- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00206037
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
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)
49
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
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Hannover, Germany, 30171
- Henriettenstiftung Hannover
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Tuebingen, Germany, 72076
- BGU Tuebingen
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Luzern, Switzerland, 6016
- Kantonsspital Luzern
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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
No
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
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6 weeks
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Secondary Outcome Measures
Outcome Measure |
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Complication rate
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Bone union
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Pain asset on the VAS
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Deviation planing angle
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Immuno reaction on equine proteins
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Range of motion
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Ligament stability
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Time to pain free walking
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WOMAC osteoarthritis index
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SF36 Index
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
September 14, 2005
First Posted (ESTIMATE)
September 21, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
November 20, 2007
Last Update Submitted That Met QC Criteria
November 19, 2007
Last Verified
November 1, 2007
More Information
Terms related to this study
Other Study ID Numbers
- 03-hto-colloss-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on High Tibia Osteotomy
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University of WinchesterHampshire Hospitals NHS Foundation TrustSuspendedHigh Tibial Osteotomy With Allograft Wedge | High Tibial Osteotomy Without Allograft Wedge | Pre- and Post-operative Physical Activity LevelsUnited Kingdom
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Fowler Kennedy Sport Medicine ClinicCompletedOpening Wedge High Tibial OsteotomyCanada
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Yonsei UniversityUnknownCorrectional OsteotomyKorea, Republic of
-
Augusta UniversityRecruiting
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Chinese University of Hong KongCompletedRandomized Controlled Trial | OsteotomyHong Kong
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Hams Hamed AbdelrahmanCompleted
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Minia UniversityDar Al Shifa HospitalCompleted
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Klinik Diakonissen Linz GmbHSurgebright GmbhCompleted
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Cairo UniversityUnknown
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