Open Wedge High Tibia Osteotomy

Phase 4

Terminated

• Conditions: High Tibia Osteotomy

• Registration Number: NCT00206037
• Lead Sponsor: AO Clinical Investigation and Publishing 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.

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 Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-21
• Study Completion: 2007-02
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-19
• Last Update Posted: 2007-11-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 49

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of the osteotomy gap volume filled with bone healing tissue as determined on the MRI at 2 and 6 weeks postoperatively	6 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Henriettenstiftung Hannover; 🇩🇪 Hannover, Germany

BGU Tuebingen; 🇩🇪 Tuebingen, Germany

Kantonsspital Luzern; 🇨🇭 Luzern, Switzerland