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

Not Applicable

Terminated

Conditions: Traumatic Arthritis
Rheumatoid Arthritis
Osteoarthritis

Interventions: Device: Regular Maxim® Knee System
Device: Maxim® Knee System with Removable Molded Polyethylene Tibia

Registration Number: NCT00579059

Lead Sponsor: Biomet Orthopedics, LLC

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 31

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Regular Maxim® Knee System	Maxim® Regular Tibia
1	Maxim® Knee System with Removable Molded Polyethylene Tibia	Maxim® Pop-Top® Tibia

Primary Outcome Measures

Name	Time	Method
Knee Society Function Score	1 Year	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