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

July 2, 2010
June 11, 2013
June 2010
March 2013   (final data collection date for primary outcome measure)
- 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 ]
Same as current
Complete list of historical versions of study NCT01156766 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Metaphyseal Distal Radius Fractures
Locking Plate Versus Pins for Surgical Treatment of Posteriorly Tilted Distal Radius Fracture

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metaphyseal Radius Fractures (AO Type A2, A3, C1 et C2)
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.

Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01156766
CHU-0077
Not Provided
University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
  • Stryker SA
  • Polyclinique du Parc Rambot
Principal Investigator: Stéphane DESCAMPS, MD University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP