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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chronOS Inject | Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chronOS Inject | Device | chronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Chang-Wug Oh, MD | Kyungpook National University Hospital | Principal Investigator |
| Kichul Park, MD | Hanyang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Hospital | Daegu | 700-721 | South Korea | |||
| Hanyang University Guri Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | chronOS Inject | Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | chronOS Inject | Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fracture Union | Fracture union (complete bone healing) was assessed by the investigators based on anteroposterior and lateral X-rays | Posted | Number | participants | 12 months |
|
|
Adverse events were recorded from treatment (implantation of the device) through the end of the follow-up period at 12 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | chronOS Inject | Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect chronOS Inject: chronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-union of lateral tibial condyle | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Operative action taken (autogenous cancellous bone graft) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| K-wire irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Scientist Biomaterials | Synthes GmbH | 0041327204465 | clinicalaffairs.emea@synthes.com |
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| 12 months |
| Total Range of Motion | 12 months |
| Anatomical Gradings Assessed Radiographically | The following was assessed:
| 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:
| 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 |
| Guri-si |
| 471-701 |
| South Korea |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Smoking status | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body mass index | Mean | Standard Deviation | kg/m2 |
|
| Exercise per week | Number | participants |
|
| Health status | Number | participants |
|
| Occupation | Number | participants |
|
| Preoperative medical condition | Number | participants |
|
| Preoperative medical conditions (description) | Subjects can have more than one medical condition. | Number | participants |
|
| Accident type | Patients can have more than one accident type. | Number | participants |
|
| Fracture type | Patients can have more than one fracture type. | Number | participants |
|
|
| Primary | Articular Subsidence | Evidence of articular subsidence (collapse of surface pertaining to the joint) of ≥2 mm was assessed by the investigators | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Absorption Rate of Calcium Phosphate Cement | Absorption of calcium phosphate cement over time was calculated from X-rays with the INFINITT program. | Posted | Mean | Standard Deviation | percentage of absorption at 12 months | 12 months |
|
|
|
| Secondary | Patients Who Reached Full Weight Bearing | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Total Range of Motion | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Anatomical Gradings Assessed Radiographically | The following was assessed:
| Posted | Number | participants | 12 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Post-surgery |
|
|
|
| Secondary | Extension Ability and Stability | The following was assessed:
| Posted | Number | participants | 12 months |
|
|
|
| Secondary | Peri-operative Complications | Posted | Number | participants | 12 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
|
| Secondary | 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. | Posted | Number | participants | 12 months |
|
|
|
| Primary | Mean Time to Union | Mean time to union was calculated based on the Kaplan-Meier estimator of the survivorship function | Posted | Mean | Standard Deviation | months | 12 months |
|
|
|
| 1 |
| 36 |
| 9 |
| 36 |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Volar mass on finger (MP joint) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Articular subsidence, loss of reduction and depression of lateral condyle of the tibia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment | Drug treatment with Synerjet, Stillen and O Grand on April 8, 2011 (at 6 Months follow-up) |
|
| Cartilage damage at the initial injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Posterior neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Non-union of lateral tibial condyle | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| Title |
|---|
| Measurements |
|---|
|
| Title | Measurements |
|---|---|
|
| Moldability |
|
| Setting time |
|
| Rate of chronOS over bone graft |
|
|
| Abnormal extension stability |
|
| Title | Measurements |
|---|---|
|
| Poor (<65) |
|