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

NCT ID: NCT00579059

Last Updated: 2017-07-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2007-11-30

Brief Summary

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.

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.

Conditions

Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Maxim® Pop-Top® Tibia

Group Type: OTHER

Maxim® Knee System with Removable Molded Polyethylene Tibia

Intervention Type: DEVICE

Used for total knee replacements

2

Maxim® Regular Tibia

Group Type: OTHER

Regular Maxim® Knee System

Intervention Type: DEVICE

Used for total knee replacements

Interventions

Maxim® Knee System with Removable Molded Polyethylene Tibia

Used for total knee replacements

Intervention Type: DEVICE

Regular Maxim® Knee System

Used for total knee replacements

Intervention Type: DEVICE

Other Intervention Names

Maxim® Pop-Top® Tibia; Modular Tibia

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biomet Orthopedics, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Russell Wagner, MD

Role: PRINCIPAL_INVESTIGATOR

Harris Methodist Hospital

Locations

Biomet Orthopedics, LLC

Warsaw, Indiana, United States

Countries

United States

Other Identifiers

62-U-007

Identifier Type: -

Identifier Source: org_study_id