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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis

Intervention / Treatment
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* Device: Maxim® Knee System with Removable Molded Polyethylene Tibia
* Device: Regular Maxim® Knee System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Maxim® Pop-Top® Tibia | Device: Maxim® Knee System with Removable Molded Polyethylene Tibia<br>* Used for total knee replacements<br>* Other names: Maxim® Pop-Top® Tibia;|
| Other: 2<br>Maxim® Regular Tibia | Device: Regular Maxim® Knee System<br>* Used for total knee replacements<br>* Other names: Modular Tibia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion - Flexion | This represents how far the patients were able to flex the knee in the clinic at 1-year. | 1 Year |