A Multicenter Study to Evaluate Functional Outcome After Knee Replacement
NCT ID: NCT02494544
Last Updated: 2025-11-21
Study Results
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View full resultsBasic Information
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TERMINATED
NA
215 participants
INTERVENTIONAL
2015-07-01
2022-11-16
Brief Summary
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The patient will conduct functional testing and answer questionnaires.
The results will compare the ConforMIS iTotal with an Off the Shelf Knee replacement.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
SINGLE
Study Groups
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ConforMIS iTotal Knee replacement
iTotal patient-specific knee replacement system
ConforMIS iTotal Knee Replacement
A knee replacement performed with patient specific implant and surgical jigs.
DePuy total knee replacement
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement
A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
Zimmer total knee replacement
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement
A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
Biomet total knee replacement
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement
A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
Smith & Nephew total knee replacement
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement
A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
Stryker total knee replacement
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement
A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
Interventions
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Off the Shelf Total Knee Replacement
A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
ConforMIS iTotal Knee Replacement
A knee replacement performed with patient specific implant and surgical jigs.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Restor3D
INDUSTRY
Responsible Party
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Principal Investigators
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Mary O'Connor, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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University of California in San Diego
La Jolla, California, United States
Sharp Healthcare
San Diego, California, United States
Denver-Vail Orthopedics
Parker, Colorado, United States
Yale School of Medicine
New Haven, Connecticut, United States
Tufts University
Boston, Massachusetts, United States
University of Missouri
Columbia, Missouri, United States
OrthoNY
Albany, New York, United States
The Lindner Center for Research and Education
Cincinnati, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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12-005
Identifier Type: -
Identifier Source: org_study_id
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