Maxx Orthopedics' PCK Revision TKA Study of Component Survivorship

A Prospective, Multi-center, Single Arm Adaptive-design Study to Evaluate the Survivorship of the Maxx Orthopedics' PCK System in Revision Cases

The objectives of this clinical investigation are to evaluate the safety and performance of the Freedom Total Knee® PCK System.

Study Overview

• Status: Recruiting
• Conditions: Bone Loss; Periprosthetic Fractures; Infection; Aseptic Loosening; MCL - Medial Collateral Ligament Rupture of the Knee
• Intervention / Treatment: Device: Freedom Knee PCK Components

Detailed Description

The clinical investigation is designed to be prospective to ensure that the population is representative of the type of population for which the Freedom Total Knee® System with the revision components is intended to treat. Subjects with a primary diagnosis of end-stage symptomatic revision knee who require a uni-lateral knee prosthesis and have been evaluated as appropriate candidates for a revision total knee arthroplasty, by the Investigator, will be invited to take part in this clinical investigation. Patients will be drawn from hospital clinics focusing on this type of treatment.

The treatment period of 36 months is considered sufficient to monitor the safety and clinical performance of the device. However, the patients will be contacted annually for 10 years or as long as the patient is willing to monitor their long-term progress.

An interim report will be issued when at least 120 patients will complete the 12-month follow-up.

No treatments will be withheld as part of this clinical investigation although any other treatments that need to be administered during the clinical investigation will be recorded.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Coreyn Perine; Phone Number: +1 (484) 342-0092; Email: corey.perine@maxxortho.com

Study Locations

• United States
  • Florida
    • Bradenton, Florida, United States, 34209
      • Recruiting
      • Coastal Orthopedics
      • Contact: Mallory Simms; Phone Number: 3450 941-792-1404; Email: msimms@coastalorthopedics.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients having undergone a primary TKR and are candidates for a revision surgery based on aseptic loosening, infections, bone loss, MCL disruption, and/or periprosthetic fractures.

Description

Inclusion Criteria:

• Male and female subjects aged 40 years of age or older and less than 80 years of age (>40 and <80 years).
• Patients having undergone a primary TKR and are candidates for a revision surgery based on aseptic loosening, infections, bone loss, MCL disruption, and/or periprosthetic fractures.
• Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and the prescribed rehabilitation.
• Subjects who, in the opinion of the Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
• Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.

Exclusion Criteria:

• Primary knee replacement of the affected knee joint
• Other significant disabling problems from the muscular-skeletal system than in the knees (i.e muscular dystrophy, polio, neuropathic joints)
• Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living.
• Patients who are found to be non-compliant by their physician
• Patients with or having; malignancy - active malignancy, active or suspected systemic infection, Paget's disease, renal osteodystrophy, immunologically suppressed, sickle cell anemia, and systemic lupus erythmatosus.
• The patient has a neuromuscular or neurosensory deficit.
• Female patients planning a pregnancy during the course of the study.
• Patients, who are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule.
• Varus or valgus deformity > 20 degrees
• Bilateral TKR

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survivorship	"No Explants"	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revision rates of any component (including insert) for any reason.	Revision rates of any component (including insert) for any reason.	36 months
Revision rates of any component (including insert) for any reason except infection.	Revision rates of any component (including insert) for any reason except infection.	36 months
KSS	Knee Society Score	36 months
WOMAC	Pain Score	36 months
ROM	Range of Motion	36 months

Collaborators and Investigators

• Sponsor: Maxx Orthopedics Inc
• Investigators: Principal Investigator: David Cashin, MD, Coastal Orthopedics

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: October 16, 2017
• First Posted (Actual): October 17, 2017

Study Record Updates

• Last Update Posted (Actual): July 15, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Rupture; Periprosthetic Fractures
• Other Study ID Numbers: MO-2017-PCK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes