Open Wedge High Tibia Osteotomy

This study has been terminated.
(Interim analysis showed significant results, thus study was stopped)
Sponsor:
Collaborator:
Ossacur Inc.
Information provided by:
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT00206037
First received: September 14, 2005
Last updated: November 19, 2007
Last verified: November 2007
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00206037     History of Changes
Other Study ID Numbers: 03-hto-colloss-05
Study First Received: September 14, 2005
Last Updated: November 19, 2007
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 18, 2014