Outcomes of MAKOplasty Patellofemoral Arthroplasty in Younger Active Patients

NCT ID: NCT02738476

Last Updated: 2020-10-08

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2022-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Osteoarthritis, Knee

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Patellofemoral arthroplasty

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cincinnati Sportsmedicine Research and Education Foundation

OTHER

Sponsor Role lead

Responsible Party

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Sue Barber-Westin

Director Clinical Studies

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Frank R Noyes, MD

Role: CONTACT

513-347-9999

Cassie Fleckenstein, MS

Role: CONTACT

513-792-3232

Facility Contacts

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Cassie Fleckenstein, M.S.

Role: primary

513-794-8466

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.

Reference Type DERIVED
PMID: 38656145 (View on PubMed)

Other Identifiers

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MAKOplasty PFA-001

Identifier Type: -

Identifier Source: org_study_id

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