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Knee Prosthesis for Osteoarthritis
This trial is to compare the results of the Medacta GMK Sphere® knee to the Posterior Stabilized knee at the two and five year time points.
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
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Who is running the clinical trial?
- You need to have a surgery to completely replace your knee joint.Your ligaments in the affected area are not torn or damaged.You have arthritis with inflammation.You have previously had surgery on your thigh bone or shin bone.You have a condition that affects your muscles or nerves, which would make it difficult to evaluate how well the device works.Your bones are weakened by disease or infection and cannot support or hold the prosthesis securely.You have a weakened immune system or have been taking steroids for a long time.You have a fused knee joint.You have had previous surgeries to completely replace or partially repair the joint that is being studied.You have a medical condition that causes your bones to weaken and deteriorate over time.You have been diagnosed with certain types of joint conditions like osteoarthritis, traumatic arthritis, or avascular necrosis.
- Group 1: Medacta GMK Sphere® Knee Prosthesis
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is the cutoff age for participation in this trial above 35 years?
"Conforming to the prerequisite of this medical trial, eligible patients must be between 21 and 80 years old. For those younger/older than that range there are 30 trials for minors and 583 studies with older individuals."
Is this clinical investigation currently open to participation?
"Contrary to expectations, the clinical trial listed on clinicialtrials.gov is not currently recruiting patients; it first became available for enrolment in June 2015 and was last updated in May 2022. Despite this setback, there are 613 other medical trials welcoming participants at this time."
For whom is this trial an appropriate option?
"This medical trial seeks 260 volunteers in the age bracket of 21 to 80 years old who are currently suffering from arthrosis. These candidates should possess a diagnosis of traumatic arthritis (TA), osteoarthritisc arthritis (TA), osteoarthritis (OA) or avascular necrosis (AVN). Furthermore, they must also have intact collateral ligaments and be willing to comply with postoperative weight bearing restrictions as well as self evaluations. Male and non-pregnant female participants are welcome."
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