if not, then we have to re-evaluate our indications for using locking distal radius plates distal radius Methods: Group 1: Treatment of distal radius fractures with either volar or dorsal locking plates. No fixation postoperatively, immediate ROM (range of motion) exercises and usage of the wrist in activities of daily life (ADL) allowed.
Radiological and clinical controls 2 weeks, 6 weeks and 12 weeks postoperatively. Endpoints are time to return to work / return to independency (in older people), ROM; Grip strength (with Jamar Dynamometer).
Outcome scores are DASH (Disability of Arm, Shoulder and Hand Score)and PRWE (Patient related wrist evaluation).
Group 2 Treatment of distal radius fractures with either an external fixator +/- K-wires or with K-wires and forearm cast or by cast alone. Main issue is that the wrist is immobilized for a period of 6 weeks. Radiological and clinical controls 2 weeks, 6 weeks and 12 weeks postoperatively. Endpoints are time to return to work / return to independency (in older people), ROM; Grip strength (with Jamar Dynamometer). Outcome scores are DASH and PRWE. Both plating and external fixation / cast fixation are standard and accepted treatment modalities for distal radius fractures. A power analysis indicated that a total sample size of 52 patients randomized equally (1:1) to each treatment arm without any blocking or stratification would provide 80 % statistical power (alpha = .05, beta = .20) to detect a 20% difference in mean DASH and PRWE scores.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Queensland
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Mackay, Queensland, Australia, 4740
- Mackay Base Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- distal radius fracture
- age > 18
Exclusion Criteria:
- intellectual or mental impairment
- < 18 years of age
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 |
---|---|
Active Comparator: 2
|
closed reduction and external fixation
|
Active Comparator: 1
volar locking plating of distal radius fractures
|
open reduction and internal fixation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
20% difference in DASH scores
Time Frame: twelve weeks
|
twelve weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
return to work
Time Frame: twelve weeks
|
twelve weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Herwig Drobetz, MD, Mackay Base Hospital
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 (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DCDRS00407
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.
Clinical Trials on Distal Radius Fractures
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The Methodist Hospital Research InstituteRecruitingDistal Radius FracturesUnited States
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Clinical Trials on volar locking plating
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Sunnybrook Health Sciences CentreCompletedDistal Radius FractureCanada
-
Oslo University HospitalActive, not recruitingDistal Radius FractureNorway
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Goorens Chul KiRecruitingRadius Fracture DistalBelgium
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University of OuluCompletedDistal Radius Fractures
-
Tampere University HospitalRecruiting
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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
-
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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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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Oslo University HospitalSophies MindeActive, not recruitingColles' Fracture | Distal Radius Fractures | Wrist FractureNorway
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University of MalayaWithdrawn