se of a reinforced injectable calcium phosphate bone cement in the treatment of Tibial Plateau fractures
- Conditions
- tibia plateau fracture10017322
- Registration Number
- NL-OMON34737
- Lead Sponsor
- Synthes GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Duration of the surgery (operating room time)<br /><br>Blood loss<br /><br>Complications<br /><br>Ease of use</p><br>
- Secondary Outcome Measures
Name Time Method <p>To define the clinical and radiographic outcome of using Norian Drillable by<br /><br>evaluating:<br /><br>1. fracture stabilization and<br /><br>2. patient function and pain over time.</p><br>