Persona Partial Knee Clinical Outcomes Study
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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 |
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Recruitment Status :
Active, not recruiting
First Posted : January 27, 2017
Last Update Posted : August 21, 2020
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| 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 |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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PPK subjects
Subjects that receive the Persona Partial Knee system
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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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient is at least 18 years of age
- Patient qualifies for knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the Persona Partial Knee system.
- Patient has participated in a study-related Informed Consent process
- Patient is willing and able to provide written Informed Consent by signing and dating the IRB/EC approved Informed Consent form
- Patient is willing and able to complete scheduled study procedures and follow-up evaluations
- Independent of study participation, patient is a candidate for the commercially available Persona Partial Knee, implanted in accordance with product labeling
Exclusion Criteria:
- Patient is currently participating in any other surgical intervention studies or pain management studies
- Infection, sepsis, and osteomyelitis
- Rheumatoid arthritis or other forms of inflammatory joint disease
- Insufficiency of the collateral, anterior or posterior cruciate ligaments which would preclude stability of the device
- Full thickness damage to the weight bearing area of the contralateral compartment
- Uncooperative patient or patient with neurologic disorders who is incapable of following directions
- Insufficient bone stock to provide adequate support and/or fixation to the prosthesis
- Metabolic disorders which may impair bone formation
- Osteomalacia
- Distant foci of infections which may spread to the implant site
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- Vascular insufficiency, muscular atrophy, neuromuscular disease
- Incomplete or deficient soft tissue surrounding the knee
- Charcot's disease
- Fixed varus deformity (not passively correctable) of greater than 15 degrees
- Fixed flexion deformity (not passively correctable) of greater than 15 degrees
- Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
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
Show 24 study locations
| Study Director: | Kacy Arnold, RN, MBA | Zimmer Biomet |
| Responsible Party: | Zimmer Biomet |
| ClinicalTrials.gov Identifier: | NCT03034811 |
| Other Study ID Numbers: |
K.CR.I.G.16.16 |
| First Posted: | January 27, 2017 Key Record Dates |
| Last Update Posted: | August 21, 2020 |
| Last Verified: | August 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Product Manufactured in and Exported from the U.S.: | Yes |
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Noninflammatory degenerative joint disease Osteoarthritis Avascular necrosis |
Traumatic arthritis Partial knee arthroplasty Unicompartmental knee arthroplasty |
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Arthritis Osteoarthritis Necrosis Joint Diseases |
Musculoskeletal Diseases Rheumatic Diseases Pathologic Processes |