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Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures | Clinical Trials | Clareo Health

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

NCT01132508•Synthes GmbH

View on ClinicalTrials.gov

Summary

Case series of tibial plateau fractures using Norian Drillable.

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

ALL

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)
+8 more criteria

Locations (6)

Liverpool Hospital

Liverpool, New South Wales, Australia

John Hunter Hospital

New Lambton, New South Wales, Australia

Queen Mary Hospital

Hong Kong, China

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

St. Elisabeth Ziekenhuis

Tilburg, Netherlands

Sykehuset I Vestfold

Tønsberg, Norway

Key Dates

Start Date

September 1, 2008

Primary Completion Date

September 1, 2013

Completion Date

September 1, 2013

Last Updated

June 11, 2015

Enrollment

ACTUAL participants

Conditions

Tibial Fractures

Interventions

Norian Drillable Bone Void Filler

DEVICE

Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study

NCT05022485

Tibial FracturesFracture Infection

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RECRUITINGPHASE3

Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial

NCT07006675

Tibial FracturesPain

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 11, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study

Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial

Tibio-talo-calcaneal Fusion by Hindfoot Nail Versus Open Reduction and Internal Fixation in Treatment of Complex Fractures Distal Tibial and Fragility Ankle Fractures in Elderly

Conjoint Analysis of Patient Preferences in Joint Interventions

Distal Targeter vs Free-hand

A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System