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Comparison of TKAs Using Force Plate Analysis

Primary Purpose

Knee Osteoarthritis, Total Knee Arthroplasty, Knee Injuries

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MicroPort Orthopedics EVOLUTION Medial Pivot TKA
Depuy Synthes ATTUNE PCR TKA
Sponsored by
Russell Nevins, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects who have been appropriately designated for treatment with a primary total knee arthroplasty
  • Subjects who are willing to participate and are willing to sign the Informed Consent/HIPPA documents.

Exclusion Criteria:

  • Subjects who are unsuitable candidates for the two types of knee implants under investigation.
  • Subjects with significant deformities or arthritis that might affect the procedural decision making, expected outcomes and functions are total knee arthroplasty.
  • Subjects with significant comorbidities that might be at an increased risk of post-operative complications.
  • Subjects who are unwilling to sign Informed Consent/HIPAA documents.
  • Subjects who cannot perform the required activities after the surgery.

Sites / Locations

  • Desert Orthopaedic CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Depuy Attune

MicroPort Medial Pivot

Arm Description

Subjects will have been implanted with the Depuy Attune PCR TKA

Subjects will have been implanted with the Microport Evolution Medial Pivot TKA

Outcomes

Primary Outcome Measures

Knee Injury and Osteoarthritis Outcome Score
KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms
Knee Injury and Osteoarthritis Outcome Score
KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms
Knee Injury and Osteoarthritis Outcome Score
KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms
Force generated by operative extremity - walking
Distribution of maximum force between implanted and non- implanted leg during walking
Force generated by operative extremity - walking
Distribution of maximum force between implanted and non- implanted leg during walking
Force generated by operative extremity - walking
Distribution of maximum force between implanted and non- implanted leg during walking
Force generated by operative extremity - standing from seated position
Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair
Force generated by operative extremity - standing from seated position
Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair
Force generated by operative extremity - standing from seated position
Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair
Force generated by operative extremity - squatting to a seated position
Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position
Force generated by operative extremity - squatting to a seated position
Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position
Force generated by operative extremity - squatting to a seated position
Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position
Force generated by operative extremity - walking up stairs
Distribution of maximum force between implanted and non- implanted leg during walking up stairs
Force generated by operative extremity - walking up stairs
Distribution of maximum force between implanted and non- implanted leg during walking up stairs
Force generated by operative extremity - walking up stairs
Distribution of maximum force between implanted and non- implanted leg during walking up stairs

Secondary Outcome Measures

Full Information

First Posted
November 6, 2019
Last Updated
July 31, 2021
Sponsor
Russell Nevins, M.D.
Collaborators
MicroPort Orthopedics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04163445
Brief Title
Comparison of TKAs Using Force Plate Analysis
Official Title
Comparison of Different TKAs Using Objective Dynamic Functional Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 11, 2020 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Russell Nevins, M.D.
Collaborators
MicroPort Orthopedics Inc.

