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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04163445
Other study ID # 17IISK01 0
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 11, 2020
Est. completion date November 2022

Study information

Verified date July 2021
Source Desert Orthopedic Center
Contact Russell Nevins, MD
Phone 702-731-1616
Email russellnevinsmd@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date November 2022
Est. primary completion date November 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Device:
MicroPort Orthopedics EVOLUTION Medial Pivot TKA
Subjects will have been implanted with the Microport Evolution Medial Pivot TKA
Depuy Synthes ATTUNE PCR TKA
Subjects will have been implanted with the Depuy Attune PCR TKA

Locations

Country Name City State
United States Desert Orthopaedic Center Las Vegas Nevada

Sponsors (2)

Lead Sponsor Collaborator
Russell Nevins, M.D. MicroPort Orthopedics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 pre-operatively
Primary 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 6 weeks post-operatively
Primary 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 3 months post-operatively
Primary Force generated by operative extremity - walking Distribution of maximum force between implanted and non- implanted leg during walking pre-operatively
Primary Force generated by operative extremity - walking Distribution of maximum force between implanted and non- implanted leg during walking 6 weeks post-operatively
Primary Force generated by operative extremity - walking Distribution of maximum force between implanted and non- implanted leg during walking 3 months post-operatively
Primary 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 pre-operatively
Primary 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 6 weeks post-operatively
Primary 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 3 months post-operatively
Primary 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 pre-operatively
Primary 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 6 weeks post-operatively
Primary 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 3 months post-operatively
Primary Force generated by operative extremity - walking up stairs Distribution of maximum force between implanted and non- implanted leg during walking up stairs pre-operatively
Primary Force generated by operative extremity - walking up stairs Distribution of maximum force between implanted and non- implanted leg during walking up stairs 6 weeks post-operatively
Primary Force generated by operative extremity - walking up stairs Distribution of maximum force between implanted and non- implanted leg during walking up stairs 3 months post-operatively
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