Open Wedge High Tibia Osteotomy

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00206037

Enrollment

Registered

2005-09-21

Start date

2005-05-31

Completion date

2007-02-28

Last updated

2007-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Tibia Osteotomy

Keywords

Tibia osteotomy, Bone healing, Bone filler, Equine Protein, COLLOSS E, TomoFix

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.

Interventions

DEVICECOLLOSS E

DEVICETomoFix Plate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Bone union	—
Complication rate	—
Pain asset on the VAS	—
Deviation planing angle	—
Ligament stability	—
Range of motion	—
Time to pain free walking	—
WOMAC osteoarthritis index	—
SF36 Index	—
Immuno reaction on equine proteins	—

Countries

Germany, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026