Outcomes of MAKOplasty Patellofemoral Arthroplasty in Younger Active Patients
Investigation of the Clinical Outcomes of Patellofemoral Arthroplasty Implanted With the MAKOplasty Knee Resurfacing System in Younger Active Patients
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 11, 2016
CompletedFirst Posted
Study publicly available on registry
April 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedOctober 8, 2020
October 1, 2020
5.7 years
April 11, 2016
October 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Short-term clinical outcomes of patellofemoral arthroplasty
The clinical outcomes will be determined by comparing the preoperative questionnaire data collected with the 2 and 3-year follow-up data.
3 years
Secondary Outcomes (2)
Comparison clinical outcomes of patellofemoral arthroplasty with historical controls
3 years
Comparison of complications, reoperation, and failures rates of patellofemoral arthroplasty with historical controls
3 years
Interventions
Eligibility Criteria
The population will include 60 patients (men and women) who undergo patellofemoral arthroplasty by one surgeon.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Sportsmedicine and Orthopaedic Center
Cincinnati, Ohio, 45242, United States
Related Publications (1)
Noyes FR, Fleckenstein CM, Nolan J. Return to Sports in Patients Aged 50 Years or Younger After Robotic-Assisted Patellofemoral Arthroplasty: A 10-Year Experience Reporting High Clinical Benefits and High Patient Satisfaction With Return to an Active Lifestyle. Am J Sports Med. 2024 May;52(6):1514-1526. doi: 10.1177/03635465241237460. Epub 2024 Apr 24.
PMID: 38656145DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank R Noyes, MD
Cincinnati Sportsmedicine and Orthopaedic Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director Clinical Studies
Study Record Dates
First Submitted
April 11, 2016
First Posted
April 14, 2016
Study Start
April 1, 2016
Primary Completion
December 1, 2021
Study Completion
February 1, 2022
Last Updated
October 8, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share