Prospective, In-Vivo, Post-Market Safety and Efficacy Surveillance Registry of the MAXX Orthopedics, Freedom Total Knee® System

Launched by MAXX ORTHOPEDICS INC · Oct 3, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a specific knee replacement system called the Freedom Total Knee® System, which is used for people with knee osteoarthritis who need surgery. The study will monitor patients who are scheduled to have a knee replacement, either on one knee or both, to ensure that the device works well and is safe for use after it has been approved for patients.

To be part of this trial, participants must be at least 18 years old and have already tried other treatment options for their knee pain without success. They cannot have had previous knee surgeries or certain medical conditions that could complicate the results. This trial is not yet recruiting participants, and it will involve regular check-ins to track how well the knee replacement is doing after surgery. Overall, this study aims to gather important information that helps both patients and doctors understand how effective this knee replacement system is over time.

Gender

ALL

Eligibility criteria

• INCLUSION CRITERIA:
• Candidates for this registry must meet ALL of the following criteria:
• • 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
• EXCLUSION CRITERIA:
• Candidates will be excluded from the evaluation if ANY of the following apply:
• • 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)
• • Patients with or having; malignancy - active malignancy, Paget's disease, renal osteodystrophy, immunologically suppressed, sickle cell anemia and systemic lupus erythematosus
• • Patients with neuromuscular or neurosensory deficit
• • Women who are pregnant
• • Prisoner or transient
• • Recent history of known narcotic abuse
• • Any significant psychological disturbance past or present, that could impair the consent process or ability to complete subject self-report questionnaires