Metaphyseal Distal Radius Fractures

Metaphyseal Radius Fractures (AO Type A2, A3, C1 et C2) Clinical Trial

Official title:

Locking Plate Versus Pins for Surgical Treatment of Posteriorly Tilted Distal Radius Fracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156766
• Other study ID #: CHU-0077
• Status: Completed
• Phase: N/A
• First received: July 2, 2010
• Last updated: June 11, 2013
• Start date: June 2010
• Est. completion date: March 2013

Study information

• Verified date: June 2013
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Metaphyseal Radius Fractures (AO Type A2, A3, C1 et C2)
• Radius Fractures

Intervention

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.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Polyclinique du Parc Rambot, Stryker SA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- X-ray assessments (preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths)		preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths	Yes
Secondary	PAIN score (2 weeks, 5 weeks, 3, 6 and 12 months)		2 weeks, 5 weeks, 3, 6 and 12 months	Yes
Secondary	Gartland, O'Brien, DASH and Euroquol EQ-5D scores (5 weeks, 3, 6 and 12 months)		5 weeks, 3, 6 and 12 months	Yes
Secondary	Grip and pinch strength (5 weeks, 3, 6 and 12 months)		5 weeks, 3, 6 and 12 months	Yes