Arthroscopic Labral Repair Versus Physical Therapy for Tears of the Acetabular Labrum

Osteoarthritis, Hip Clinical Trial

Official title:

Arthroscopic Labral Repair Versus Physical Therapy for Tears of the Acetabular Labrum in Patients Age 40 and Older

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03909178
• Other study ID #: 2013P001442
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 21, 2013
• Est. completion date: June 2030

Study information

• Verified date: April 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Tears of the acetabular labrum appear to be common with the prevalence of asymptomatic tears in the general population approaching 66% and 70% based on cadaveric dissection and magnetic resonance imaging, respectively. Despite this prevalence, there is no currently accepted justification for performing labral repair in an asymptomatic patient despite the many postulated biomechanical benefits that an intact labrum imparts to the hip joint.

Representing a smaller proportion of all tears, symptomatic tears of the acetabular labrum present a therapeutic challenge. Current treatment modalities range from conservative measures to open surgical intervention. Conservative measures have typically included: activity modification, the use of non-steroidal anti-inflammatory drugs (NSAIDs), physical therapy (PT), core strengthening and improvement of sensory motor control. In the past two decades, technological advances in the form of surgical instrumentation and traction devices have facilitated less invasive arthroscopic techniques to diagnose and treat hip problems and as such is now the preferred treatment modality for many orthopedic surgeons treating patients with hip pathology.

Determining which patients, using age and arthritic burden as predictors, can benefit from labral repair is paramount for several reasons. Showing arthroscopic repair is of little or no benefit to a specific cohort can reduce the number of unnecessary surgeries performed, increase the use of conservative therapy (if validated) and reduce the interval between diagnosis and total hip replacement.

Description:

There has been only one prospective study documenting the outcomes of patients treated with physical therapy for intra-articular conditions of the hip. These conditions included mild FAI and mild developmental dysplasia of the hip. Here, physical therapy was given as a first line treatment. Those who did not make satisfactory improvements in pain or wished to have surgery were then scheduled for surgery to repair the defects. Patients saw improvement in validated outcome measures at one year.

Although there have been studies looking at age secondarily in patients with labral tears, there is no prospective evidence to endorse or refute a recommendation of hip arthroscopy for patients of any age being treated for a tear of the acetabular labrum.

Most recently, the authors involved in this study performed a retrospective investigation (unpublished data) to capture patients with clinically and radiographically confirmed acetabular labral pathology electing to undergo conservative management defined as the refusal of surgical intervention. Based on a retrospective review of 894 patients presenting to clinic over a 10-year period, the investigators identified 22 patients with labral pathology that were treated non-operatively. Retrospective case control analysis was performed using outcome questionnaires administered to both surgical and non-surgical cohorts. The investigators found that patients with labral tears managed non-operatively appear to score highly on hip function outcome scores, preliminarily indicating there may be some benefit in using conservative management alone in the treatment of labral pathology.

This is a 12-month prospective randomized control trial (RCT), which will enroll 121 subjects with evidence consistent with a tear of the acetabular labrum. Labral tear will be diagnosed by clinical exam and positive MRI findings. Subjects will receive conservative physical therapy treatment alone or arthroscopic surgical labral repair and physical therapy. The investigators anticipate that pain, range of motion, activity level, and functional performance, as judged by validated outcome measures and serial physical exams, will improve when compared to baseline. The investigators also anticipate that the level of response will be greater in the surgical treatment group than in the physical therapy group at 12 months.

Our Primary Outcome is change in the modified Harris Hip Score at 12 months. Secondary outcomes include changes in other outcomes measures (LEFS, HOS, NAHS, iHOT-33), patient satisfaction, degree of improvement on physical exam, longer-term functional outcomes (i.e., at 2, 5, and 10 years), and the influence of OA severity (Outerbridge scoring) and location on the aforementioned outcome measures.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: June 2030
• Est. primary completion date: June 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 40 or greater: higher likelihood or undetectable OA on imaging

2. Symptoms consistent with a tear of the acetabular labrum (at least one: catching, clicking, popping, pain with sitting, episodic pain, pain with hip flexion, adduction, and/or internal rotation): asymptomatic labral tears do exist in the general population however there is not definitive evidence to suggest treatment of asymptomatic tears is beneficial.

3. Symptoms not due to some other acute process in or around the hip (including septic arthritis, osteonecrosis, hemarthrosis, iliotibial band syndrome, fractures of the femoral neck or head, fractures of the acetabulum, greater trochanteric pain syndrome, sacroiliac joint pain, piriformis syndrome, low back pain associated with hip pain and not knee nor acute low back injury): certain conditions are not treatable by either arthroscopy or physical therapy. Some of these conditions can be managed with physical therapy but not arthroscopy.

4. Availability of hip radiographs and MRI: needed to assess eligibility

5. Evidence on MRI of a tear of the acetabular labrum: documentation of acetabular labrum tear

6. Willingness to undergo randomization and ability to understand and sign informed consent document: ability to understand study and consent willingly

Exclusion Criteria:

1. Less than 2 mm of joint space on standing plain anterior-posterior radiographs of the hip: indicative of severe osteoarthritic disease and the patient would benefit more from a total hip replacement

2. Developmental dysplasia of the hip: distorted acetabular anatomy and biomechanics

3. Kellgren-Lawrence Grade 4 changes: classified as large osteophytes, marked narrowing of joint space, severe sclerosis, and definite deformity of bone contour; indicative of severe OA

4. Tonnis Grade 3 changes: classified as large cysts in the head or acetabulum, severe narrowing or obliteration of the joint space, severe deformity of the head, and necrosis; indicative of OA

5. Unexpected pathology at the time of arthroscopy: source of pain less likely to due dysfunction of the labrum and more likely due to aberrant extra-articular biology

6. Same site surgery: complex anatomy

7. Back pain greater than hip pain or back pain associated with leg symptoms below the knee: source of pain less likely to be originating from the hip and more likely to be referred from the back/spine

8. Back pain associated with positive neural tension signs e.g. positive slump test, positive SLR (straight leg raise), positive reflex changes or drop foot: source of pain less likely to be originating from the hip and more likely to be referred from the back/spine

9. Knee pain greater than hip pain: source of pain less likely to be originating from the hip and more likely to referred from the knee

10. Bilateral tears of the acetabular labrum: difficult to gauge patient progress after treatment

11. Contraindication to surgery or physical therapy: cannot tolerate either treatment grouping

12. Alternate form of PT for greater than 6 weeks: will negatively augment results. May affect recruitment.

Related Conditions & MeSH terms

• Acetabular Labrum Tear
• Femoracetabular Impingement
• Femoro Acetabular Impingement
• Hip Arthroscopy
• Osteoarthritis
• Osteoarthritis, Hip
• Physical Therapy

Intervention

Procedure:
• Hip Arthroscopy Surgery with Acetabular Labral Repair (SPT group)
Patients randomized to the SPT group provided consent for arthroscopic acetabular labral repair with femoroacetabular osteoplasty. As previously described in various technique publications from our group, the senior surgeon's (S.D.M.) hip arthroscopy technique includes intra-articular fluid distension for initial portal placement, puncture capsulotomy, autograft capsular augmentation if insufficient or degenerative labral tissue is encountered, intermittent traction, sparing use of electrocautery, and preservation of the chrondrolabral junction. All SPT patients underwent a standardized postoperative physical therapy protocol developed jointly by the senior author (a sports medicine fellowship-trained orthopaedic surgeon) and the physical therapists. Patients were kept weightbearing as tolerated on crutches for 6 weeks to maintain a level pelvis without lurching when walking and were instructed to avoid impact loading exercises for 6 months.
• Physical Therapy Focused on the Hip and Hemi-pelvis (PT group)
PTA patients were assigned a standardized, 24-week course of supervised, core-based PT. This course was designed in concert with physical therapists within our institution to help address symptoms of labral tear in patients older than 40 who had mild to moderate OA. Weeks 1 and 2 focused on normalizing gait, and weeks 3 through 24 focused on optimizing range of motion (ROM) while slowly integrating strength training. Unlike the prerandomization PT protocol, the PTA protocol was predominantly physical therapist-supervised (at least 1 in-person visit per week).

