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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAO with adjunctive hip arthroscopy | Experimental | Patients undergoing periacetabular osteotomy (PAO) with adjunctive hip arthroscopy. |
|
| PAO WITHOUT adjunctive hip arthroscopy | Active Comparator | Patients undergoing periacetabular osteotomy (PAO) WITHOUT adjunctive hip arthroscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjunctive hip arthroscopy to accompany PAO | Procedure | This is the experimental group: those patients who undergo adjunctive hip arthroscopy in addition to periacetabular osteotomy (PAO). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of reoperation by final follow-up | Incidence of repeat arthroscopy due to persistent mechanical symptoms after index PAO | One year |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| HOS: Hip Outcome Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael P Muldoon, MD | Contact | 8582788300 | mpmuldoon@cox.net | |
| Gregory M Gosey, MD, MAS | Contact | 3037484337 | ggosey@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael P Muldoon, MD | Sharp HealthCare | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18196405 | Background | Ganz R, Leunig M, Leunig-Ganz K, Harris WH. The etiology of osteoarthritis of the hip: an integrated mechanical concept. Clin Orthop Relat Res. 2008 Feb;466(2):264-72. doi: 10.1007/s11999-007-0060-z. Epub 2008 Jan 10. | |
| 1670443 | Background | Klaue K, Durnin CW, Ganz R. The acetabular rim syndrome. A clinical presentation of dysplasia of the hip. J Bone Joint Surg Br. 1991 May;73(3):423-9. doi: 10.1302/0301-620X.73B3.1670443. |
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| ID | Term |
|---|---|
| D006617 | Hip Dislocation |
| D000082602 | Developmental Dysplasia of the Hip |
| D002357 | Cartilage Diseases |
| ID | Term |
|---|---|
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
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Not provided
| ID | Term |
|---|---|
| D000097667 | Polyamine Oxidase |
| ID | Term |
|---|---|
| D000587 | Oxidoreductases Acting on CH-NH Group Donors |
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
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| PAO without adjunctive hip arthroscopy | Procedure | This is the control group: those patients who undergo periacetabular osteotomy (PAO) alone, without adjunctive hip arthroscopy. |
|
questionnaire known as the HOS: Hip Outcome Score
| one year |
| mHHS: Modified Harris Hip Score | questionnaire known as mHHS: Modified Harris Hip Score | one year |
| 10379300 | Background | Siebenrock KA, Scholl E, Lottenbach M, Ganz R. Bernese periacetabular osteotomy. Clin Orthop Relat Res. 1999 Jun;(363):9-20. |
| 3383491 | Background | Ganz R, Klaue K, Vinh TS, Mast JW. A new periacetabular osteotomy for the treatment of hip dysplasias. Technique and preliminary results. Clin Orthop Relat Res. 1988 Jul;(232):26-36. |
| 18449617 | Background | 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. |
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| 10379302 | Background | Davey JP, Santore RF. Complications of periacetabular osteotomy. Clin Orthop Relat Res. 1999 Jun;(363):33-7. |
| 20660233 | Background | 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. |
| 23054510 | Background | 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. |
| Background | Muldoon MP, Santore RF. Abstract presented at Western Orthopedic Association. Adjunctive Hip Arthroscopy with Periacetabular Osteotomy for Hip Dysplasia. 2007. |
| 22058293 | Background | Fujii M, Nakashima Y, Noguchi Y, Yamamoto T, Mawatari T, Motomura G, Iwamoto Y. Effect of intra-articular lesions on the outcome of periacetabular osteotomy in patients with symptomatic hip dysplasia. J Bone Joint Surg Br. 2011 Nov;93(11):1449-56. doi: 10.1302/0301-620X.93B11.27314. |
| 24843847 | Background | Domb BG, LaReau J, Redmond JM. Combined hip arthroscopy and periacetabular osteotomy: indications, advantages, technique, and complications. Arthrosc Tech. 2014 Jan 10;3(1):e95-e100. doi: 10.1016/j.eats.2013.09.002. eCollection 2014 Feb. |
| 23395033 | Background | Ginnetti JG, Erickson J, Peters CL. Periacetabular osteotomy: intra-articular work. Instr Course Lect. 2013;62:279-86. |
| 21709035 | Background | 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. |
| 23138238 | Background | 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. |
| 22723243 | Background | 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. No abstract available. |
| 15116646 | Background | McCarthy JC. The diagnosis and treatment of labral and chondral injuries. Instr Course Lect. 2004;53:573-7. |
| 18760208 | Background | 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. |
| 24461141 | Background | 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. |
| 25091227 | Background | 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. |
| 23610683 | Background | Papavasiliou AV, Bardakos NV. Complications of arthroscopic surgery of the hip. Bone Joint Res. 2012 Jul 1;1(7):131-44. doi: 10.1302/2046-3758.17.2000108. Print 2012 Jul. |
| 18719916 | Background | 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. |
| 20844169 | Background | 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. |
| 11249165 | Background | Soderman 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. doi: 10.1097/00003086-200103000-00022. |
| 18984718 | Background | Clohisy JC, Carlisle JC, Beaule PE, Kim YJ, Trousdale RT, Sierra RJ, Leunig M, Schoenecker PL, Millis MB. A systematic approach to the plain radiographic evaluation of the young adult hip. J Bone Joint Surg Am. 2008 Nov;90 Suppl 4(Suppl 4):47-66. doi: 10.2106/JBJS.H.00756. No abstract available. |
| 19341931 | Background | Bond JL, Knutson ZA, Ebert A, Guanche CA. The 23-point arthroscopic examination of the hip: basic setup, portal placement, and surgical technique. Arthroscopy. 2009 Apr;25(4):416-29. doi: 10.1016/j.arthro.2008.08.021. Epub 2008 Nov 22. |
| 21543683 | Background | 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. |
| 16818969 | Background | Burnett RS, Della Rocca GJ, Prather H, Curry M, Maloney WJ, Clohisy JC. Clinical presentation of patients with tears of the acetabular labrum. J Bone Joint Surg Am. 2006 Jul;88(7):1448-57. doi: 10.2106/JBJS.D.02806. |
| 25586913 | Background | Thorborg K, Tijssen M, Habets B, Bartels EM, Roos EM, Kemp J, Crossley KM, Holmich 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. |
| 22542434 | Background | 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. |
| 23544691 | Background | 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. |
| 19028166 | Background | Bedi A, Chen N, Robertson W, Kelly BT. The management of labral tears and femoroacetabular impingement of the hip in the young, active patient. Arthroscopy. 2008 Oct;24(10):1135-45. doi: 10.1016/j.arthro.2008.06.001. |
| D025981 |
| Hip Injuries |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |