Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
Conditions
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.
Interventions
DEVICEMaxim® Knee System with Removable Molded Polyethylene Tibia
Used for total knee replacements
DEVICERegular Maxim® Knee System
Used for total knee replacements
Sponsors
Biomet Orthopedics, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion - Flexion | 1 Year | This represents how far the patients were able to flex the knee in the clinic at 1-year. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited by the investigator.
Pre-assignment details
There were no pre-assignment details to report.
Participants by arm
| Arm | Count |
|---|---|
| Maxim® Pop-Top® Tibia tibia with removable polyethylene | 21 |
| Maxim® Regular Tibia Tibia with Modular Polyethylene | 10 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study Canceled at 1 Year | 21 | 10 |
Baseline characteristics
| Characteristic | Maxim® Pop-Top® Tibia | Maxim® Regular Tibia | Total |
|---|---|---|---|
| Age, Continuous | 68 years FULL_RANGE 8 | 62 years FULL_RANGE 6 | 65 years |
| Region of Enrollment United States | 21 participants | 10 participants | 31.0 participants |
| Sex: Female, Male Female | 17 Participants | 5 Participants | 22 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 10 |
| serious Total, serious adverse events | 0 / 21 | 0 / 10 |
Outcome results
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.
Time frame: 1 Year
Population: This population represents patients that returned for follow-up at 1-year post-op per protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maxim® Pop-Top® Tibia | Knee Society Function Score | 90-100 | 6 knees |
| Maxim® Pop-Top® Tibia | Knee Society Function Score | 60-89 | 2 knees |
| Maxim® Pop-Top® Tibia | Knee Society Function Score | 30-59 | 0 knees |
| Maxim® Pop-Top® Tibia | Knee Society Function Score | 0-29 | 0 knees |
| Maxim® Regular Tibia | Knee Society Function Score | 0-29 | 0 knees |
| Maxim® Regular Tibia | Knee Society Function Score | 90-100 | 2 knees |
| Maxim® Regular Tibia | Knee Society Function Score | 30-59 | 0 knees |
| Maxim® Regular Tibia | Knee Society Function Score | 60-89 | 1 knees |
Secondary
Range of Motion - Flexion
This represents how far the patients were able to flex the knee in the clinic at 1-year.
Time frame: 1 Year
Population: This population represents patients that returned for follow-up at 1-year post-op per protocol.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Maxim® Pop-Top® Tibia | Range of Motion - Flexion | 118 degrees |
| Maxim® Regular Tibia | Range of Motion - Flexion | 113 degrees |