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Periacetabular Osteotomy With Versus Without Adjunctive Hip Arthroscopy (PRSPAO)

Primary Purpose

Hip Dysplasia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Adjunctive hip arthroscopy to accompany PAO
PAO without adjunctive hip arthroscopy
Sponsored by
Sharp HealthCare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Dysplasia focused on measuring Developmental hip dysplasia, Intra-articular pathology, Adult hip dysplasia, Labral tear, hip, Chondromalacia, hip

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages 18 to 50
  • Moderate or severe dysplasia by radiographic parameters
  • Physical examination and/or MR arthrography consistent with intra-articular pathology (equivocal or even negative MR arthrogram for labral tear, chondral flap, ligamentum teres tear, or osteochondral defect, is not grounds for exclusion, since broadly spaced "cuts" of MR imaging may miss small tears)
  • English- or Spanish-speaking
  • signed written informed consent for surgery and for research prior to surgery

Exclusion Criteria:

  • Tönnis grade II or III arthritis at baseline
  • MR cartilage imaging indicating severe arthritis
  • Prior surgery on the same hip
  • Contralateral lower limb pathology that threatens validity of outcomes measures directed at the operative hip
  • History of thromboembolic disease in the lower extremity, pulmonary embolus, or pre-existing thrombophilic blood disorder
  • Inability to participate in or comply with appropriate rehabilitation protocols
  • Inability to comprehend and follow instructions, or mental incapacity barring consent
  • Pregnant women
  • Lost to follow-up before one year, unless total hip replacement performed before one year (then included for survival analysis)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    PAO with adjunctive hip arthroscopy

    PAO WITHOUT adjunctive hip arthroscopy

    Arm Description

    Patients undergoing periacetabular osteotomy (PAO) with adjunctive hip arthroscopy.

    Patients undergoing periacetabular osteotomy (PAO) WITHOUT adjunctive hip arthroscopy.

    Outcomes

    Primary Outcome Measures

    Incidence of reoperation by final follow-up
    Incidence of repeat arthroscopy due to persistent mechanical symptoms after index PAO
    NAHS (non-arthritic hip score)
    Absolute value of, and measure of post-operative improvement in, validated questionnaire known as NAHS--Non-Arthritic Hip Score

    Secondary Outcome Measures

    iHOT-12: 12-question version of the international Hip Outcome Tool
    questionnaire known as iHOT-12: the 12-question version of the international Hip Outcome Tool
    HOS: Hip Outcome Score
    questionnaire known as the HOS: Hip Outcome Score
    mHHS: Modified Harris Hip Score
    questionnaire known as mHHS: Modified Harris Hip Score

    Full Information

    First Posted
    May 18, 2016
    Last Updated
    June 3, 2016
    Sponsor
    Sharp HealthCare
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02790749
    Brief Title
    Periacetabular Osteotomy With Versus Without Adjunctive Hip Arthroscopy
    Acronym
    PRSPAO
    Official Title
    Periacetabular Osteotomy With Versus Without Adjunctive Hip Arthroscopy for Intra-Articular Pathology in Hip Dysplasia: a Prospective Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2016 (undefined)
    Primary Completion Date
    December 2017 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sharp HealthCare

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Although evidence is amassing regarding the role of intra-articular pathology in the surgical management of adolescents and adults with hip dysplasia, the optimal method of detection and especially management of this pathology remains unclear. No studies exist to compare clinical outcomes and hip survival between arthroscopy and arthrotomy in patients with mechanical hip pain undergoing periacetabular osteotomy (PAO) for dysplasia, and this is what the investigators aim to achieve in the current prospective randomized surgical trial.
    Detailed Description
    Developmental dysplasia of the hip is an increasingly well-recognized problem in adolescents, young adults, and middle-age adults. Surgical correction with periacetabular osteotomy (PAO) gives good results at moderate-term follow-up, according to recent studies. Increasingly recognized also is the presence of intra-articular sources of hip pain in these patients, such as cartilage disease and labral pathology. These can manifest as certain clinical and radiologic findings pre-operatively. However, the role of operative management of these problems, and specifically the role of arthroscopy, remains unclear. Historically, intra-articular pathology in patients with dysplasia has been managed with open incision of the joint capsule (arthrotomy) toward the end of the PAO procedure. However, recent evidence suggests that this open arthrotomy may be missing the detection of subtle intra-articular pathology and that arthroscopy immediately prior to PAO, under the same anesthetic, may be a safe and highly effective management strategy. The exact clinical implications of these subtle findings are not yet clear. In this prospective randomized comparative effectiveness study, the investigators aim to compare clinical and surgical outcomes measures including rates of reoperation and the patient reported outcomes measures (PROMs) non-arthritic hip score (NAHS), Hip Outcome Score (HOS), modified Harris Hip Score (mHHS), iHOT-12 score, between two groups of patients (N=22 per parallel arm) undergoing PAO for dysplasia: those randomized to arthroscopy with PAO versus those randomized to PAO alone. The investigators aim to elucidate the degree of clinical benefit of improved detection and management of intra-articular pathology afforded by arthroscopy versus PAO with arthrotomy alone at follow-up of a minimum of one year. Rates of reoperation and PROMs will be assessed at one year post-operatively and at the conclusion of the study two years after enrollment of the first patient. PROMs will also be assessed at 3 and 6 months post-operatively to allow repeated-measures analysis in measuring improvement from pre-operative values.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Dysplasia
    Keywords
    Developmental hip dysplasia, Intra-articular pathology, Adult hip dysplasia, Labral tear, hip, Chondromalacia, hip

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    44 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PAO with adjunctive hip arthroscopy
    Arm Type
    Experimental
    Arm Description
    Patients undergoing periacetabular osteotomy (PAO) with adjunctive hip arthroscopy.
    Arm Title
    PAO WITHOUT adjunctive hip arthroscopy
    Arm Type
    Active Comparator
    Arm Description
    Patients undergoing periacetabular osteotomy (PAO) WITHOUT adjunctive hip arthroscopy.
    Intervention Type
    Procedure
    Intervention Name(s)
    Adjunctive hip arthroscopy to accompany PAO
    Intervention Description
    This is the experimental group: those patients who undergo adjunctive hip arthroscopy in addition to periacetabular osteotomy (PAO).
    Intervention Type
    Procedure
    Intervention Name(s)
    PAO without adjunctive hip arthroscopy
    Intervention Description
    This is the control group: those patients who undergo periacetabular osteotomy (PAO) alone, without adjunctive hip arthroscopy.
    Primary Outcome Measure Information:
    Title
    Incidence of reoperation by final follow-up
    Description
    Incidence of repeat arthroscopy due to persistent mechanical symptoms after index PAO
    Time Frame
    One year
    Title
    NAHS (non-arthritic hip score)
    Description
    Absolute value of, and measure of post-operative improvement in, validated questionnaire known as NAHS--Non-Arthritic Hip Score
    Time Frame
    One year
    Secondary Outcome Measure Information:
    Title
    iHOT-12: 12-question version of the international Hip Outcome Tool
    Description
    questionnaire known as iHOT-12: the 12-question version of the international Hip Outcome Tool
    Time Frame
    one year
    Title
    HOS: Hip Outcome Score
    Description
    questionnaire known as the HOS: Hip Outcome Score
    Time Frame
    one year
    Title
    mHHS: Modified Harris Hip Score
    Description
    questionnaire known as mHHS: Modified Harris Hip Score
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ages 18 to 50 Moderate or severe dysplasia by radiographic parameters Physical examination and/or MR arthrography consistent with intra-articular pathology (equivocal or even negative MR arthrogram for labral tear, chondral flap, ligamentum teres tear, or osteochondral defect, is not grounds for exclusion, since broadly spaced "cuts" of MR imaging may miss small tears) English- or Spanish-speaking signed written informed consent for surgery and for research prior to surgery Exclusion Criteria: Tönnis grade II or III arthritis at baseline MR cartilage imaging indicating severe arthritis Prior surgery on the same hip Contralateral lower limb pathology that threatens validity of outcomes measures directed at the operative hip History of thromboembolic disease in the lower extremity, pulmonary embolus, or pre-existing thrombophilic blood disorder Inability to participate in or comply with appropriate rehabilitation protocols Inability to comprehend and follow instructions, or mental incapacity barring consent Pregnant women Lost to follow-up before one year, unless total hip replacement performed before one year (then included for survival analysis)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michael P Muldoon, MD
    Phone
    8582788300
    Email
    mpmuldoon@cox.net
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gregory M Gosey, MD, MAS
    Phone
    3037484337
    Email
    ggosey@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael P Muldoon, MD
    Organizational Affiliation
    Sharp HealthCare
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
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    Periacetabular Osteotomy With Versus Without Adjunctive Hip Arthroscopy

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