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Surgical Plate Osteosynthesis of Distal Radius Fractures

Primary Purpose

Distal Radius Fractures

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Locking Compression Plate 2,4mm
Locking Compression Plate 3,5mm
Sponsored by
AO Clinical Investigation and Publishing Documentation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fractures focused on measuring Locking Compression Plate, Conservative treatment, Surgical treatment, Radius fractures, AO 23

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: skeletally mature female and male Distal radius and ulnar fractures AO 23 10 days after injury Exclusion Criteria: 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

Sites / Locations

  • Harvard Medical School
  • BG-Unfallklinik Ludwigshafen
  • York District Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

- 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

Full Information

First Posted
September 13, 2005
Last Updated
April 26, 2007
Sponsor
AO Clinical Investigation and Publishing Documentation
Collaborators
Synthes Inc., AO Hand Expert Group
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1. Study Identification

Unique Protocol Identification Number
NCT00205998
Brief Title
Surgical Plate Osteosynthesis of Distal Radius Fractures
Official Title
Surgical Plate Osteosynthesis of Distal Radius Fractures. Prospective Study of the Locking Compression Plate (LCP)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Terminated
Why Stopped
Study completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AO Clinical Investigation and Publishing Documentation
Collaborators
Synthes Inc., AO Hand Expert Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
In addition the differences between the surgical treatment compared to conservative treatment with respect to fracture healing, functional outcome and subject satisfaction will be analysed after 6w./6m./1y./2y.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fractures
Keywords
Locking Compression Plate, Conservative treatment, Surgical treatment, Radius fractures, AO 23

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
450 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Locking Compression Plate 2,4mm
Intervention Type
Device
Intervention Name(s)
Locking Compression Plate 3,5mm
Primary Outcome Measure Information:
Title
- Document specific indications for the surgical treatment of distal radius fractures using the LCP
Secondary Outcome Measure Information:
Title
- Primary reduction and maintenance of reduction of the plate fixation
Title
- Functional outcome scoring using "Garetland and Werley, DASH and SF-36 scoring
Title
- Patient and surgeon satisfaction
Title
- Analysis of the occured complications

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: skeletally mature female and male Distal radius and ulnar fractures AO 23 10 days after injury Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas W Wentzensen, Prof. MD
Organizational Affiliation
BG-Unfallklinik Ludwigshafen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jesse B Jupiter, Prof. MD
Organizational Affiliation
Harvard Medical School (HMS and HSDM)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter G De Boer, F.R.C.S.
Organizational Affiliation
York District Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harvard Medical School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
BG-Unfallklinik Ludwigshafen
City
Ludwigshafen
ZIP/Postal Code
67071
Country
Germany
Facility Name
York District Hospital
City
York
ZIP/Postal Code
YO31 8HE
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Surgical Plate Osteosynthesis of Distal Radius Fractures

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