Clinical trial NCT02056834: chronOS Inject in Proximal Tibial Fractures
Official title: Prospective, Multi-Center, Observational Study Evaluating the Augmentation With Calcium Phosphate Cement (chronOS Inject) for Bone Defect After Internal Fixation of Proximal Tibial Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Closed Proximal Tibial Fracture Schatzker I - VI
Closed Proximal Tibial Fracture AO-OTA 41
Closed Proximal Tibial Fracture AO-OTA 42
Lead sponsor: Synthes GmbH
Sponsor class: INDUSTRY
First posted: 2014-02-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with proximal tibial fractures of type Schatzter I - VI, AO-OTA 41, AO-OTA 42 with bone defect are assessed for eligibility to enter the study. A computerized tomography is performed if necessary to confirm the fracture type and the amount of bone defect. Patients eligible for the study are followed over time to 12 months after surgery.

A total of 30 patients who meet the inclusion/exclusion criteria are enrolled in the study, which is conducted at Kyungpook National University Hospital and Hanyang University Guri Hospital in the Republic of Korea.

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.

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
* Active rheumatoid arthritis, non-controlled diabetes mellitus, or any other medical condition(s) that would represent a significant increase in surgical risk or interfere with normal healing
* Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol)
* Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for \>1 month within last 12 months
* Pregnant or planning to become pregnant during study period
* Involved in study of another investigational product that may affect outcome
* History of psychosocial disorders that could prevent accurate completion of self reporting assessment scales
* Patients who are incarcerated

Primary outcomes:
measure: Fracture Union
timeFrame: 12 months
measure: Articular Subsidence
timeFrame: 12 months
measure: Mean Time to Union
timeFrame: 12 months
Secondary outcomes:
measure: Absorption Rate of Calcium Phosphate Cement
timeFrame: 12 months
measure: Patients Who Reached Full Weight Bearing
timeFrame: 12 months
measure: Total Range of Motion
timeFrame: 12 months
measure: Anatomical Gradings Assessed Radiographically
timeFrame: 12 months
measure: Patient's Satisfaction
timeFrame: 12 months
measure: Surgeon's Satisfaction With the Product
timeFrame: Post-surgery
measure: Extension Ability and Stability
timeFrame: 12 months
measure: Peri-operative Complications
timeFrame: 12 months
measure: SF-12 Short Form Health Survey Physical Composite Score (PCS)
timeFrame: 12 months
measure: SF-12 Short Form Health Survey Mental Composite Score (MCS)
timeFrame: 12 months
measure: VAS Leg Pain Intensity
timeFrame: 12 months
measure: VAS Leg Pain Frequency
timeFrame: 12 months
measure: Lysholm Knee Scale
timeFrame: 12 months
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Guri
country: Korea, Republic of
facility: Hanyang University Guri Hospital
Study officials:
affiliation: Kyungpook National University Hospital
name: Chang-Wug Oh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanyang University
name: Kichul Park, MD
role: PRINCIPAL_INVESTIGATOR
References: