A Multicenter Study to Evaluate Functional Outcome After Knee Replacement

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Status: Terminated

Conditions: Osteoarthritis

Treatments: Device: Off the Shelf Total Knee Replacement; Device: ConforMIS iTotal Knee Replacement

Study type: Interventional

Funder types: Industry

Identifiers

NCT02494544

12-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 215 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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215 participants in 6 patient groups

ConforMIS iTotal Knee replacement

Active Comparator group

Description:

iTotal patient-specific knee replacement system

Treatment:

Device: ConforMIS iTotal Knee Replacement

DePuy total knee replacement

Active Comparator group

Description:

Off the shelf knee replacement system

Treatment:

Device: Off the Shelf Total Knee Replacement

Zimmer total knee replacement

Active Comparator group

Description:

Off the shelf knee replacement system

Treatment:

Device: Off the Shelf Total Knee Replacement

Biomet total knee replacement

Active Comparator group

Description:

Off the shelf knee replacement system

Treatment:

Device: Off the Shelf Total Knee Replacement

Smith & Nephew total knee replacement

Active Comparator group

Description:

Off the shelf knee replacement system

Treatment:

Device: Off the Shelf Total Knee Replacement

Stryker total knee replacement

Active Comparator group

Description:

Off the shelf knee replacement system

Treatment:

Device: Off the Shelf Total Knee Replacement