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Open Wedge High Tibia Osteotomy

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ClinicalTrials.gov Identifier: NCT00206037
Recruitment Status : Terminated (Interim analysis showed significant results, thus study was stopped)
First Posted : September 21, 2005
Last Update Posted : November 20, 2007
Sponsor:
Collaborator:
Ossacur Inc.
Information provided by:
AO Clinical Investigation and Documentation

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 to patients receiving TomoFix without COLLOSS E.

Condition or disease Intervention/treatment Phase
High Tibia Osteotomy Device: COLLOSS E Device: TomoFix Plate Phase 4

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  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Open Wedge High Tibia Osteotomy Surgeries Using Colloss E and Tomofix and Tomofix Only, Regarding the Bone Healing
Study Start Date : May 2005
Actual Study Completion Date : February 2007



Primary Outcome Measures :
  1. 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 :
  1. Bone union
  2. Complication rate
  3. Pain asset on the VAS
  4. Deviation planing angle
  5. Immuno reaction on equine proteins
  6. Range of motion
  7. Ligament stability
  8. Time to pain free walking
  9. WOMAC osteoarthritis index
  10. SF36 Index


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00206037     History of Changes
Other Study ID Numbers: 03-hto-colloss-05
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: November 20, 2007
Last Verified: November 2007

Keywords provided by AO Clinical Investigation and Documentation:
Tibia osteotomy
Bone healing
Bone filler
Equine Protein
COLLOSS E
TomoFix