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
|Condition or disease||Intervention/treatment||Phase|
|Hip Dysplasia||Procedure: Adjunctive hip arthroscopy to accompany PAO Procedure: PAO without adjunctive hip arthroscopy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- Incidence of reoperation by final follow-up [ Time Frame: One year ]Incidence of repeat arthroscopy due to persistent mechanical symptoms after index PAO
- 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
- 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
- HOS: Hip Outcome Score [ Time Frame: one year ]questionnaire known as the HOS: Hip Outcome Score
- mHHS: Modified Harris Hip Score [ Time Frame: one year ]questionnaire known as mHHS: Modified Harris Hip Score
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
|Contact: Michael P Muldoon, MDemail@example.com|
|Contact: Gregory M Gosey, MD, MASfirstname.lastname@example.org|
|Principal Investigator:||Michael P Muldoon, MD||Sharp HealthCare|