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Robotic Instrumentation in THA

Primary Purpose

Osteoarthritis, Hip

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
One of the following hip implants may be used within this arm of the study: G7 Acetabular System, Taperloc Complete System, Avenir and Avenir Complete Systems, and Echo Bi-Metric System
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age 18 - 80 years
  2. Body mass index ≤40 kg/m2
  3. Patient is willing and able to provide informed consent.
  4. Patient qualifies for primary THA, via an anterior approach, due to osteoarthritis of the hip based on investigator's clinical judgment
  5. Independent of study participation, patient is a candidate and meets the indications and none of the contraindications for use with the ROSA Hip System

Exclusion Criteria:

  1. Has undergone an orthopaedic procedure, of the spine or lower extremity, or is currently participating in a pain management study of any joint within the last 6 months or planned within the next 6 months
  2. Infection, sepsis, osteomyelitis, avascular necrosis of the hip joint
  3. Patient is at a high risk for dislocation including those with long-segment spinal fusions (>3 levels) and neuromuscular disorders.
  4. Inflammatory or Post-traumatic arthropathy, or any other degenerative joint disease not consistent with osteoarthritis.
  5. Would, in the investigator's opinion, be unwilling or unable to comply with the postoperative follow-up schedule
  6. Patient is considered a member of a vulnerable population (Pregnant, prisoner, mentally incompetent, etc.)
  7. Previous hardware in the proximal femur or acetabulum from a prior orthopaedic procedure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Robotic-Assisted THA

    Traditional/Conventional THA

    Arm Description

    Randomized participants will receive THA via the ROSA Hip System.

    Randomized participants will receive the THA via Conventional/Traditional THA Methods.

    Outcomes

    Primary Outcome Measures

    Accuracy of implant position
    To compare and evaluate the accuracy of implant position of robotic-arm surgical assistant (ROSA® Total Hip System) with that of conventional instrumentation (Traditional THA). Accuracy of the implant will be evaluated by assessing radiographic alignment post-operatively for participants enrolled for both Conventional Instrumentation and the ROSA® Hip System. Accuracy of acetabular implant position will be assessed by evaluating the percentage of participants who are within the range of the Callanan safe zones for Acetabular Inclination (30 - 45 degrees). A patient is considered a success if their 4-week CT scan shows the postoperative acetabular inclination to be within this safe zone range.

    Secondary Outcome Measures

    Evaluation of Patient safety
    Frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated serious adverse device effects as well as device deficiencies.
    Patient Reported Outcome Measure (Oxford Hip Score)
    A questionnaire completed by the patient consisting of twelve questions that utilize a 5-point Likert scoring system (0 - 4) resulting in a score ranging from 0 (worst) to 48 (best).
    Patient Reported Outcome Measure (HOOS-Jr)
    A questionnaire completed by the patient consisting of 6 items from the original HOOS survey. Items are coded from 0 to 4, none to extreme respectively
    Numeric Pain Rating Scale (NPRS)
    An 11-point NPRS is a patient self-completed reported outcome and will be used to assess the current level of pain for the affected hip. On this scale, 0 will indicate no pain and 10 will indicate the worst pain imaginable
    Subject Satisfaction
    A questionnaire consisting of a single satisfaction question in regard to the subjects hip replacement. Answers will include the following: Very Dissatisfied, Dissatisfied, Neutral, Satisfied, Very Satisfied.
    Clinical performance will be assessed with evaluation of range of motion.
    Range of motion will be evaluated in a supine position and assess flexion, abduction (in flexion), adduction (in flexion), external rotation (in extension), and internal rotation (in extension). Range of motion will be measured in degrees.
    Clinical performance will be assessed with evaluation of stability using the Trendelenburg test.
    The test is negative when the hip of the leg that is lifted, will also go up i.e., hiking of hip or the pelvis tilts upwards. The test is positive, when there is a drop of the hip or a downwards tilt of the pelvis. The test is level when the subject presents normal gait and adequate pelvic stability. If the subject is unable to perform the test, this will be noted "unable to perform test".
    Clinical performance will be assessed by testing leg length discrepancy.
    This will be assessed by (3) categories (legs equal, right short, left short) and discrepancies will be measured in mm or cm.

    Full Information

    First Posted
    February 23, 2022
    Last Updated
    August 10, 2022
    Sponsor
    Zimmer Biomet
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05497206
    Brief Title
    Robotic Instrumentation in THA
    Official Title
    A Post-Market, Multi-Center, Randomized Controlled Trial on Robotic Instrumentation in Patients Undergoing Total Hip Arthroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2023 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Zimmer Biomet

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a prospective, multi-center, two-arm, randomized, controlled post-market study to evaluate and compare the clinical accuracy of component placement in robotic-assisted THA and that of traditional methods.
    Detailed Description
    Sites will enroll participants into two separate arms for this study (rTHA and Conventional Instrumentation), following the assigned randomization. Consecutive patients who meet all of the inclusion criteria and none of the exclusion criteria will be eligible for participation in the study, and will be pre-screened for participation in the informed consent process. The primary objective of this study is to evaluate and compare the accuracy of the Robotic Total Hip System in regards to implant placement with that of traditional instrumentation. Secondary Objectives include the evaluation of safety and efficacy of this system and will include the assessment of common adverse events, physical exam findings, radiologic results and patient reported outcome measures. Data collection will occur at the following intervals: Pre-operative, Operative, 6-weeks, 3-months, 1-year, and 2-years. Enrollment for the study is anticipated to last approximately 12 months. Allowing for 24 months of follow-up, the total estimated study time to final-patient final-visit will be approximately 36-42 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Hip