Locations

Country	Name	City	State
United States	MGH, Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (62)

Alexander JW, Crawford MJ, Vega CE, Thompson MT, Miller AR, Noble PC. The impact of labral tears on the stability of the hip joint. Trans Orthop Res Soc. 2007; 32:71.

Aprato A, Jayasekera N, Villar RN. Does the modified Harris hip score reflect patient satisfaction after hip arthroscopy? Am J Sports Med. 2012 Nov;40(11):2557-60. doi: 10.1177/0363546512460650. Epub 2012 Sep 28. — View Citation

Beck M, Kalhor M, Leunig M, Ganz R. Hip morphology influences the pattern of damage to the acetabular cartilage: femoroacetabular impingement as a cause of early osteoarthritis of the hip. J Bone Joint Surg Br. 2005 Jul;87(7):1012-8. doi: 10.1302/0301-620X.87B7.15203. — View Citation

Beck M, Leunig M, Parvizi J, Boutier V, Wyss D, Ganz R. Anterior femoroacetabular impingement: part II. Midterm results of surgical treatment. Clin Orthop Relat Res. 2004 Jan;(418):67-73. — View Citation

Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83. — View Citation

Byrd JW, Jones KS. Prospective analysis of hip arthroscopy with 2-year follow-up. Arthroscopy. 2000 Sep;16(6):578-87. doi: 10.1053/jars.2000.7683. — View Citation

Byrd JW. The role of hip arthroscopy in the athletic hip. Clin Sports Med. 2006 Apr;25(2):255-78, viii. doi: 10.1016/j.csm.2005.12.007. — View Citation

Christensen CP, Althausen PL, Mittleman MA, Lee JA, McCarthy JC. The nonarthritic hip score: reliable and validated. Clin Orthop Relat Res. 2003 Jan;(406):75-83. doi: 10.1097/01.blo.0000043047.84315.4b. — View Citation

Clohisy JC, Carlisle JC, Trousdale R, Kim YJ, Beaule PE, Morgan P, Steger-May K, Schoenecker PL, Millis M. Radiographic evaluation of the hip has limited reliability. Clin Orthop Relat Res. 2009 Mar;467(3):666-75. doi: 10.1007/s11999-008-0626-4. Epub 2008 Dec 2. — View Citation

Clohisy JC, Keeney JA, Schoenecker PL. Preliminary assessment and treatment guidelines for hip disorders in young adults. Clin Orthop Relat Res. 2005 Dec;441:168-79. doi: 10.1097/01.blo.0000193511.91643.2a. — View Citation

Cohen, J. Statistical power analysis for behavioral studies. (2nd ed). New Jersey: Lawrence Erlbaum.

Crawford MJ, Dy CJ, Alexander JW, Thompson M, Schroder SJ, Vega CE, Patel RV, Miller AR, McCarthy JC, Lowe WR, Noble PC. The 2007 Frank Stinchfield Award. The biomechanics of the hip labrum and the stability of the hip. Clin Orthop Relat Res. 2007 Dec;465:16-22. doi: 10.1097/BLO.0b013e31815b181f. — View Citation

Egerton T, Hinman RS, Takla A, Bennell KL, O'Donnell J. Intraoperative cartilage degeneration predicts outcome 12 months after hip arthroscopy. Clin Orthop Relat Res. 2013 Feb;471(2):593-9. doi: 10.1007/s11999-012-2594-y. Epub 2012 Sep 20. — View Citation

Emara K, Samir W, Motasem el H, Ghafar KA. Conservative treatment for mild femoroacetabular impingement. J Orthop Surg (Hong Kong). 2011 Apr;19(1):41-5. doi: 10.1177/230949901101900109. — View Citation

Enseki KR, Martin RL, Draovitch P, Kelly BT, Philippon MJ, Schenker ML. The hip joint: arthroscopic procedures and postoperative rehabilitation. J Orthop Sports Phys Ther. 2006 Jul;36(7):516-25. doi: 10.2519/jospt.2006.2138. — View Citation

Farr J, Cole B, Dhawan A, Kercher J, Sherman S. Clinical cartilage restoration: evolution and overview. Clin Orthop Relat Res. 2011 Oct;469(10):2696-705. doi: 10.1007/s11999-010-1764-z. — View Citation

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. — 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

Groh MM, Herrera J. A comprehensive review of hip labral tears. Curr Rev Musculoskelet Med. 2009 Jun;2(2):105-17. doi: 10.1007/s12178-009-9052-9. Epub 2009 Apr 7. — View Citation

Haemer JM, Carter DR, Giori NJ. The low permeability of healthy meniscus and labrum limit articular cartilage consolidation and maintain fluid load support in the knee and hip. J Biomech. 2012 May 11;45(8):1450-6. doi: 10.1016/j.jbiomech.2012.02.015. Epub 2012 Mar 3. — View Citation

Horisberger M, Brunner A, Herzog RF. Arthroscopic treatment of femoral acetabular impingement in patients with preoperative generalized degenerative changes. Arthroscopy. 2010 May;26(5):623-9. doi: 10.1016/j.arthro.2009.09.003. Epub 2010 Feb 11. — View Citation

Hunt D, Prather H, Harris Hayes M, Clohisy JC. Clinical outcomes analysis of conservative and surgical treatment of patients with clinical indications of prearthritic, intra-articular hip disorders. PM R. 2012 Jul;4(7):479-87. doi: 10.1016/j.pmrj.2012.03.012. Epub 2012 May 16. — View Citation

Hunter DJ. Insights from imaging on the epidemiology and pathophysiology of osteoarthritis. Radiol Clin North Am. 2009 Jul;47(4):539-51. doi: 10.1016/j.rcl.2009.03.004. — View Citation

Jerosch J, Schunck J, Khoja A. Arthroscopic treatment of the hip in early and midstage degenerative joint disease. Knee Surg Sports Traumatol Arthrosc. 2006 Jul;14(7):641-5. doi: 10.1007/s00167-005-0009-2. Epub 2005 Dec 14. — View Citation

Katz JN, Brophy RH, Chaisson CE, de Chaves L, Cole BJ, Dahm DL, Donnell-Fink LA, Guermazi A, Haas AK, Jones MH, Levy BA, Mandl LA, Martin SD, Marx RG, Miniaci A, Matava MJ, Palmisano J, Reinke EK, Richardson BE, Rome BN, Safran-Norton CE, Skoniecki DJ, Solomon DH, Smith MV, Spindler KP, Stuart MJ, Wright J, Wright RW, Losina E. Surgery versus physical therapy for a meniscal tear and osteoarthritis. N Engl J Med. 2013 May 2;368(18):1675-84. doi: 10.1056/NEJMoa1301408. Epub 2013 Mar 18. Erratum In: N Engl J Med. 2013 Aug 15;369(7):683. — View Citation

Katz JN, Chaisson CE, Cole B, Guermazi A, Hunter DJ, Jones M, Levy BA, Mandl LA, Martin S, Marx RG, Safran-Norton C, Roemer FW, Skoniecki D, Solomon DH, Spindler KP, Wright J, Wright RW, Losina E. The MeTeOR trial (Meniscal Tear in Osteoarthritis Research): rationale and design features. Contemp Clin Trials. 2012 Nov;33(6):1189-96. doi: 10.1016/j.cct.2012.08.010. Epub 2012 Sep 5. — View Citation

Kellgren JH, Jeffrey MR, Ball J. The Epidemiology of Chronic Rheumatism. Atlas of Standard Radiographs of Arthritis. Oxford, UK: Blackwell Scientific Publications; 1963:vii-11.

Kelly BT, Weiland DE, Schenker ML, Philippon MJ. Arthroscopic labral repair in the hip: surgical technique and review of the literature. Arthroscopy. 2005 Dec;21(12):1496-504. doi: 10.1016/j.arthro.2005.08.013. — 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. — View Citation

Khanduja V, Villar RN. Arthroscopic surgery of the hip: current concepts and recent advances. J Bone Joint Surg Br. 2006 Dec;88(12):1557-66. doi: 10.1302/0301-620X.88B12.18584. — View Citation

Kim KC, Hwang DS, Lee CH, Kwon ST. Influence of femoroacetabular impingement on results of hip arthroscopy in patients with early osteoarthritis. Clin Orthop Relat Res. 2007 Mar;456:128-32. doi: 10.1097/01.blo.0000246542.49574.2c. — View Citation

Kopjar B. The SF-36 health survey: a valid measure of changes in health status after injury. Inj Prev. 1996 Jun;2(2):135-9. doi: 10.1136/ip.2.2.135. — View Citation

Larson CM, Giveans MR, Taylor M. Does arthroscopic FAI correction improve function with radiographic arthritis? Clin Orthop Relat Res. 2011 Jun;469(6):1667-76. doi: 10.1007/s11999-010-1741-6. Epub 2010 Dec 22. — View Citation

Lawrence RC, Felson DT, Helmick CG, Arnold LM, Choi H, Deyo RA, Gabriel S, Hirsch R, Hochberg MC, Hunder GG, Jordan JM, Katz JN, Kremers HM, Wolfe F; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008 Jan;58(1):26-35. doi: 10.1002/art.23176. — View Citation

Lewis CL, Sahrmann SA. Acetabular labral tears. Phys Ther. 2006 Jan;86(1):110-21. doi: 10.1093/ptj/86.1.110. No abstract available. — View Citation

Longo UG, Franceschetti E, Maffulli N, Denaro V. Hip arthroscopy: state of the art. Br Med Bull. 2010;96:131-57. doi: 10.1093/bmb/ldq018. Epub 2010 Jul 6. — View Citation

Madhusudhan TR, Kumar TM, Bastawrous SS, Sinha A. Clinical examination, MRI and arthroscopy in meniscal and ligamentous knee Injuries - a prospective study. J Orthop Surg Res. 2008 May 19;3:19. doi: 10.1186/1749-799X-3-19. — View Citation

Margheritini F, Villar RN. The efficacy of arthroscopy in the treatment of hip osteoarthritis. Chir Organi Mov. 1999 Jul-Sep;84(3):257-61. English, Italian. — View Citation

Martin RL, Kelly BT, Philippon MJ. Evidence of validity for the hip outcome score. Arthroscopy. 2006 Dec;22(12):1304-11. doi: 10.1016/j.arthro.2006.07.027. — View Citation

Martin RL, Philippon MJ. Evidence of reliability and responsiveness for the hip outcome score. Arthroscopy. 2008 Jun;24(6):676-82. doi: 10.1016/j.arthro.2007.12.011. Epub 2008 Mar 12. — View Citation

McCarthy JC, Jarrett BT, Ojeifo O, Lee JA, Bragdon CR. What factors influence long-term survivorship after hip arthroscopy? Clin Orthop Relat Res. 2011 Feb;469(2):362-71. doi: 10.1007/s11999-010-1559-2. — View Citation

McCarthy JC, Lee J. Hip arthroscopy: indications and technical pearls. Clin Orthop Relat Res. 2005 Dec;441:180-7. doi: 10.1097/01.blo.0000195057.27653.93. — View Citation

McCormick F, Nwachukwu BU, Alpaugh K, Martin SD. Predictors of hip arthroscopy outcomes for labral tears at minimum 2-year follow-up: the influence of age and arthritis. Arthroscopy. 2012 Oct;28(10):1359-64. doi: 10.1016/j.arthro.2012.04.059. Epub 2012 Aug 17. — View Citation

Mohtadi NG, Griffin DR, Pedersen ME, Chan D, Safran MR, Parsons N, Sekiya JK, Kelly BT, Werle JR, Leunig M, McCarthy JC, Martin HD, Byrd JW, Philippon MJ, Martin RL, Guanche CA, Clohisy JC, Sampson TG, Kocher MS, Larson CM; Multicenter Arthroscopy of the Hip Outcomes Research Network. The Development and validation of a self-administered quality-of-life outcome measure for young, active patients with symptomatic hip disease: the International Hip Outcome Tool (iHOT-33). Arthroscopy. 2012 May;28(5):595-605; quiz 606-10.e1. doi: 10.1016/j.arthro.2012.03.013. — View Citation

