Recruiting PHASE4 Knee Osteoarthritis

New treatment option for Knee Osteoarthritis

Official title Using ROSA for Challenging The TKA Standard of Care

ClinicalTrials.gov ID: NCT06267482

What this study is testing

What it's testing
This is a prospective, randomized controlled trial using the cruciate retaining, MC Persona to comparing the conventional TKA to ROSA assisted TKA. Patients will be randomized to one of three study trial arms.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 21 to 80

You may be able to join if

  • Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
  • Varus knee deformity of 0 to 10 degrees
  • Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
  • Between the ages of 21 and 80 inclusive
  • Patients willing and able to comply with follow-up requirements and self-evaluations

You likely can't join if

  • Active or prior infection
  • Medical condition precluding major surgery
  • Predominantly inflammatory arthropathy
  • Patellectomy
  • PCL deficiency
  • Major coronal plane deformity
See the full eligibility criteria
Who can join
  • Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
  • Varus knee deformity of 0 to 10 degrees
  • Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
  • Between the ages of 21 and 80 inclusive
  • Patients willing and able to comply with follow-up requirements and self-evaluations
  • Ability to give informed consent
What rules you out
  • Active or prior infection
  • Medical condition precluding major surgery
  • Predominantly inflammatory arthropathy
  • Patellectomy
  • PCL deficiency
  • Major coronal plane deformity
  • Prior trauma to the tibia or femur resulting in malalignment, canal occlusion, or open reduction and internal fixation
  • Valgus alignment
  • Neurologic condition limiting mobility
  • Bone defects requiring augments, cones and/or stemmed implants

The study team makes the final eligibility decision.

Where it's taking place

  • London, Ontario, Canada

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, 21 years to 80 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include London, Ontario, Canada. 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.