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Anterior Advantage With KINCISE

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04191733
Recruitment Status : Not yet recruiting
First Posted : December 10, 2019
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics

Brief Summary:
This is a post-market prospective, 1:1 randomized, multicenter non-inferiority study to compare the femoral broaching time for THA with the Anterior Advantage approach with KINCISE vs. without KINCISE. Follow-up will continue through 24 weeks post-op.

Condition or disease Intervention/treatment Phase
Osteoarthritis Rheumatoid Arthritis Post Traumatic Arthritis Device: KINCISE(TM) Surgical Automated System Not Applicable

Detailed Description:

The primary endpoint is femoral broaching time (in minutes), which is collected intraoperatively. The primary objective is to demonstrate that femoral broaching time with KINCISE is non-inferior to femoral broaching time with manual instruments (not using KINCISE) when used in THA with Anterior Advantage.

Note: If non-inferiority is successfully demonstrated, then the study will be deemed to be successful, and a test for superiority of femoral broaching time will be conducted.

If the primary endpoint analysis successfully demonstrates non-inferiority of femoral broaching time, then the following three secondary objectives will be assessed with formal hypotheses, in order, under a gatekeeping strategy:

  • Non-inferiority of skin-to-skin OR time when KINCISE is used vs. when KINCISE is not used.
  • Non-inferiority of the percent of subjects with optimal acetabular cup abduction angle when KINCISE is used vs. when KINCISE is not used.
  • Non-inferiority of the percent of subjects with optimal acetabular cup version angle when KINCISE is used vs. when KINCISE is not used.

In addition, the following secondary endpoints do not have prospectively planned hypotheses; these will be summarized for both treatment groups:

  • Harris Hip Score (HHS) and HHS change from preoperative baseline
  • Forgotten Joint Score (FJS) and FJS change from 6-week postoperative baseline
  • EQ-5D-5L and changes in these assessments from preoperative baseline
  • Pain (Groin, Thigh, and Buttock)
  • Patient Satisfaction
  • Post-op time when functional activities can be accomplished (return to work, self-care, etc.)
  • Radiographic Outcomes (based upon AP Hip, AP Pelvis, and Lateral)
  • Length of hospital stay after index THA
  • Re-hospitalizations during the study (including a specific summary of re-hospitalizations within 90 days)
  • Narcotic drug usage throughout the study
  • Complications (including a specific summary of complications within 90 days post-surgery)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 Block Randomization
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Multi-center Post-Market Study of Anterior Advantage Surgical Approach in Total Hip Arthroplasty With and Without the KINCISE™ Surgical Automated System.
Estimated Study Start Date : January 15, 2020
Estimated Primary Completion Date : May 28, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Anterior Approach with KINCISE
Anterior Approach THA using KINCISE(TM) Surgical Automated System
Device: KINCISE(TM) Surgical Automated System
Uncemented Total Hip Arthroplasty via Anterior Approach with and without the KINCISE(TM) Surgical Automated System

Active Comparator: Anterior Approach without KINCISE
Anterior Approach THA with a mallet (without KINCISE)
Device: KINCISE(TM) Surgical Automated System
Uncemented Total Hip Arthroplasty via Anterior Approach with and without the KINCISE(TM) Surgical Automated System




Primary Outcome Measures :
  1. Femoral Broach Time [ Time Frame: Operative ]
    The primary endpoint analysis is to demonstrate that femoral broaching time (in minutes) with KINCISE is non-inferior to femoral broaching time with manual instruments (not using KINCISE) under a non-inferiority margin of 1.25 minutes.


Secondary Outcome Measures :
  1. Skin-to-skin Time [ Time Frame: Operative ]
    A non-inferiority test of skin-to-skin OR time will be conducted with a non-inferiority margin of 3.75 minutes, using a 2-sample t-test

  2. Cup Abduction Angle [ Time Frame: 6 weeks post-op ]
    A non-inferiority test of the percent of subjects with acetabular cup abduction angle within +/- 10 degrees of plan under a NI margin of 10%

  3. Cup Version Angle [ Time Frame: 6 weeks post-op ]
    A non-inferiority test of the percent of subjects with acetabular cup version angle within +/- 10 degrees of plan under a NI margin of 10%

  4. Harris Hip Score [ Time Frame: Baseline (pre-op), 6 and 24 weeks ]
    Harris Hip Score (HHS) and HHS change from preoperative baseline

  5. Forgotten Joint Score (FJS-12) [ Time Frame: 6 and 24 weeks ]
    Forgotten Joint Score (FJS) and FJS change from 6-week postoperative baseline

  6. Pain (Patient Questionnaire) [ Time Frame: Baseline (pre-op), 6 and 24 weeks ]
    Pain (Groin, Thigh, and Buttock); determined via patient questionnaire

  7. Patient Satisfaction (Patient Questionnaire) [ Time Frame: Baseline (pre-op), 6 and 24 weeks ]
    Assessment of expected satisfaction pre-operatively and post-op patient satisfaction at 6 and 24 weeks post-op

  8. Functional Outcomes [ Time Frame: Baseline (pre-op), 6 and 24 weeks ]
    Post-op time when functional activities can be accomplished (return to work; self-care; etc.)

  9. Length of Stay [ Time Frame: Operative/Discharge (Day 0 to day of discharge) ]
    Length of hospital stay after index THA

  10. Re-hospitalizations [ Time Frame: 24 weeks ]
    Re-hospitalizations during the study (including a specific summary of re-hospitalizations within 90 days)

  11. Narcotic Drug Use [ Time Frame: 24 weeks ]
    Narcotic drug usage throughout the study

  12. Complications [ Time Frame: 24 weeks ]
    Complications (including a specific summary of complications within 90 days post-surgery)

  13. Acetabular Cup Position [ Time Frame: 6 and 24 weeks ]
    Measure (in degrees) of acetabular cup inclination and version

  14. Acetabular Cup Migration [ Time Frame: 6 and 24 weeks ]
    Measure and summary of any reports of acetabular cup migration

  15. Acetabular Cup Radiographic Outcomes [ Time Frame: 6 and 24 weeks ]
    Measure and summary of any reports of acetabular cup radiolucency, osteolysis, and sclerotic lines

  16. Femoral Stem Position [ Time Frame: 6 and 24 weeks ]
    Measure and summary of femoral stem position, tilt and subsidence

  17. Femoral Stem Radiographic Outcomes [ Time Frame: 6 and 24 weeks ]
    Measure and summary of any reported femoral stem radiolucency, osteolysis, sclerotic lines


Other Outcome Measures:
  1. Surgeon Surface Electromyography (EMG) [ Time Frame: Operative ]
    Exploratory analysis of surgeon EMG and data collected through a wearable system to be conducted by DePuy Synthes research and development (R&D) partners.

  2. Surgeon Heart Rate [ Time Frame: Operative ]
    Exploratory of surgeon heart rate data collected through a wearable system to be conducted by DePuy Synthes research and development (R&D) partners



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient is undergoing a standard of care primary cementless hip replacement with the Pinnacle cup and a Corail or Actis stem via the Anterior Advantage approach. All devices are to be used according to the approved indications.
  2. Individuals who are able to speak, read, and comprehend the Institutional Review Board approved Informed Consent Document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of his/her information to DePuy Synthes.
  3. Individuals who are willing and able to complete follow-up visits and questionnaires as specified by the study protocol.
  4. Individuals who are not bedridden per the discretion of the investigator (The intent of "not bedridden" means a permanent situation, not a temporary situation as in a hip fracture or trauma case).
  5. Individuals who are a minimum age of 21 years at the time of consent.

Exclusion Criteria:

  1. Active local or systemic infection.
  2. Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
  3. Poor bone quality, such as osteoporosis, where, in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s).
  4. Charcot's or Paget's disease.
  5. The Subject is a woman who is pregnant or lactating.
  6. Subject had a contralateral amputation.
  7. Previous partial hip replacement in affected hip.
  8. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.
  9. Contralateral hip was replaced less than 3 months prior to surgery date, contralateral hip is already enrolled in the study, or simultaneous or staged hip replacement is planned
  10. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
  11. Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
  12. Subject has a medical condition with less than 2 years of life expectancy.
  13. Subject, in the opinion of the Investigator, is a drug or alcohol abuser or has a physical or psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.

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): NCT04191733


Contacts
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Contact: David Fawley, MS, MA 574-371-4748 dfawley1@its.jnj.com

Locations
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United States, Colorado
Colorado Joint Replacement
Denver, Colorado, United States, 80210
United States, North Carolina
Carolina Orthopaedic & Sports Medicine
Gastonia, North Carolina, United States, 28054
United States, Tennessee
Southern Joint Replacement Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Institute for Hip and Knee Surgery
Austin, Texas, United States, 78751
W.B. Carrell Memorial Clinic
Dallas, Texas, United States, 75231
Sponsors and Collaborators
DePuy Orthopaedics

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Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT04191733    
Other Study ID Numbers: DSJ_2019_03
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu/
URL: http://yoda.yale.edu/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases
Imidacloprid
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs