Maxim® Knee Pop-Top® Tibia vs. Regular Maxim® Knee Tibia

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.

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 Function Score
  • Time Frame: 1 Year
    Safety Issue?: No

Secondary Measures

• Range of Motion - Flexion
  • Time Frame: 1 Year
    Safety Issue?: No

Inclusion Criteria:

• Identical to the indications stated in the FDA approved labeling for the device (cleared in 510(k) K991753,

K984623, K993159, K010027). These indications are stated below:

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

Patient selection factors to be considered include:

• need to obtain pain relief and improve function,
• ability and willingness of the patient to follow instructions, including control of weight and activity level,
• a good nutritional state of the patient,
• the patient must have reached full skeletal maturity.
• Porous coated knee joint replacement prostheses have not been approved for non-cemented applications in the United States.

Exclusion Criteria:

• Identical to the contraindications stated in the FDA approved labeling for the device (cleared in 510(k) K991753, K984623, K993159, K010027's). These contraindications are stated below:

Absolute contraindications include:

• infection,
• sepsis
• osteomyelitis.

Relative contraindications include:

• uncooperative patient or patient with neurologic disorders who are incapable of following directions,
• Osteoporosis,
• metabolic disorders which may impair bone formation,
• osteomalacia,
• distant foci of infections which may spread to the implant site,
• rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram,
• vascular insufficiency, muscular atrophy, neuromuscular disease,
• incomplete or deficient soft tissue surrounding the knee.

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 Investigator: Biomet Orthopedics, LLC Industry

Overall Clinical Trial Officials and Contacts

Russell Wagner, MD Principal Investigator Harris Methodist Hospital  

Information obtained from ClinicalTrials.gov on February 12, 2012

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