Operative Treatment of Extraarticular Colles' Fractures of the Distal Radius (OTEC)

Sponsor

Heinrich-Heine University, Duesseldorf (Other)

Overall Status

Unknown status

CT.gov ID

NCT00271726

Collaborator

Philipps University Marburg Medical Center (Other)

Enrollment

Location

Study Details

Study Description

Brief Summary

This is a prospective, randomized, multi-center pilot study of unstable extraarticular fractures of the distal radius with dorsal displacement of the distal fragment in elderly patients. The patients are randomly assigned to osteosynthesis with palmar locking plate, external fixator, or Kirschner wires.

The aim of this pilot study is to allow a sample size calculation for a main randomized controlled trial (RCT). The primary outcome criterion is the functional status measured by the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Secondary outcome criteria are pain, range of motion (ROM), grip strength, and radiological parameters. Since this is a pilot study it is intended to generate a study hypothesis for the main RCT.

Condition or Disease	Intervention/Treatment	Phase
Colles' Fracture Radius Fractures	Procedure: Osteosynthesis with palmar locking plate Procedure: Osteosynthesis with external fixator Procedure: Osteosynthesis with Kirschner wires	N/A

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Prospective, Randomized, Multi-Center Pilot Study on the Treatment of Unstable, Extraarticular Colles Fractures of the Distal Radius by Palmar Locking Plate, External Fixator or Kirschner Wires

Study Start Date :

Nov 1, 2005

Outcome Measures

Primary Outcome Measures

Functional status measured by DASH questionnaire []

Secondary Outcome Measures

Pain []
Range of motion (ROM) []
Grip strength []
Radiological parameters []
Feasibility []

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Isolated, extraarticular, unstable Colles' fracture of the metaphysis of the distal radius (AO type A3)
Age 65 years or older
Patient agreed with and signed the "informed consent" form

Exclusion Criteria:

Fractures older than 7 days (more than 1 week between injury and treatment)
Other injuries of the hand
Other relevant injuries of the upper extremities
Open fracture
Patients with one hand missing
Clinical or radiological signs of any rheumatoid disease, osteoarthritis, or polyarthritis
Previous skeletal injury or severe soft tissue injury of the arm
History of drug or alcohol abuse
Patients unlikely to cooperate or attend all scheduled visits
Patients who have participated in any other device or drug clinical trial within the previous month
Patients with legal incompetence

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Trauma and Hand Surgery, University Hospital	Düsseldorf		Germany	D - 40225

Sponsors and Collaborators

Heinrich-Heine University, Duesseldorf
Philipps University Marburg Medical Center

Investigators

Principal Investigator: Michael Schädel-Höpfner, MD, Department of Trauma and Hand Surgery, University Hospital, Moorenstrasse 5, D - 40225 Düsseldorf