Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures

DePuy Synthes

Status: Completed

Conditions: Tibial Fractures

Treatments: Device: Norian Drillable Bone Void Filler

Study type: Observational

Funder types: Industry

Identifiers

NCT01132508

ND-AUS-01

Details and patient eligibility

About

Case series of tibial plateau fractures using Norian Drillable.

Full description

This study is a multi-center, non-randomized prospective case series of tibial plateau fractures using Norian Drillable to fill bone voids, to evaluate OR time, blood loss, complications, ease of use, fracture stabilization and patient function and pain over time.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with closed tibial plateau fractures classified as OTA B2, B3 or C3 resulting in a bone void.
• At least 18 years of age.
• Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.
• Signed informed consent.

Exclusion criteria

• Critically ill
• Mentally ill or mentally disordered
• Wards of the state
• Prisoners
• Refugees
• In an employer - employee, teacher - student relationship or any other dependant with the researchers or their associates
• Active or suspected infection - systemic or local
• Gustillo classification of 2 or 3
• Bilateral tibial plateau fractures when both fracture patterns extend into the joint
• Have an existing calcium metabolism disorder (e.g. hypercalcemia)
• Chronic renal disease/renal failure
• Insulin dependent diabetes
• Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids).
• Rheumatoid arthritis or other autoimmune disease.
• Systemic disease including AIDS, HIV, hepatitis.
• 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.
• Subjects involved in other studies within the last month, prior to screening.
• 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.

Trial design

33 participants in 1 patient group

Treatment

Treatment:

Device: Norian Drillable Bone Void Filler