Status:
TERMINATED
Open Wedge High Tibia Osteotomy
Lead Sponsor:
AO Clinical Investigation and Publishing Documentation
Collaborating Sponsors:
Ossacur Inc.
Conditions:
High Tibia Osteotomy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 t...
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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00206037
Start Date
May 1 2005
End Date
February 1 2007
Last Update
November 20 2007
Active Locations (3)
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1
Henriettenstiftung Hannover
Hanover, Germany, 30171
2
BGU Tuebingen
Tübingen, Germany, 72076
3
Kantonsspital Luzern
Lucerne, Switzerland, 6016