High Tibia Osteotomy Clinical Trial
Official title:
Comparison of Open Wedge High Tibia Osteotomy Surgeries Using Colloss E and Tomofix and Tomofix Only, Regarding the Bone Healing
| Verified date | November 2007 |
| Source | AO Clinical Investigation and Documentation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Swissmedic |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 49 |
| Est. completion date | February 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Henriettenstiftung Hannover | Hannover | |
| Germany | BGU Tuebingen | Tuebingen | |
| Switzerland | Kantonsspital Luzern | Luzern |
| Lead Sponsor | Collaborator |
|---|---|
| AO Clinical Investigation and Documentation | Ossacur Inc. |
Germany, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Bone union | |||
| Secondary | Complication rate | |||
| Secondary | Pain asset on the VAS | |||
| Secondary | Deviation planing angle | |||
| Secondary | Immuno reaction on equine proteins | |||
| Secondary | Range of motion | |||
| Secondary | Ligament stability | |||
| Secondary | Time to pain free walking | |||
| Secondary | WOMAC osteoarthritis index | |||
| Secondary | SF36 Index |