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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
History of Changes
  Purpose

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.


Condition Intervention
Osteoarthritis
Rheumatoid Arthritis
Traumatic Arthritis
 Device: Maxim® Knee System with Removable Molded Polyethylene Tibia
Device: Regular Maxim® Knee System

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Data Collection of the Maxim® Knee System With Removable Molded Polyethylene Tibia and the Regular Maxim® Knee System

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • 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."


Secondary Outcome Measures:
  • 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.


Enrollment: 31
Study Start Date: May 2004
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Maxim® Pop-Top® Tibia
 Device: Maxim® Knee System with Removable Molded Polyethylene Tibia
Used for total knee replacements
Other Name: Maxim® Pop-Top® Tibia
2
Maxim® Regular Tibia
 Device: Regular Maxim® Knee System
Used for total knee replacements
Other Name: Modular Tibia

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00579059

Locations
United States, Indiana
Biomet Orthopedics, LLC
Warsaw, Indiana, United States, 46581
Sponsors and Collaborators
Biomet Orthopedics, LLC
Investigators
Principal Investigator: Russell Wagner, MD Harris Methodist Hospital
  More Information

No publications provided

Responsible Party: Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier: NCT00579059     History of Changes
Other Study ID Numbers: 62-U-007
Study First Received: December 17, 2007
Results First Received: May 20, 2009
Last Updated: February 29, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013