Closed Proximal Tibial Fracture AO-OTA 41, Closed Proximal Tibial Fracture AO-OTA 42, Closed Proximal Tibial Fracture Schatzker I - VI
Conditions
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.
Interventions
DEVICEchronOS Inject
chronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures
Sponsors
Synthes GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fracture Union | 12 months | Fracture union (complete bone healing) was assessed by the investigators based on anteroposterior and lateral X-rays |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
| 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. |
| 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. |
| Patients Who Reached Full Weight Bearing | 12 months | — |
| Total Range of Motion | 12 months | — |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| chronOS Inject Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 7 |
Baseline characteristics
| Characteristic | chronOS Inject |
|---|---|
| Accident type Car occupant in traffic accident | 7 participants |
| Accident type Direct blow | 9 participants |
| Accident type Fall from height | 3 participants |
| Accident type High energy | 23 participants |
| Accident type Low energy | 1 participants |
| Accident type Motorcycle accident | 4 participants |
| Accident type Other | 2 participants |
| Accident type Pedestrian in traffic accident | 11 participants |
| Accident type Simple fall | 3 participants |
| Accident type Sport | 1 participants |
| Age, Continuous | 55.4 years STANDARD_DEVIATION 14.6 |
| Age, Customized Age group <=58 years | 19 participants |
| Age, Customized Age group >58 years | 17 participants |
| Body mass index | 23.3 kg/m2 STANDARD_DEVIATION 3.67 |
| Exercise per week 1-2 times per week | 21 participants |
| Exercise per week 3-4 times per week | 5 participants |
| Exercise per week 5 or more times per week | 1 participants |
| Exercise per week Never | 9 participants |
| Fracture type AO-OTA 41 (proximal tibia fracture) | 29 participants |
| Fracture type AO-OTA 42 (diaphyseal tibia fracture) | 0 participants |
| Fracture type Schatzker Type III (pure lateral depression) | 0 participants |
| Fracture type Schatzker Type II (split with depression) | 14 participants |
| Fracture type Schatzker Type I (lateral split) | 1 participants |
| Fracture type Schatzker Type IV (pure medial depression) | 2 participants |
| Fracture type Schatzker Type V (bicondylar) | 6 participants |
| Fracture type Schatzker Type VI (split extends to metadiaphysis) | 10 participants |
| Health status Excellent | 4 participants |
| Health status Fair | 3 participants |
| Health status Good | 28 participants |
| Health status Missing | 1 participants |
| Health status Poor | 0 participants |
| Height | 163.4 cm STANDARD_DEVIATION 8.99 |
| Occupation Home worker | 7 participants |
| Occupation Light industrial or light industrial labour | 6 participants |
| Occupation Moderate industrial or moderate physical labour | 5 participants |
| Occupation Office worker | 5 participants |
| Occupation Other | 4 participants |
| Occupation Retired | 6 participants |
| Occupation Student | 3 participants |
| Preoperative medical condition Any | 14 participants |
| Preoperative medical condition None | 22 participants |
| Preoperative medical conditions (description) Adiposity | 1 participants |
| Preoperative medical conditions (description) Allergies | 0 participants |
| Preoperative medical conditions (description) Cancer | 0 participants |
| Preoperative medical conditions (description) Cardiac | 4 participants |
| Preoperative medical conditions (description) Congenital | 0 participants |
| Preoperative medical conditions (description) Dermatological | 1 participants |
| Preoperative medical conditions (description) Endocrine | 4 participants |
| Preoperative medical conditions (description) Hematologic | 0 participants |
| Preoperative medical conditions (description) Implants/Prosthesis | 0 participants |
| Preoperative medical conditions (description) Infection | 0 participants |
| Preoperative medical conditions (description) Musculoskeletal including fractures | 0 participants |
| Preoperative medical conditions (description) Neurologic | 1 participants |
| Preoperative medical conditions (description) Other | 3 participants |
| Preoperative medical conditions (description) Psychiatric | 0 participants |
| Preoperative medical conditions (description) Respiratory | 2 participants |
| Preoperative medical conditions (description) Urogenital | 0 participants |
| Preoperative medical conditions (description) Vascular | 3 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 36 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Korea, Republic of | 36 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 21 Participants |
| Smoking status Current | 9 participants |
| Smoking status Former | 4 participants |
| Smoking status Never | 23 participants |
| Weight | 62.6 kg STANDARD_DEVIATION 12.15 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 36 |
| serious Total, serious adverse events | 1 / 36 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| chronOS Inject | Articular Subsidence | Absent | 28 participants |
| chronOS Inject | Articular Subsidence | Present | 1 participants |
Primary
Fracture Union
Fracture union (complete bone healing) was assessed by the investigators based on anteroposterior and lateral X-rays
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| chronOS Inject | Fracture Union | Union | 27 participants |
| chronOS Inject | Fracture Union | Non-union | 2 participants |
Primary
Mean Time to Union
Mean time to union was calculated based on the Kaplan-Meier estimator of the survivorship function
