RECRUITING

Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee Arthroplasty

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Patients with degenerative joint disease can effectively be treated with a primary total knee replacement to reduce pain and improve function in their daily lives. Theoretically, achievement of normal knee motion using a medial pivot design in total knee replacements can be recreated in comparison to single radius designs, which could lead to an improvement in post-surgical outcomes and satisfaction with the procedure. The aim of this study is to compare two types of implant designs (medial pivot and single radius) in a total knee replacement using clinical outcomes, patient reported outcomes, and overall function assessed by a specialized gait laboratory.

Official Title

Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot

Quick Facts

Study Start:2021-02-01
Study Completion:2027-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04814082

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject is male or non-pregnant female aged between 18 and 75 years of age.
  2. * Subject is willing to provide informed consent to participate in the research study.
  3. * Subject is indicated for a primary total knee arthroplasty (TKA) based on the approved labeling of knee implant, either a medial pivot or single radius design, specifically: MicroPort Evolution Medial-Pivot Knee System, Cruciate Retaining (CS) or Stryker Triathlon Tritanium (CS)
  4. * Subject does not have a history of previous prosthetic replacement device on the operative knee.
  5. * Subject is currently ambulating and does not have a condition on the contralateral limb in the opinion of the investigator that would interfere with the gait laboratory evaluations.
  6. * Subject is willing and able to comply with the schedule of events for the study and is available to return to the clinic for all required follow-up visits.
  1. * Subject has a Body Mass Index (BMI) \>40
  2. * Subject has a diagnosis of avascular necrosis or inflammatory arthritis.
  3. * Subject has any mental or neuromuscular disorder that would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
  4. * Subject is a prisoner
  5. * Subject has any condition, in the opinion of the Investigator that might interfere with the evaluation of the study objectives.

Contacts and Locations

Study Contact

Martin Gesheff
CONTACT
410-601-9467
mgesheff@lifebridgehealth.org
Nirav Patel
CONTACT
410-601-8860
nirpatel@lifebridgehealth.org

Principal Investigator

James Nace, MD
PRINCIPAL_INVESTIGATOR
LifeBridge Health

Study Locations (Sites)

Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
United States

Collaborators and Investigators

Sponsor: LifeBridge Health

  • James Nace, MD, PRINCIPAL_INVESTIGATOR, LifeBridge Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-01
Study Completion Date2027-07-01

Study Record Updates

Study Start Date2021-02-01
Study Completion Date2027-07-01

Terms related to this study

Keywords Provided by Researchers

  • Total Knee Arthroplasty
  • Total Knee Replacement

Additional Relevant MeSH Terms

  • Osteoarthritis, Knee
  • Knee Osteoarthritis
  • Osteoarthritis Knees Both
  • Osteoarthritis Knee Left
  • Osteoarthritis Knee Right
  • Knee Pain Chronic
  • Knee Disease
  • Arthropathy of Knee Joint