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

Maxx Orthopedics

Status: Not yet enrolling

Conditions: Total Knee Anthroplasty; Knee Osteoarthristis

Treatments: Device: Total Knee Arthroplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT06627699

PK-00002

Details and patient eligibility

About

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.

Full description

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.

To maintain equal site distribution per device, patient recruitment will include up to a total of twenty (20) registry sites and thirty (30) primary TKA candidates per site / surgeon for a total of 600 registry patients. A total of no more than 200 patients across all sites will be recruited per level of constraint (e.g.: 200 CR, 200:PS, 200:UC) for this registry with a 10-month accrual target from study initiation per site (~3 patients consented / month).

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 1 patient group

Patients receiving the Maxx Freedom Total Knee System for primary TKA

Description:

TARGETED PATIENTS Adult male and female patients greater than 18 years of age Candidate for primary TKA GENERAL EXCLUSIONS Active infection Revision / conversion TKA (Prior UKA or HTO)

Treatment:

Device: Total Knee Arthroplasty