chronOS Inject in Proximal Tibial Fractures

Completed

Conditions: Closed Proximal Tibial Fracture AO-OTA 42
Closed Proximal Tibial Fracture Schatzker I - VI
Closed Proximal Tibial Fracture AO-OTA 41

Interventions: Device: chronOS Inject

Registration Number: NCT02056834

Lead Sponsor: Synthes GmbH

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 36

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
chronOS Inject	chronOS Inject	Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect

Primary Outcome Measures

Name	Time	Method
Articular Subsidence	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	12 months	Mean time to union was calculated based on the Kaplan-Meier estimator of the survivorship function
Fracture Union	12 months	Fracture union (complete bone healing) was assessed by the investigators based on anteroposterior and lateral X-rays

Secondary Outcome Measures

Name	Time	Method
Anatomical Gradings Assessed Radiographically	12 months	The following was assessed: * depression of knee joint: presence or absence * condylar widening (enlargement of the knee joint): presence or absence * angulation; valgus/varus (abnormal outward/inward turning of the knee): presence or absence
Peri-operative Complications	12 months
Absorption Rate of Calcium Phosphate Cement	12 months	Absorption of calcium phosphate cement over time was calculated from X-rays with the INFINITT program.
Patients Who Reached Full Weight Bearing	12 months
Total Range of Motion	12 months
Patient's Satisfaction	12 months	Satisfaction with treatment was assessed by the subjects, where subjects indicated their satisfaction with treatment on a 100-mm visual analog scale. A score of zero indicated no satisfaction, while a score of 100 indicated completely satisfied.
Surgeon's Satisfaction With the Product	Post-surgery	Satisfaction with product was assessed by the surgeon post-operatively, where surgeons indicated their satisfaction with treatment on a 100-mm visual analog scale. A score of zero indicated absolutely unacceptable, while a score of 100 indicated very satisfying.
Extension Ability and Stability	12 months	The following was assessed: * extension ability of the knee * stability of the knee in extension
SF-12 Short Form Health Survey Physical Composite Score (PCS)	12 months	The SF-12 short form health survey was self-administered to subjects preoperatively and all follow up visits. This health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score \[PCS\] and mental composite score \[MCS\]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person.
SF-12 Short Form Health Survey Mental Composite Score (MCS)	12 months	The SF-12 short form health survey was self-administered to subjects preoperatively and at follow up visits. This health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score \[PCS\] and mental composite score \[MCS\]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person.
VAS Leg Pain Intensity	12 months	The subjects completed questionnaires assessing the intensity and frequency of pain experienced in the leg at the baseline visit and postoperatively. Pain intensity was rated on a 100-mm visual analog scale where zero indicated no pain at all, and 100 represented the worst possible pain.
VAS Leg Pain Frequency	12 months	The subjects completed questionnaires assessing the intensity and frequency of pain experienced in the leg at the baseline visit and postoperatively. Pain frequency was rated on a 100-mm visual analog scale where zero indicated no pain at all and 100 represented pain always.
Lysholm Knee Scale	12 months	The Lysholm knee scale is a condition-specific outcome measure that was originally designed to assess ligament injuries of the knee. The survey was administered to subject at follow-up visits and comprises 8 subscales related to limp, support, stair climbing, squatting, walking, running and jumping as well as a question related to the atrophy of the thigh. The responses to these 8 questions are graded to provide a maximum result of 100 points.