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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2013-09-30

Brief Summary

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Case series of tibial plateau fractures using Norian Drillable.

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Detailed Description

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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.

Conditions

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Tibial Fractures

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment

Norian Drillable Bone Void Filler

Intervention Type DEVICE

Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler

Interventions

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Norian Drillable Bone Void Filler

Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler

Intervention Type DEVICE

Other Intervention Names

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Norian Drillable

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No