BridgeMD
Compares treatment options for Osteoarthritis, Knee
Official title Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot Versus Single Radius Design for Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT04814082
What this study is testing
- What it's testing
- Patients with degenerative joint disease can effectively be treated with a primary total knee replacement to reduce pain and improve function in their daily lives. Theoretically, achievement of normal knee motion using a medial pivot design in total knee replacements can be recreated in comparison to single radius designs, which could lead to an improvement in post-surgical outcomes and satisfaction with the procedure.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Subject is male or non-pregnant female aged between 18 and 75 years of age.
- Subject is willing to provide informed consent to participate in the research study.
- Subject is indicated for a primary total knee arthroplasty (TKA) based on the approved labeling of knee implant, either a medial pivot or single...
- Subject does not have a history of previous prosthetic replacement device on the operative knee.
- Subject is currently ambulating and does not have a condition on the contralateral limb in the opinion of the investigator that would interfere with...
You likely can't join if
- Subject has a Body Mass Index (BMI) \>40
- Subject has a diagnosis of avascular necrosis or inflammatory arthritis.
- Subject has any mental or neuromuscular disorder that would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or...
- Subject is a prisoner
- Subject has any condition, in the opinion of the Investigator that might interfere with the evaluation of the study objectives.
See the full eligibility criteria
- Subject is male or non-pregnant female aged between 18 and 75 years of age.
- Subject is willing to provide informed consent to participate in the research study.
- Subject is indicated for a primary total knee arthroplasty (TKA) based on the approved labeling of knee implant, either a medial pivot or single radius design, specifically: MicroPort Evolution Medial-Pivot Knee System...
- Subject does not have a history of previous prosthetic replacement device on the operative knee.
- Subject is currently ambulating and does not have a condition on the contralateral limb in the opinion of the investigator that would interfere with the gait laboratory evaluations.
- Subject is willing and able to comply with the schedule of events for the study and is available to return to the clinic for all required follow-up visits.
- Subject has a Body Mass Index (BMI) \>40
- Subject has a diagnosis of avascular necrosis or inflammatory arthritis.
- Subject has any mental or neuromuscular disorder that would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
- Subject is a prisoner
- Subject has any condition, in the opinion of the Investigator that might interfere with the evaluation of the study objectives.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.