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Metaphyseal Distal Radius Fractures

This study has been completed.
Sponsor:
Collaborators:
Stryker SA
Polyclinique du Parc Rambot
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01156766
First received: July 2, 2010
Last updated: June 11, 2013
Last verified: June 2013
History of Changes
  Purpose

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 Intervention
Metaphyseal Radius Fractures (AO Type A2, A3, C1 et C2)
 Device: - locking anterior plate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Locking Plate Versus Pins for Surgical Treatment of Posteriorly Tilted Distal Radius Fracture

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • - 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • PAIN score (2 weeks, 5 weeks, 3, 6 and 12 months) [ Time Frame: 2 weeks, 5 weeks, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Grip and pinch strength (5 weeks, 3, 6 and 12 months) [ Time Frame: 5 weeks, 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
Enrollment: 90
Study Start Date: June 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
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.

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.

  Eligibility
Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01156766     History of Changes
Other Study ID Numbers: CHU-0077 
Study First Received: July 2, 2010
Last Updated: June 11, 2013
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on September 27, 2016