Back to resultsPost-Market Study of Robotic-Arm Assisted Total Knee Arthroplasty
Primary Purpose
Osteoarthritis, Knee
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Total Knee Arthroplasty using Manual Instrumentation
Total Knee Arthroplasty using Robotic Arm
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
Inclusion Criteria:
- Patient requires primary total knee surgery
- Patient is willing and able to comply with postoperative follow-up requirements and self evaluations
- Patient is willing to sign an IRB approved informed consent
- Patient is at least 18 years of age
Exclusion Criteria:
- Patient has a BMI > 50
- Patient is skeletally immature
- Patient has an active infection or suspected infection in or about the joint
- Bone stock that is inadequate to support fixation of the prosthesis
- Neuromuscular disorders, muscular atrophy or vascular deficiency in the affected limb rendering the procedure unjustified.
- Patients with mental or neurological conditions which may be incapable of following instructions.
- Blood supply limitations
- Collateral ligament insufficiency.
- Patients with prior HTOs or Unis.
Sites / Locations
- Athens Orthopedic Clinic
- Rothman Institute
- Cleveland Clinic
- Rothman Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Manual instrument total knee replacement
Robitic arm total knee replacement
Arm Description
Outcomes
Primary Outcome Measures
Component alignment
CT scan measurement
Secondary Outcome Measures
Full Information
NCT ID
NCT03106558
First Posted
February 7, 2017
Last Updated
April 4, 2017
Sponsor
Rothman Institute Orthopaedics
Collaborators
Stryker Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT03106558
Brief Title
Post-Market Study of Robotic-Arm Assisted Total Knee Arthroplasty
Official Title
Post-Market Study of Robotic-Arm Assisted Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics
Collaborators
Stryker Orthopaedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
Brief Summary
This is an early user evaluation of the robotic-assisted total knee arthroplasty platform. The objective of this surgeon group is to capture data on the defined objectives and provide Stryker with feedback.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Manual instrument total knee replacement
Arm Type
Active Comparator
Arm Title
Robitic arm total knee replacement
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Total Knee Arthroplasty using Manual Instrumentation
Intervention Type
Device
Intervention Name(s)
Total Knee Arthroplasty using Robotic Arm
Primary Outcome Measure Information:
Title
Component alignment
Description
CT scan measurement
Time Frame
6 weeks post knee arthroplasty
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient requires primary total knee surgery
Patient is willing and able to comply with postoperative follow-up requirements and self evaluations
Patient is willing to sign an IRB approved informed consent
Patient is at least 18 years of age
Exclusion Criteria:
Patient has a BMI > 50
Patient is skeletally immature
Patient has an active infection or suspected infection in or about the joint
Bone stock that is inadequate to support fixation of the prosthesis
Neuromuscular disorders, muscular atrophy or vascular deficiency in the affected limb rendering the procedure unjustified.
Patients with mental or neurological conditions which may be incapable of following instructions.
Blood supply limitations
Collateral ligament insufficiency.
Patients with prior HTOs or Unis.
Facility Information:
Facility Name
Athens Orthopedic Clinic
City
Athens
State/Province
Georgia
ZIP/Postal Code
30606
Country
United States
Facility Name
Rothman Institute
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Rothman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Post-Market Study of Robotic-Arm Assisted Total Knee Arthroplasty
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