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A Multicenter Study to Evaluate Functional Outcome After Knee Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02494544
Recruitment Status : Active, not recruiting
First Posted : July 10, 2015
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
ConforMIS, Inc.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Off the Shelf Total Knee Replacement Device: ConforMIS iTotal Knee Replacement Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Site staff that is performing functional testing on subject is blinded to what implant the patient has.
Primary Purpose: Basic Science
Official Title: A Prospective, Multicenter Study to Evaluate Functional Outcome After Knee Replacement
Actual Study Start Date : July 1, 2015
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : August 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ConforMIS iTotal Knee replacement
iTotal patient-specific knee replacement system
 Device: ConforMIS iTotal Knee Replacement
A knee replacement performed with patient specific implant and surgical jigs.
Active Comparator: DePuy total knee replacement
Off the shelf knee replacement system
 Device: Off the Shelf Total Knee Replacement
A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker
Active Comparator: Zimmer total knee replacement
Off the shelf knee replacement system
 Device: Off the Shelf Total Knee Replacement
A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker
Active Comparator: Biomet total knee replacement
Off the shelf knee replacement system
 Device: Off the Shelf Total Knee Replacement
A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker
Active Comparator: Smith & Nephew total knee replacement
Off the shelf knee replacement system
 Device: Off the Shelf Total Knee Replacement
A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker
Active Comparator: Stryker total knee replacement
Off the shelf knee replacement system
 Device: Off the Shelf Total Knee Replacement
A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker


Outcome Measures
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Primary Outcome Measures :
  1. Functional Testing [ Time Frame: 1 year ]
    Comparing the functional testing differences between iTotal and off the shelf


Secondary Outcome Measures :
  1. Patient reported outcome using questionnaires such as the KOOS and VAS [ Time Frame: 1 year ]
    Measuring and comparing the differences between iTotal and off the shelf knees with patient reported outcomes.

  2. Incidents of major procedure-related and device related complications (including revision rates) [ Time Frame: 1 year ]
    To compare revision rates between groups

  3. Post-operative limb alignment based using x-ray views [ Time Frame: 1 year ]
    To compare post-operative limb alignment between two groups


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494544


Locations
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United States, California
University of California in San Diego
La Jolla, California, United States, 92037
Sharp Healthcare
San Diego, California, United States, 92123
United States, Colorado
Denver-Vail Orthopedics
Parker, Colorado, United States, 80134
United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06520
United States, Massachusetts
Tufts University
Boston, Massachusetts, United States, 02111
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
United States, New York
OrthoNY
Albany, New York, United States, 12205
United States, Ohio
The Lindner Center for Research and Education
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
ConforMIS, Inc.
Investigators
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Principal Investigator: Mary O'Connor, MD Yale School of Medicine
More Information
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Responsible Party: ConforMIS, Inc.
ClinicalTrials.gov Identifier: NCT02494544    
Other Study ID Numbers: 12-005
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by ConforMIS, Inc.:
knee implant
knee replacement
total knee replacement
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases