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Minimally Invasive Surgery of the Hip Versus Standard Approach

Primary Purpose

Hip Arthroplasty, Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Minimally Invasive Surgery
Standard Surgery
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hip Arthroplasty focused on measuring Osteoarthritis, Total Hip Arthroplasty, Minimally Invasive Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: BMI > 30 kg/m2 No prior ipsilateral hip surgery Osteoarthritis Exclusion Criteria: Patients with grossly distorted bony anatomy whereby standard implants are contraindicated; i.e. congenital dysplasia of the hip, proximal femoral abnormalities, etc Rheumatoid Arthritis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Minimally Invasive Surgery (MIS)

    Standard Surgery

    Arm Description

    In minimally invasive surgery, the surgeon makes a shorter incision (about 10 cm or less) along the side of the thigh and replaces the hip through this smaller incision. The surgeon is able to do the surgery through a shorter incision by using special instruments which can guide him or her.

    The standard way an orthopaedic surgeon performs a hip replacement surgery is that they make a long incision (about 20 cm) down the side of the thigh and then replaces the hip joint through this long incision

    Outcomes

    Primary Outcome Measures

    Clinical Outcomes
    Hospital length of stay

    Secondary Outcome Measures

    Harris Hip Score
    Questionnaire to measure health outcome status. An index score of 100 is the highest score and is indicative of better outcome, while 0 is the lowest score and indicative of worse outcome. With regards to health, a score between 90-100 is considered "Excellent." 80-89 is considered "Good." 70-79 is considered "Fair." Less than 70 is considered "Poor."
    Change in Timed Get-up-and-Go Test (TUG)
    A timed assessment to assess a participants mobility. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. A faster time is indicative of better mobility, while a slower time is indicative of worse mobility.
    Operating Time Duration
    Duration of the surgical procedure
    Estimated Blood Loss
    Estimated blood loss during the operative procedure

    Full Information

    First Posted
    November 30, 2005
    Last Updated
    March 25, 2020
    Sponsor
    Ottawa Hospital Research Institute
    Collaborators
    Zimmer Biomet
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00261040
    Brief Title
    Minimally Invasive Surgery of the Hip Versus Standard Approach
    Official Title
    Minimally Invasive Surgery of the Hip: A Randomized Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2003 (undefined)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    May 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ottawa Hospital Research Institute
    Collaborators
    Zimmer Biomet

    4. Oversight

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

    5. Study Description

    Brief Summary
    The purpose of this study is to determine if there is a difference in terms of length of hospital stay and post-operative outcomes between patients whose total hip replacement surgery is performed with a minimally invasive versus standard surgical approach.
    Detailed Description
    Traditional techniques for total hip arthroplasty (THA) require complete visualization of the acetabulum and proximal femur since anatomic landmarks are crucial for correct orientation of the prosthetic components. All surgeons are taught that a wide surgical exposure is one of the most important factors in performing successful THA. Traditionally, it was impossible to achieve accurate fixation and orientation of the components without complete visualization of bony landmarks. These extensile exposures facilitate accurate implant alignment, but at the expense of more extensive soft tissue dissection. Little clinical research has been undertaken to relate the surgical approach to postoperative complications or patient function. Furthermore, despite the good overall results of THA, the recovery time to improved function can be lengthy. Blood loss is expected to be directly related to the extent of the surgical exposure and to influence patients outcomes. Based upon these facts, an important principle of arthroplasty surgery is to minimize the amount of soft tissue trauma while being able to achieve the surgical goal of reconstructing the arthritic hip joint. By definition, minimally invasive surgical (MIS) procedures result in less soft tissue disruption, which in turn should reduce pain, expedite healing, decrease recovery time, and potentially reduce the number of associated complications.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Arthroplasty, Osteoarthritis
    Keywords
    Osteoarthritis, Total Hip Arthroplasty, Minimally Invasive Surgery

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Minimally Invasive Surgery (MIS)
    Arm Type
    Active Comparator
    Arm Description
    In minimally invasive surgery, the surgeon makes a shorter incision (about 10 cm or less) along the side of the thigh and replaces the hip through this smaller incision. The surgeon is able to do the surgery through a shorter incision by using special instruments which can guide him or her.
    Arm Title
    Standard Surgery
    Arm Type
    Sham Comparator
    Arm Description
    The standard way an orthopaedic surgeon performs a hip replacement surgery is that they make a long incision (about 20 cm) down the side of the thigh and then replaces the hip joint through this long incision
    Intervention Type
    Procedure
    Intervention Name(s)
    Minimally Invasive Surgery
    Intervention Description
    In minimally invasive surgery, the surgeon makes a shorter incision (about 10 cm or less) along the side of the thigh and replaces the hip through this smaller incision. The surgeon is able to do the surgery through a shorter incision by using special instruments which can guide him or her.
    Intervention Type
    Procedure
    Intervention Name(s)
    Standard Surgery
    Other Intervention Name(s)
    non applicable
    Intervention Description
    The standard way that an orthopaedic surgeon performs a hip replacement surgery is that they make a long incision (about 20 cm) down the side of the thigh and then replaces the hip joint through this long incision.
    Primary Outcome Measure Information:
    Title
    Clinical Outcomes
    Description
    Hospital length of stay
    Time Frame
    24 months
    Secondary Outcome Measure Information:
    Title
    Harris Hip Score
    Description
    Questionnaire to measure health outcome status. An index score of 100 is the highest score and is indicative of better outcome, while 0 is the lowest score and indicative of worse outcome. With regards to health, a score between 90-100 is considered "Excellent." 80-89 is considered "Good." 70-79 is considered "Fair." Less than 70 is considered "Poor."
    Time Frame
    24 months
    Title
    Change in Timed Get-up-and-Go Test (TUG)
    Description
    A timed assessment to assess a participants mobility. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. A faster time is indicative of better mobility, while a slower time is indicative of worse mobility.
    Time Frame
    3 months
    Title
    Operating Time Duration
    Description
    Duration of the surgical procedure
    Time Frame
    Day of Surgery
    Title
    Estimated Blood Loss
    Description
    Estimated blood loss during the operative procedure
    Time Frame
    Day of surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: BMI > 30 kg/m2 No prior ipsilateral hip surgery Osteoarthritis Exclusion Criteria: Patients with grossly distorted bony anatomy whereby standard implants are contraindicated; i.e. congenital dysplasia of the hip, proximal femoral abnormalities, etc Rheumatoid Arthritis
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paul Kim, MD
    Organizational Affiliation
    OHRI
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Minimally Invasive Surgery of the Hip Versus Standard Approach

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