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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00271726

Enrollment

Registered

2006-01-04

Start date

2005-11-30

Completion date

Unknown

Last updated

2007-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colles' Fracture, Radius Fractures

Keywords

distal radius fracture, extraarticular Colles fracture

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.

Interventions

PROCEDUREOsteosynthesis with palmar locking plate

PROCEDUREOsteosynthesis with external fixator

PROCEDUREOsteosynthesis with Kirschner wires

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Functional status measured by DASH questionnaire	—

Secondary

Measure	Time frame
Pain	—
Range of motion (ROM)	—
Grip strength	—
Radiological parameters	—
Feasibility	—

Countries

Germany

Contacts

Primary ContactMichael Schädel-Höpfner, MD

schaedel@uni-duesseldorf.de+49 211 8104405

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026