Maxim® Knee Pop-Top® Tibia vs. Regular Maxim® Knee Tibia
A Randomized Data Collection of the Maxim® Knee System With Removable Molded Polyethylene Tibia and the Regular Maxim® Knee System
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
-
Warsaw, Indiana, United States, 46581
- Biomet Orthopedics, LLC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 1
Maxim® Pop-Top® Tibia
|
Used for total knee replacements
Other Names:
|
|
Other: 2
Maxim® Regular Tibia
|
Used for total knee replacements
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee Society Function Score
Time Frame: 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."
|
1 Year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of Motion - Flexion
Time Frame: 1 Year
|
This represents how far the patients were able to flex the knee in the clinic at 1-year.
|
1 Year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Russell Wagner, MD, Harris Methodist Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 62-U-007
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