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| General |
| Study Status |
Study Pending |
| 522 Number / Requirement Number |
PS240012 / PSS001 |
| Date Original Plan Accepted |
12/13/2024
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| Study Name |
ELEOS Post-Market Clinical Study
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| Device Name |
Eleos™ limb salvage system with nanocept™ technology (previously eleosx™ limb salvage system)
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| Root Document Number |
DEN210058
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This postmarket surveillance study will be a prospective, single-arm, multi-center observational cohort study to evaluate the safety profile of the ELEOS™ Limb Salvage System with NanoCept™ Technology for the intended use population.
The primary objective of this study is to obtain clinical data to evaluate the safety of the ELEOS™ Limb Salvage System with NanoCept™ Technology.
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| Study Population |
Subjects who are skeletally mature and will undergo surgical treatment with the ELEOS™ Limb Salvage System with NanoCept™ Technology
Inclusion/Exclusion Criteria
Inclusion:
Subjects will be considered for inclusion in the clinical study if all of the following criteria are met:
1. Subject is skeletally mature (validated by radiographic confirmation of growth plate closure) and will undergo treatment with the ELEOS™ Limb Salvage System with NanoCept™ Technology for non-inflammatory degenerative joint disease (i.e., osteoarthritis, traumatic arthritis, avascular necrosis, ankylosis, protrusion acetabula, painful hip dysplasia), inflammatory degenerative joint disease (i.e., rheumatoid arthritis, etc.), correction of functional deformity, revision procedures where other treatments and/or devices have failed, treatment of fractures that are unmanageable using other techniques, severe arthropathy of the hip and/or knee that does not respond to any conservative therapy or better alternative surgical treatment, severe trauma, revision hip or knee arthroplasties, oncology indications, or metastatic diseases.
2. Subject has signed a HIPAA authorization.
3. Subject has signed an informed consent.
4. Subject agrees to participate in all follow-up visits to capture safety data related to the limb salvage procedure following treatment with the ELEOS™ Limb Salvage System with NanoCept™ Technology.
Exclusion:
Subjects will be excluded from this clinical study if they meet any of the following criteria:
1. Subject has existing infection which may cause hematogenous spread to the implant site.
2. Subject has inadequate neuromuscular status (e.g., prior paralysis, fusion and/or inadequate abductor strength) or poor bone stock which would make the procedure unjustifiable
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| Sample Size |
Number of subjects: At a minimum, 115 subjects (Enrollment targets account for a potential 15% attrition/lost to follow-up rate), including at a minimum 10 subjects with cancer in the affected limb, will be treated with the ELEOS™ Limb Salvage System with NanoCept™ Technology for limb salvage procedures of the femur and/or tibia.
Number of sites: Up to 10 US sites
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| Key Study Endpoints |
Safety Endpoints
Subjects enrolled in the study will have the following safety data related to their limb salvage procedure and care collected at clinical visits through the 3-year follow-up evaluation:
• AEs
• SSIs
All data deemed necessary by the treating physician related to the AE evaluation will be captured at each site and will be made available to the sponsor upon request including:
• Imaging for clinical purposes (i.e., immediate post-operative (baseline) and follow-up visits)
• Data from cultures (e.g., known infections and deep wound cultures) including microorganism species and sensitivity
• Physical examination data
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| Follow-up Visits and Length of Follow-up |
Follow-up visits are within 6 weeks, at 3 months, 6 months, 1 year, 2 years, and 3 years.
Length of follow-up is 3 years.
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