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| chronOS Inject | Mean Time to Union | 7.5 months | Standard Deviation 0.441 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| chronOS Inject | Absorption Rate of Calcium Phosphate Cement | 0.64 percentage of absorption at 12 months | Standard Deviation 0.115 |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| chronOS Inject | Anatomical Gradings Assessed Radiographically | Absence of depression | 28 participants |
| chronOS Inject | Anatomical Gradings Assessed Radiographically | Absence of condylar widening | 28 participants |
| chronOS Inject | Anatomical Gradings Assessed Radiographically | Absence of angulation | 29 participants |
Secondary
Extension Ability and Stability
The following was assessed: * extension ability of the knee * stability of the knee in extension
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| chronOS Inject | Extension Ability and Stability | Normal extension ability | 26 participants |
| chronOS Inject | Extension Ability and Stability | 0-10 degree extension ability | 3 participants |
| chronOS Inject | Extension Ability and Stability | Normal extension stability | 28 participants |
| chronOS Inject | Extension Ability and Stability | Abnormal extension stability | 1 participants |
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.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| chronOS Inject | Lysholm Knee Scale | Excellent (95-100) | 14 participants |
| chronOS Inject | Lysholm Knee Scale | Good (84-94) | 11 participants |
| chronOS Inject | Lysholm Knee Scale | Fair (65-83) | 3 participants |
| chronOS Inject | Lysholm Knee Scale | Poor (<65) | 1 participants |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| chronOS Inject | Patient's Satisfaction | 80.52 units on a scale | Standard Deviation 16.02 |
Secondary
Patients Who Reached Full Weight Bearing
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| chronOS Inject | Patients Who Reached Full Weight Bearing | 29 participants |
Secondary
Peri-operative Complications
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| chronOS Inject | Peri-operative Complications | Microscopic or radiologic cement leakage during OP | 0 participants |
| chronOS Inject | Peri-operative Complications | Breakage of fixing device post-OP | 0 participants |
| chronOS Inject | Peri-operative Complications | Re-OP during hospital stay | 0 participants |
| chronOS Inject | Peri-operative Complications | Suffer from surgical wound complication post-OP | 0 participants |
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| chronOS Inject | SF-12 Short Form Health Survey Mental Composite Score (MCS) | Score at baseline | 46.3 units on a scale | Standard Deviation 9.707 |
| chronOS Inject | SF-12 Short Form Health Survey Mental Composite Score (MCS) | Score at 12 months | 46.45 units on a scale | Standard Deviation 7.145 |
Comparison: Paired T-Test p-value tests the significance of the percent change from baseline within each treatment group.p-value: 0.3785t-test, 2 sided
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| chronOS Inject | SF-12 Short Form Health Survey Physical Composite Score (PCS) | Score at baseline | 37.02 units on a scale | Standard Deviation 9.616 |
| chronOS Inject | SF-12 Short Form Health Survey Physical Composite Score (PCS) | Score at 12 months | 42.43 units on a scale | Standard Deviation 4.589 |
Comparison: Paired T-Test p-value tests the significance of the percent change from baseline within each treatment group.p-value: 0.0166t-test, 2 sided
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.
Time frame: Post-surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| chronOS Inject | Surgeon's Satisfaction With the Product | Mixing ability | 87.3 units on a scale | Standard Deviation 6.16 |
| chronOS Inject | Surgeon's Satisfaction With the Product | Injecting ability | 87 units on a scale | Standard Deviation 6.31 |
| chronOS Inject | Surgeon's Satisfaction With the Product | Application time | 87 units on a scale | Standard Deviation 6.31 |
| chronOS Inject | Surgeon's Satisfaction With the Product | Moldability | 81.7 units on a scale | Standard Deviation 9.59 |
| chronOS Inject | Surgeon's Satisfaction With the Product | Setting time | 77.1 units on a scale | Standard Deviation 13.54 |
| chronOS Inject | Surgeon's Satisfaction With the Product | Rate of chronOS over bone graft | 68.6 units on a scale | Standard Deviation 28.39 |
Secondary
Total Range of Motion
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| chronOS Inject | Total Range of Motion | At least 140 degree | 17 participants |
| chronOS Inject | Total Range of Motion | At least 120 degree | 11 participants |
| chronOS Inject | Total Range of Motion | At least 90 degree | 1 participants |
| chronOS Inject | Total Range of Motion | At least 60 degree | 0 participants |
| chronOS Inject | Total Range of Motion | At least 30 degree | 0 participants |
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| chronOS Inject | VAS Leg Pain Frequency | Score at baseline | 57.28 units on a scale | Standard Deviation 33.505 |
| chronOS Inject | VAS Leg Pain Frequency | Score at 12 months | 20.52 units on a scale | Standard Deviation 20.051 |
Comparison: Paired T-Test p-value tests the significance of the change from baseline within treatment group.p-value: <0.0001t-test, 2 sided
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| chronOS Inject | VAS Leg Pain Intensity | Score at baseline | 61.19 units on a scale | Standard Deviation 32.714 |
| chronOS Inject | VAS Leg Pain Intensity | Score at 12 months | 17 units on a scale | Standard Deviation 18.592 |
Comparison: Paired T-Test p-value tests the significance of the change from baseline within treatment group.p-value: <0.0001t-test, 2 sided