NCT00205998

Brief Summary

Primary objective of the study is to demonstrate specific indications for the surgical treatment of distal radius fractures using the locking compression plate.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2001

Longer than P75 for phase_4

Geographic Reach
3 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

April 27, 2007

Status Verified

April 1, 2007

First QC Date

September 13, 2005

Last Update Submit

April 26, 2007

Conditions

Distal Radius Fractures

Keywords

Locking Compression PlateConservative treatmentSurgical treatmentRadius fracturesAO 23

Outcome Measures

Primary Outcomes (1)

  • - Document specific indications for the surgical treatment of distal radius fractures using the LCP

Secondary Outcomes (4)

  • - Primary reduction and maintenance of reduction of the plate fixation

  • - Functional outcome scoring using "Garetland and Werley, DASH and SF-36 scoring

  • - Patient and surgeon satisfaction

  • - Analysis of the occured complications

Interventions

Locking Compression Plate 2,4mmDEVICE
Locking Compression Plate 3,5mmDEVICE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • skeletally mature female and male
  • Distal radius and ulnar fractures AO 23
  • days after injury

You may not qualify if:

  • general or local conditions adversely affecting the bone physiology
  • ISS \>16
  • osteosynthesis close to the wrist joint where a different implant has been used
  • history of drug and alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Harvard Medical School

Boston, Massachusetts, 02114, United States

Location

BG-Unfallklinik Ludwigshafen

Ludwigshafen, 67071, Germany

Location

York District Hospital

York, YO31 8HE, United Kingdom

Location

MeSH Terms

Conditions

Wrist FracturesRadius Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, BoneForearm Injuries

Study Officials

  • Andreas W Wentzensen, Prof. MD

    BG-Unfallklinik Ludwigshafen

    PRINCIPAL INVESTIGATOR

  • Jesse B Jupiter, Prof. MD

    Harvard Medical School (HMS and HSDM)

    PRINCIPAL INVESTIGATOR

  • Peter G De Boer, F.R.C.S.

    York District Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

December 1, 2001

Study Completion

December 1, 2005

Last Updated

April 27, 2007

Record last verified: 2007-04

Locations

US(1)DE(1)GB(1)