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Medacta GMK Sphere® Knee Prosthesis for Osteoarthritis
Study Summary
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have inflammatory arthritis.I have a weakened immune system or have been on steroids for more than 30 days.I have or might have an infection in my knee.I need a total knee replacement surgery.I have been diagnosed with osteoarthritis, traumatic arthritis, or avascular necrosis.I have a condition that is causing my bones to deteriorate over time.My ligaments are not damaged.I am between 21 and 80 years old and not pregnant.I can follow post-surgery instructions and check my own progress.I have been diagnosed with osteoarthritis, traumatic arthritis, or avascular necrosis.My collateral ligaments are not damaged.I need a total knee replacement surgery.I have had surgery to realign my knee.My BMI is over 40, classifying me as morbidly obese.I have had surgery to replace or repair a joint.My affected joint is fused.My bones are too weak or damaged to support an implant due to disease or infection.
- 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), 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."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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