Open Wedge High Tibia Osteotomy

This study has been terminated.

( Interim analysis showed significant results, thus study was stopped )

First Received: September 14, 2005 Last Updated: November 19, 2007 History of Changes

Sponsors and Collaborators:	AO Clinical Investigation and Documentation Ossacur Inc.
Information provided by:	AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:	NCT00206037

Purpose

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.

Condition	Intervention	Phase
High Tibia Osteotomy	Device: COLLOSS E Device: TomoFix Plate	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Comparison of Open Wedge High Tibia Osteotomy Surgeries Using Colloss E and Tomofix and Tomofix Only, Regarding the Bone Healing

Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Bone union
Complication rate
Pain asset on the VAS
Deviation planing angle
Immuno reaction on equine proteins
Range of motion
Ligament stability
Time to pain free walking
WOMAC osteoarthritis index
SF36 Index

Enrollment:	49
Study Start Date:	May 2005
Study Completion Date:	February 2007

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206037

Locations

Germany
Henriettenstiftung Hannover
Hannover, Germany, 30171
BGU Tuebingen
Tuebingen, Germany, 72076
Switzerland
Kantonsspital Luzern
Luzern, Switzerland, 6016

Sponsors and Collaborators

AO Clinical Investigation and Documentation

Ossacur Inc.

Investigators

Principal Investigator:

René K Marti, Prof. MD

Klinik Gut, St. Moritz

More Information

No publications provided

Study ID Numbers:	03-hto-colloss-05
Study First Received:	September 14, 2005
Last Updated:	November 19, 2007
ClinicalTrials.gov Identifier:	NCT00206037 History of Changes
Health Authority:	Switzerland: Swissmedic

Keywords provided by AO Clinical Investigation and Documentation:

Tibia osteotomy
Bone healing
Bone filler

Equine Protein
COLLOSS E
TomoFix

ClinicalTrials.gov processed this record on September 11, 2009