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Periacetabular Osteotomy With Versus Without Adjunctive Hip Arthroscopy (PRSPAO)

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ClinicalTrials.gov Identifier: NCT02790749
Recruitment Status : Unknown
Verified May 2016 by Michael Muldoon, M.D., Sharp HealthCare.
Recruitment status was:  Not yet recruiting
First Posted : June 6, 2016
Last Update Posted : June 6, 2016
Sponsor:
Information provided by (Responsible Party):
Michael Muldoon, M.D., Sharp HealthCare

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.

Condition or disease Intervention/treatment Phase
Hip Dysplasia Procedure: Adjunctive hip arthroscopy to accompany PAO Procedure: PAO without adjunctive hip arthroscopy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Periacetabular Osteotomy With Versus Without Adjunctive Hip Arthroscopy for Intra-Articular Pathology in Hip Dysplasia: a Prospective Randomized Trial
Study Start Date : August 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: PAO with adjunctive hip arthroscopy
Patients undergoing periacetabular osteotomy (PAO) with adjunctive hip arthroscopy.
Procedure: Adjunctive hip arthroscopy to accompany PAO
This is the experimental group: those patients who undergo adjunctive hip arthroscopy in addition to periacetabular osteotomy (PAO).

Active Comparator: PAO WITHOUT adjunctive hip arthroscopy
Patients undergoing periacetabular osteotomy (PAO) WITHOUT adjunctive hip arthroscopy.
Procedure: PAO without adjunctive hip arthroscopy
This is the control group: those patients who undergo periacetabular osteotomy (PAO) alone, without adjunctive hip arthroscopy.




Primary Outcome Measures :
  1. Incidence of reoperation by final follow-up [ Time Frame: One year ]
    Incidence of repeat arthroscopy due to persistent mechanical symptoms after index PAO

  2. NAHS (non-arthritic hip score) [ Time Frame: One year ]
    Absolute value of, and measure of post-operative improvement in, validated questionnaire known as NAHS--Non-Arthritic Hip Score


Secondary Outcome Measures :
  1. iHOT-12: 12-question version of the international Hip Outcome Tool [ Time Frame: one year ]
    questionnaire known as iHOT-12: the 12-question version of the international Hip Outcome Tool

  2. HOS: Hip Outcome Score [ Time Frame: one year ]
    questionnaire known as the HOS: Hip Outcome Score

  3. mHHS: Modified Harris Hip Score [ Time Frame: one year ]
    questionnaire known as mHHS: Modified Harris Hip Score



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790749


Contacts
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Contact: Michael P Muldoon, MD 8582788300 mpmuldoon@cox.net
Contact: Gregory M Gosey, MD, MAS 3037484337 ggosey@gmail.com

Sponsors and Collaborators
Sharp HealthCare
Investigators
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Principal Investigator: Michael P Muldoon, MD Sharp HealthCare

Publications:
Muldoon MP, Santore RF. Abstract presented at Western Orthopedic Association. Adjunctive Hip Arthroscopy with Periacetabular Osteotomy for Hip Dysplasia. 2007.

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Responsible Party: Michael Muldoon, M.D., Staff Physician, Sharp HealthCare
ClinicalTrials.gov Identifier: NCT02790749     History of Changes
Other Study ID Numbers: 1603903
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Michael Muldoon, M.D., Sharp HealthCare:
Developmental hip dysplasia
Intra-articular pathology
Adult hip dysplasia
Labral tear, hip
Chondromalacia, hip
Additional relevant MeSH terms:
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Hip Dislocation
Hip Dislocation, Congenital
Joint Dislocations
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities