Outcomes of MAKOplasty Patellofemoral Arthroplasty in Younger Active Patients

Sponsor

Cincinnati Sportsmedicine Research and Education Foundation (Other)

Overall Status

Recruiting

CT.gov ID

NCT02738476

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Investigation of the Clinical Outcomes of Patellofemoral Arthroplasty Implanted With the MAKOplasty Knee Resurfacing System in Younger Active Patients

Study Start Date :

Apr 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Feb 1, 2022

Outcome Measures

Primary Outcome Measures

Short-term clinical outcomes of patellofemoral arthroplasty [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

Comparison clinical outcomes of patellofemoral arthroplasty with historical controls [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Sportsmedicine and Orthopaedic Center	Cincinnati	Ohio	United States	45242

Sponsors and Collaborators

Cincinnati Sportsmedicine Research and Education Foundation

Investigators

Principal Investigator: Frank R Noyes, MD, Cincinnati Sportsmedicine and Orthopaedic Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sue Barber-Westin, Director Clinical Studies, Cincinnati Sportsmedicine Research and Education Foundation

ClinicalTrials.gov Identifier:

NCT02738476

Other Study ID Numbers:

MAKOplasty PFA-001

First Posted:

Apr 14, 2016

Last Update Posted:

Oct 8, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Additional relevant MeSH terms:

Osteoarthritis, Knee

Study Results

No Results Posted as of Oct 8, 2020