Outcomes of MAKOplasty Patellofemoral Arthroplasty in Younger Active Patients
NCT ID: NCT02738476
Last Updated: 2020-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2016-04-30
2022-02-28
Brief Summary
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Detailed Description
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The secondary purpose is to compare the short-term outcomes, complication rates, and survival rates of this operation to those of our historical controls of patients who underwent either osteochondral autograft transfer or autologous chondrocyte implantation for full-thickness patellofemoral articular cartilage lesions. The investigators believe these data will provide strong evidence to improve the selection criteria for patellofemoral arthroplasty.
All patients will complete validated questionnaires from the Cincinnati Knee Rating System, including the Sports Activity and Function Form, the Occupational Rating Form, and the Symptom Rating Form. Patients will also complete the SF-12 general health questionnaire. In addition to the above mentioned rating systems, patients will also complete questionnaires on post-surgical expectations and general fitness level.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Patellofemoral arthroplasty
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
65 Years
ALL
No
Sponsors
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Cincinnati Sportsmedicine Research and Education Foundation
OTHER
Responsible Party
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Sue Barber-Westin
Director Clinical Studies
Principal Investigators
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Frank R Noyes, MD
Role: PRINCIPAL_INVESTIGATOR
Cincinnati Sportsmedicine and Orthopaedic Center
Locations
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Cincinnati Sportsmedicine and Orthopaedic Center
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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MAKOplasty PFA-001
Identifier Type: -
Identifier Source: org_study_id
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