Murphy S, Tannast M, Kim YJ, Buly R, Millis MB. Debridement of the adult hip for femoroacetabular impingement: indications and preliminary clinical results. Clin Orthop Relat Res. 2004 Dec;(429):178-81. doi: 10.1097/01.blo.0000150307.75238.b9. — View Citation

OUTERBRIDGE RE. The etiology of chondromalacia patellae. J Bone Joint Surg Br. 1961 Nov;43-B:752-7. doi: 10.1302/0301-620X.43B4.752. No abstract available. — View Citation

Philippon MJ, Schroder E Souza BG, Briggs KK. Hip arthroscopy for femoroacetabular impingement in patients aged 50 years or older. Arthroscopy. 2012 Jan;28(1):59-65. doi: 10.1016/j.arthro.2011.07.004. Epub 2011 Oct 7. — View Citation

Register B, Pennock AT, Ho CP, Strickland CD, Lawand A, Philippon MJ. Prevalence of abnormal hip findings in asymptomatic participants: a prospective, blinded study. Am J Sports Med. 2012 Dec;40(12):2720-4. doi: 10.1177/0363546512462124. Epub 2012 Oct 25. — View Citation

Ruta D, Garratt A, Abdalla M, Buckingham K, Russell I. The SF 36 health survey questionnaire. A valid measure of health status.. BMJ. 1993 Aug 14;307(6901):448-9. doi: 10.1136/bmj.307.6901.448-b. No abstract available. — View Citation

Safran MR. The acetabular labrum: anatomic and functional characteristics and rationale for surgical intervention. J Am Acad Orthop Surg. 2010 Jun;18(6):338-45. doi: 10.5435/00124635-201006000-00006. — View Citation

Samora JB, Ng VY, Ellis TJ. Femoroacetabular impingement: a common cause of hip pain in young adults. Clin J Sport Med. 2011 Jan;21(1):51-6. doi: 10.1097/JSM.0b013e318205dfde. — View Citation

Sangha O, Stucki G, Liang MH, Fossel AH, Katz JN. The Self-Administered Comorbidity Questionnaire: a new method to assess comorbidity for clinical and health services research. Arthritis Rheum. 2003 Apr 15;49(2):156-63. doi: 10.1002/art.10993. — View Citation

Song Y, Ito H, Kourtis L, Safran MR, Carter DR, Giori NJ. Articular cartilage friction increases in hip joints after the removal of acetabular labrum. J Biomech. 2012 Feb 2;45(3):524-30. doi: 10.1016/j.jbiomech.2011.11.044. Epub 2011 Dec 15. — View Citation

Stevens MS, Legay DA, Glazebrook MA, Amirault D. The evidence for hip arthroscopy: grading the current indications. Arthroscopy. 2010 Oct;26(10):1370-83. doi: 10.1016/j.arthro.2010.07.016. — View Citation

Streich NA, Gotterbarm T, Barie A, Schmitt H. Prognostic value of chondral defects on the outcome after arthroscopic treatment of acetabular labral tears. Knee Surg Sports Traumatol Arthrosc. 2009 Oct;17(10):1257-63. doi: 10.1007/s00167-009-0833-x. Epub 2009 Jun 30. — View Citation

Tijssen M, van Cingel R, van Melick N, de Visser E. Patient-Reported Outcome questionnaires for hip arthroscopy: a systematic review of the psychometric evidence. BMC Musculoskelet Disord. 2011 May 27;12:117. doi: 10.1186/1471-2474-12-117. — View Citation

Tonnis D, Heinecke A, Nienhaus R, Thiele J. [Predetermination of arthrosis, pain and limitation of movement in congenital hip dysplasia (author's transl)]. Z Orthop Ihre Grenzgeb. 1979 Oct;117(5):808-15. German. — View Citation

