Closed Proximal Tibial Fracture AO-OTA 41 Clinical Trial
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
| Verified date | June 2014 |
| Source | Synthes GmbH |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | South Korea: Institutional Review Board |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | September 2012 |
| Est. primary completion date | September 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Kyungpook National University Hospital | Daegu | |
| Korea, Republic of | Hanyang University Guri Hospital | Guri |
| Lead Sponsor | Collaborator |
|---|---|
| Synthes GmbH |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Fracture Union | Fracture union (complete bone healing) was assessed by the investigators based on anteroposterior and lateral X-rays | 12 months | No |
| Primary | Articular Subsidence | Evidence of articular subsidence (collapse of surface pertaining to the joint) of =2 mm was assessed by the investigators | 12 months | No |
| Primary | Mean Time to Union | Mean time to union was calculated based on the Kaplan-Meier estimator of the survivorship function | 12 months | No |
| Secondary | Absorption Rate of Calcium Phosphate Cement | Absorption of calcium phosphate cement over time was calculated from X-rays with the INFINITT program. | 12 months | No |
| Secondary | Patients Who Reached Full Weight Bearing | 12 months | No | |
| Secondary | Total Range of Motion | 12 months | No | |
| 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 |
12 months | No |
| 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. | 12 months | No |
| 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. | Post-surgery | No |
| Secondary | Extension Ability and Stability | The following was assessed: extension ability of the knee stability of the knee in extension |
12 months | No |
| Secondary | Peri-operative Complications | 12 months | Yes | |
| 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. | 12 months | No |
| 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. | 12 months | No |
| 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. | 12 months | No |
| 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. | 12 months | No |
| 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. | 12 months | No |