Clinical trial NCT02494544: A Multicenter Study to Evaluate Functional Outcome After Knee Replacement
Official title: A Prospective, Multicenter Study to Evaluate Functional Outcome After Knee Replacement
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis
Keywords: knee implant
knee replacement
total knee replacement
Lead sponsor: Restor3D
Sponsor class: INDUSTRY
First posted: 2015-07-10
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Functional Testing
timeFrame: 1 year
Secondary outcomes:
measure: Patient reported outcome using questionnaires such as the KOOS and VAS
timeFrame: 1 year
measure: Incidents of major procedure-related and device related complications (including revision rates)
timeFrame: 1 year
measure: Post-operative limb alignment based using x-ray views
timeFrame: 1 year
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California in San Diego
state: California
city: San Diego
country: United States
facility: Sharp Healthcare
state: California
city: Parker
country: United States
facility: Denver-Vail Orthopedics
state: Colorado
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Boston
country: United States
facility: Tufts University
state: Massachusetts
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Albany
country: United States
facility: OrthoNY
state: New York
city: Cincinnati
country: United States
facility: The Lindner Center for Research and Education
state: Ohio
Study officials:
affiliation: Yale University
name: Mary O'Connor, MD
role: PRINCIPAL_INVESTIGATOR
References: