Clinical trial NCT01820650: A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System
Official title: A Prospective, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis
knee replacement
patient-specific
Lead sponsor: Restor3D
Sponsor class: INDUSTRY
First posted: 2013-03-29
Enrollment: 359
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with osteoarthritis of the knee

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 2011 Knee Society Score
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Atlantis
country: United States
facility: JFK Medical Center
state: Florida
city: Bangor
country: United States
facility: EMMC - Orthopaedic Surgery of Maine
state: Maine
city: Battle Creek
country: United States
facility: Great Lakes Bone and Joint
state: Michigan
city: Henderson
country: United States
facility: Orthopaedic Instatute of Henderson
state: Nevada
city: Las Vegas
country: United States
facility: Desert Orthopedic Center
state: Nevada
city: Nashville
country: United States
facility: Tennessee Orthopaedic Alliance
state: Tennessee
city: Cypress
country: United States
facility: Advanced Orthopedics and Sports Medicine
state: Texas
city: Houston
country: United States
facility: Joint Replacement Associates
state: Texas
city: Morrisville
country: United States
facility: Mansfield Orthopaedics
state: Vermont
Study officials:
affiliation: Restor3D
name: Marc Quartulli
role: STUDY_DIRECTOR
affiliation: The University of Texas Health Science Center, Houston
name: Terry Clyburn, MD
role: PRINCIPAL_INVESTIGATOR
References: