Recruiting

Knee Arthroplasty

Sponsor:

Russell Nevins, M.D.

Code:

NCT04163445

Conditions

Knee Osteoarthritis

Total Knee Arthroplasty

Knee Injuries

Knee Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MicroPort Orthopedics EVOLUTION Medial Pivot TKA

Depuy Synthes ATTUNE PCR TKA

Study Details

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

Study ID

NCT04163445

Start date

Nov 11, 2020

Status verified date

Jul, 2021

Completion date

Nov, 2022

Anticipated

Primary completion date

Nov, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Depuy Attune

Subjects will have been implanted with the Depuy Attune PCR TKA

active comparator: MicroPort Medial Pivot

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

Interventions

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

Primary outcome measure

  • Knee Injury and Osteoarthritis Outcome Score [ Time Frame: pre-operatively ]
  • Knee Injury and Osteoarthritis Outcome Score [ Time Frame: 6 weeks post-operatively ]
  • Knee Injury and Osteoarthritis Outcome Score [ Time Frame: 3 months post-operatively ]
  • Force generated by operative extremity - walking [ Time Frame: pre-operatively ]
  • Force generated by operative extremity - walking [ Time Frame: 6 weeks post-operatively ]
  • Force generated by operative extremity - walking [ Time Frame: 3 months post-operatively ]
  • Force generated by operative extremity - standing from seated position [ Time Frame: pre-operatively ]
  • Force generated by operative extremity - standing from seated position [ Time Frame: 6 weeks post-operatively ]
  • Force generated by operative extremity - standing from seated position [ Time Frame: 3 months post-operatively ]
  • Force generated by operative extremity - squatting to a seated position [ Time Frame: pre-operatively ]
  • Force generated by operative extremity - squatting to a seated position [ Time Frame: 6 weeks post-operatively ]
  • Force generated by operative extremity - squatting to a seated position [ Time Frame: 3 months post-operatively ]
  • Force generated by operative extremity - walking up stairs [ Time Frame: pre-operatively ]
  • Force generated by operative extremity - walking up stairs [ Time Frame: 6 weeks post-operatively ]
  • Force generated by operative extremity - walking up stairs [ Time Frame: 3 months post-operatively ]

Central Contacts and Locations

Central contacts

Russell Nevins, MD

702-731-1616russellnevinsmd@gmail.com

Kevin Sagers

702-538-6929kevsagers11@gmail.com

Locations

Desert Orthopaedic Center

Recruiting

Las Vegas, Nevada, United States, 89121

Contacts

Russell Nevins, MD

702-731-1616russellnevinsmd@gmail.com

More Information

Sponsor

Russell Nevins, M.D.

Last update posted

Aug 6, 2021

Last verified

Jul, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Russell Nevins, M.D. on 2021-08-06.