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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Synthes Asia Pacific
Information provided by (Responsible Party):
Synthes GmbH
ClinicalTrials.gov Identifier:
NCT01132508
First received: February 16, 2010
Last updated: March 21, 2013
Last verified: March 2013
History of Changes
  Purpose

Case series of tibial plateau fractures using Norian Drillable.


Condition Intervention
Tibial Fractures
 Device: Norian Drillable Bone Void Filler

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Synthes GmbH:

Primary Outcome Measures:
  • Duration of time the patient was in the OR as a measure of effectiveness of the treatment [ Time Frame: Day 0 (Day of surgery) ] [ Designated as safety issue: No ]
    Immediately after the surgery in which Norian Drillable was implanted, the surgeon will complete a surgeon's questionnaire in which he will record the duration of time the patient was in the OR

  • Estimate of blood loss in ml as a measure of effectiveness of the treatment [ Time Frame: Day 0 (Day of surgery) ] [ Designated as safety issue: Yes ]
    Immediately after the surgery in which Norian Drillable was implanted, the surgeon will complete a surgeon's questionnaire in which he will record the estimated amount of blood loss (The amount of fluid used in irrigation should be subtracted from the amount of fluid present in the suction canister at the completion of surgery. Any gauze used in the procedure should be estimated for the ml of blood lost)

  • Number of patients with complications as a measure of safety and tolerability of the device [ Time Frame: At enrolment (between day -7 and day 0), day 0 (day of surgery), 6 weeks, 12 weeks, 26 weeks, 52 weeks and 78 weeks postoperative ] [ Designated as safety issue: Yes ]
  • Ease of use score measured with a surgeon's questionnaire [ Time Frame: Day 0 (Date of surgery) ] [ Designated as safety issue: No ]
    Immediately after the surgery in which Norian Drillable was implanted, the surgeon will complete a surgeon's questionnaire in which he will record the perceived ease of use of the implant


Secondary Outcome Measures:
  • Fracture stabilization assessments with imaging techniques and clinical evaluation [ Time Frame: 6 weeks, 12 weeks, 26 weeks, 52 weeks and 78 weeks postoperative ] [ Designated as safety issue: No ]
    • Imaging techniques: AP, lateral, oblique radiographies or CT scan, MRI optional
    • Clinical evaluation: extension, range of motion and stability assessment

  • Function measured with the Lysholm Knee Scale [ Time Frame: 6 weeks, 12 weeks, 26 weeks, 52 weeks and 78 weeks postoperative ] [ Designated as safety issue: No ]
  • Pain assessed with the Lysholm Knee Scale [ Time Frame: 6 weeks, 12 weeks, 26 weeks, 52 weeks and 78 weeks postoperative ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Treatment Device: 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
Other Name: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132508

Locations
Australia, New South Wales
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
John Hunter Hospital
New Lambton, New South Wales, Australia, 2305
China
Queen Mary Hospital
Hong Kong, China
Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435
St. Elisabeth Ziekenhuis
Tilburg, Netherlands, 5022
Norway
Sykehuset I Vestfold
Tønsberg, Norway, 3103
Sponsors and Collaborators
Synthes GmbH
Synthes Asia Pacific
Investigators
Principal Investigator: Zsolt Balogh, MD John Hunter Hospital, New Lambton, NSW, Australia
Principal Investigator: Ian Harris, MD Liverpool Hospital, Liverpool, NSW, Australia
  More Information

No publications provided

Responsible Party: Synthes GmbH
ClinicalTrials.gov Identifier: NCT01132508     History of Changes
Other Study ID Numbers: ND-AUS-01
Study First Received: February 16, 2010
Last Updated: March 21, 2013
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Synthes GmbH:
Tibial plateau fracture
OTA B2 B3 C3
Bone Void

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on May 19, 2013