← Back to Search

Joint Replacement

Medacta GMK Sphere® Knee Prosthesis for Osteoarthritis

N/A

Waitlist Available

Research Sponsored by Medacta USA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with intact collateral ligaments

Patients requiring a primary total knee replacement

Must not have

Patients with inflammatory arthritis

Patients that are immunologically compromised, or receiving chronic steroids (> 30 days)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2 and 5 year time points

Awards & highlights

No Placebo-Only Group

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.

Who is the study for?

This trial is for individuals aged 21-80 with osteoarthritis or similar knee conditions needing a total knee replacement, who can follow post-op care and self-evaluations. It excludes those with severe obesity (BMI > 40), infections around the knee, prisoners, inflammatory arthritis sufferers, previous major knee surgeries, neuromuscular issues affecting assessment, compromised bone stock or immune system.

What is being tested?

The study tests the Medacta GMK Sphere® Knee Prosthesis in patients requiring a primary total knee replacement. The goal is to measure patient satisfaction using the Forgotten Knee Score at two and five years after surgery among participants previously enrolled in a related study.

What are the potential side effects?

While specific side effects are not listed for this device trial, common risks of knee prosthesis may include pain at the site of surgery, infection risk increase around the implant area, swelling or stiffness of the joint involved.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My collateral ligaments are not damaged.

Select...

I need a total knee replacement surgery.

Select...

I have been diagnosed with osteoarthritis, traumatic arthritis, or avascular necrosis.

Select...

I am between 21 and 80 years old and not pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have inflammatory arthritis.

Select...

I have a weakened immune system or have been on steroids for more than 30 days.

Select...

I have or might have an infection in my knee.

Select...

I have a condition that is causing my bones to deteriorate over time.

Select...

I have had surgery to realign my knee.

Select...

My BMI is over 40, classifying me as morbidly obese.

Select...

I have had surgery to replace or repair a joint.

Select...

My affected joint is fused.

Select...

My bones are too weak or damaged to support an implant due to disease or infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2 and 5 year time points

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2 and 5 year time points

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 and 5 year time points for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evaluate the change in Forgotten Knee Scores (FJS) of those patients receiving the Medacta GMK Sphere from baseline to years 2 and 5 post-operatively.

Secondary study objectives

AP long standing X-ray

Krackow Activity Scale (KAS)

Total Knee Society Score (KSS)