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Open Wedge High Tibia Osteotomy

NCT ID: NCT00206037

Last Updated: 2007-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2007-02-28

Brief Summary

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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

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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.

Conditions

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High Tibia Osteotomy

Keywords

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Tibia osteotomy Bone healing Bone filler Equine Protein COLLOSS E TomoFix

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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COLLOSS E

Intervention Type DEVICE

TomoFix Plate

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ossacur Inc.

INDUSTRY

Sponsor Role collaborator

AO Clinical Investigation and Publishing Documentation

OTHER

Sponsor Role lead

Principal Investigators

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René K Marti, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Klinik Gut, St. Moritz

Locations

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Henriettenstiftung Hannover

Hanover, , Germany

Site Status

BGU Tuebingen

Tübingen, , Germany

Site Status

Kantonsspital Luzern

Lucerne, , Switzerland

Site Status

Countries

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Germany Switzerland

Other Identifiers

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03-hto-colloss-05

Identifier Type: -

Identifier Source: org_study_id