Clinical trial NCT01132508: Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures
Official title: Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tibial Fractures
Keywords: Tibial plateau fracture
Orthopaedic Trauma Association (OTA) B2 B3 C3
Bone Void
Lead sponsor: Synthes GmbH
Sponsor class: INDUSTRY
Collaborators: name: Synthes Asia Pacific
First posted: 2010-05-28
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief 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 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.

Primary outcomes:
measure: Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment
timeFrame: Day 0 (Day of surgery)
measure: Estimate of Blood Loss in Cubic Centimeter as a Measure of Effectiveness of the Treatment
timeFrame: Day 0 (Day of surgery)
measure: Number of Patients With Adverse Events as a Measure of Safety and Tolerability of the Device
timeFrame: At enrolment (between day -7 and day 0), day 0 (day of surgery), 6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 (for Australian sites only) postoperative
measure: Ease of Use Score Measured With a Surgeon Questionnaire: Drill
timeFrame: Day 0 (Date of surgery)
measure: Ease of Use Score Measured With a Surgeon Questionnaire: K-wire
timeFrame: Day 0 (Date of surgery)
measure: Ease of Use Score Measured With a Surgeon Questionnaire: Tap
timeFrame: Day 0 (Date of surgery)
measure: Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion
timeFrame: Day 0 (Date of surgery)
measure: Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing
timeFrame: Day 0 (Date of surgery)
measure: Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling
timeFrame: Day 0 (Date of surgery)
measure: Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties
timeFrame: Day 0 (Date of surgery)
measure: Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure
timeFrame: Day 0 (Date of surgery)
measure: Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use
timeFrame: Day 0 (Date of surgery)
measure: Surgeons Overall Satisfaction With Norian Drillable
timeFrame: Surgery
Secondary outcomes:
measure: Pain and Function Assessed With the Lysholm Knee Scale
timeFrame: 6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 weeks (for Australian sites only)
measure: Radiographic Parameters: Depression at Baseline
timeFrame: Baseline
measure: Radiographic Parameters: Depression at Surgery
timeFrame: Surgery
measure: Radiographic Parameters: Depression at 6 Weeks
timeFrame: 6 week
measure: Radiographic Parameters: Depression at 12 Weeks
timeFrame: 12 weeks
measure: Radiographic Parameters: Depression at 26 Weeks
timeFrame: 26 weeks
measure: Radiographic Parameters:: Depression at 52 Weeks
timeFrame: 52 weeks
measure: Radiographic Parameters: Depression at 78 Weeks
timeFrame: 78 weeks
measure: Radiographic Parameters: Condylar Widening at Baseline
timeFrame: Baseline
measure: Radiographic Parameters: Condylar Widening at Surgery
timeFrame: Surgery
measure: Radiographic Parameters: Condylar Widening at 6 Weeks
timeFrame: 6 weeks
measure: Radiographic Parameters: Condylar Widening at 12 Weeks
timeFrame: 12 weeks
measure: Radiographic Parameters: Condylar Widening at 26 Weeks
timeFrame: 26 weeks
measure: Radiographic Parameters: Condylar Widening at 52 Weeks
timeFrame: 52 weeks
measure: Radiographic Parameters: Condylar Widening at 78 Weeks
timeFrame: 78 weeks
measure: Radiographic Parameters: Angulation (Valgus/Varus) at Baseline
timeFrame: Baseline
measure: Radiographic Parameters: Angulation (Valgus/Varus) at Surgery
timeFrame: Surgery
measure: Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks
timeFrame: 6 weeks
measure: Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks
timeFrame: 12 weeks
measure: Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks
timeFrame: 26 weeks
measure: Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks
timeFrame: 52 weeks
measure: Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks
timeFrame: 78 weeks
measure: Knee Function and Stability: Extension at Baseline
timeFrame: Baseline
measure: Knee Function and Stability: Extension at 6 Weeks
timeFrame: 6 weeks
measure: Knee Function and Stability: Extension at 12 Weeks
timeFrame: 12 weeks
measure: Knee Function and Stability: Extension at 26 Week
timeFrame: 26 weeks
measure: Knee Function and Stability: Extension at 52 Weeks
timeFrame: 52 weeks
measure: Knee Function and Stability: Extension at 78 Weeks
timeFrame: 78 weeks
measure: Knee Function and Stability: Total Range of Motion at Baseline
timeFrame: Baseline
measure: Knee Function and Stability: Total Range of Motion at 6 Weeks
timeFrame: 6 weeks
measure: Knee Function and Stability: Total Range of Motion at 12 Weeks
timeFrame: 12 weeks
measure: Knee Function and Stability: Total Range of Motion at 26 Weeks
timeFrame: 26 weeks
measure: Knee Function and Stability: Total Range of Motion at 52 Weeks
timeFrame: 52 weeks
measure: Knee Function and Stability: Total Range of Motion at 78 Weeks
timeFrame: 78 weeks
measure: Knee Function and Stability: Extension Stability at Baseline
timeFrame: Baseline
measure: Knee Function and Stability: Extension Stability at 6 Weeks
timeFrame: 6 weeks
measure: Knee Function and Stability: Extension Stability at 12 Weeks
timeFrame: 12 weeks
measure: Knee Function and Stability: Extension Stability at 26 Weeks
timeFrame: 26 weeks
measure: Knee Function and Stability: Extension Stability at 52 Weeks
timeFrame: 52 weeks
measure: Knee Function and Stability: Extension Stability at 78 Weeks
timeFrame: 78 weeks
Other outcomes:
Locations:
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: New Lambton
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Hong Kong
country: China
facility: Queen Mary Hospital
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Tilburg
country: Netherlands
facility: St. Elisabeth Ziekenhuis
city: Tønsberg
country: Norway
facility: Sykehuset I Vestfold
Study officials:
affiliation: John Hunter Hospital, New Lambton, NSW, Australia
name: Zsolt Balogh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Liverpool Hospital, Liverpool, NSW, Australia
name: Ian Harris, MD
role: PRINCIPAL_INVESTIGATOR
References: