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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
Sponsor:
Information provided by (Responsible Party):
Sue Barber-Westin, Cincinnati Sportsmedicine Research and Education Foundation

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.

Condition or disease Intervention/treatment
Osteoarthritis, Knee Procedure: Patellofemoral arthroplasty

Detailed Description:

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The population will include 60 patients (men and women) who undergo patellofemoral arthroplasty by one surgeon.
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Frank R Noyes, MD 513-347-9999 frnoyes@gmaili.com
Contact: Cassie Fleckenstein, MS 513-792-3232 cfleckenstein@csmref.org

Locations
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United States, Ohio
Cincinnati Sportsmedicine and Orthopaedic Center Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Cassie Fleckenstein, M.S.    513-794-8466    cfleckenstein@csmref.org   
Principal Investigator: Frank Noyes, M.D.         
Sponsors and Collaborators
Cincinnati Sportsmedicine Research and Education Foundation
Investigators
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Principal Investigator: Frank R Noyes, MD Cincinnati Sportsmedicine and Orthopaedic Center

Additional Information:

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Responsible Party: Sue Barber-Westin, Director Clinical Studies, Cincinnati Sportsmedicine Research and Education Foundation
ClinicalTrials.gov Identifier: NCT02738476     History of Changes
Other Study ID Numbers: MAKOplasty PFA-001
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases