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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 and 5 year time points
Awards & highlights

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.

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.Check my eligibility
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.See study design
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
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My collateral ligaments are not damaged.
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I need a total knee replacement surgery.
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I have been diagnosed with osteoarthritis, traumatic arthritis, or avascular necrosis.
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I am between 21 and 80 years old and not pregnant.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
AP long standing X-ray
Krackow Activity Scale (KAS)
Radiographic Analysis
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Medacta GMK Sphere® Knee ProsthesisExperimental Treatment1 Intervention
All subjects enrolled will receive the Medacta GMK Sphere® Medial Knee Prosthesis

Find a Location

Who is running the clinical trial?

Medacta USALead Sponsor
16 Previous Clinical Trials
1,820 Total Patients Enrolled
9 Trials studying Osteoarthritis
689 Patients Enrolled for Osteoarthritis
Mukesh Ahuja, MBBS, MSStudy DirectorMedacta USA, Inc.
4 Previous Clinical Trials
56 Total Patients Enrolled
4 Trials studying Osteoarthritis
56 Patients Enrolled for Osteoarthritis

Media Library

Medacta GMK Sphere® Medial Knee Prosthesis (Joint Replacement) Clinical Trial Eligibility Overview. Trial Name: NCT02501733 — N/A
Osteoarthritis Research Study Groups: Medacta GMK Sphere® Knee Prosthesis
Osteoarthritis Clinical Trial 2023: Medacta GMK Sphere® Medial Knee Prosthesis Highlights & Side Effects. Trial Name: NCT02501733 — N/A
Medacta GMK Sphere® Medial Knee Prosthesis (Joint Replacement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02501733 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What site did they apply to?
Norhtwestern University
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I've tried many meds and the only thing that seems to help is cortisone. I don't want cortisone.
PatientReceived 1 prior treatment
~7 spots leftby Jul 2024