Official Title: “A Randomized Data Collection of the Maxim® Knee System With Removable Molded Polyethylene Tibia and the Regular Maxim® Knee System”

The purpose of this prospective clinical data collection is to compare the outcomes of two different tibial bearings: the Maxim Pop Top Tibia and Maxim Modular Tibia.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment

Study Primary Completion Date: November 2007

The purpose of this prospective clinical data collection is to document and compare the performance and clinical outcomes between the Maxim Knee System with Removable Molded Poly Tibia and the Maxim Knee System with Modular Tibial Bearing as two treatment groups.

FDA has cleared these devices via Premarket Notification 510(k)'s K991753, K984623, K993159, K010027. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts and answer potential questions from reimbursement agencies.

Intervention(s) in this Clinical Trial

• Device: Maxim® Knee System with Removable Molded Polyethylene Tibia
  • Used for total knee replacements
• Device: Regular Maxim® Knee System
  • Used for total knee replacements

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1
  • Maxim Pop Top Tibia
• Other: 2
  • Maxim Regular Tibia

Primary Measures

• Knee Society Score, Radiographic information
  • Time Frame: 10 years
    Safety Issue?: No

Inclusion Criteria:

• Patients with painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
• Patients requiring correction of varus, valgus, or posttraumatic deformity.
• Patients requiring correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

Exclusion Criteria:

• Patients with infection, sepsis, or osteomyelitis.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Biomet Orthopedics, LLC

Overall Clinical Trial Officials and Contacts

Russell Wagner, MD Principal Investigator Harris Methodist Hospital  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00579059

Study ID Number: 62-U-007

ClinicalTrials.gov Identifier: NCT00579059

Health Authority: United States: Institutional Review Board