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

5. Study Description

Brief Summary
The purpose of this study is to evaluate performance of two modern total knee arthroplasty designs using patient reported outcomes and force exhibited during various activities of daily living.
Detailed Description
48 patients with primary osteoarthritis of the knee who have been appropriately designated for treatment with a total knee arthroplasty (TKA) will be randomly assigned to one of two groups; one group (24 patients) will receive a Depuy Attune PCR knee implant, and one group (24 patients) will receive a MicroPort Orthopedics Evolution Medial Pivot knee implant utilizing standard and modern techniques. These two implants are designed to recreate the kinematic motion of a native knee articulation using different biomechanical design philosophies. The patients will be monitored post-operatively using subjective and objective measures. Subjective patient reported outcomes will be analyzed using the Knee Injury and Osteoarthritis Outcome Score (KOOS), recorded preoperatively, as well as at 6 weeks, and 3 months postoperatively. Objective outcomes will be measured by having the patients perform four activities over force plates that will measure the amount of force a patient generates. The four activities will be: walking, standing from a seated position in a chair, squatting to a seated position, and walking up stairs. These objective measures will also be recorded preoperatively, 6 weeks, and 3 months postoperatively. The patient reported outcomes and the objective measures will then be compared between the two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Total Knee Arthroplasty, Knee Injuries, Knee Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
The patient will be randomized to one of 2 treatment arms using a random number generator. The care provider will not be blinded as he will be implanting the device and following the patients' progress in clinic postoperatively, including radiographs which will show the implants. He will be blinded, however, to the results of the KOOS score and the data derived from the force plate analysis. The research assistants performing those assessments will be blinded to which treatment arm the patient belongs to.
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Depuy Attune
Arm Type
Active Comparator
Arm Description
Subjects will have been implanted with the Depuy Attune PCR TKA
Arm Title
MicroPort Medial Pivot
Arm Type
Active Comparator
Arm Description
Subjects will have been implanted with the Microport Evolution Medial Pivot TKA
Intervention Type
Device
Intervention Name(s)
MicroPort Orthopedics EVOLUTION Medial Pivot TKA
Intervention Description
Subjects will have been implanted with the Microport Evolution Medial Pivot TKA
Intervention Type
Device
Intervention Name(s)
Depuy Synthes ATTUNE PCR TKA
Intervention Description
Subjects will have been implanted with the Depuy Attune PCR TKA
Primary Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcome Score
Description
KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms
Time Frame
pre-operatively
Title
Knee Injury and Osteoarthritis Outcome Score
Description
KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms
Time Frame
6 weeks post-operatively
Title
Knee Injury and Osteoarthritis Outcome Score
Description
KOOS Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms
Time Frame
3 months post-operatively
Title
Force generated by operative extremity - walking
Description
Distribution of maximum force between implanted and non- implanted leg during walking
Time Frame
pre-operatively
Title
Force generated by operative extremity - walking
Description
Distribution of maximum force between implanted and non- implanted leg during walking
Time Frame
6 weeks post-operatively
Title
Force generated by operative extremity - walking
Description
Distribution of maximum force between implanted and non- implanted leg during walking
Time Frame
3 months post-operatively
Title
Force generated by operative extremity - standing from seated position
Description
Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair
Time Frame
pre-operatively
Title
Force generated by operative extremity - standing from seated position
Description
Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair
Time Frame
6 weeks post-operatively
Title
Force generated by operative extremity - standing from seated position
Description
Distribution of maximum force between implanted and non- implanted leg during standing from a seated position in a chair
Time Frame
3 months post-operatively
Title
Force generated by operative extremity - squatting to a seated position
Description
Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position
Time Frame
pre-operatively
Title
Force generated by operative extremity - squatting to a seated position
Description
Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position
Time Frame
6 weeks post-operatively
Title
Force generated by operative extremity - squatting to a seated position
Description
Distribution of maximum force between implanted and non- implanted leg during squatting to a seated position
Time Frame
3 months post-operatively
Title
Force generated by operative extremity - walking up stairs
Description
Distribution of maximum force between implanted and non- implanted leg during walking up stairs
Time Frame
pre-operatively
Title
Force generated by operative extremity - walking up stairs
Description
Distribution of maximum force between implanted and non- implanted leg during walking up stairs
Time Frame
6 weeks post-operatively
Title
Force generated by operative extremity - walking up stairs
Description
Distribution of maximum force between implanted and non- implanted leg during walking up stairs
Time Frame
3 months post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who have been appropriately designated for treatment with a primary total knee arthroplasty Subjects who are willing to participate and are willing to sign the Informed Consent/HIPPA documents. Exclusion Criteria: Subjects who are unsuitable candidates for the two types of knee implants under investigation. Subjects with significant deformities or arthritis that might affect the procedural decision making, expected outcomes and functions are total knee arthroplasty. Subjects with significant comorbidities that might be at an increased risk of post-operative complications. Subjects who are unwilling to sign Informed Consent/HIPAA documents. Subjects who cannot perform the required activities after the surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Russell Nevins, MD
Phone
702-731-1616
Email
russellnevinsmd@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Sagers
Phone
702-538-6929
Email
kevsagers11@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell Nevins
Organizational Affiliation
Desert Orthopedics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Desert Orthopaedic Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Russell Nevins, MD
Phone
702-731-1616
Email
russellnevinsmd@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of TKAs Using Force Plate Analysis

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