Recruiting

MAKOplasty

Sponsor:

Cincinnati Sportsmedicine Research and Education Foundation

Code:

NCT02738476

Conditions

Osteoarthritis, Knee

Eligibility Criteria

Sex: All

Age: 20 - 65

Healthy Volunteers: Not accepted

Interventions

Patellofemoral arthroplasty

Study Details

Brief summary:

The primary purpose of this investigation is to report the short-term clinical outcomes (2-3 years) of patellofemoral arthroplasty implanted using the MAKOplasty knee resurfacing system.

Conditions

Osteoarthritis, Knee

Study ID

NCT02738476

Start date

Apr, 2016

Status verified date

Oct, 2020

Completion date

Feb, 2022

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Arthroscopically demonstrated localized and isolated full-thickness articular cartilage lesions (Grade 2B or 3A-B as defined by Noyes \& Stabler9) on the patellofemoral joint.
  • Lesion is symptomatic as defined by pain, swelling, locking, or catching that affects daily activities.
  • Patient provides informed consent.
  • Patient agrees to comply with postoperative rehabilitation program.

Exclusion Criteria:

  • Obesity (body mass index greater than 35).
  • Arthroscopically demonstrated full-thickness articular cartilage lesions (Grade 2B or 3A-B) in the other compartments of the knee.
  • Uncorrected varus or valgus malalignment
  • Uncorrected knee joint instability
  • Knee arthrofibrosis
  • Patient unwilling to comply with postoperative rehabilitation
  • Significant muscular atrophy and weakness that does not respond to rehabilitation
  • History of alcohol or drug abuse within 3 years of the operation.
  • Disabling or widespread osteoarthritis or other joint disease in any other joint.
  • Presence of a significant connective tissue disease, autoimmune disease, HIV-positive, or immune deficiency syndrome.
  • Any contraindications to surgery or other medical disorder that in the opinion of the principal investigator would interfere with the conduct of the study.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Interventions

Patellofemoral arthroplasty

Primary outcome measure

  • Short-term clinical outcomes of patellofemoral arthroplasty [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Frank R Noyes, MD

513-347-9999frnoyes@gmaili.com

Cassie Fleckenstein, MS

513-792-3232cfleckenstein@csmref.org

Locations

Cincinnati Sportsmedicine and Orthopaedic Center

Recruiting

Cincinnati, Ohio, United States, 45242

Contacts

Cassie Fleckenstein, M.S.

513-794-8466cfleckenstein@csmref.org

Principal Investigator:

Frank Noyes, M.D.

More Information

Sponsor

Cincinnati Sportsmedicine Research and Education Foundation

Last update posted

Oct 8, 2020

Last verified

Oct, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cincinnati Sportsmedicine Research and Education Foundation on 2020-10-08.