A Single Time-Point Study to Evaluate the ConforMIS iTotal® (CR) Knee Versus Off-the-Shelf
NCT ID: NCT02251522
Last Updated: 2023-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
873 participants
OBSERVATIONAL
2014-10-31
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System
NCT01820650
A Multicenter Study to Evaluate Functional Outcome After Knee Replacement
NCT02494544
A Retrospective Study to Evaluate the ConforMIS iTotal® Posterior Stabilized (PS) Knee Replacement System
NCT03289000
A Single Time-Point Study to Evaluate the ConforMIS iTotal (PS) Knee Replacement System Versus Off-the-Shelf
NCT03146819
A Prospective Study to Evaluate the ConforMIS iTotal® (PS) Knee Replacement System
NCT03152162
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ConforMIS iTotal Knee Replacement System
Patients who have had an iTotal knee replacement at least 6 months prior to testing
ConforMIS Total Knee Replacement System
Total knee replacement system using a patient specific implant.
Off-the-Shelf Knee Replacement System
Patients who have had an off-the-shelf knee replacement at least 6 months prior to testing
Off-the-Shelf Knee Replacement System
Total knee replacement system not using a patient specific implant.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ConforMIS Total Knee Replacement System
Total knee replacement system using a patient specific implant.
Off-the-Shelf Knee Replacement System
Total knee replacement system not using a patient specific implant.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient has had a total CR knee implant
* \> 18 years of age
Exclusion Criteria
* BMI \> 40
* Other physical disability that requires an aid for walking or disability affecting the hips, spine, contralateral knee or other joint that limits function
* Participation in another clinical study which would confound results
* Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Restor3D
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert Tait, MD
Role: PRINCIPAL_INVESTIGATOR
Orthopaedic Institute of Henderson
Mary O'Connor, MD
Role: STUDY_CHAIR
Yale University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Denver-Vail Orthopedics
Parker, Colorado, United States
Institute for Orthopaedic Surgery & Sports Medicine
Fort Myers, Florida, United States
Baptist Health South Florida
Miami, Florida, United States
Coastal Orthopaedic & Sports Medicine Ctr
Port Saint Lucie, Florida, United States
Bethesda Orthopedic
Bethesda, Maryland, United States
Excel Orthopaedic Specialists
Woburn, Massachusetts, United States
Great Lakes Bone & Joint Center
Battle Creek, Michigan, United States
Lederman-Kwartowitz Center for Orthopedics and Sports Medicine
West Bloomfield, Michigan, United States
Orthopaedic Institute of Henderson
Henderson, Nevada, United States
St. Lawrence Health System
Potsdam, New York, United States
Orthopedic Specialties of Spartanburg
Spartanburg, South Carolina, United States
Advanced Orthopedics & Sports Medicine
Cypress, Texas, United States
Vitos Orthopädische Klinik Kassel
Kassel, , Germany
MedArtes
Neutraubling, , Germany
Elblandkliniken Stiftung
Radebeul, , Germany
Sportklinik Stuttgart
Stuttgart, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
14-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.