tibia plateau fracture
Conditions
Interventions
All patients will receive Norian Drillable to fill the bone void in the tibia
plateau fracture
Sponsors
Synthes GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Subjects with closed tibial plateau fractures classified as OTA B2, B3 or C3 resulting in a bone void. 2.At least 18 years of age. 3.Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.
Exclusion criteria
Exclusion criteria: 1.Critically ill 2.Mentally ill or mentally disordered 3.Wards of the state 4.Prisoners 5.Refugees 6.In an employer - employee, teacher - student relationship or any other dependant with the researchers or their associates 7.Active or suspected infection - systemic or local 8.Gustillo classification of 2 or 3 9.Bilateral tibial plateau fractures when both fracture patterns extend into the joint 10.Have an existing calcium metabolism disorder (e.g. hypercalcemia) 11.Chronic renal disease/renal failure 12.Insulin dependent diabetes 13.Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids). 14.Rheumatoid arthritis or other autoimmune disease. 15.Systemic disease including AIDS, HIV, hepatitis. 16.Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years. 17.Subjects involved in other studies within the last month, prior to screening. 18.Pregnant or interested in becoming pregnant in the next 18 months. Females of child-bearing potential must use an acceptable method of contraception during trial participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of the surgery (operating room time) Blood loss Complications Ease of use | — |
Secondary
| Measure | Time frame |
|---|---|
| To define the clinical and radiographic outcome of using Norian Drillable by evaluating: 1. fracture stabilization and 2. patient function and pain over time. | — |
Countries
Netherlands
Outcome results
None listed