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Post-Market Study of Robotic-Arm Assisted Total Knee Arthroplasty

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: NCT03106558
Recruitment Status : Unknown
Verified February 2017 by Rothman Institute Orthopaedics.
Recruitment status was:  Enrolling by invitation
First Posted : April 10, 2017
Last Update Posted : April 10, 2017
Sponsor:
Collaborator:
Stryker Orthopaedics
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Device: Total Knee Arthroplasty using Manual Instrumentation Device: Total Knee Arthroplasty using Robotic Arm Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-Market Study of Robotic-Arm Assisted Total Knee Arthroplasty
Actual Study Start Date : June 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

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: Manual instrument total knee replacement Device: Total Knee Arthroplasty using Manual Instrumentation
Active Comparator: Robitic arm total knee replacement Device: Total Knee Arthroplasty using Robotic Arm


Outcome Measures
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Primary Outcome Measures :
  1. Component alignment [ Time Frame: 6 weeks post knee arthroplasty ]
    CT scan measurement


Eligibility Criteria
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Information from the National Library of Medicine

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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 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.
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): NCT03106558


Locations
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United States, Georgia
Athens Orthopedic Clinic
Athens, Georgia, United States, 30606
United States, New Jersey
Rothman Institute
Egg Harbor Township, New Jersey, United States, 08234
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
Stryker Orthopaedics
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT03106558    
Other Study ID Numbers: 2017WHoz
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: February 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases