Open Wedge High Tibia Osteotomy

November 19, 2007 updated by: AO Clinical Investigation and Publishing Documentation

Comparison of Open Wedge High Tibia Osteotomy Surgeries Using Colloss E and Tomofix and Tomofix Only, Regarding the Bone Healing

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.

Study Overview

Status

Terminated

Conditions

High Tibia Osteotomy

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	6 weeks

Secondary Outcome Measures

Outcome Measure
Complication rate
Bone union
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AO Clinical Investigation and Publishing Documentation

Collaborators

Ossacur Inc.

Investigators

Principal Investigator: René K Marti, Prof. MD, Klinik Gut, St. Moritz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Study Completion (ACTUAL)

February 1, 2007

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria