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Cemented vs Cementless Persona Keel RCT

Primary Purpose

Knee Pain Chronic, Rheumatoid Arthritis, Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cementless Persona Knee System
Cemented Persona Knee System
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Pain Chronic focused on measuring Total Knee Replacement, Total Knee Arthroplasty, Osteoarthritis, Rheumatoid Arthritis, Cementless, Cementless Knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient is of legal age and skeletally mature Patient is willing and able to provide written Informed Consent by signing and dating the IRB/EC approved Informed Consent document Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol Independent of study participation, patient qualifies for either cemented or cementless total knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the commercially available Persona Keel Knee System with appropriately matched Zimmer Biomet components implanted in accordance with product labeling. Exclusion Criteria: Patient is unwilling to sign the Informed Consent Patient is currently participating in any other surgical intervention or pain management study Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study would be inappropriate (e.g., prisoner; pediatric patients) Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions Patient has a condition which would, in the judgement of the Investigator, place the patient at undue risk or interfere with the conduct of the study Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation Patient is scheduled to undergo simultaneous bilateral total knee arthroplasty Study Device-Specific Exclusion Criteria: Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint Insufficient bone stock on femoral or tibial surfaces. 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 (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin The kinematic alignment surgical technique is contraindicated for patients with greater than 5° valgus deformity with MCL insufficiency

Sites / Locations

  • Centura Health
  • Baptist Health South FloridaRecruiting
  • Rothman Institute
  • Lehigh Valley Hospital - Dickson City
  • Anderson Orthopaedic Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cementless Persona Keel Knee System

Cemented Persona Keel Knee System

Arm Description

Persona PPS CoCr Cementless Femur and Persona OsseoTi Keel Cementless Tibia

Persona Keel Cemented Tibia

Outcomes

Primary Outcome Measures

Oxford Knee Score (OKS)
A 12-item PROM was specifically designed and developed to assess function and pain after TKA. This tool is short, reproducible, valid, and sensitive to clinically important changes. Possible scores range from a minimum 0 to maximum 48 points, with higher scores indicating less pain and fewer functional limitations. The primary endpoint is based on the change in OKS scores from baseline to 2-year postoperative follow-up as well as from baseline to 5-year postoperative follow-up.

Secondary Outcome Measures

Survival Rate of Implant
Survival Rate (Survivorship) will be both assessed by revision/additional surgeries to the affected joint due to aseptic loosening only or by revision, removal, exchange of the implanted device due to any reason. Aseptic loosening and other reasons for additional surgeries may be identified by radiographic imaging.
Frequency and types of Adverse Events
The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
EuroQol-5 Dimension-5 Level (EQ-5D-5L) Questionnaire
The EQ-5D-5L instrument comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS). The questionnaire produces an "index" score that ranges from 0 to 1, where 0 is the value of a health state equivalent to dead; and 1 is the value of full health, with higher scores indicating higher health utility. The EQ VAS is a 0 -100 scale where patients are asked to indicate their overall health on the day of questionnaire completion. 100 indicates the best health imaginable and 0 indicates the worst health imaginable. Change in Index and EQ VAS scores will be compared from baseline to 2-year follow-up as well as from baseline to 5-year postoperative follow-up for each cohort (cemented or cementless). This change will also be compared between the cohorts (delta from baseline to 2 years and baseline to 5 years in the cementless group compared to the same delta in the cemented group).
Numeric Rating Scale (Pain)
The 11-item pain NRS asks patients to rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"). It is the most widely used instrument for pain screening with higher scores indicating greater pain intensity.
Patient Expectations Pre- and Post-op
Per the 2011 Knee Society scoring manual: "[This] is a three-question fifteen-point scale that is collected pre-operatively and post-operatively. The pre-operative questions reflect the patient's opinion on the extent to which the patient expects that the operation will improve their knee pain, and their ability to perform their activities of daily living and recreational activities. The post-operative questions reflect the extent to which the outcome after the operation has met the patient's pre-operative expectations with respect to pain and function." Higher scores preoperatively indicate more positive expectations of the patient's total knee replacement surgery, and higher scores postoperatively indicate
Rate of Radiolucencies
Radiographic parameters to be evaluated include, but are not limited to, radiolucencies, osteolysis, hypertrophy, subsidence, and heterotopic ossification. All radiographic evaluations performed according to the protocol will be reviewed by the investigator at the time of the evaluation for significant radiographic findings.

Full Information

First Posted
October 18, 2022
Last Updated
August 27, 2023
Sponsor
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT05630053
Brief Title
Cemented vs Cementless Persona Keel RCT
Official Title
Randomized Controlled Trial to Compare Persona OsseoTi Keel Cementless TKA vs Persona Keel Cemented TKA
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2023 (Actual)
Primary Completion Date
May 2032 (Anticipated)
Study Completion Date
December 2032 (Anticipated)

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 main objective of this study is to evaluate the safety, performance, and clinical benefits of the Persona Keel cementless and cemented knee.
Detailed Description
This is a prospective, multi-center, randomized controlled trial to demonstrate safety, performance, and clinical benefits of the Persona Keel CR Knee System and instrumentation. Participants that meet eligibility criteria and sign an institutional review board (IRB) Informed Consent form will be randomized to receive either the Persona OsseoTi Keel Cementless System or the Persona Keel Cemented System. Participants will be blinded to which arm they have been randomized to until after surgery. All study participants will undergo preoperative clinical evaluations prior to their total knee arthroplasty. Investigators will collect clinical data for up to 5 years; follow-up clinic visits will occur at 3 months, 1 year, 2 years, and 5 years after surgery. A maximum of 10 sites will contribute to this study. There will be a maximum of 300 participants enrolled (150 Cementless, 150 Cemented).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Pain Chronic, Rheumatoid Arthritis, Osteoarthritis, Traumatic Arthritis, Polyarthritis, Avascular Necrosis, Varus Deformity, Valgus Deformity, Flexion Deformity of Knee
Keywords
Total Knee Replacement, Total Knee Arthroplasty, Osteoarthritis, Rheumatoid Arthritis, Cementless, Cementless Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants should be masked until after the surgical procedure.
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cementless Persona Keel Knee System
Arm Type
Active Comparator
Arm Description
Persona PPS CoCr Cementless Femur and Persona OsseoTi Keel Cementless Tibia
Arm Title
Cemented Persona Keel Knee System
Arm Type
Active Comparator
Arm Description
Persona Keel Cemented Tibia
Intervention Type
Device
Intervention Name(s)
Cementless Persona Knee System
Other Intervention Name(s)
Persona PPS CoCr Cementless Femur, Persona PPS Femur, PPS Femur, OsseoTi 0° Spiked Keel Tibia, OsseoTi Tibia, OsseoTi Spiked Keel Tibia, Spiked Keel Tibia, Cementless Tibia
Intervention Description
The Persona Keel Knee system is a total knee system used in the replacement of the knee joint.
Intervention Type
Device
Intervention Name(s)
Cemented Persona Knee System
Other Intervention Name(s)
Persona Keel Cemented Tibia, Keel Tibia
Intervention Description
The Persona Keel Knee system is a total knee system used in the replacement of the knee joint.
Primary Outcome Measure Information:
Title
Oxford Knee Score (OKS)
Description
A 12-item PROM was specifically designed and developed to assess function and pain after TKA. This tool is short, reproducible, valid, and sensitive to clinically important changes. Possible scores range from a minimum 0 to maximum 48 points, with higher scores indicating less pain and fewer functional limitations. The primary endpoint is based on the change in OKS scores from baseline to 2-year postoperative follow-up as well as from baseline to 5-year postoperative follow-up.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Survival Rate of Implant
Description
Survival Rate (Survivorship) will be both assessed by revision/additional surgeries to the affected joint due to aseptic loosening only or by revision, removal, exchange of the implanted device due to any reason. Aseptic loosening and other reasons for additional surgeries may be identified by radiographic imaging.
Time Frame
5 years
Title
Frequency and types of Adverse Events
Description
The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
Time Frame
5 years
Title
EuroQol-5 Dimension-5 Level (EQ-5D-5L) Questionnaire
Description
The EQ-5D-5L instrument comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS). The questionnaire produces an "index" score that ranges from 0 to 1, where 0 is the value of a health state equivalent to dead; and 1 is the value of full health, with higher scores indicating higher health utility. The EQ VAS is a 0 -100 scale where patients are asked to indicate their overall health on the day of questionnaire completion. 100 indicates the best health imaginable and 0 indicates the worst health imaginable. Change in Index and EQ VAS scores will be compared from baseline to 2-year follow-up as well as from baseline to 5-year postoperative follow-up for each cohort (cemented or cementless). This change will also be compared between the cohorts (delta from baseline to 2 years and baseline to 5 years in the cementless group compared to the same delta in the cemented group).
Time Frame
5 years
Title
Numeric Rating Scale (Pain)
