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

Rheumatoid Arthritis Clinical Trial

Official title:

A Randomized Data Collection of the Maxim® Knee System With Removable Molded Polyethylene Tibia and the Regular Maxim® Knee System

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00579059
• Other study ID #: 62-U-007
• Status: Terminated
• Phase: N/A
• First received: December 17, 2007
• Last updated: February 29, 2012
• Start date: May 2004
• Est. completion date: November 2007

Study information

• Verified date: February 2012
• Source: Biomet, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Osteoarthritis
• Rheumatoid Arthritis
• Traumatic Arthritis

Intervention

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

Locations

Country	Name	City	State
United States	Biomet Orthopedics, LLC	Warsaw	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Biomet Orthopedics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Society Function Score	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."	1 Year	No
Secondary	Range of Motion - Flexion	This represents how far the patients were able to flex the knee in the clinic at 1-year.	1 Year	No