A Multicenter Study to Evaluate Functional Outcome After Knee Replacement



Status:Recruiting
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:11/4/2018
Start Date:July 1, 2015
End Date:June 2029
Contact:Marc Quartulli
Email:marc.quartulli@conformis.com
Phone:781-345-9191

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A Prospective, Multicenter Study to Evaluate Functional Outcome After Knee Replacement

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.

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.

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
We found this trial at
8
sites
New Haven, Connecticut 06520
Principal Investigator: Mary O'Connor, MD
Phone: 203-737-2843
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Albany, New York 12205
Principal Investigator: Frederick Fletcher, MD
Phone: 518-489-2663
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Boston, Massachusetts 02111
Principal Investigator: Eric Smith, MD
Phone: 617-636-5159
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Cincinnati, Ohio 45219
Principal Investigator: Michael Swank, MD
Phone: 513-585-1777
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Columbia, Missouri 65211
(573) 882-2121
Principal Investigator: Thomas J Aleto, MD
Phone: 573-882-2663
University of Missouri T he University of Missouri was founded in 1839 in Columbia, Mo.,...
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Principal Investigator: Scott Ball, MD
Phone: 858-210-8727
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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Parker, Colorado 80134
Principal Investigator: Derek R Johnson, MD
Phone: 303-214-4500
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San Diego, California 32123
Principal Investigator: Richard Coutts, MD
Phone: 858-499-5026
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