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The Influence of Hip Replacement on Lower Extremity Hemodynamics in Crowe IV Hip Dysplasia Patient

Primary Purpose

Hip Dysplasia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
total hip replacement with subtrochanteral osteotomy
total hip replacement with no osteotomy
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Dysplasia

Eligibility Criteria

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

Inclusion Criteria:

  • Unilateral Crow IV hip dysplasia;
  • Bilateral Crow IV hip dysplasia without osteoarthritis on the other side

Exclusion Criteria:

  • Patients with serious medical disease;
  • Patients with lower extremity vascular disease; 3. Patients with severe mental illness.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    total hip replacement with subtrochanteral osteotomy

    total hip replacement with no osteotomy

    Arm Description

    subtrochanteral osteotomy is applied during total hip replacement

    no osteotomy is applied during total hip replacement.

    Outcomes

    Primary Outcome Measures

    Hip Harris Score
    change of hip harris score scale from baseline(preoperative) to 1 year after surgery.
    Leg Length Change
    change of Leg Length from baseline(preoperative) to 1 year after surgery.
    Radiographic Results
    change of Radiographic Results from 1 week after surger to 1 year after surgery
    Lower Limb Arterial CT Angiography
    change of vascular diameter and vascular cross-sectional from baseline(preoperative) to 1 year after surgery baseline(preoperative) to 12 weeks after surgery.
    Vascular Ultrasound Examination
    change of systolic peak velocity, end-diastolic velocity, pulsation index, resistance index and blood flow from baseline(preoperative) to 1 year after surgery.
    Blood Viscosity
    change of blood viscosity from baseline(preoperative) to 1 year after surgery.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 23, 2019
    Last Updated
    November 6, 2019
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04157842
    Brief Title
    The Influence of Hip Replacement on Lower Extremity Hemodynamics in Crowe IV Hip Dysplasia Patient
    Official Title
    The Influence of Hip Replacement (Subtrochanteric Osteotomy vs. Non-osteotomy) on Lower Extremity Hemodynamics in Crowe IV Hip Dysplasia Patient
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2019 (Anticipated)
    Primary Completion Date
    November 1, 2021 (Anticipated)
    Study Completion Date
    November 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Explore the influence of hip replacement on lower extremity hemodynamics in Crowe Ⅳ hip dysplasia patient.
    Detailed Description
    Changes of limb length after total hip replacement is common, especially for Crowe Ⅳ hip dysplasia patient. Such change potentially increases tension of vessel and influence lower extremity hemodynamics. Till now, little is known in this area.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    total hip replacement with subtrochanteral osteotomy
    Arm Type
    Experimental
    Arm Description
    subtrochanteral osteotomy is applied during total hip replacement
    Arm Title
    total hip replacement with no osteotomy
    Arm Type
    Sham Comparator
    Arm Description
    no osteotomy is applied during total hip replacement.
    Intervention Type
    Procedure
    Intervention Name(s)
    total hip replacement with subtrochanteral osteotomy
    Intervention Description
    applying subtrochanteral osteotomy during the operation to release the tension of vessels and nerve
    Intervention Type
    Procedure
    Intervention Name(s)
    total hip replacement with no osteotomy
    Intervention Description
    just total hip replacement
    Primary Outcome Measure Information:
    Title
    Hip Harris Score
    Description
    change of hip harris score scale from baseline(preoperative) to 1 year after surgery.
    Time Frame
    preoperative, 1 week, 6 weeks, 12 weeks, 24 weeks and 1 year after the surgery.
    Title
    Leg Length Change
    Description
    change of Leg Length from baseline(preoperative) to 1 year after surgery.
    Time Frame
    preoperative, 1 week, 6 weeks, 12 weeks, 24 weeks and 1 year after the surgery.
    Title
    Radiographic Results
    Description
    change of Radiographic Results from 1 week after surger to 1 year after surgery
    Time Frame
    1 week, 12 weeks, 24 weeks and 1 year after the surgery.
    Title
    Lower Limb Arterial CT Angiography
    Description
    change of vascular diameter and vascular cross-sectional from baseline(preoperative) to 1 year after surgery baseline(preoperative) to 12 weeks after surgery.
    Time Frame
    preoperative, 1 week, 12 weeks after the surgery.
    Title
    Vascular Ultrasound Examination
    Description
    change of systolic peak velocity, end-diastolic velocity, pulsation index, resistance index and blood flow from baseline(preoperative) to 1 year after surgery.
    Time Frame
    preoperative, 1 week, 6 weeks, 12 weeks, 24 weeks and 1 year after the surgery.
    Title
    Blood Viscosity
    Description
    change of blood viscosity from baseline(preoperative) to 1 year after surgery.
    Time Frame
    preoperative, 1 week, 6 weeks, 12 weeks, 24 weeks and 1 year after the surgery.

    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: Unilateral Crow IV hip dysplasia; Bilateral Crow IV hip dysplasia without osteoarthritis on the other side Exclusion Criteria: Patients with serious medical disease; Patients with lower extremity vascular disease; 3. Patients with severe mental illness.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    SHIGUI YAN, MD
    Phone
    +86-13906531308
    Email
    zrjwsj@zju.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    SHIGUI YAN, MD
    Organizational Affiliation
    2nd affiliated hospital, School of Medicine, Zhejiang University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    The Influence of Hip Replacement on Lower Extremity Hemodynamics in Crowe IV Hip Dysplasia Patient

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