Persona Partial Knee Clinical Outcomes Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03034811|
Recruitment Status : Active, not recruiting
First Posted : January 27, 2017
Last Update Posted : August 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Avascular Necrosis Traumatic Arthritis Conditional Tibial Condyle or Plateau Fractures Conditional Revision of the Articular Surface||Device: Persona Partial Knee system||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||643 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Persona Partial Knee Clinical Outcomes Study|
|Actual Study Start Date :||February 8, 2017|
|Estimated Primary Completion Date :||September 2027|
|Estimated Study Completion Date :||July 2029|
Subjects that receive the Persona Partial Knee system
Device: Persona Partial Knee system
Fixed bearing partial knee
- Oxford Knee Score [ Time Frame: 10 years ]A Patient reported functional outcome score for knee arthroplasty
- EQ-5D [ Time Frame: 10 years ]a questionnaire completed by the Patient and assesses his/her General health Status. The EQ5D is used to derive a Quality of life index used for health economics considerations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034811
|Study Director:||Kacy Arnold, RN, MBA||Zimmer Biomet|