Trials / Active Not Recruiting
Active Not RecruitingNCT03034811
Persona Partial Knee Clinical Outcomes Study
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 643 (actual)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona Partial Knee System.
Detailed description
The study design is a prospective, multicenter, noncontrolled study of the commercially available Persona Partial Knee. The study will require each site to obtain IRB approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process. All study subjects will undergo preoperative clinical evaluations prior to their partial knee arthroplasty. Investigators will collect clinical data for a required 2 years with the option to continue follow-up assessment up to 10 years. Follow-up clinical visits include 3 months, 1 year, 2, 5, and 10 years post-operatively. The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona Partial Knee System. The assessments will include: implant survivorship based on revision with removal of the study device; safety based on incidence and frequency of adverse events; and clinical performance measured by overall pain and function, quality of life data, radiographic parameters, and survivorship.
Conditions
- Osteoarthritis
- Avascular Necrosis
- Traumatic Arthritis
- Conditional Tibial Condyle or Plateau Fractures
- Conditional Revision of the Articular Surface
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Persona Partial Knee system | Fixed bearing partial knee |
Timeline
- Start date
- 2017-02-08
- Primary completion
- 2027-09-01
- Completion
- 2029-07-01
- First posted
- 2017-01-27
- Last updated
- 2025-02-24
Locations
24 sites across 10 countries: United States, Austria, Belgium, France, Germany, Italy, Spain, Sweden, Switzerland, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03034811. Inclusion in this directory is not an endorsement.