N/A
N=36
chronOS Inject in Proximal Tibial Fractures
Closed Proximal Tibial Fracture Schatzker I - VI · Closed Proximal Tibial Fracture AO-OTA 41 · Closed Proximal Tibial Fracture AO-OTA 42
Bottom Line
View on ClinicalTrials.gov: NCT02056834 ↗Enrolled (actual)
36
Serious AEs
2.8%
Results posted
Jun 2014
Primary outcome: Primary: Fracture Union — 27; 2 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- chronOS Inject (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Synthes GmbH
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fracture Union |
27; 2 | — |
| PRIMARY Articular Subsidence |
28; 1 | — |
| PRIMARY Mean Time to Union |
7.5 | — |
| SECONDARY Absorption Rate of Calcium Phosphate Cement |
0.64 | — |
| SECONDARY Patients Who Reached Full Weight Bearing |
29 | — |
| SECONDARY Total Range of Motion |
17; 11; 1; 0; 0 | — |
| SECONDARY Anatomical Gradings Assessed Radiographically |
28; 28; 29 | — |
| SECONDARY Patient's Satisfaction |
80.52 | — |
| SECONDARY Surgeon's Satisfaction With the Product |
87.3; 87; 87; 81.7; 77.1; 68.6 | — |
| SECONDARY Extension Ability and Stability |
26; 3; 28; 1 | — |
| SECONDARY Peri-operative Complications |
0; 0; 0; 0 | — |
| SECONDARY SF-12 Short Form Health Survey Physical Composite Score (PCS) |
37.02; 42.43 | 0.0166 sig |
| SECONDARY SF-12 Short Form Health Survey Mental Composite Score (MCS) |
46.3; 46.45 | 0.3785 |
| SECONDARY VAS Leg Pain Intensity |
61.19; 17 | <0.0001 sig |
| SECONDARY VAS Leg Pain Frequency |
57.28; 20.52 | <0.0001 sig |
| SECONDARY Lysholm Knee Scale |
14; 11; 3; 1 | — |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT02056834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.