Back to resultsA Multicenter Study to Evaluate Functional Outcome After Knee Replacement
Primary Purpose
Osteoarthritis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Off the Shelf Total Knee Replacement
ConforMIS iTotal Knee Replacement
Sponsored by
About this trial
This is an interventional basic science trial for Osteoarthritis focused on measuring knee implant, knee replacement, total knee replacement
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
Sites / Locations
- University of California in San Diego
- Sharp Healthcare
- Denver-Vail Orthopedics
- Yale School of Medicine
- Tufts University
- University of Missouri
- OrthoNY
- The Lindner Center for Research and Education
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
ConforMIS iTotal Knee replacement
DePuy total knee replacement
Zimmer total knee replacement
Biomet total knee replacement
Smith & Nephew total knee replacement
Stryker total knee replacement
Arm Description
iTotal patient-specific knee replacement system
Off the shelf knee replacement system
Off the shelf knee replacement system
Off the shelf knee replacement system
Off the shelf knee replacement system
Off the shelf knee replacement system
Outcomes
Primary Outcome Measures
Functional Testing
Comparing the functional testing differences between iTotal and off the shelf
Secondary Outcome Measures
Patient reported outcome using questionnaires such as the KOOS and VAS
Measuring and comparing the differences between iTotal and off the shelf knees with patient reported outcomes.
Incidents of major procedure-related and device related complications (including revision rates)
To compare revision rates between groups
Post-operative limb alignment based using x-ray views
To compare post-operative limb alignment between two groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02494544
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Decision of investigational team
Study Start Date
July 1, 2015 (Actual)
Primary Completion Date
November 16, 2022 (Actual)
Study Completion Date
November 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Restor3D
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
knee implant, knee replacement, total knee replacement
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Outcomes Assessor
Masking Description
Site staff that is performing functional testing on subject is blinded to what implant the patient has.
Allocation
Non-Randomized
Enrollment
187 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ConforMIS iTotal Knee replacement
Arm Type
Active Comparator
Arm Description
iTotal patient-specific knee replacement system
Arm Title
DePuy total knee replacement
Arm Type
Active Comparator
Arm Description
Off the shelf knee replacement system
Arm Title
Zimmer total knee replacement
Arm Type
Active Comparator
Arm Description
Off the shelf knee replacement system
Arm Title
Biomet total knee replacement
Arm Type
Active Comparator
Arm Description
Off the shelf knee replacement system
Arm Title
Smith & Nephew total knee replacement
Arm Type
Active Comparator
Arm Description
Off the shelf knee replacement system
Arm Title
Stryker total knee replacement
Arm Type
Active Comparator
Arm Description
Off the shelf knee replacement system
Intervention Type
Device
Intervention Name(s)
Off the Shelf Total Knee Replacement
Intervention Description
A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker
Intervention Type
Device
Intervention Name(s)
ConforMIS iTotal Knee Replacement
Intervention Description
A knee replacement performed with patient specific implant and surgical jigs.
Primary Outcome Measure Information:
Title
Functional Testing
Description
Comparing the functional testing differences between iTotal and off the shelf
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Patient reported outcome using questionnaires such as the KOOS and VAS
Description
Measuring and comparing the differences between iTotal and off the shelf knees with patient reported outcomes.
Time Frame
1 year
Title
Incidents of major procedure-related and device related complications (including revision rates)
Description
To compare revision rates between groups
Time Frame
1 year
Title
Post-operative limb alignment based using x-ray views
Description
To compare post-operative limb alignment between two groups
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary O'Connor, MD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California in San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Sharp Healthcare
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Denver-Vail Orthopedics
City
Parker
State/Province
Colorado
ZIP/Postal Code
80134
Country
United States
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Tufts University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
OrthoNY
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
The Lindner Center for Research and Education
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Multicenter Study to Evaluate Functional Outcome After Knee Replacement
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