Phase 3
Completed N=120
Non-bridging Fixator Versus Percutaneous Pinning for Distal Radius Fractures
Radius Fractures
Source: ClinicalTrials.gov NCT00908895 ↗
Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Jun 2010
Primary outcomePrimary: The Grip Strength — 98.3; 62.6 Percentage of opposite side — p=<0.05
Summary
The treatment of extra-articular distal radius fractures is still controversial. In Canada, most patients with unstable fractures are treated with pinning and cast. Results are often associated with shortening and lack of function.
The purpose of the study is to compare stabilization with a radio-radial fixator to the usual method, suggesting that the radio-radial fixator will provide more strength at 6 months follow-up.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Grip Strength |
98.3; 62.6 | <0.05 sig |
| SECONDARY Range of Movement of Wrist |
93.8; 81.7; 93.5; 74.7; 98; 90 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- Distal radius fracture Frykman I or II
- Unstable fracture according to Lafontaine's criteria
- Fracture line more than 1cm form the joint line
- Closed fracture
- Age > 18 years
- Surgery performed between 72 hours from the trauma
- Monotrauma
- Patient signed the informed consent
Exclusion Criteria
- Distal radius fracture Frykman III-VI (intra-articular fracture)
- Open fracture
- Polytraumatism
- Stable or non-displaced fracture
Data sourced from ClinicalTrials.gov (NCT00908895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.