Metaphyseal Distal Radius Fractures
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ClinicalTrials.gov Identifier: NCT01156766 |
Recruitment Status
:
Completed
First Posted
: July 5, 2010
Last Update Posted
: June 12, 2013
|
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The number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques are described in particular locking plates and intrafocal pinning techniques.
The aim of the study is to compare (X-ray assessments and functional outcome) these two types of treatment by using a prospective, randomised multicentric analysis.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metaphyseal Radius Fractures (AO Type A2, A3, C1 et C2) | Device: - locking anterior plate | Not Applicable |
Because an increasing number of elderly patient, the number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques exist of which in particular locking plates and intrafocal pinning.
The availability of new materials (locking plates with angular stability) seems to reduce the risks of osteosynthesis failure and seems to give more constant results: hawever, the price to pay is a more invasive technique and a superior cost. The rehabilitation seems also faster, allowing the possibility to get back the maximum of autonomy.
These clinical facts need of course to be validated.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 90 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Locking Plate Versus Pins for Surgical Treatment of Posteriorly Tilted Distal Radius Fracture |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | March 2013 |
Actual Study Completion Date : | March 2013 |
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Device: - locking anterior plate
The number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques are described in particular locking plates and intrafocal pinning techniques.
The aim of the study is to compare (X-ray assessments and functional outcome) these two types of treatment by using a prospective, randomised multicentric analysis.
- - X-ray assessments (preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths) [ Time Frame: preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths ]
- PAIN score (2 weeks, 5 weeks, 3, 6 and 12 months) [ Time Frame: 2 weeks, 5 weeks, 3, 6 and 12 months ]
- Gartland, O'Brien, DASH and Euroquol EQ-5D scores (5 weeks, 3, 6 and 12 months) [ Time Frame: 5 weeks, 3, 6 and 12 months ]
- Grip and pinch strength (5 weeks, 3, 6 and 12 months) [ Time Frame: 5 weeks, 3, 6 and 12 months ]

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Ages Eligible for Study: | 60 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- - metaphyseal inferior radius fractures (AO classification 23A2, 23A3, 23C1, 23C2)
- age 60 years or older
Exclusion Criteria:
- open fracture
- fractures AO classification: 23A1, 23C3, 23B1, 23B2, 23B3
- polytraumatized patient
- fractures older than 15 days
- infection of the operating site
- previous osseous disease

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156766
France | |
CHU Clermont-Ferrand | |
Clermont-Ferrand, France, 63003 |
Principal Investigator: | Stéphane DESCAMPS, MD | University Hospital, Clermont-Ferrand |
Responsible Party: | University Hospital, Clermont-Ferrand |
ClinicalTrials.gov Identifier: | NCT01156766 History of Changes |
Other Study ID Numbers: |
CHU-0077 |
First Posted: | July 5, 2010 Key Record Dates |
Last Update Posted: | June 12, 2013 |
Last Verified: | June 2013 |
Keywords provided by University Hospital, Clermont-Ferrand:
Fracture Radius Osteosynthesis |
Metaphyseal Pinning Locking anterior plate |
Additional relevant MeSH terms:
Fractures, Bone Radius Fractures Wounds and Injuries Forearm Injuries Arm Injuries |