Trials / Withdrawn
WithdrawnNCT01462240
LPS Flex Porous Femoral Components
Prospective Multicenter Post-market Study of the Zimmer NexGen LPS-Flex Porous Femoral Components
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective multicenter study of the LPS-Flex Porous Femoral Components when used in primary total knee arthroplasty. The purpose of the study is to obtain short-, mid-, and long-term clinical outcomes and implant survivorship data for the NexGen LPS-Flex Porous Femoral components.
Detailed description
Survival and outcome data on the NexGen LPS-Flex Porous Femoral Components will be done by an analysis of standard scoring system, radiographs and adverse event records. Survivorship will be evaluated by monitoring the frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated adverse device effects. Outcomes will be measured by comparing the overall pain and function performances (based on the Knee Society Scoring System), survivorship, subject quality of life and radiographic parameters of study subjects receiving the LPS-Flex Porous Femoral Components.
Conditions
- Osteoarthritis
- Rheumatoid Arthritis
- Traumatic Arthritis
- Poly Arthritis
- Collagen Disorders
- Avascular Necrosis of Femoral Condyle
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LPS Flex Porous Femoral Components | Porous femoral components in total knee arthroplasty |
Timeline
- Start date
- 2008-05-20
- Primary completion
- 2012-03-01
- Completion
- 2012-03-01
- First posted
- 2011-10-31
- Last updated
- 2021-08-24
Source: ClinicalTrials.gov record NCT01462240. Inclusion in this directory is not an endorsement.