Clinical trial NCT03312088: Maxx Orthopedics' PCK Revision TKA Study of Component Survivorship
Official title: A Prospective, Multi-center, Single Arm Adaptive-design Study to Evaluate the Survivorship of the Maxx Orthopedics' PCK System in Revision Cases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aseptic Loosening
Infection
Bone Loss
MCL - Medial Collateral Ligament Rupture of the Knee
Periprosthetic Fractures
Lead sponsor: Maxx Orthopedics Inc
Sponsor class: INDUSTRY
First posted: 2017-10-17
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Survivorship
timeFrame: 36 months
Secondary outcomes:
measure: Revision rates of any component (including insert) for any reason.
timeFrame: 36 months
measure: Revision rates of any component (including insert) for any reason except infection.
timeFrame: 36 months
measure: KSS
timeFrame: 36 months
measure: WOMAC
timeFrame: 36 months
measure: ROM
timeFrame: 36 months
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Coastal Orthopedics
state: Florida
Study officials:
affiliation: Coastal Orthopedics
name: David Cashin, MD
role: PRINCIPAL_INVESTIGATOR
References: