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

This study has been terminated.
(The study sponsor canceled the study.)
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:
NCT00579059
First received: December 17, 2007
Last updated: February 29, 2012
Last verified: February 2012

December 17, 2007
February 29, 2012
May 2004
November 2007   (final data collection date for primary outcome measure)
Knee Society Function Score [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
The function score is detailed below as a Range; 100 being the highest score, and 0 being the lowest score. 90-100 is considered "Excellent," 60-89 is considered "Good," 30-59 is considered "fair," and 0-29 is considered "poor."
Knee Society Score, Radiographic information [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00579059 on ClinicalTrials.gov Archive Site
Range of Motion - Flexion [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
This represents how far the patients were able to flex the knee in the clinic at 1-year.
Not Provided
Not Provided
Not Provided
 
Maxim® Knee Pop-Top® Tibia vs. Regular Maxim® Knee Tibia
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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Traumatic Arthritis
  • Device: Maxim® Knee System with Removable Molded Polyethylene Tibia
    Used for total knee replacements
    Other Name: Maxim® Pop-Top® Tibia
  • Device: Regular Maxim® Knee System
    Used for total knee replacements
    Other Name: Modular Tibia
  • 1
    Maxim® Pop-Top® Tibia
    Intervention: Device: Maxim® Knee System with Removable Molded Polyethylene Tibia
  • 2
    Maxim® Regular Tibia
    Intervention: Device: Regular Maxim® Knee System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
31
November 2007
November 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00579059
62-U-007
No
Biomet, Inc. ( Biomet Orthopedics, LLC )
Biomet Orthopedics, LLC
Not Provided
Principal Investigator: Russell Wagner, MD Harris Methodist Hospital
Biomet, Inc.
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP