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Comparison of Direct Anterior and Posterior Surgical Approaches in Regards to the Patient' Physical Characteristics (MOPHEM)

Primary Purpose

Hip Arthropathy

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The posterolateral approach
Direct anterior technique
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hip Arthropathy focused on measuring hip arthroplasty, surgeries, physical fitness, perception, energetic cost, autonomy

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 50 years
  • Body mass index < 35
  • Scheduled hip arthroplasty surgery
  • Exclusion Criteria:
  • No health coverage
  • Age > 85 years
  • Body mass index ≥ 35
  • Cognitive impairment (score Mini Mental Statue < 24)
  • Any other osteo-articular diseases than the operated hip, any muscular or neurological diseases that could penalize the walk

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    The posterolateral approach

    Direct anterior techniques.

    Arm Description

    The posterolateral approach was used for implantation among patients in lateral position. This approach goes through the gluteus maximus, the piriformis and superior gemeli muscles are detached and later reattached to bone

    . In the direct anterior technique, patients were fixed in a supine position, a small entry incision was made in the vessel free interval between the tensor fasciae latae and the sartorius muscles and the prosthesis socket were put in place. Via a second dorsal incision, after releasing the external rotators, the prosthesis stem and ball were implanted and the two parts of the prosthesis were attached.

    Outcomes

    Primary Outcome Measures

    hip's range of motion.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 5, 2018
    Last Updated
    December 10, 2020
    Sponsor
    Centre Hospitalier Universitaire, Amiens
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03472755
    Brief Title
    Comparison of Direct Anterior and Posterior Surgical Approaches in Regards to the Patient' Physical Characteristics
    Acronym
    MOPHEM
    Official Title
    Subjective Walking Capacity : Comparison of Direct Anterior and Posterior Surgical Approaches in Regards to the Patient' Physical Characteristics (MOPHEM)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    difficulty in setting up the study in the investigator site
    Study Start Date
    March 23, 2018 (Anticipated)
    Primary Completion Date
    December 20, 2019 (Anticipated)
    Study Completion Date
    January 20, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire, Amiens

    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
    Recent increased interest in tissue-sparing and minimally invasive arthroplasty has given rise to a sharp increase in the utilization of direct anterior total hip arthroplasty.
    Detailed Description
    Purpose: The direct anterior approach to the hip has been suggested to have several advantages compared to previously classical approaches. However, no studies focused on the effects of these different surgeries on patients' perception recovery and walking efficiency according the initial physical fitness. Therefore, the purpose of this study is to compare the effects of surgical procedures on perceptual walking skills and efficiency according to the patients' physical fitness. Abstract : Some earlier studies report differences between surgery types in self- reported mobility, functional recovery and residual hip pain. The direct anterior approach to the hip has been suggested to have several advantages compared to previously popular approaches through its use of an intra-muscular and intra-nervous interval between the tensor fasciae latae and sartorius muscles. However, patients' physical fitness, postural response and perceptual walking skill relation was not taking account. 80 patients will be tested, one before and at various times after hip surgery. In randomized conditions, our patients will be divided in two groups, according the surgery approaches and their physical fitness. All patients performed a Performance-Oriented Mobility Assessment Walking test with and without step and the PMA, Harris, Oxford 12 and Womac scores will be evaluated before, 3 weeks, 6 weeks, 3 months and 1 year after the surgery. During the Performance-Oriented Mobility Assessment Walking test, self-reported walking capacity, rating of exertion perception and walking parameters will be measured.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Arthropathy
    Keywords
    hip arthroplasty, surgeries, physical fitness, perception, energetic cost, autonomy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients provided written informed consent to participate in this study, as approved by the local ethics committee. Prior to surgery, patients were informed about the benefits and risk of the conventional posterolateral and direct anterior approaches. Then they performed postural test and a Performance-Oriented Mobility Assessment Walking test with and without step. After randomization, patients were operated according the conventional posterolateral or direct anterior techniques.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    The posterolateral approach
    Arm Type
    Other
    Arm Description
    The posterolateral approach was used for implantation among patients in lateral position. This approach goes through the gluteus maximus, the piriformis and superior gemeli muscles are detached and later reattached to bone
    Arm Title
    Direct anterior techniques.
    Arm Type
    Other
    Arm Description
    . In the direct anterior technique, patients were fixed in a supine position, a small entry incision was made in the vessel free interval between the tensor fasciae latae and the sartorius muscles and the prosthesis socket were put in place. Via a second dorsal incision, after releasing the external rotators, the prosthesis stem and ball were implanted and the two parts of the prosthesis were attached.
    Intervention Type
    Other
    Intervention Name(s)
    The posterolateral approach
    Intervention Description
    The posterolateral approach was used for implantation among patients in lateral position. This approach goes through the gluteus maximus, the piriformis and superior gemeli muscles are detached and later reattached to bone
    Intervention Type
    Other
    Intervention Name(s)
    Direct anterior technique
    Intervention Description
    patients were fixed in a supine position, a small entry incision was made in the vessel free interval between the tensor fasciae latae and the sartorius muscles and the prosthesis socket were put in place. Via a second dorsal incision, after releasing the external rotators, the prosthesis stem and ball were implanted and the two parts of the prosthesis were attached
    Primary Outcome Measure Information:
    Title
    hip's range of motion.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age > 50 years Body mass index < 35 Scheduled hip arthroplasty surgery Exclusion Criteria: No health coverage Age > 85 years Body mass index ≥ 35 Cognitive impairment (score Mini Mental Statue < 24) Any other osteo-articular diseases than the operated hip, any muscular or neurological diseases that could penalize the walk

    12. IPD Sharing Statement

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    Comparison of Direct Anterior and Posterior Surgical Approaches in Regards to the Patient' Physical Characteristics

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