A Prospective Study to Evaluate the ConforMIS iTotal® (PS) Knee Replacement System

Study Purpose

This is a prospective clinical study designed to observe the long-term clinical outcomes of total knee arthroplasty using a patient-specific, posterior stabilized implant in patients with osteoarthritis.

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.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Clinical condition included in the approved Indications For Use for the iTotal® PS.

- 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 Criteria:

- Simultaneous bilateral procedure required.

- 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.

- Neuromuscular conditions which prevent patient from participating in study activities.

- Active local or systemic infection.

- Immunocompromised.

- Fibromyalgia or other general body pain related condition.

- Rheumatoid arthritis or other forms of inflammatory joint disease.

- Loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated on, to an extent that the procedure is unjustified.

- Diagnosed with or receiving treatment for Osteoporosis.

- Other physical disability affecting the hips, spine, or contralateral knee.

- Severe instability due to advanced loss of osteochondral structure.

- Prior arthroplasty of the affected knee, including High Tibial Osteotomy (HTO) - Unwilling or unable to comply with study requirements.

- Participation in another clinical study which would confound results.

- Allergy to any of the implant materials

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.	NCT03152162
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.
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.	Marc Quartulli
Principal Investigator Affiliation	ConforMIS, Inc.
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, Knee

Additional Details

The study is prospective. Subjects will be implanted with an iTotal® PS Knee Replacement System. The study will include a minimum of 100 subjects across up to 10 sites. The patients enrolled in this study may represent the first cases of the iTotal PS KRS implanted at a particular site; data collected for the first 15 patients at each site will be analyzed separately from the rest of the enrolled population. This will provide visibility towards determining if there exists a learning curve in the implantation process of the iTotal PS KRS. The study sites will be located in the United States.

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.

UNC Orthopedics, Chapel Hill, North Carolina

Status

Recruiting

Address

UNC Orthopedics

Chapel Hill, North Carolina, 27599

Site Contact

Julie Titter

[email protected]

919-966-5495

Texas Institute for Hip & Knee Surgery, Austin, Texas

Status