chronOS Inject in Proximal Tibial Fractures

Prospective, Multi-Center, Observational Study Evaluating the Augmentation With Calcium Phosphate Cement (chronOS Inject) for Bone Defect After Internal Fixation of Proximal Tibial Fractures

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.

Study Overview

• Status: Completed
• Conditions: Closed Proximal Tibial Fracture Schatzker I - VI; Closed Proximal Tibial Fracture AO-OTA 41; Closed Proximal Tibial Fracture AO-OTA 42
• Intervention / Treatment: Device: chronOS Inject

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.

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 700-721
    • Kyungpook National University Hospital
  • Guri, Korea, Republic of, 471-701
    • Hanyang University GURI Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
chronOS Inject; Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect	Device: chronOS Inject; chronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fracture Union	Fracture union (complete bone healing) was assessed by the investigators based on anteroposterior and lateral X-rays	12 months
Articular Subsidence	Evidence of articular subsidence (collapse of surface pertaining to the joint) of ≥2 mm was assessed by the investigators	12 months
Mean Time to Union	Mean time to union was calculated based on the Kaplan-Meier estimator of the survivorship function	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absorption Rate of Calcium Phosphate Cement	Absorption of calcium phosphate cement over time was calculated from X-rays with the INFINITT program.	12 months
Patients Who Reached Full Weight Bearing		12 months
Total Range of Motion		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	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.	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.	Post-surgery
Extension Ability and Stability	The following was assessed: extension ability of the knee; stability of the knee in extension	12 months
Peri-operative Complications		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.	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.	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.	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.	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.	12 months

Collaborators and Investigators

• Sponsor: Synthes GmbH
• Investigators: Principal Investigator: Chang-Wug Oh, MD, Kyungpook National University Hospital; Principal Investigator: Kichul Park, MD, Hanyang University

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): September 1, 2012
• Study Completion (ACTUAL): September 1, 2012

Study Registration Dates

• First Submitted: January 31, 2014
• First Submitted That Met QC Criteria: February 5, 2014
• First Posted (ESTIMATE): February 6, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): June 25, 2014
• Last Update Submitted That Met QC Criteria: June 24, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures
• Other Study ID Numbers: STU-BIO-T-XX-004-04