Description
The 11-item pain NRS asks patients to rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"). It is the most widely used instrument for pain screening with higher scores indicating greater pain intensity.
Time Frame
5 years
Title
Patient Expectations Pre- and Post-op
Description
Per the 2011 Knee Society scoring manual: "[This] is a three-question fifteen-point scale that is collected pre-operatively and post-operatively. The pre-operative questions reflect the patient's opinion on the extent to which the patient expects that the operation will improve their knee pain, and their ability to perform their activities of daily living and recreational activities. The post-operative questions reflect the extent to which the outcome after the operation has met the patient's pre-operative expectations with respect to pain and function." Higher scores preoperatively indicate more positive expectations of the patient's total knee replacement surgery, and higher scores postoperatively indicate
Time Frame
5 years
Title
Rate of Radiolucencies
Description
Radiographic parameters to be evaluated include, but are not limited to, radiolucencies, osteolysis, hypertrophy, subsidence, and heterotopic ossification. All radiographic evaluations performed according to the protocol will be reviewed by the investigator at the time of the evaluation for significant radiographic findings.
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Operative Room Time
Description
Evaluation of differences in operative times between implantation of cemented and cementless systems.
Time Frame
During surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient is of legal age and skeletally mature Patient is willing and able to provide written Informed Consent by signing and dating the IRB/EC approved Informed Consent document Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol Independent of study participation, patient qualifies for either cemented or cementless total knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the commercially available Persona Keel Knee System with appropriately matched Zimmer Biomet components implanted in accordance with product labeling. Exclusion Criteria: Patient is unwilling to sign the Informed Consent Patient is currently participating in any other surgical intervention or pain management study Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study would be inappropriate (e.g., prisoner; pediatric patients) Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions Patient has a condition which would, in the judgement of the Investigator, place the patient at undue risk or interfere with the conduct of the study Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation Patient is scheduled to undergo simultaneous bilateral total knee arthroplasty Study Device-Specific Exclusion Criteria: Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint Insufficient bone stock on femoral or tibial surfaces. 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 (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin The kinematic alignment surgical technique is contraindicated for patients with greater than 5° valgus deformity with MCL insufficiency
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brittany Nierste
Phone
574-527-3850
Email
brittany.nierste@zimmerbiomet.com
First Name & Middle Initial & Last Name or Official Title & Degree
Branden Kemp
Phone
574-286-3043
Email
branden.kemp1@zimmerbiomet.com
Facility Information:
Facility Name
Centura Health
City
Westminster
State/Province
Colorado
ZIP/Postal Code
80023
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah Audet
Email
hannahaudet@centura.org
First Name & Middle Initial & Last Name & Degree
Ian Weber, M.D.
Facility Name
Baptist Health South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yvette Hernandez
Email
yvettesal@baptisthealth.net
First Name & Middle Initial & Last Name & Degree
Juan Suarez, M.D.
First Name & Middle Initial & Last Name & Degree
Charles Lawrie, M.D.
Facility Name
Rothman Institute
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brooke Olin
Email
Brooke.olin@rothmanortho.com
First Name & Middle Initial & Last Name & Degree
Jess Lonner, M.D.
First Name & Middle Initial & Last Name & Degree
Yale Fillingham, M.D.
First Name & Middle Initial & Last Name & Degree
Maxwell Courtney, M.D.
Facility Name
Lehigh Valley Hospital - Dickson City
City
Dickson City
State/Province
Pennsylvania
ZIP/Postal Code
18519
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Gogal
Email
Christina_C.Gogal@lvhn.org
First Name & Middle Initial & Last Name & Degree
Harry Schmaltz, M.D.
Facility Name
Anderson Orthopaedic Research Institute
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22306
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Parks
Email
nparks@aori.org
First Name & Middle Initial & Last Name & Degree
Robert Sershon, M.D.
First Name & Middle Initial & Last Name & Degree
Kevin Fricka, M.D.

12. IPD Sharing Statement

Learn more about this trial

Cemented vs Cementless Persona Keel RCT

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