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Non-bridging Fixator Versus Percutaneous Pinning for Distal Radius Fractures

Primary Purpose

Radius Fractures

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Radio-radial fixator

Percutaneous pinning

About this trial

This is an interventional treatment trial for Radius Fractures focused on measuring Radius fractures, Radio-radial fixator, Percutaneous pinning, Grip strength

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Département d'orthopédie, CHA-Pavillon Enfant-Jésus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Radio-radial fixator

Percutaneous pinning

Arm Description

Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)

Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks

Outcomes

Primary Outcome Measures

The Grip Strength

Grip strength measured with Jamar dynamometer in kilograms and adjusted to the opposite side in percentage. Correction made according to dominance.

Secondary Outcome Measures

Range of Movement of Wrist

Range of motion were divided in subgroups: dorsal flexion, volar flexion, pronation, supination, radial inclination, cubital inclination. Motion is described as a percentage of the opposite side.

Full Information

NCT ID

NCT00908895

First Posted

May 26, 2009

Last Updated

February 25, 2011

Sponsor

Hopital de l'Enfant-Jesus

1. Study Identification

Unique Protocol Identification Number

NCT00908895

Brief Title

Non-bridging Fixator Versus Percutaneous Pinning for Distal Radius Fractures

Official Title

Non-bridging Radio-radial Fixator Compared to Percutaneous Pinning for Unstable Distal Radius Fracture. A Prospective Randomized Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

May 2007 (Actual)

Study Completion Date

May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Hopital de l'Enfant-Jesus

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Radius Fractures

Keywords

Radius fractures, Radio-radial fixator, Percutaneous pinning, Grip strength

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Radio-radial fixator

Arm Type

Experimental

Arm Description

Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)

Arm Title

Percutaneous pinning

Arm Type

Active Comparator

Arm Description

Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks

Intervention Type

Procedure

Intervention Name(s)

Radio-radial fixator

Intervention Description

Using the Distal Radius Fixator from Synthes. A single splint for 5 days.

Intervention Type

Procedure

Intervention Name(s)

Percutaneous pinning

Intervention Description

Insert two K-wires in the distal radius, one in the fracture line dorsally and one from the styloid. A cast for 6 weeks.

Primary Outcome Measure Information:

Title

The Grip Strength

Description

Grip strength measured with Jamar dynamometer in kilograms and adjusted to the opposite side in percentage. Correction made according to dominance.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Range of Movement of Wrist

Description

Range of motion were divided in subgroups: dorsal flexion, volar flexion, pronation, supination, radial inclination, cubital inclination. Motion is described as a percentage of the opposite side.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Département d'orthopédie, CHA-Pavillon Enfant-Jésus

City

Québec

State/Province

Quebec

ZIP/Postal Code

G1J1Z4

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Non-bridging Fixator Versus Percutaneous Pinning for Distal Radius Fractures

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