Prospective, Multi-Center, Observational Study Evaluating the Augmentation With Calcium Phosphate Cement (chronOS Inject) for Bone Defect After Internal Fixation of Proximal Tibial Fractures
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Closed Proximal Tibial Fracture Schatzker I - VI
- Sponsor
- Synthes GmbH
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Articular Subsidence
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The primary objective of this study is to observe the safety, the radiological and clinical outcomes of chronOS Inject after having been used as bone void filler in internal fixation of proximal tibial fractures.
Detailed Description
The primary objective of this study was to observe the safety, the radiological and clinical outcomes of chronOS Inject after having been used as bone void filler in internal fixation of proximal tibial fractures. Secondary objectives were to assess the surgeon's satisfaction in using chronOS Inject and patient satisfaction post surgery. The study was planned to be a multi-center, prospective, observational study. Patients with proximal tibial fractures of type Schatzker I - VI, AO-Müller-Orthopaedic Trauma Association (AO-OTA) 41, AO-OTA 42 with bone defect were assessed for eligibility to enter the study. Patients eligible for the study were followed over time to twelve months after surgery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects with closed proximal tibial fractures defined by : Tibia plateau, Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
- •Skeletally mature adult 18 years or older, with close of growth plate at the time of surgery
- •Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures
- •Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study
Exclusion Criteria
- •Open fractures with severe soft tissue damage
- •Proximal tibial fractures with tumor or osteomyelitis
- •Any tibial anatomy or disease process that would interfere with deployment or performance of the device as defined by the surgeon
- •Osteopenia or Osteoporosis: if dual energy x-ray absorptiometry (DEXA) is required, exclusion will be defined as a DEXA bone density measured T score \<=-1.0
- •Known history of Paget's disease, osteomalacia, or any other metabolic bone disease
- •Morbid obesity defined as a body mass index \>40 kg/m2 or weight more than 50 kg over ideal body weight
- •Active malignancy. A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy \>5 years
- •Known or documented history of communicable disease, including AIDS and HIV
- •Active Hepatitis (receiving medical treatment within two years)
- •Active systemic or local infection
Outcomes
Primary Outcomes
Articular Subsidence
Time Frame: 12 months
Evidence of articular subsidence (collapse of surface pertaining to the joint) of ≥2 mm was assessed by the investigators
Mean Time to Union
Time Frame: 12 months
Mean time to union was calculated based on the Kaplan-Meier estimator of the survivorship function
Fracture Union
Time Frame: 12 months
Fracture union (complete bone healing) was assessed by the investigators based on anteroposterior and lateral X-rays
Secondary Outcomes
- Anatomical Gradings Assessed Radiographically(12 months)
- Peri-operative Complications(12 months)
- Absorption Rate of Calcium Phosphate Cement(12 months)
- Patients Who Reached Full Weight Bearing(12 months)
- Total Range of Motion(12 months)
- Patient's Satisfaction(12 months)
- Surgeon's Satisfaction With the Product(Post-surgery)
- Extension Ability and Stability(12 months)
- SF-12 Short Form Health Survey Physical Composite Score (PCS)(12 months)
- SF-12 Short Form Health Survey Mental Composite Score (MCS)(12 months)
- VAS Leg Pain Intensity(12 months)
- VAS Leg Pain Frequency(12 months)
- Lysholm Knee Scale(12 months)