Osteoarthritis, KneeNCT02738476
Outcomes of MAKOplasty Patellofemoral Arthroplasty in Younger Active Patients
An observational study of Osteoarthritis, Knee, run by Cincinnati Sportsmedicine Research and Education Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Patellofemoral arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Feb 2022
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population will include 60 patients (men and women) who undergo patellofemoral arthroplasty by one surgeon.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cincinnati Sportsmedicine and Orthopaedic Center
Cincinnati, Ohio, 45242
Cassie Fleckenstein, M.S., 513-794-8466, cfleckenstein@csmref.org
Frank Noyes, M.D.
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Patellofemoral arthroplasty
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patellofemoral arthroplastyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (2)
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
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Cincinnati Sportsmedicine Research and Education Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sue Barber-Westin, Cincinnati Sportsmedicine Research and Education Foundation
- Investigators
- Frank R Noyes, MD, Principal investigator, Cincinnati Sportsmedicine and Orthopaedic Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02738476
- Sponsor's protocol ID
- MAKOplasty PFA-001
- Status last verified
- Oct 2020
- First submitted
- 11 Apr 2016
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 38656145
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Clinical Outcomes of Patellofemoral Arthroplasty Implanted With the MAKOplasty Knee Resurfacing System in Younger Active Patients
- ClinicalTrials.gov ID
- NCT02738476
- Acronym / sponsor ID
- MAKOplasty PFA-001
- Conditions
- Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cincinnati Sportsmedicine Research and Education FoundationUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will include 60 patients (men and women) who undergo patellofemoral arthroplasty by one surgeon.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patellofemoral arthroplasty | Procedure or surgery | – |
Primary outcome
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.
2 secondary outcomes
Comparison clinical outcomes of patellofemoral arthroplasty with historical controls
Time frame: 3 years
Comparison of complications, reoperation, and failures rates of patellofemoral arthroplasty with historical controls
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 38656145Noyes 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank R Noyes, MD principal investigator
Cincinnati Sportsmedicine and Orthopaedic Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Cincinnati Sportsmedicine Research and Education Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frank R Noyes, MD (513-347-9999, frnoyes@gmaili.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term clinical outcomes of patellofemoral arthroplasty (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02738476, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.