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Status unknownNCT00271726Updated Apr 27, 2007

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

An interventional study of Osteosynthesis with palmar locking plate and Osteosynthesis with external fixator in Colles' Fracture and Radius Fractures, sponsored by Heinrich-Heine University, Duesseldorf. Status unknown at 1 site in Germany. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2007-04-27.

Sponsored by Heinrich-Heine University, Duesseldorf · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2007), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Colles' Fracture
  • Radius Fractures

Keywords

  • distal radius fracture
  • extraarticular Colles fracture
03

In context

Colles' Fracture

30 studies on the registry are indexed under Colles' Fracture; 4 are open to participants now.

This study's enrollment of 90 is above the median of 80 across 27 interventional studies indexed under Colles' Fracture.

Browse Colles' Fracture studies →

Lead sponsor

Heinrich-Heine University, Duesseldorf is the lead sponsor of 174 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants

Interventions

  • ProcedureOsteosynthesis with palmar locking plate
  • ProcedureOsteosynthesis with external fixator
  • ProcedureOsteosynthesis with Kirschner wires
06

What researchers measure

Primary outcomes

  1. Functional status measured by DASH questionnaire

Secondary outcomes

  1. Pain

  2. Range of motion (ROM)

  3. Grip strength

  4. Radiological parameters

  5. Feasibility

07

Study locations

1 of 1 sites recruiting
  • Department of Trauma and Hand Surgery, University Hospital
    Düsseldorf, D - 40225, Germany
    • Michael Schädel-Höpfner, MD · Contact · schaedel@uni-duesseldorf.de · +49 211 8104405
    • Michael Schädel-Höpfner, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00271726
Lead sponsor
Heinrich-Heine University, Duesseldorf
Collaborators
Philipps University Marburg
First posted
Jan 4, 2006
Start date
Nov 2005
Last update
Apr 27, 2007

Study contacts

Michael Schädel-Höpfner, MD
Contact
schaedel@uni-duesseldorf.de
+49 211 8104405
Michael Schädel-Höpfner, MD
principal investigator · Department of Trauma and Hand Surgery, University Hospital, Moorenstrasse 5, D - 40225 Düsseldorf
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

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