A Multicenter Study to Evaluate Functional Outcome After Knee Replacement

Study Purpose

Patients will be consecutively enrolled by implant. Implant groups will be those who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system. The patient will conduct functional testing and answer questionnaires. The results will compare the ConforMIS iTotal with an Off the Shelf Knee replacement.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion:

- Clinical condition included in the approved Indications For Use for the iTotal CR - Osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a TKR procedure.

Disease status is assessed by Clinical and Radiographic assessment - Willingness to participate in the clinical study, to give informed consent and to attend all follow-up visits - > 18 years of age Exclusion: - Subject will require a simultaneous bilateral procedure - Other lower extremity surgery within 1 year - Severe (> 15º) fixed valgus or varus deformity - Severe (> 15º) extension deficit - Severe instability due to advanced loss of osteochondral structure - Loss of bone or musculature, osteoporosis, neuromuscular or vascular compromise in the area of the joint to be operated on to an extent that the procedure is unjustified - Insufficient bone stock on the femoral or tibial surfaces - Contralateral knee replacement surgery within the past 6 months - BMI > 40 - Active malignancy (defined as a history of any invasive malignancy - except non-melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years - Poorly controlled diabetes (defined as HbA1c >7 or surgeon discretion) - Immunocompromised - Other physical disability affecting the hips, spine, or contralateral knee that limits function - Disabling chronic pain with narcotic dependence - Compromised PCL or collateral ligament - Prior history of failed implant surgery of the joint to be treated, including Unicompartmental Knee Arthroplasty (UKA), or Bicompartmental Knee Arthroplasty (BKA) - Prior history of failed high tibial osteotomy (HTO) - 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02494544
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	ConforMIS, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Mary O'Connor, MD
Principal Investigator Affiliation	Yale School of Medicine
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis

Additional Details

To compare functional and patient reported outcome data for a consecutively enrolled group of subjects who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system.The person conducting the functional testing will be blinded to the device implanted. Sites will perform the off-the-shelf total knees conventional instrumentation.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California in San Diego, La Jolla, California

Status

Recruiting

Address

University of California in San Diego

La Jolla, California, 92037

Site Contact

Jesal Parekh, PhD

[email protected]

858-210-8727

Sharp Healthcare, San Diego, California

Status