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.
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.
Study Type
OBSERVATIONAL
Enrollment
36
chronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures
Kyungpook National University Hospital
Daegu, South Korea
Hanyang University Guri Hospital
Guri-si, South Korea
Fracture Union
Fracture union (complete bone healing) was assessed by the investigators based on anteroposterior and lateral X-rays
Time frame: 12 months
Articular Subsidence
Evidence of articular subsidence (collapse of surface pertaining to the joint) of ≥2 mm was assessed by the investigators
Time frame: 12 months
Mean Time to Union
Mean time to union was calculated based on the Kaplan-Meier estimator of the survivorship function
Time frame: 12 months
Absorption Rate of Calcium Phosphate Cement
Absorption of calcium phosphate cement over time was calculated from X-rays with the INFINITT program.
Time frame: 12 months
Patients Who Reached Full Weight Bearing
Time frame: 12 months
Total Range of Motion
Time frame: 12 months
Anatomical Gradings Assessed Radiographically
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
Time frame: 12 months
Patient's Satisfaction
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.
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Time frame: 12 months
Surgeon's Satisfaction With the Product
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.
Time frame: Post-surgery
Extension Ability and Stability
The following was assessed: * extension ability of the knee * stability of the knee in extension
Time frame: 12 months
Peri-operative Complications
Time frame: 12 months
SF-12 Short Form Health Survey Physical Composite Score (PCS)
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.
Time frame: 12 months
SF-12 Short Form Health Survey Mental Composite Score (MCS)
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.
Time frame: 12 months
VAS Leg Pain Intensity
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.
Time frame: 12 months
VAS Leg Pain Frequency
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.
Time frame: 12 months
Lysholm Knee Scale
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.
Time frame: 12 months