Clinical trial NCT00923858: The Natural History of Asymptomatic Rotator Cuff Tears
Official title: Asymptomatic Cuff Tears: A Model for Pain Development - Part B
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tear
Keywords: Rotator Cuff
Ultrasound
Pain
Tear Progression
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2009-06-18
Enrollment: 495
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are recruited from orthopaedic surgeon's clinic.

Brief summary: The purpose of this project is to provide information which can help us understand what happens over time to rotator cuff tears. In this study, the investigators will follow a population of people with rotator cuff tears that do not hurt (asymptomatic) and to establish the probability that an asymptomatic rotator cuff tear, identified in the context of contralateral symptoms, will become symptomatic over time. To determine with ultrasound the probability that a rotator cuff tear will enlarge over time. To determine if symptom progression correlates with enlargement of the rotator cuff tear and/or degenerative changes on radiographs. In order to obtain data, study subjects will be recalled for follow-up at 1 year time points over a 5 year period. The study subjects will have repeat physical exam, ultrasound and radiographic examinations. A control group of normal patients will also be followed for comparison.

Detailed description: The specific aims of our study are:

1. To determine the probability that an asymptomatic rotator cuff tear will become symptomatic over time.
2. To determine which epidemiological factors correlate with symptomatic progression.
3. To determine if symptomatic progression correlates with enlargement of the rotator cuff tear as determined at sonography.
4. To determine the value of routine sonographic scanning of the asymptomatic shoulder.

Eligibility criteria: Group 1 (Cohorts I \& II) Inclusion Criteria:

* Participants who enrolled at age 65 years or younger will remain in the study.
* Less than 11 annual visits of non-operative surveillance of study shoulder.
* Less than 3 annual visits following a rotator cuff repair of study shoulder.

Group 1 (Cohorts I \& II) Exclusion Criteria:

* Workman's Compensation claim involving the shoulders.
* Use of crutch, cane or weight-bearing device on study shoulder.
* Moderate or severe glenohumeral arthritis.
* Inflammatory or other disease process affecting neurological/musculoskeletal systems that may impact weight-bearing activities or normal use of upper body.
* Inability to return for routine study visits.
* Traumatic injury to rotator cuff.
* Rotator Cuff Tear greater than 30mm in width.
* Advanced fatty muscle degeneration.

Patients who are currently enrolled but require a shoulder replacement will not remain in the study. Cohorts I \& II will now be considered the control group for comparison to those enrolled in this next recruitment period.

Group 2 (Cohort III) Inclusion Criteria:

* Age 65 years or younger.
* Surgical candidate for primary, double-row repair of a rotator.
* Able to comply with post operative therapy protocol.
* Bilateral partial or full thickness rotator cuff tears: one symptomatic requiring surgery and the contralateral shoulder asymptomatic.

Group 2 (Cohort III) Exclusion Criteria:

* Workman's Compensation claim involving the shoulders.
* Use of crutch, cane or weight-bearing device on study shoulder.
* Moderate or severe glenohumeral arthritis.
* Inflammatory or other disease process affecting neurological/musculoskeletal systems that may impact weight-bearing activities or normal use of upper body.
* Inability to return for routine study visits.
* Traumatic injury to rotator cuff.
* Rotator Cuff Tear greater than 30mm in width.
* Advanced fatty muscle degeneration.

Primary outcomes:
measure: Standardized Shoulder Ultrasound & Radiographs
timeFrame: Through study completion, an average of 1 per year
Secondary outcomes:
measure: American Shoulder & Elbow Survey (ASES)
timeFrame: Through study completion, an average of 1 per year
measure: Western Ontario Rotator Cuff (WORC) Index
timeFrame: Through study completion, an average of 1 per year
measure: Short Form Health Survey (SF-12)
timeFrame: Through study completion, an average of 1 per year
Other outcomes:
measure: Physical Examination by the study coordinator (Range of motion)
timeFrame: Through study completion, an average of 1 per year
measure: Physical Examination by the study coordinator (Strength)
timeFrame: Through study completion, an average of 1 per year
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jay D Keener, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baumgarten KM, Gerlach D, Galatz LM, Teefey SA, Middleton WD, Ditsios K, Yamaguchi K. Cigarette smoking increases the risk for rotator cuff tears. Clin Orthop Relat Res. 2010 Jun;468(6):1534-41. doi: 10.1007/s11999-009-0781-2. Epub 2009 Mar 13.
citation: Bright AS, Torpey B, Magid D, Codd T, McFarland EG. Reliability of radiographic evaluation for acromial morphology. Skeletal Radiol. 1997 Dec;26(12):718-21. doi: 10.1007/s002560050317.
citation: Codman EA, Akerson IB. THE PATHOLOGY ASSOCIATED WITH RUPTURE OF THE SUPRASPINATUS TENDON. Ann Surg. 1931 Jan;93(1):348-59. doi: 10.1097/00000658-193101000-00043. No abstract available.
citation: COTTON RE, RIDEOUT DF. TEARS OF THE HUMERAL ROTATOR CUFF; A RADIOLOGICAL AND PATHOLOGICAL NECROPSY SURVEY. J Bone Joint Surg Br. 1964 May;46:314-28. No abstract available.
citation: Deutsch A, Altchek DW, Schwartz E, Otis JC, Warren RF. Radiologic measurement of superior displacement of the humeral head in the impingement syndrome. J Shoulder Elbow Surg. 1996 May-Jun;5(3):186-93. doi: 10.1016/s1058-2746(05)80004-7.
citation: Dunn WR, Schackman BR, Walsh C, Lyman S, Jones EC, Warren RF, Marx RG. Variation in orthopaedic surgeons' perceptions about the indications for rotator cuff surgery. J Bone Joint Surg Am. 2005 Sep;87(9):1978-84. doi: 10.2106/JBJS.D.02944.
citation: Galatz LM, Ball CM, Teefey SA, Middleton WD, Yamaguchi K. The outcome and repair integrity of completely arthroscopically repaired large and massive rotator cuff tears. J Bone Joint Surg Am. 2004 Feb;86(2):219-24. doi: 10.2106/00004623-200402000-00002.
citation: Goodman RS. Abnormal findings on magnetic resonance images of asymptomatic shoulders. J Bone Joint Surg Am. 1996 Apr;78(4):633. No abstract available.
citation: Goutallier D, Postel JM, Bernageau J, Lavau L, Voisin MC. Fatty muscle degeneration in cuff ruptures. Pre- and postoperative evaluation by CT scan. Clin Orthop Relat Res. 1994 Jul;(304):78-83.
citation: Harryman DT 2nd, Mack LA, Wang KY, Jackins SE, Richardson ML, Matsen FA 3rd. Repairs of the rotator cuff. Correlation of functional results with integrity of the cuff. J Bone Joint Surg Am. 1991 Aug;73(7):982-9.
citation: Hollister MS, Mack LA, Patten RM, Winter TC 3rd, Matsen FA 3rd, Veith RR. Association of sonographically detected subacromial/subdeltoid bursal effusion and intraarticular fluid with rotator cuff tear. AJR Am J Roentgenol. 1995 Sep;165(3):605-8. doi: 10.2214/ajr.165.3.7645478.
citation: Kamath G, Galatz LM, Keener JD, Teefey S, Middleton W, Yamaguchi K. Tendon integrity and functional outcome after arthroscopic repair of high-grade partial-thickness supraspinatus tears. J Bone Joint Surg Am. 2009 May;91(5):1055-62. doi: 10.2106/JBJS.G.00118.
citation: Kowalsky MS, Keener JD. Revision arthroscopic rotator cuff repair: repair integrity and clinical outcome: surgical technique. J Bone Joint Surg Am. 2011 Mar;93 Suppl 1:62-74. doi: 10.2106/JBJS.J.01173.
