Persona TM Tibia Clinical Outcomes Study



Status:Recruiting
Conditions:Arthritis, Osteoarthritis (OA), Rheumatoid Arthritis, Rheumatology
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:April 30, 2018
End Date:September 2021
Contact:Scott Abshagen, RN, BS
Email:scott.abshagen@zimmerbiomet.com
Phone:574-371-9782

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Persona® TM Tibia Clinical Outcomes Study: Prospective Multicenter Study of the Persona® Trabecular Metal Tibia

The primary objective of this study is to evaluate clinical performance for the commercially
available Persona TM Tibia used in primary cementless tibia total knee arthroplasty.

This is a prospective, multicenter, non-randomized clinical study designed to facilitate the
collection and evaluation of radiographic parameters, pain and function, survival of the
device,and adverse event data.

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 cementless
tibia total knee arthroplasty. An immediate postoperative radiograph will be required.
Postoperative clinical follow-up and radiographic evaluations will be conducted at 6 weeks, 6
months, 1 year, and 2 years.

The primary endpoint of this study is to evaluate the clinical performance of the implant at
2 years postoperatively using radiographic parameters. Radiographs will be assessed for the
absence of progressive tibial radiolucencies, as defined in the radiographic protocol.

The secondary endpoints of this study will evaluate the clinical performance of the implant
at 2 years postoperatively, based upon:

- No revisions for any reason

- Oxford Knee Score >38

Inclusion Criteria:

1. Patient is at least 18 years of age.

2. Patient qualifies for a primary cementless tibia total knee arthroplasty based on
physical exam and medical history, including diagnosis of severe knee pain and
disability due to at least one of the following:

1. Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

2. Collagen disorders and/or avascular necrosis of the femoral condyle.

3. Post-traumatic loss of joint configuration, particularly when there is
patellofemoral erosion, dysfunction or prior patellectomy.

4. Moderate valgus, varus, or flexion deformities.

5. The salvage of previously failed surgical attempts that did not include partial
or total knee arthroplasty of the ipsilateral knee.

3. Patient has participated in the study-related Informed Consent process.

4. Patient is willing and able to provide written Informed Consent by signing and dating
the IRB approved Informed Consent Form.

5. Patient is willing and able to complete scheduled study procedures and follow-up
evaluations as described in the Informed Consent Form.

6. Independent of study participation, patient is a candidate for commercially available
cementless Persona TM tibial knee component, implanted in accordance with product
labeling.

Exclusion Criteria:

1. Previous history of infection in the affected joint.

2. Active local or systemic infection that may affect the prosthetic joint.

3. Insufficient bone stock on femoral or tibial surfaces.

4. Skeletal immaturity.

5. Neuropathic arthropathy.

6. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the
affected limb.

7. A stable, painless arthrodesis in a satisfactory functional position.

8. Severe instability secondary to the absence of collateral ligament integrity.

9. Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent
breakdown of the skin.

10. Patient has previously received partial or total knee arthroplasty for the ipsilateral
knee.

11. Patient is currently participating in any other surgical intervention studies or pain
management studies.

12. Patient is known to be pregnant or considered a member of a protected population
(e.g., prisoner, mentally incompetent, etc.).

13. Patient has a known or suspected sensitivity or allergy to one or more of the implant
materials.
We found this trial at
7
sites
5 1st Village Drive
Pinehurst, North Carolina 28374
Principal Investigator: John R Moore, IV, MD
Phone: 910-295-0224
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South Woods Mill Road South Woods Mill Road
Chesterfield, Missouri 63017
Principal Investigator: Richard D Rames, MD
Phone: 314-576-7013
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Honolulu, Hawaii 96813
Principal Investigator: Cass K Nakasone, MD
Phone: 808-522-4822
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Honolulu, HI
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New Castle, Indiana 47362
Principal Investigator: Lindsey R Rolston, MD
Phone: 765-521-7385
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New Castle, IN
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Craig L Israelite, MD
Phone: 215-294-9166
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Torrance, California 90502
Principal Investigator: Louis M Kwong, MD
Phone: 310-781-3634
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Torrance, CA
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3455 Lutheran Parkway West
Wheat Ridge, Colorado 80033
Principal Investigator: Ian C Weber, MD
Phone: 303-456-6000
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Wheat Ridge, CO
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