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Prosthesis
Smith & Nephew total knee replacement for Osteoarthritis
N/A
Waitlist Available
Led By Mary O'Connor, MD
Research Sponsored by Restor3D
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will enroll patients who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system in order to compare the two types of knee replacements. Functional testing and questionnaires will be used to assess the results.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Functional Testing
Secondary outcome measures
Incidents of major procedure-related and device related complications (including revision rates)
Patient reported outcome using questionnaires such as the KOOS and VAS
Post-operative limb alignment based using x-ray views
Trial Design
6Treatment groups
Active Control
Group I: Smith & Nephew total knee replacementActive Control1 Intervention
Off the shelf knee replacement system
Group II: Stryker total knee replacementActive Control1 Intervention
Off the shelf knee replacement system
Group III: ConforMIS iTotal Knee replacementActive Control1 Intervention
iTotal patient-specific knee replacement system
Group IV: DePuy total knee replacementActive Control1 Intervention
Off the shelf knee replacement system
Group V: Zimmer total knee replacementActive Control1 Intervention
Off the shelf knee replacement system
Group VI: Biomet total knee replacementActive Control1 Intervention
Off the shelf knee replacement system
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Who is running the clinical trial?
Restor3DLead Sponsor
25 Previous Clinical Trials
12,373 Total Patients Enrolled
17 Trials studying Osteoarthritis
4,181 Patients Enrolled for Osteoarthritis
ConforMIS, Inc.Lead Sponsor
22 Previous Clinical Trials
12,170 Total Patients Enrolled
17 Trials studying Osteoarthritis
4,181 Patients Enrolled for Osteoarthritis
Mary O'Connor, MDPrincipal InvestigatorYale School of Medicine
3 Previous Clinical Trials
1,179 Total Patients Enrolled
1 Trials studying Osteoarthritis
873 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- There is not enough bone on your thigh or shin bones for the treatment to work properly.You had surgery to replace your other knee within the last 6 months.Your immune system is not strong enough to participate in the study.You have long-term pain that requires strong pain medication and you are dependent on narcotics.You are already taking part in another study that could affect the outcome of this one.CR-H bearing abutments are:
The iTotal CR CR-H bearing abutments are intended for use in clinical conditions that are included in the approved indications for use.You have a physical disability affecting your hips, spine or opposite knee that limits your ability to function.You had surgery on your legs within the last year.You have a problem with the ligaments that connect your bones, specifically the PCL or collateral ligament.You had surgery in the past on the joint that needs treatment, such as a partial or total knee replacement, that was not successful.You have bone or muscle loss, osteoporosis, or nerve and blood vessel problems around the joint that needs surgery, making the procedure too risky.You had a surgery called high tibial osteotomy (HTO) in the past that was not successful.You are unable to fully extend a body part by more than 15 degrees.and fragmentation of articular cartilage
The bones in the knee joint are severely unstable due to a loss of osteochondral structure and fragmentation of articular cartilage.You have a severe and fixed inward or outward bending of your joints greater than 15 degrees.
Research Study Groups:
This trial has the following groups:- Group 1: Smith & Nephew total knee replacement
- Group 2: Stryker total knee replacement
- Group 3: ConforMIS iTotal Knee replacement
- Group 4: DePuy total knee replacement
- Group 5: Zimmer total knee replacement
- Group 6: Biomet total knee replacement
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT02494544 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many trial sites are being overseen for this research project?
"This study is enrolling patients at 8 different locations, which are The Lindner Center for Research and Education in Cincinnati, University of California in San Diego in La Jolla, OrthoNY in Albany, and 8 other sites."
Answered by AI
Are there any spots left for new patients in this trial?
"No, this particular clinical trial is not currently looking for patients according to the latest information available on clinicaltrials.gov. This trial was first posted on July 1st, 2015 and was last edited on November 17th, 2020. There are, however, 639 other trials that are recruiting patients."
Answered by AI
Who else is applying?
What state do they live in?
Connecticut
California
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Why did patients apply to this trial?
I HAVE HAD A KNEE REPLACEMENT ON MY LEFT KNEE IT IS A SUCCES NOW MY RIGHT KNEE IS GIVING OUT I FALL AT LEAST 2 TIMES A DAY SOME DAYS THE THE PAIN IS SO BAD I CANT GET OUT OF BED I NEED HELP PLEASE MY QUALITY OF LIFE IS NOW AT 5% OUT OF 100 I HOPE AND PRAY THAT YOU CAN HELP ME.
PatientReceived no prior treatments
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