Maxim® Knee Pop-Top® Tibia vs. Regular Maxim® Knee Tibia
Stopped early · Not applicable
Conditions studied: Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis
In brief
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.
Key facts
- Study ID
- NCT00579059
- Run by
- Biomet Orthopedics, LLC
- People needed
- 31
- Starts
- 2004-05-01
- Expected to finish
- 2007-11-01
- Last updated by the study team
- 2017-07-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Biomet Orthopedics, LLC — Warsaw, Indiana, United States
Full record on ClinicalTrials.gov
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