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    The participant will be randomized into one of the two available study arms, and will be blinded from treatment until surgery has occurred.
    Allocation
    Randomized
    Enrollment
    176 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Robotic-Assisted THA
    Arm Type
    Active Comparator
    Arm Description
    Randomized participants will receive THA via the ROSA Hip System.
    Arm Title
    Traditional/Conventional THA
    Arm Type
    Active Comparator
    Arm Description
    Randomized participants will receive the THA via Conventional/Traditional THA Methods.
    Intervention Type
    Device
    Intervention Name(s)
    One of the following hip implants may be used within this arm of the study: G7 Acetabular System, Taperloc Complete System, Avenir and Avenir Complete Systems, and Echo Bi-Metric System
    Intervention Description
    Total Hip Arthroplasty
    Primary Outcome Measure Information:
    Title
    Accuracy of implant position
    Description
    To compare and evaluate the accuracy of implant position of robotic-arm surgical assistant (ROSA® Total Hip System) with that of conventional instrumentation (Traditional THA). Accuracy of the implant will be evaluated by assessing radiographic alignment post-operatively for participants enrolled for both Conventional Instrumentation and the ROSA® Hip System. Accuracy of acetabular implant position will be assessed by evaluating the percentage of participants who are within the range of the Callanan safe zones for Acetabular Inclination (30 - 45 degrees). A patient is considered a success if their 4-week CT scan shows the postoperative acetabular inclination to be within this safe zone range.
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Evaluation of Patient safety
    Description
    Frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated serious adverse device effects as well as device deficiencies.
    Time Frame
    24 months
    Title
    Patient Reported Outcome Measure (Oxford Hip Score)
    Description
    A questionnaire completed by the patient consisting of twelve questions that utilize a 5-point Likert scoring system (0 - 4) resulting in a score ranging from 0 (worst) to 48 (best).
    Time Frame
    24 months
    Title
    Patient Reported Outcome Measure (HOOS-Jr)
    Description
    A questionnaire completed by the patient consisting of 6 items from the original HOOS survey. Items are coded from 0 to 4, none to extreme respectively
    Time Frame
    24 months
    Title
    Numeric Pain Rating Scale (NPRS)
    Description
    An 11-point NPRS is a patient self-completed reported outcome and will be used to assess the current level of pain for the affected hip. On this scale, 0 will indicate no pain and 10 will indicate the worst pain imaginable
    Time Frame
    24 months
    Title
    Subject Satisfaction
    Description
    A questionnaire consisting of a single satisfaction question in regard to the subjects hip replacement. Answers will include the following: Very Dissatisfied, Dissatisfied, Neutral, Satisfied, Very Satisfied.
    Time Frame
    24 months
    Title
    Clinical performance will be assessed with evaluation of range of motion.
    Description
    Range of motion will be evaluated in a supine position and assess flexion, abduction (in flexion), adduction (in flexion), external rotation (in extension), and internal rotation (in extension). Range of motion will be measured in degrees.
    Time Frame
    24 months
    Title
    Clinical performance will be assessed with evaluation of stability using the Trendelenburg test.
    Description
    The test is negative when the hip of the leg that is lifted, will also go up i.e., hiking of hip or the pelvis tilts upwards. The test is positive, when there is a drop of the hip or a downwards tilt of the pelvis. The test is level when the subject presents normal gait and adequate pelvic stability. If the subject is unable to perform the test, this will be noted "unable to perform test".
    Time Frame
    24 months
    Title
    Clinical performance will be assessed by testing leg length discrepancy.
    Description
    This will be assessed by (3) categories (legs equal, right short, left short) and discrepancies will be measured in mm or cm.
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age 18 - 80 years Body mass index ≤40 kg/m2 Patient is willing and able to provide informed consent. Patient qualifies for primary THA, via an anterior approach, due to osteoarthritis of the hip based on investigator's clinical judgment Independent of study participation, patient is a candidate and meets the indications and none of the contraindications for use with the ROSA Hip System Exclusion Criteria: Has undergone an orthopaedic procedure, of the spine or lower extremity, or is currently participating in a pain management study of any joint within the last 6 months or planned within the next 6 months Infection, sepsis, osteomyelitis, avascular necrosis of the hip joint Patient is at a high risk for dislocation including those with long-segment spinal fusions (>3 levels) and neuromuscular disorders. Inflammatory or Post-traumatic arthropathy, or any other degenerative joint disease not consistent with osteoarthritis. Would, in the investigator's opinion, be unwilling or unable to comply with the postoperative follow-up schedule Patient is considered a member of a vulnerable population (Pregnant, prisoner, mentally incompetent, etc.) Previous hardware in the proximal femur or acetabulum from a prior orthopaedic procedure
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ryan D Boylan
    Phone
    574.371.9784
    Email
    ryan.boylan@zimmerbiomet.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hillary Overholser
    Organizational Affiliation
    Zimmer Biomet
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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