Surgical Plate Osteosynthesis of Distal Radius Fractures | NCT00205998

Studies
Surgical Plate Osteosynthesis of Distal Radius Fractures

NCT00205998

Sponsor

AO Clinical Investigation and Publishing Documentation

Status

Terminated

Last Update Posted

Apr 27, 2007Estimated

Enrollment

450Actual

Phase

Phase 4

Conditions

Distal Radius Fractures

Interventions

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

Countries

United States
Germany
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study completed

Expanded Access Info

Start Date

Dec 2001

Primary Completion Date

Not provided

Completion Date

Dec 2005Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2007

Last Update Posted Date

Apr 27, 2007Estimated

Name	Class
Synthes Inc.	INDUSTRY
AO Hand Expert Group	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

450Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
- Document specific indications for the surgical treatment of distal radius fractures using the LCP

Secondary Outcomes

Measure	Description	Time Frame
- Primary reduction and maintenance of reduction of the plate fixation
- Functional outcome scoring using "Garetland and Werley, DASH and SF-36 scoring

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Harvard Medical School		Boston	Massachusetts	02114	United States
BG-Unfallklinik Ludwigshafen

Condition Browse Module

MeSH Terms

ID	Term
D000092503	Wrist Fractures
D011885	Radius Fractures

Ancestor Terms

ID	Term
D014954	Wrist Injuries
D001134	Arm Injuries
D014947	Wounds and Injuries
D050723	Fractures, Bone

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Locking Compression Plate 2,4mm	Device
Locking Compression Plate 3,5mm	Device