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Mild Hip Dysplasia

Primary Purpose

Hip Dysplasia

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hip Arthroscopy
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Dysplasia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of symptomatic mild DDH
  • Lateral center-edge angle 18° - 25° and/or Tӧnnis angle 8° - 15°
  • Skeletally mature
  • Age 18 - 45
  • Tonnis Grade 0 or 1 osteoarthritis (minimal or no arthritis)
  • Ability to receive a standard of care preoperative MRI arthrogram of the hip

Exclusion Criteria:

  • Pregnant women
  • Neurogenic dysplasia
  • Legg-Calvé-Perthes disease
  • Previous surgery about the hip including previous hip arthroscopy to address intra-articular pathology

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Hip Arthroscopy (HA)

    Periacetabular Osteootmy (PAO)

    Arm Description

    This approach addresses intraarticular pathology in the form of labral tears and cartilage that are often concomitant with DDH 3. Furthermore, capsular plication can be performed through HA to reduce instability of the joint.

    The Bernese periacetabular osteotomy (PAO) remains the gold standard for treatment of symptomatic developmental dysplasia of the hip (DDH) in most patients with closed triradiate cartilage. First developed by Ganz in 1984, this technique utilizes 4 osteotomies to completely mobilize the acetabular fragment 1. Although a technically demanding procedure, it allows optimal correction in all planes and maintains integrity of the posterior column, enabling early weight bearing and mobilization.

    Outcomes

    Primary Outcome Measures

    The Forgotten Joint Score-12 (FJS-12)
    Outcome

    Secondary Outcome Measures

    Full Information

    First Posted
    April 9, 2018
    Last Updated
    February 23, 2019
    Sponsor
    Mayo Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03530878
    Brief Title
    Mild Hip Dysplasia
    Official Title
    Periacetabular Osteotomy Versus Arthroscopic Management of Mild Hip Dysplasia: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No enrollment
    Study Start Date
    June 1, 2018 (Actual)
    Primary Completion Date
    January 11, 2019 (Actual)
    Study Completion Date
    January 11, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mayo Clinic

    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
    Hip dysplasia is a complex problem that exists on a spectrum from mild to severe disease. Periacetabular osteotomy (PAO) remains the gold standard for most patients with dysplasia; however, the procedure is quite invasive making the decision to proceed in cases of mild disease difficult. Hip arthroscopy (HA) is an alternative minimally invasive technique that can be used to address mild dysplasia. Nevertheless, HA has less capability for correction and in rare instances can exacerbate instability in the dysplastic hip. There is a paucity of data examining outcomes between these two treatment strategies for this challenging problem.
    Detailed Description
    The Bernese periacetabular osteotomy (PAO) remains the gold standard for treatment of symptomatic developmental dysplasia of the hip (DDH) in most patients with closed triradiate cartilage. First developed by Ganz in 1984, this technique utilizes 4 osteotomies to completely mobilize the acetabular fragment 1. Although a technically demanding procedure, it allows optimal correction in all planes and maintains integrity of the posterior column, enabling early weight bearing and mobilization. Several groups have confirmed the long-term efficacy of this joint preservation procedure with a recent report from the inventing institution documented impressive survivorship up to 30 years after surgery 2. Treatment with PAO is more controversial for mild forms of dysplasia where the lateral center-edge angle (LCEA) is 18° - 25° and/or the Tӧnnis angle is 8° - 15°. In these patients the delta correction is more limited, thus creating a more unpredictable result with equally invasive surgery.

    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
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hip Arthroscopy (HA)
    Arm Type
    Experimental
    Arm Description
    This approach addresses intraarticular pathology in the form of labral tears and cartilage that are often concomitant with DDH 3. Furthermore, capsular plication can be performed through HA to reduce instability of the joint.
    Arm Title
    Periacetabular Osteootmy (PAO)
    Arm Type
    No Intervention
    Arm Description
    The Bernese periacetabular osteotomy (PAO) remains the gold standard for treatment of symptomatic developmental dysplasia of the hip (DDH) in most patients with closed triradiate cartilage. First developed by Ganz in 1984, this technique utilizes 4 osteotomies to completely mobilize the acetabular fragment 1. Although a technically demanding procedure, it allows optimal correction in all planes and maintains integrity of the posterior column, enabling early weight bearing and mobilization.
    Intervention Type
    Procedure
    Intervention Name(s)
    Hip Arthroscopy
    Intervention Description
    Intraarticular pathology in the form of labral tears and cartilage that are often concomitant with DDH
    Primary Outcome Measure Information:
    Title
    The Forgotten Joint Score-12 (FJS-12)
    Description
    Outcome
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of symptomatic mild DDH Lateral center-edge angle 18° - 25° and/or Tӧnnis angle 8° - 15° Skeletally mature Age 18 - 45 Tonnis Grade 0 or 1 osteoarthritis (minimal or no arthritis) Ability to receive a standard of care preoperative MRI arthrogram of the hip Exclusion Criteria: Pregnant women Neurogenic dysplasia Legg-Calvé-Perthes disease Previous surgery about the hip including previous hip arthroscopy to address intra-articular pathology
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rafael J Sierra
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    https://www.mayo.edu/research/clinical-trials
    Description
    Mayo Clinic Clinical Trials

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    Mild Hip Dysplasia

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