Periacetabular Osteotomy With Versus Without Adjunctive Hip Arthroscopy

Hip Dysplasia Clinical Trial

— PRSPAO  

Official title:

Periacetabular Osteotomy With Versus Without Adjunctive Hip Arthroscopy for Intra-Articular Pathology in Hip Dysplasia: a Prospective Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02790749
• Other study ID #: 1603903
• Status: Not yet recruiting
• Phase: N/A
• First received: May 18, 2016
• Last updated: June 3, 2016
• Start date: August 2016
• Est. completion date: December 2018

Study information

• Verified date: May 2016
• Source: Sharp HealthCare
• Contact: Michael P Muldoon, MD
• Phone: 8582788300
• Email: mpmuldoon[@]cox.net
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hip Dislocation
• Hip Dislocation, Congenital
• Hip Dysplasia

Intervention

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).
• PAO without adjunctive hip arthroscopy
This is the control group: those patients who undergo periacetabular osteotomy (PAO) alone, without adjunctive hip arthroscopy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sharp HealthCare

References & Publications (33)

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Clohisy JC, Schutz AL, St John L, Schoenecker PL, Wright RW. Periacetabular osteotomy: a systematic literature review. Clin Orthop Relat Res. 2009 Aug;467(8):2041-52. doi: 10.1007/s11999-009-0842-6. Epub 2009 Apr 21. Review. — View Citation

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Ginnetti JG, Erickson J, Peters CL. Periacetabular osteotomy: intra-articular work. Instr Course Lect. 2013;62:279-86. — View Citation

Ginnetti JG, Pelt CE, Erickson JA, Van Dine C, Peters CL. Prevalence and treatment of intraarticular pathology recognized at the time of periacetabular osteotomy for the dysplastic hip. Clin Orthop Relat Res. 2013 Feb;471(2):498-503. doi: 10.1007/s11999-012-2602-2. — View Citation

Griffin DR, Parsons N, Mohtadi NG, Safran MR; Multicenter Arthroscopy of the Hip Outcomes Research Network. A short version of the International Hip Outcome Tool (iHOT-12) for use in routine clinical practice. Arthroscopy. 2012 May;28(5):611-6; quiz 616-8. doi: 10.1016/j.arthro.2012.02.027. — View Citation

Harris JD, McCormick FM, Abrams GD, Gupta AK, Ellis TJ, Bach BR Jr, Bush-Joseph CA, Nho SJ. Complications and reoperations during and after hip arthroscopy: a systematic review of 92 studies and more than 6,000 patients. Arthroscopy. 2013 Mar;29(3):589-95. doi: 10.1016/j.arthro.2012.11.003. Review. — View Citation

Kemp JL, Collins NJ, Makdissi M, Schache AG, Machotka Z, Crossley K. Hip arthroscopy for intra-articular pathology: a systematic review of outcomes with and without femoral osteoplasty. Br J Sports Med. 2012 Jul;46(9):632-43. doi: 10.1136/bjsports-2011-090428. Epub 2011 Dec 22. Review. — View Citation

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Martin RL, Irrgang JJ, Sekiya JK. The diagnostic accuracy of a clinical examination in determining intra-articular hip pain for potential hip arthroscopy candidates. Arthroscopy. 2008 Sep;24(9):1013-8. doi: 10.1016/j.arthro.2008.04.075. Epub 2008 Jun 16. — View Citation

Matheney T, Kim YJ, Zurakowski D, Matero C, Millis M. Intermediate to long-term results following the bernese periacetabular osteotomy and predictors of clinical outcome: surgical technique. J Bone Joint Surg Am. 2010 Sep;92 Suppl 1 Pt 2:115-29. doi: 10.2106/JBJS.J.00646. — View Citation

McCarthy JC. The diagnosis and treatment of labral and chondral injuries. Instr Course Lect. 2004;53:573-7. Review. — View Citation

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

Nassif NA, Schoenecker PL, Thorsness R, Clohisy JC. Periacetabular osteotomy and combined femoral head-neck junction osteochondroplasty: a minimum two-year follow-up cohort study. J Bone Joint Surg Am. 2012 Nov 7;94(21):1959-66. doi: 10.2106/JBJS.K.01038. — View Citation

