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

Heinrich-Heine University, Duesseldorf

Status

Unknown

Conditions

Radius Fractures

Colles' Fracture

Treatments

Procedure: Osteosynthesis with palmar locking plate

Procedure: Osteosynthesis with Kirschner wires

Procedure: Osteosynthesis with external fixator

Study type

Interventional

Funder types

Other

Identifiers

NCT00271726

OTEC Pilot 1 KKS MR

Details and patient eligibility

About

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.

Sex

All

Ages

65+ years old

Volunteers

No 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