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Joint Replacement

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 requiring a primary total knee replacement

Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN)

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upbaseline, 2 and 5 year time points

Awards & highlights

No Placebo-Only Group

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

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You need to have a surgery to completely replace your knee joint.

Select...

You have been diagnosed with certain types of joint conditions like osteoarthritis, traumatic arthritis, or avascular necrosis.

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Your ligaments in the affected area are not torn or damaged.

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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medacta USALead Sponsor

16 Previous Clinical Trials

1,805 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 c 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

Recent research and studies

clinicaltrials.govStudy

Medacta GMK Sphere® Multicenter Post-Market Outcomes Study

2015. "Medacta GMK Sphere® Multicenter Post-Market Outcomes Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02501733.

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