Outcomes of MAKOplasty Patellofemoral Arthroplasty in Younger Active Patients
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|ClinicalTrials.gov Identifier: NCT02738476|
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : July 21, 2017
|Condition or disease||Intervention/treatment|
|Osteoarthritis, Knee||Procedure: Patellofemoral arthroplasty|
The primary purpose of this investigation is to report the short-term clinical outcomes of patellofemoral arthroplasty implanted using the MAKOplasty knee resurfacing system.
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||60 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||Investigation of the Clinical Outcomes of Patellofemoral Arthroplasty Implanted With the MAKOplasty Knee Resurfacing System in Younger Active Patients|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||February 2020|
- Short-term clinical outcomes of patellofemoral arthroplasty [ Time Frame: 3 years ]The clinical outcomes will be determined by comparing the preoperative questionnaire data collected with the 2 and 3-year follow-up data.
- Comparison clinical outcomes of patellofemoral arthroplasty with historical controls [ Time Frame: 3 years ]The clinical outcomes of patellofemoral arthroplasty will be compared with those of osteochondral autograft transfer and autologous chondrocyte implantation procedures
- Comparison of complications, reoperation, and failures rates of patellofemoral arthroplasty with historical controls [ Time Frame: 3 years ]The complications, reoperation rates, and failure rates of patellofemoral arthroplasty patients will be compared with those of osteochondral autograft transfer and autologous chondrocyte implantation patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738476
|Contact: Frank R Noyes, MDemail@example.com|
|Contact: Cassie Fleckenstein, MSfirstname.lastname@example.org|
|United States, Ohio|
|Cincinnati Sportsmedicine and Orthopaedic Center||Recruiting|
|Cincinnati, Ohio, United States, 45242|
|Contact: Cassie Fleckenstein, M.S. 513-794-8466 email@example.com|
|Principal Investigator: Frank Noyes, M.D.|
|Principal Investigator:||Frank R Noyes, MD||Cincinnati Sportsmedicine and Orthopaedic Center|