Closed Proximal Tibial Fracture Schatzker I - VINCT02056834
chronOS Inject in Proximal Tibial Fractures
An observational study of Closed Proximal Tibial Fracture Schatzker I - VI and Closed Proximal Tibial Fracture AO-OTA 41, run by Synthes GmbH at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Closed Proximal Tibial Fracture Schatzker I - VI, Closed Proximal Tibial Fracture AO-OTA 41, Closed Proximal Tibial Fracture AO-OTA 42
- What is being tested?
- chronOS Inject
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Mar 2010to 30 Sep 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Kyungpook National University Hospital
Daegu, 700-721
Hanyang University Guri Hospital
Guri-si, 471-701
About this study
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
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.
Read the 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.
- Conditions
- Closed Proximal Tibial Fracture Schatzker I - VI, Closed Proximal Tibial Fracture AO-OTA 41, Closed Proximal Tibial Fracture AO-OTA 42
- Being tested
- chronOS Inject
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chronOS InjectDevice
chronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures
| Study group | Role | What they receive |
|---|---|---|
| chronOS Inject | Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect Receives: Device: chronOS Inject |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture Union
Fracture union (complete bone healing) was assessed by the investigators based on anteroposterior and lateral X-rays
Measured: 12 months
Articular Subsidence
Evidence of articular subsidence (collapse of surface pertaining to the joint) of ≥2 mm was assessed by the investigators
Measured: 12 months
Mean Time to Union
Mean time to union was calculated based on the Kaplan-Meier estimator of the survivorship function
Measured: 12 months
Secondary outcomes (13)
Absorption Rate of Calcium Phosphate Cement
Absorption of calcium phosphate cement over time was calculated from X-rays with the INFINITT program.
Measured: 12 months
Patients Who Reached Full Weight Bearing
Measured: 12 months
Total Range of Motion
Measured: 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
Measured: 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.
Measured: 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.
Measured: Post-surgery
Extension Ability and Stability
The following was assessed:
- extension ability of the knee
- stability of the knee in extension
Measured: 12 months
Peri-operative Complications
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study start1 Mar 2010
- Primary completion30 Sep 2012
- Study completion30 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Closed Proximal Tibial Fracture Schatzker I - VIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synthes GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chang-Wug Oh, MD, Principal investigator, Kyungpook National University HospitalKichul Park, MD, Principal investigator, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056834
- Sponsor's protocol ID
- STU-BIO-T-XX-004-04
- Status last verified
- Feb 2025
- First submitted
- 31 Jan 2014
- Last updated
- 3 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02056834
- Acronym / sponsor ID
- STU-BIO-T-XX-004-04
- Conditions
- Closed Proximal Tibial Fracture Schatzker I - VI, Closed Proximal Tibial Fracture AO-OTA 41, Closed Proximal Tibial Fracture AO-OTA 42
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Synthes GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2010 (actual)
- Primary completion
- 30 Sep 2012 (actual)
- Study completion
- 30 Sep 2012 (actual)
- First posted
- 6 Feb 2014 (estimated)
- Results
- Posted 25 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronOS Inject | – | Device: chronOS InjectClosed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chronOS InjectchronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures | Device | chronOS Inject |
Primary outcome
Fracture Union
Time frame: 12 months
Fracture union (complete bone healing) was assessed by the investigators based on anteroposterior and lateral X-rays
Articular Subsidence
Time frame: 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
Time frame: 12 months
Mean time to union was calculated based on the Kaplan-Meier estimator of the survivorship function
13 secondary outcomes
Absorption Rate of Calcium Phosphate Cement
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
Time frame: 12 months
Patient's Satisfaction
Time frame: 12 months
Surgeon's Satisfaction With the Product
Time frame: Post-surgery
Extension Ability and Stability
Time frame: 12 months
Peri-operative Complications
Time frame: 12 months
SF-12 Short Form Health Survey Physical Composite Score (PCS)
Time frame: 12 months
SF-12 Short Form Health Survey Mental Composite Score (MCS)
Time frame: 12 months
VAS Leg Pain Intensity
Time frame: 12 months
VAS Leg Pain Frequency
Time frame: 12 months
Lysholm Knee Scale
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chang-Wug Oh, MD principal investigator
Kyungpook National University Hospital
Kichul Park, MD principal investigator
Hanyang University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Closed Proximal Tibial Fracture Schatzker I - VI and Closed Proximal Tibial Fracture AO-OTA 41, run by Synthes GmbH at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture Union (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.