citation: Keyes EL. Observations on Rupture of the Supraspinatus Tendon: Based Upon a Study of Seventy-Three Cadavers. Ann Surg. 1933 Jun;97(6):849-56. doi: 10.1097/00000658-193306000-00007. No abstract available.
citation: Kim HM, Dahiya N, Teefey SA, Keener JD, Yamaguchi K. Sonography of the teres minor: a study of cadavers. AJR Am J Roentgenol. 2008 Mar;190(3):589-94. doi: 10.2214/AJR.07.2960.
citation: Mall NA, Kim HM, Keener JD, Steger-May K, Teefey SA, Middleton WD, Stobbs G, Yamaguchi K. Symptomatic progression of asymptomatic rotator cuff tears: a prospective study of clinical and sonographic variables. J Bone Joint Surg Am. 2010 Nov 17;92(16):2623-33. doi: 10.2106/JBJS.I.00506.
citation: Tashjian RZ, Hollins AM, Kim HM, Teefey SA, Middleton WD, Steger-May K, Galatz LM, Yamaguchi K. Factors affecting healing rates after arthroscopic double-row rotator cuff repair. Am J Sports Med. 2010 Dec;38(12):2435-42. doi: 10.1177/0363546510382835. Epub 2010 Oct 28.
citation: Keener JD, Wei AS, Kim HM, Paxton ES, Teefey SA, Galatz LM, Yamaguchi K. Revision arthroscopic rotator cuff repair: repair integrity and clinical outcome. J Bone Joint Surg Am. 2010 Mar;92(3):590-8. doi: 10.2106/JBJS.I.00267.
citation: Kitay GS, Iannotti JP, Williams GR, Haygood T, Kneeland BJ, Berlin J. Roentgenographic assessment of acromial morphologic condition in rotator cuff impingement syndrome. J Shoulder Elbow Surg. 1995 Nov-Dec;4(6):441-8. doi: 10.1016/s1058-2746(05)80036-9.
citation: Middleton WD. Ultrasonography of the shoulder. Radiol Clin North Am. 1992 Sep;30(5):927-40.
citation: Middleton WD, Edelstein G, Reinus WR, Melson GL, Murphy WA. Ultrasonography of the rotator cuff: technique and normal anatomy. J Ultrasound Med. 1984 Dec;3(12):549-51. doi: 10.7863/jum.1984.3.12.549.
citation: Middleton WD, Payne WT, Teefey SA, Hildebolt CF, Rubin DA, Yamaguchi K. Sonography and MRI of the shoulder: comparison of patient satisfaction. AJR Am J Roentgenol. 2004 Nov;183(5):1449-52. doi: 10.2214/ajr.183.5.1831449.
citation: Middleton WD, Reinus WR, Totty WG, Melson CL, Murphy WA. Ultrasonographic evaluation of the rotator cuff and biceps tendon. J Bone Joint Surg Am. 1986 Mar;68(3):440-50.
citation: Middleton WD, Reinus WR, Totty WG, Melson GL, Murphy WA. US of the biceps tendon apparatus. Radiology. 1985 Oct;157(1):211-5. doi: 10.1148/radiology.157.1.3898217.
citation: Middleton WD, Teefey SA, Yamaguchi K. Sonography of the rotator cuff: analysis of interobserver variability. AJR Am J Roentgenol. 2004 Nov;183(5):1465-8. doi: 10.2214/ajr.183.5.1831465.
citation: Milgrom C, Schaffler M, Gilbert S, van Holsbeeck M. Rotator-cuff changes in asymptomatic adults. The effect of age, hand dominance and gender. J Bone Joint Surg Br. 1995 Mar;77(2):296-8.
citation: Miniaci A, Dowdy PA, Willits KR, Vellet AD. Magnetic resonance imaging evaluation of the rotator cuff tendons in the asymptomatic shoulder. Am J Sports Med. 1995 Mar-Apr;23(2):142-5. doi: 10.1177/036354659502300202.
citation: Norwood LA, Barrack R, Jacobson KE. Clinical presentation of complete tears of the rotator cuff. J Bone Joint Surg Am. 1989 Apr;71(4):499-505.
citation: Paletta GA Jr, Warner JJ, Warren RF, Deutsch A, Altchek DW. Shoulder kinematics with two-plane x-ray evaluation in patients with anterior instability or rotator cuff tearing. J Shoulder Elbow Surg. 1997 Nov-Dec;6(6):516-27. doi: 10.1016/s1058-2746(97)90084-7.
citation: Poppen NK, Walker PS. Normal and abnormal motion of the shoulder. J Bone Joint Surg Am. 1976 Mar;58(2):195-201.
citation: Prickett WD, Teefey SA, Galatz LM, Calfee RP, Middleton WD, Yamaguchi K. Accuracy of ultrasound imaging of the rotator cuff in shoulders that are painful postoperatively. J Bone Joint Surg Am. 2003 Jun;85(6):1084-9. doi: 10.2106/00004623-200306000-00016.
