Prospective, In-Vivo, Post-Market Safety and Efficacy Surveillance Registry of the MAXX Orthopedics, Freedom Total Knee® System
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMaxx Orthopedics Inc
About this trial
In an effort to satisfy regulatory requirements for post-market surveillance of product safety and efficacy, a representative sample of patients will be recruited for prospective monitoring.
Eligibility criteria
Qualifiers
Patient is > 18 years of age
Patient has failed attempts at non-operative conservative therapy
Patient has participated in the informed consent process and signed an IRB approved informed consent
Patient is scheduled to undergo unilateral or bilateral primary TKA of the knee
Disqualifiers
Patients with previous TKA, UKA, HTO or knee fusion of the indicated knee
Patients that have undergone previous surgery of indicated knee for tumor, trauma or fracture
Evidence of active or suspected (systemic or local) infection at time of surgery
Other significant disabling problems from the musculoskeletal system than in the knee (i.e.: muscular dystrophy, polio, neuropathic joints)
Trial design
Treatments tested in this trial
- Total Knee Arthroplasty
Treatment groups
300 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov