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

NCT01132508 | Completed Results

• 1 other identifier: ND-AUS-01
• Study Type: observational
• Target: 33
• Locations: 4 countries
• Sites: 6

Brief Summary

Case series of tibial plateau fractures using Norian Drillable.

Conditions

Tibial Fractures

Keywords

Tibial plateau fracture; Orthopaedic Trauma Association (OTA) B2 B3 C3; Bone Void

Outcome Measures

Primary Outcomes (13)

• Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment

  Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the duration of time the patient was in the operating room (OR)

  Day 0 (Day of surgery)

• Estimate of Blood Loss in Cubic Centimeter as a Measure of Effectiveness of the Treatment

  Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the estimated amount of blood loss (the amount of fluid used in irrigation should have been subtracted from the amount of fluid present in the suction canister at the completion of surgery. Any gauze used in the procedure should have been estimated for the ml of blood loss)

  Day 0 (Day of surgery)

• Number of Patients With Adverse Events as a Measure of Safety and Tolerability of the Device

  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

• Ease of Use Score Measured With a Surgeon Questionnaire: Drill

  Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.

  Day 0 (Date of surgery)

• Ease of Use Score Measured With a Surgeon Questionnaire: K-wire

  Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable. Kirschner wires or K-wires are sterilized, sharpened, smooth stainless steel pins widely used to hold bone fragments together (pin fixation) or to provide an anchor for skeletal traction in fractures.

  Day 0 (Date of surgery)

• Ease of Use Score Measured With a Surgeon Questionnaire: Tap

  Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable. A tap is an instrument used to create threads in a hole drilled in bone.

  Day 0 (Date of surgery)

• Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion

  Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.

  Day 0 (Date of surgery)

• Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing

  Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.

  Day 0 (Date of surgery)

• Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling

  Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.

  Day 0 (Date of surgery)

• Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties

  Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.

  Day 0 (Date of surgery)

• Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure

  Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.

  Day 0 (Date of surgery)

• Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use

  Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.

  Day 0 (Date of surgery)

• Surgeons Overall Satisfaction With Norian Drillable

  The overall satisfaction of the ease of use of Norian Drillable was rated by the surgeon.

  Surgery

Secondary Outcomes (40)

• Pain and Function Assessed With the Lysholm Knee Scale

  6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 weeks (for Australian sites only)

• Radiographic Parameters: Depression at Baseline

  Baseline

• Radiographic Parameters: Depression at Surgery

  Surgery

• Radiographic Parameters: Depression at 6 Weeks

  6 week

• Radiographic Parameters: Depression at 12 Weeks

  12 weeks

Study Arms (1)

Treatment

Device: Norian Drillable Bone Void Filler

Interventions

Norian Drillable Bone Void Filler 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

Also known as: Norian Drillable

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Synthes GmbH: lead
• Synthes Asia Pacific: collaborator

Study Sites (6)

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

John Hunter Hospital

New Lambton, New South Wales, 2305, Australia

Location

Queen Mary Hospital

Hong Kong, China

Location

St. Antonius Ziekenhuis

Nieuwegein, 3435, Netherlands

Location

St. Elisabeth Ziekenhuis

Tilburg, 5022, Netherlands

Location

Sykehuset I Vestfold

Tønsberg, 3103, Norway

Location

MeSH Terms

Conditions

Tibial Fractures; Tibial Plateau Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Knee Fractures; Knee Injuries

Results Point of Contact

• Title: Clinical Research Scientist
• Organization: Synthes GmbH

clinicalaffairs.emea@synthes.com

+41619656592

Study Officials

• Zsolt Balogh, MD

  John Hunter Hospital, New Lambton, NSW, Australia

  PRINCIPAL INVESTIGATOR

• Ian Harris, MD

  Liverpool Hospital, Liverpool, NSW, Australia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2010
• First Posted: May 28, 2010
• Study Start: September 1, 2008
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: June 11, 2015
• Results First Posted: June 11, 2015

Record last verified: 2015-05

Locations

CN (1); NL (2); AU (2); NO (1)