Open Wedge High Tibia Osteotomy

Phase 4TerminatedNCT00206037

AO Clinical Investigation and Publishing Documentation49 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

High Tibia Osteotomy

Interventions

COLLOSS EDEVICE

TomoFix PlateDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Henriettenstiftung Hannover

Hanover, Germany

BGU Tuebingen

Tübingen, Germany

Kantonsspital Luzern

Lucerne, Switzerland

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

Data from ClinicalTrials.gov

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