Outcomes of MAKOplasty Patellofemoral Arthroplasty in Younger Active Patients

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

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Recruiting
      • Cincinnati Sportsmedicine and Orthopaedic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The population will include 60 patients (men and women) who undergo patellofemoral arthroplasty by one surgeon.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-term clinical outcomes of patellofemoral arthroplasty	The clinical outcomes will be determined by comparing the preoperative questionnaire data collected with the 2 and 3-year follow-up data.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison clinical outcomes of patellofemoral arthroplasty with historical controls	The clinical outcomes of patellofemoral arthroplasty will be compared with those of osteochondral autograft transfer and autologous chondrocyte implantation procedures	3 years
Comparison of complications, reoperation, and failures rates of patellofemoral arthroplasty with historical controls	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	3 years

Collaborators and Investigators

• Sponsor: Cincinnati Sportsmedicine Research and Education Foundation

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): February 1, 2022

Study Registration Dates

• First Submitted: April 11, 2016
• First Submitted That Met QC Criteria: April 13, 2016
• First Posted (ESTIMATE): April 14, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: MAKOplasty PFA-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES