Open Wedge High Tibia Osteotomy | NCT00206037

Studies
Open Wedge High Tibia Osteotomy

NCT00206037

Sponsor

AO Clinical Investigation and Publishing Documentation

Status

Terminated

Last Update Posted

Nov 20, 2007Estimated

Enrollment

49Actual

Phase

Phase 4

Conditions

High Tibia Osteotomy

Interventions

COLLOSS E
TomoFix Plate

Countries

Germany
Switzerland

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

Nov 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Interim analysis showed significant results, thus study was stopped

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Not provided

Completion Date

Feb 2007Actual

First Submitted Date

Sep 14, 2005

First Submission Date that Met QC Criteria

Sep 14, 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

Nov 19, 2007

Last Update Posted Date

Nov 20, 2007Estimated

Name	Class
Ossacur Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The aim of this RCT is to show, that in a patient group receiving COLLOSS E combined with TomoFix for medical open wedge high tibial osteotomy, the onset of bone healing is earlier in time, compared to patients receiving TomoFix without COLLOSS E.

Detailed Description

The healing effect should be demonstrated by using MRI pictures during the entire FU's in order to demonstrate the differences if COLLOSS E is applied or not.

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

49Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of the osteotomy gap volume filled with bone healing tissue as determined on the MRI at 2 and 6 weeks postoperatively		6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Bone union
Complication rate
Pain asset on the VAS

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult and active patient
Varus malalignment of the leg
Intact lateral joint compartment
Physiological age-appropriate ROM in hip, knee and ankle of affected leg

Exclusion Criteria:

BMI>35
Drug or alcohol abuse
Known equine protein allergy or immunological anormalities
Immunosuppressive treatment
Systemic or severe local inflammation or infections
History of active malignancy or systemic disease
Impossible to obtain informed consent
Legal incompetence
Pregnant and nursing women
Patients before, during or one year after radio- or chemotherapy
Patients with metal or metal implants near vulnerable structures
Patients with pacemakers or other implanted devices

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
René K Marti, Prof. MD	Klinik Gut, St. Moritz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Henriettenstiftung Hannover		Hanover		30171	Germany
BGU Tuebingen