A Prospective, Multicenter Study to Evaluate the Conformis iTotal Identity Knee Replacement System

Study Purpose

This is a prospective multicenter study located in the United States. Subjects will be implanted with an iTotal Identity Knee Replacement System and followed for 10 years post implantation.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

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.

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 Identity CR KRS.
  • - 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 with complete development of musculoskeletal structures.

Exclusion Criteria:

  • - Simultaneous bilateral procedure required.
  • - BMI > 40.
  • - Active malignancy (defined as a history of any invasive malignancy - except nonmelanoma skin cancer), unless subject 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 Investigator discretion) - Neuromuscular conditions which prevent subject from participating in study activities.
  • - Active local or systemic infection which precludes TKR procedure.
  • - Immunocompromised in the opinion of the Investigator.
  • - Medically diagnosed fibromyalgia or similar conditions that might impact the subject's ability to differentiate source of pain.
  • - 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 that is likely to confound results in the opinion of the Investigator.
  • - Other physical disability affecting the hips, spine, or contralateral knee that is likely to confound results in the opinion of the Investigator.
  • - Severe instability due to advanced loss of osteochondral structure.
  • - Prior arthroplasty of the affected knee, including High Tibial Osteotomy (HTO) - Compromised PCL or collateral ligament.
  • - Severe fixed valgus or varus deformity of >15º - Extensor lag > 15º - Fixed flexion contracture ≥ 15º - Unwilling or unable to comply with study requirements.
  • - Participation in another clinical study which would confound results.
  • - Allergy to any of the implant materials.
- Pregnant or planning to become pregnant prior to study TKR procedure (in case of pregnancy after study TKR procedure, eligibility to continue with the protocol will be reviewed)

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.


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.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis, Knee

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.

Boynton Beach, Florida


Not yet recruiting


Personalized Orthopedic Research Institute

Boynton Beach, Florida, 33437

Site Contact

Brenda Sapir

[email protected]

561-733-5888 #110

Tennessee Orthopaedic Alliance, Nashville, Tennessee




Tennessee Orthopaedic Alliance

Nashville, Tennessee, 37203

Site Contact

Rena Rolfe

[email protected]