Vawklang N, Lertwanich P. Prevalence of acetabular labral tears and sublabral sulci: a cadaveric study. J Med Assoc Thai. 2012 Sep;95 Suppl 9:S104-9. — View Citation

von Engelhardt LV, Kraft CN, Pennekamp PH, Schild HH, Schmitz A, von Falkenhausen M. The evaluation of articular cartilage lesions of the knee with a 3-Tesla magnet. Arthroscopy. 2007 May;23(5):496-502. doi: 10.1016/j.arthro.2006.12.027. — View Citation

Wang R, Lagakos SW, Ware JH, Hunter DJ, Drazen JM. Statistics in medicine--reporting of subgroup analyses in clinical trials. N Engl J Med. 2007 Nov 22;357(21):2189-94. doi: 10.1056/NEJMsr077003. No abstract available. — View Citation

Wilson, S.R. and I. Gordon, Calculating Sample Sizes in the Presence of Confounding Variables. J Royal Statisitical Soc, 1986. 35(2): p. 207-13.

Yazbek PM, Ovanessian V, Martin RL, Fukuda TY. Nonsurgical treatment of acetabular labrum tears: a case series. J Orthop Sports Phys Ther. 2011 May;41(5):346-53. doi: 10.2519/jospt.2011.3225. Epub 2011 Feb 18. — View Citation

* Note: There are 62 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mHHS Surveys From Preoperative to Various Postoperative Timepoints	Full Name of Outcome: modified Harris Hip Score (mHHS); Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery.; Scale of mHHS: Min: 0 Max: 100; Higher score indicates better hip functionally.; No subscores or subscales.; The mean changes in scores required to achieve a minimically clinically important difference is 6.9.	Baseline (pre-operative), 3 months, 6 months, 12 months
Secondary	Change HOS Surveys From Preoperative to Various Postoperative Timepoints	Full Name of Outcome: HOS--Hip Outcome Score.; Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery.; Scale of HOS: Min: 0 Max: 100; No standardized scoring categories (i.e. excellent, good, fair, poor).; Higher score indicates better hip functionally.; The mean change in HOS score required to achieve a minimally clinically important difference is 8.8.	Baseline (pre-operative), 3 months, 6 months, 12 months
Secondary	Change NAHS Surveys From Preoperative to Various Postoperative Timepoints	Full Name of Outcome: Non-Arthritic Hip Score (NAHS); Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery: Scale of NAHS: Min: 0 Max: 100; No standardized scoring categories (i.e. excellent, good, fair, poor).; Higher score indicates better hip functionally.; No subscores or subscales.; No specific score to indicate a minimally clinically important difference.	Baseline (pre-operative), 3 months, 6 months, 12 months
Secondary	Change iHOT--33 Surveys From Preoperative to Various Postoperative Timepoints	Full Name of Outcome: International Hip Outcome Tool--33 Questions; Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery.; Scale of iHOT-33: Min: 0 Max: 100; No standardized scoring categories (i.e. excellent, good, fair, poor).; Higher score indicates better hip functionally.; No subscores or subscales; The mean changes in iHOT-33 scores required to achieve minimally clinically important difference is 15.1.	Baseline (pre-operative), 3 months, 6 months, 12 months
Secondary	Change LEFS Surveys From Preoperative to Various Postoperative Timepoints	Full Name of Outcome: Lower Extremity Functional Scale (LEFS); Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery.; Scale of LEFS: Min: 0 Max: 100; No standardized scoring categories (i.e. excellent, good, fair, poor).; Higher score indicates better hip functionally.; There is no designated improvement that is deemed to be a minimally clinically important difference	Baseline (pre-operative), 3 months, 6 months, 12 months
Secondary	Degree of Improvement on Hip VAS Pain Score	At routine follow-up visits patients will be asked to rate hip pain using the VAS (Visual Analog Scale) Score; Min: 0--no pain Max: 10--worst pain experienced in their life; Increments of 1.; Categories: 1--3: mild pain 4--6: moderate pain 7--10: severe pain; There is no reduction in VAS score that is considered a minimally clinically important difference.	Baseline (pre-operative), 3 months, 6 months, 12 months