Open Wedge High Tibia Osteotomy

AO Clinical Investigation and Publishing Documentation

Status and phase: Terminated; Phase 4

Conditions: High Tibia Osteotomy

Treatments: Device: COLLOSS E; Device: TomoFix Plate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00206037

03-hto-colloss-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)