Comparison of TKAs Using Force Plate Analysis

NCT04163445 | Unknown FDA Device

• 1 other identifier: 17IISK01 0
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Total Knee Arthroplasty; Knee Injuries; Knee Arthritis

Outcome Measures

Primary Outcomes (15)

• 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

• 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

• 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

• Force generated by operative extremity - walking

  Distribution of maximum force between implanted and non- implanted leg during walking

  pre-operatively

• Force generated by operative extremity - walking

  Distribution of maximum force between implanted and non- implanted leg during walking

  6 weeks post-operatively

• Force generated by operative extremity - walking

  Distribution of maximum force between implanted and non- implanted leg during walking

  3 months post-operatively

• 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

• 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

• 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

• 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

• 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

• 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

• Force generated by operative extremity - walking up stairs

  Distribution of maximum force between implanted and non- implanted leg during walking up stairs

  pre-operatively

• 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

• 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

Study Arms (2)

Depuy Attune

ACTIVE COMPARATOR

Subjects will have been implanted with the Depuy Attune PCR TKA

Device: Depuy Synthes ATTUNE PCR TKA

MicroPort Medial Pivot

ACTIVE COMPARATOR

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

Device: MicroPort Orthopedics EVOLUTION Medial Pivot TKA

Interventions

MicroPort Orthopedics EVOLUTION Medial Pivot TKA DEVICE

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

MicroPort Medial Pivot

Depuy Synthes ATTUNE PCR TKA DEVICE

Subjects will have been implanted with the Depuy Attune PCR TKA

Depuy Attune

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Russell Nevins, M.D.: lead
• MicroPort Orthopedics Inc.: collaborator

Study Sites (1)

Desert Orthopaedic Center

Las Vegas, Nevada, 89121, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Knee Injuries

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Leg Injuries; Wounds and Injuries

Study Officials

• Russell Nevins

  Desert Orthopedics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Russell Nevins, MD

CONTACT

702-731-1616; russellnevinsmd@gmail.com

Kevin Sagers

CONTACT

702-538-6929; kevsagers11@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Surgery

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 14, 2019
• Study Start: November 11, 2020
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2022
• Last Updated: August 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)