Back to resultsPersona TM Tibia Clinical Outcomes Study
Primary Purpose
Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Persona TM Tibia
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Patient is at least 18 years of age.
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:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Collagen disorders and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus, or flexion deformities.
- The salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee.
- Patient has participated in the study-related Informed Consent process.
- Patient is willing and able to provide written Informed Consent by signing and dating the IRB approved Informed Consent Form.
- Patient is willing and able to complete scheduled study procedures and follow-up evaluations as described in the Informed Consent Form.
- 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:
- Previous history of infection in the affected joint.
- Active local or systemic infection that may affect the prosthetic joint.
- Insufficient bone stock on femoral or tibial surfaces.
- Skeletal immaturity.
- Neuropathic arthropathy.
- Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb.
- A stable, painless arthrodesis in a satisfactory functional position.
- Severe instability secondary to the absence of collateral ligament integrity.
- Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin.
- Patient has previously received partial or total knee arthroplasty for the ipsilateral knee.
- Patient is currently participating in any other surgical intervention studies or pain management studies.
- Patient is known to be pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.).
- Patient has a known or suspected sensitivity or allergy to one or more of the implant materials.
Sites / Locations
- LA BioMed at Harbor-UCLA Medical Center
- Cornerstone Orthopaedics & Sports Medicine, P.C.
- Hawaii Pacific Health
- Henry County Orthopedics and Sports Medicine
- Woods Mill Orthopedics, Ltd
- Pinehurst Surgical Clinic
- University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Persona TM Tibia subjects
Arm Description
Subjects that receive the Persona TM Tibia implant
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Revision Rate
Rate of the number of revisions for any reason
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03589300
Brief Title
Persona TM Tibia Clinical Outcomes Study
Official Title
Persona® TM Tibia Clinical Outcomes Study: Prospective Multicenter Study of the Persona® Trabecular Metal Tibia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 30, 2018 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
161 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Persona TM Tibia subjects
Arm Type
Other
Arm Description
Subjects that receive the Persona TM Tibia implant
Intervention Type
Device
Intervention Name(s)
Persona TM Tibia
Intervention Description
Trabecular Metal tibia used in primary cementless total knee arthroplasty
Primary Outcome Measure Information:
Title
Radiograph assessment of progressive tibial radiolucencies
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Oxford Knee Score
Description
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.
Time Frame
2 years
Title
Revision Rate
Description
Rate of the number of revisions for any reason
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is at least 18 years of age.
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:
Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
Collagen disorders and/or avascular necrosis of the femoral condyle.
Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
Moderate valgus, varus, or flexion deformities.
The salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee.
Patient has participated in the study-related Informed Consent process.
Patient is willing and able to provide written Informed Consent by signing and dating the IRB approved Informed Consent Form.
Patient is willing and able to complete scheduled study procedures and follow-up evaluations as described in the Informed Consent Form.
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:
Previous history of infection in the affected joint.
Active local or systemic infection that may affect the prosthetic joint.
Insufficient bone stock on femoral or tibial surfaces.
Skeletal immaturity.
Neuropathic arthropathy.
Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb.
A stable, painless arthrodesis in a satisfactory functional position.
Severe instability secondary to the absence of collateral ligament integrity.
Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin.
Patient has previously received partial or total knee arthroplasty for the ipsilateral knee.
Patient is currently participating in any other surgical intervention studies or pain management studies.
Patient is known to be pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.).
Patient has a known or suspected sensitivity or allergy to one or more of the implant materials.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kacy Arnold, RN, MBA
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
LA BioMed at Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Cornerstone Orthopaedics & Sports Medicine, P.C.
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Hawaii Pacific Health
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Henry County Orthopedics and Sports Medicine
City
New Castle
State/Province
Indiana
ZIP/Postal Code
47362
Country
United States
Facility Name
Woods Mill Orthopedics, Ltd
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Pinehurst Surgical Clinic
City
Pinehurst
State/Province
North Carolina
ZIP/Postal Code
28374
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Persona TM Tibia Clinical Outcomes Study
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