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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
Sponsor:
Collaborators:
Stryker SA
Polyclinique du Parc Rambot
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
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Brief Summary:

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

Detailed Description:

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 Design
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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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U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
    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.


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. - 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 ]

Secondary Outcome Measures :
  1. PAIN score (2 weeks, 5 weeks, 3, 6 and 12 months) [ Time Frame: 2 weeks, 5 weeks, 3, 6 and 12 months ]
  2. 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 ]
  3. Grip and pinch strength (5 weeks, 3, 6 and 12 months) [ Time Frame: 5 weeks, 3, 6 and 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Stryker SA
Polyclinique du Parc Rambot
Investigators
Principal Investigator: Stéphane DESCAMPS, MD University Hospital, Clermont-Ferrand
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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