Persona TM Tibia Clinical Outcomes Study

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis; Polyarthritis; Collagen Disorders and/or Avascular Necrosis of the Femoral Condyle; Post-traumatic Loss of Joint Configuration; Moderate Valgus, Varus, or Flexion Deformities
• Intervention / Treatment: Device: Persona TM Tibia

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Torrance, California, United States, 90502
      • LA Biomed at Harbor-UCLA Medical Center
  • Colorado
    • Wheat Ridge, Colorado, United States, 80033
      • Cornerstone Orthopaedics & Sports Medicine, P.C.
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Hawaii Pacific Health
  • Indiana
    • New Castle, Indiana, United States, 47362
      • Henry County Orthopedics and Sports Medicine
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Woods Mill Orthopedics, Ltd
  • North Carolina
    • Pinehurst, North Carolina, United States, 28374
      • Pinehurst Surgical Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Persona TM Tibia subjects; Subjects that receive the Persona TM Tibia implant	Device: Persona TM Tibia; Trabecular Metal tibia used in primary cementless total knee arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiograph assessment of progressive tibial radiolucencies	Progressive Tibial Radiolucency will be derived in accordance with the following definitions: Absent: No evidence of an increase in either radiolucency extent (number of zones involved) or measured width within a zone. Present: Presence of either: An increase in the number of zones with a measured Tibial Radiolucency, OR; An increase in the measured Tibial Radiolucency width within a zone of >0.5 mm.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revision Rate	Rate of the number of revisions for any reason	2 years
Oxford Knee Score	The Oxford Knee Score is a patient completed 12 question metric to rate a patient's knee pain and function using an ordinal 0 - 4 point scale. The total score is obtained by calculating the sum of the 12 items. The minimum score is 0 and the maximum score is 48 points.	2 years

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 30, 2018
• Primary Completion (ACTUAL): November 30, 2022
• Study Completion (ACTUAL): November 30, 2022

Study Registration Dates

• First Submitted: June 20, 2018
• First Submitted That Met QC Criteria: July 4, 2018
• First Posted (ACTUAL): July 17, 2018

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Arthritis; Necrosis; Rheumatic Diseases; Collagen Diseases
• Other Study ID Numbers: K.CR.I.G.16.33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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