Nunley RM, Prather H, Hunt D, Schoenecker PL, Clohisy JC. Clinical presentation of symptomatic acetabular dysplasia in skeletally mature patients. J Bone Joint Surg Am. 2011 May;93 Suppl 2:17-21. doi: 10.2106/JBJS.J.01735. — View Citation

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Peters CL, Erickson JA, Anderson MB, Anderson LA. Preservation of the rectus femoris origin during periacetabular osteotomy does not compromise acetabular reorientation. Clin Orthop Relat Res. 2015 Feb;473(2):608-14. doi: 10.1007/s11999-014-3837-x. — View Citation

Peters CL, Sierra RJ; Session Participants. Report of breakout session: Intraarticular work during periacetabular osteotomy--simultaneous arthrotomy or hip arthroscopy? Clin Orthop Relat Res. 2012 Dec;470(12):3456-8. doi: 10.1007/s11999-012-2414-4. — View Citation

Redmond JM, Gupta A, Stake CE, Domb BG. The prevalence of hip labral and chondral lesions identified by method of detection during periacetabular osteotomy: arthroscopy versus arthrotomy. Arthroscopy. 2014 Mar;30(3):382-8. doi: 10.1016/j.arthro.2013.11.013. Epub 2014 Jan 22. Review. — View Citation

Ross JR, Zaltz I, Nepple JJ, Schoenecker PL, Clohisy JC. Arthroscopic disease classification and interventions as an adjunct in the treatment of acetabular dysplasia. Am J Sports Med. 2011 Jul;39 Suppl:72S-8S. doi: 10.1177/0363546511412320. — View Citation

Sambandam SN, Hull J, Jiranek WA. Factors predicting the failure of Bernese periacetabular osteotomy: a meta-regression analysis. Int Orthop. 2009 Dec;33(6):1483-8. doi: 10.1007/s00264-008-0643-7. Epub 2008 Aug 22. — View Citation

Siebenrock KA, Schöll E, Lottenbach M, Ganz R. Bernese periacetabular osteotomy. Clin Orthop Relat Res. 1999 Jun;(363):9-20. — View Citation

Söderman P, Malchau H. Is the Harris hip score system useful to study the outcome of total hip replacement? Clin Orthop Relat Res. 2001 Mar;(384):189-97. — View Citation

Steppacher SD, Tannast M, Ganz R, Siebenrock KA. Mean 20-year followup of Bernese periacetabular osteotomy. Clin Orthop Relat Res. 2008 Jul;466(7):1633-44. doi: 10.1007/s11999-008-0242-3. Epub 2008 May 1. — View Citation

Thawrani D, Sucato DJ, Podeszwa DA, DeLaRocha A. Complications associated with the Bernese periacetabular osteotomy for hip dysplasia in adolescents. J Bone Joint Surg Am. 2010 Jul 21;92(8):1707-14. doi: 10.2106/JBJS.I.00829. — View Citation

Thorborg K, Tijssen M, Habets B, Bartels EM, Roos EM, Kemp J, Crossley KM, Hölmich P. Patient-Reported Outcome (PRO) questionnaires for young to middle-aged adults with hip and groin disability: a systematic review of the clinimetric evidence. Br J Sports Med. 2015 Jun;49(12):812. doi: 10.1136/bjsports-2014-094224. Epub 2015 Jan 13. Review. — View Citation

* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of reoperation by final follow-up	Incidence of repeat arthroscopy due to persistent mechanical symptoms after index PAO	One year	No
Primary	NAHS (non-arthritic hip score)	Absolute value of, and measure of post-operative improvement in, validated questionnaire known as NAHS--Non-Arthritic Hip Score	One year	No
Secondary	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	one year	No
Secondary	HOS: Hip Outcome Score	questionnaire known as the HOS: Hip Outcome Score	one year	No
Secondary	mHHS: Modified Harris Hip Score	questionnaire known as mHHS: Modified Harris Hip Score	one year	No