Anterior Advantage With KINCISE

Last updated: September 11, 2023
Sponsor: DePuy Orthopaedics
Overall Status: Terminated

Phase

N/A

Condition

Rheumatoid Arthritis

Osteoarthritis

Arthritis And Arthritic Pain

Treatment

KINCISE(TM) Surgical Automated System

Clinical Study ID

NCT04191733
DSJ_2019_03
  • Ages > 21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. Active local or systemic infection.
  2. Loss of musculature, neuromuscular compromise or vascular deficiency in the affectedlimb rendering the procedure unjustified.
  3. Poor bone quality, such as osteoporosis, where, in the surgeon's opinion, there couldbe considerable migration of the prosthesis or a significant chance of fracture of thefemoral 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, contralateralhip is already enrolled in the study, or simultaneous or staged hip replacement isplanned
  10. Subject is currently involved in any personal injury litigation, medical-legal orworker's compensation claims.
  11. Subject was diagnosed and is taking prescription medications to treat a musculardisorder that limits mobility due to severe stiffness and pain such as fibromyalgia orpolymyalgia.
  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 aphysical or psychological disorder that could affect their ability to complete patientreported questionnaires or be compliant with follow-up requirements.

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: KINCISE(TM) Surgical Automated System
Phase:
Study Start date:
January 28, 2020
Estimated Completion Date:
August 31, 2022

Study 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 (participant reported)

  • Complications (including a specific summary of complications within 90 days post-surgery)

Connect with a study center

  • The Orthopedic Specialty Center of Northern California

    Roseville, California 95678
    United States

    Site Not Available

  • Colorado Joint Replacement

    Denver, Colorado 80210
    United States

    Site Not Available

  • Capital Region Orthopaedic Group

    Albany, New York 12208
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Hospital for Special Surgery

    New York, New York 10021
    United States

    Site Not Available

  • Carolina Orthopaedic & Sports Medicine

    Gastonia, North Carolina 28054
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Southern Joint Replacement Institute

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Texas Institute for Hip and Knee Surgery

    Austin, Texas 78751
    United States

    Site Not Available

  • North Texas Medical Research Institute

    Dallas, Texas 75254
    United States

    Site Not Available

  • W.B. Carrell Memorial Clinic

    Dallas, Texas 75231
    United States

    Site Not Available

  • Jordan-Young Institute

    Virginia Beach, Virginia 23462
    United States

    Site Not Available

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