Maxx Orthopedics' PCK Revision TKA Study of Component Survivorship

Status unconfirmed

Conditions studied: Aseptic Loosening, Infection, Bone Loss, MCL - Medial Collateral Ligament Rupture of the Knee, Periprosthetic Fractures

In brief

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

Key facts

Study ID

NCT03312088

Run by

Maxx Orthopedics Inc

People needed

300

Starts

2019-01-01

Expected to finish

2022-02-01

Last updated by the study team

2021-07-15

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Coastal Orthopedics — Bradenton, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.