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
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
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
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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