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

Part of paid clinical trials in Leawood, Kansas.

Sponsor
Maxx Orthopedics Inc
Study ID
NCT06627699
Status
Not Yet Recruiting

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Conditions

  • Knee Osteoarthristis
  • Total Knee Anthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Total Knee Arthroplasty — DEVICE
    Post-Market Surveillance of the Freedom Total Knee System for Primary TKA

Study Details

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.

Key Dates

Start date
Nov 1, 2024
Status verified
Oct 2024
Primary completion
Nov 1, 2027
Completion
Mar 1, 2028

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Patients receiving the Maxx Freedom Total Knee System for primary TKA
    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)

Primary Outcome Measure

Device Survivorship [ Time Frame: 2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Ascentist HealthcareLeawoodKansas66211
Andrew C Palmoisano, MD (PRINCIPAL_INVESTIGATOR)
South Texas Bone & Joint InstituteSan AntonioTexas78249
Siraj A Sayeed, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Ascentist Healthcare· Leawood, KSSouth Texas Bone & Joint Institute· San Antonio, TX

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