PRSPAO: Periacetabular Osteotomy With Versus Without Adjunctive Hip Arthroscopy

Sponsor

Sharp HealthCare (Other)

Overall Status

Unknown status

CT.gov ID

NCT02790749

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hip Dysplasia	Procedure: Adjunctive hip arthroscopy to accompany PAO Procedure: PAO without adjunctive hip arthroscopy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Aug 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Incidence of reoperation by final follow-up [One year]
Incidence of repeat arthroscopy due to persistent mechanical symptoms after index PAO
NAHS (non-arthritic hip score) [One year]
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 [one year]
questionnaire known as iHOT-12: the 12-question version of the international Hip Outcome Tool
HOS: Hip Outcome Score [one year]
questionnaire known as the HOS: Hip Outcome Score
mHHS: Modified Harris Hip Score [one year]
questionnaire known as mHHS: Modified Harris Hip Score

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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)