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Clinical Trials/NCT00206037
NCT00206037
Terminated
Phase 4

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

AO Clinical Investigation and Publishing Documentation3 sites in 2 countries49 target enrollmentMay 2005
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ConditionsHigh Tibia Osteotomy

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
High Tibia Osteotomy
Sponsor
AO Clinical Investigation and Publishing Documentation
Enrollment
49
Locations
3
Primary Endpoint
Percentage of the osteotomy gap volume filled with bone healing tissue as determined on the MRI at 2 and 6 weeks postoperatively
Status
Terminated
Last Updated
18 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 2005
End Date
February 2007
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
AO Clinical Investigation and Publishing Documentation

Eligibility 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

  • •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

Outcomes

Primary Outcomes

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 Outcomes

  • 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

Study Sites (3)

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