This trial is active, not recruiting.

Condition osteoarthritis of the knee
Treatment itotal g2 cr knee replacement system
Sponsor ConforMIS, Inc.
Start date February 2013
End date March 2017
Trial size 359 participants
Trial identifier NCT01820650, 12-001


This study is designed to observe the long term clinical outcomes of patient-specific knee arthroplasty in patients with osteoarthritis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

2011 Knee Society Score
time frame: 1 Year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 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 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) - Compromised PCL or collateral ligament - Severe fixed valgus or varus deformity of >15º - Extensor lag > 15 º - Fixed flexion contracture ≥ 15 º - Unwilling or unable to comply with study requirements - Participation in another clinical study which would confound results - Allergy to any of the implant materials

Additional Information

Official title A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System
Principal investigator Terry Clyburn, MD
Description If the patient has previously received a standard total knee replacement in their contralateral knee, the primary endpoint questionnaire and some secondary endpoint questionnaires will be completed regarding BOTH their iTotal® CR knee and their standard total knee for all time points where questionnaires are required by the protocol.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by ConforMIS, Inc..