Trials / Active Not Recruiting
Active Not RecruitingNCT04301622
Post Market Clinical Follow-Up Study for EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur
Post Market Clinical Follow-Up Study for EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur With Cruciate Sacrificing Inserts
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (actual)
- Sponsor
- MicroPort Orthopedics Inc. · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® BIOFOAM® Tibia and EVOLUTION® Cruciate Sacrificing/Cruciate Retaining (CS/CR) Porous Femur components, including EVOLUTION® CS tibial inserts. This type of study is required by regulatory authorities for all devices that have been approved in Europe to evaluate the medium and long-term clinical evidence.
Detailed description
The objectives of this study are: 1. To estimate the individual component survivorship of EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur components, including EVOLUTION® CS tibial inserts 2. To find out the cumulative incidence of component revision of each component in this combination. 3. To find out the functional outcome scores at early, midterm, and long term follow-up.
Conditions
- Knee Osteoarthritis
- Traumatic Arthritis of Knee
- Avascular Necrosis
- Degenerative Joint Disease of Knee
- Rheumatoid Arthritis of Knee
- Correction of Functional Deformity
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Primary Knee implants | Primary knee arthroplasty |
Timeline
- Start date
- 2020-02-03
- Primary completion
- 2032-02-01
- Completion
- 2032-08-01
- First posted
- 2020-03-10
- Last updated
- 2024-03-20
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04301622. Inclusion in this directory is not an endorsement.