Back to resultsMaxim® Knee Pop-Top® Tibia vs. Regular Maxim® Knee Tibia
Primary Purpose
Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Maxim® Knee System with Removable Molded Polyethylene Tibia
Regular Maxim® Knee System
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
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.
Sites / Locations
- Biomet Orthopedics, LLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1
2
Arm Description
Maxim® Pop-Top® Tibia
Maxim® Regular Tibia
Outcomes
Primary Outcome Measures
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."
Secondary Outcome Measures
Range of Motion - Flexion
This represents how far the patients were able to flex the knee in the clinic at 1-year.
Full Information
NCT ID
NCT00579059
First Posted
December 17, 2007
Last Updated
June 19, 2017
Sponsor
Biomet Orthopedics, LLC
1. Study Identification
Unique Protocol Identification Number
NCT00579059
Brief Title
Maxim® Knee Pop-Top® Tibia vs. Regular Maxim® Knee Tibia
Official Title
A Randomized Data Collection of the Maxim® Knee System With Removable Molded Polyethylene Tibia and the Regular Maxim® Knee System
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
The study sponsor canceled the study.
Study Start Date
May 2004 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biomet Orthopedics, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Maxim® Pop-Top® Tibia
Arm Title
2
Arm Type
Other
Arm Description
Maxim® Regular Tibia
Intervention Type
Device
Intervention Name(s)
Maxim® Knee System with Removable Molded Polyethylene Tibia
Other Intervention Name(s)
Maxim® Pop-Top® Tibia
Intervention Description
Used for total knee replacements
Intervention Type
Device
Intervention Name(s)
Regular Maxim® Knee System
Other Intervention Name(s)
Modular Tibia
Intervention Description
Used for total knee replacements
Primary Outcome Measure Information:
Title
Knee Society Function Score
Description
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."
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Range of Motion - Flexion
Description
This represents how far the patients were able to flex the knee in the clinic at 1-year.
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell Wagner, MD
Organizational Affiliation
Harris Methodist Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Biomet Orthopedics, LLC
City
Warsaw
State/Province
Indiana
ZIP/Postal Code
46581
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Maxim® Knee Pop-Top® Tibia vs. Regular Maxim® Knee Tibia
We'll reach out to this number within 24 hrs