citation: Sher JS, Uribe JW, Posada A, Murphy BJ, Zlatkin MB. Abnormal findings on magnetic resonance images of asymptomatic shoulders. J Bone Joint Surg Am. 1995 Jan;77(1):10-5. doi: 10.2106/00004623-199501000-00002.
citation: Sofka CM, Haddad ZK, Adler RS. Detection of muscle atrophy on routine sonography of the shoulder. J Ultrasound Med. 2004 Aug;23(8):1031-4. doi: 10.7863/jum.2004.23.8.1031.
citation: Strobel K, Hodler J, Meyer DC, Pfirrmann CW, Pirkl C, Zanetti M. Fatty atrophy of supraspinatus and infraspinatus muscles: accuracy of US. Radiology. 2005 Nov;237(2):584-9. doi: 10.1148/radiol.2372041612. Epub 2005 Sep 28.
citation: Teefey SA, Rubin DA, Middleton WD, Hildebolt CF, Leibold RA, Yamaguchi K. Detection and quantification of rotator cuff tears. Comparison of ultrasonographic, magnetic resonance imaging, and arthroscopic findings in seventy-one consecutive cases. J Bone Joint Surg Am. 2004 Apr;86(4):708-16.
citation: Teefey SA. Shoulder sonography: why we do it. J Ultrasound Med. 2012 Sep;31(9):1325-31. doi: 10.7863/jum.2012.31.9.1325. No abstract available.
citation: Teefey SA, Middleton WD, Bauer GS, Hildebolt CF, Yamaguchi K. Sonographic differences in the appearance of acute and chronic full-thickness rotator cuff tears. J Ultrasound Med. 2000 Jun;19(6):377-8; quiz 383. doi: 10.7863/jum.2000.19.6.377.
citation: Teefey SA, Middleton WD, Payne WT, Yamaguchi K. Detection and measurement of rotator cuff tears with sonography: analysis of diagnostic errors. AJR Am J Roentgenol. 2005 Jun;184(6):1768-73. doi: 10.2214/ajr.184.6.01841768.
citation: Tyson LL, Crues JV 3rd. Pathogenesis of rotator cuff disorders. Magnetic resonance imaging characteristics. Magn Reson Imaging Clin N Am. 1993 Sep;1(1):37-46.
citation: Yamaguchi K, Ditsios K, Middleton WD, Hildebolt CF, Galatz LM, Teefey SA. The demographic and morphological features of rotator cuff disease. A comparison of asymptomatic and symptomatic shoulders. J Bone Joint Surg Am. 2006 Aug;88(8):1699-704. doi: 10.2106/JBJS.E.00835.
citation: Yamaguchi K, Sher JS, Andersen WK, Garretson R, Uribe JW, Hechtman K, Neviaser RJ. Glenohumeral motion in patients with rotator cuff tears: a comparison of asymptomatic and symptomatic shoulders. J Shoulder Elbow Surg. 2000 Jan-Feb;9(1):6-11. doi: 10.1016/s1058-2746(00)90002-8.
citation: Yamaguchi K, Tetro AM, Blam O, Evanoff BA, Teefey SA, Middleton WD. Natural history of asymptomatic rotator cuff tears: a longitudinal analysis of asymptomatic tears detected sonographically. J Shoulder Elbow Surg. 2001 May-Jun;10(3):199-203. doi: 10.1067/mse.2001.113086.
citation: Keener JD, Wei AS, Kim HM, Steger-May K, Yamaguchi K. Proximal humeral migration in shoulders with symptomatic and asymptomatic rotator cuff tears. J Bone Joint Surg Am. 2009 Jun;91(6):1405-13. doi: 10.2106/JBJS.H.00854.
citation: Kim HM, Dahiya N, Teefey SA, Keener JD, Galatz LM, Yamaguchi K. Relationship of tear size and location to fatty degeneration of the rotator cuff. J Bone Joint Surg Am. 2010 Apr;92(4):829-39. doi: 10.2106/JBJS.H.01746.
citation: Hamid N, Omid R, Yamaguchi K, Steger-May K, Stobbs G, Keener JD. Relationship of radiographic acromial characteristics and rotator cuff disease: a prospective investigation of clinical, radiographic, and sonographic findings. J Shoulder Elbow Surg. 2012 Oct;21(10):1289-98. doi: 10.1016/j.jse.2011.09.028. Epub 2012 Jan 3.
citation: Keener JD, Steger-May K, Stobbs G, Yamaguchi K. Asymptomatic rotator cuff tears: patient demographics and baseline shoulder function. J Shoulder Elbow Surg. 2010 Dec;19(8):1191-8. doi: 10.1016/j.jse.2010.07.017. Epub 2010 Oct 27.
citation: Kim HM, Dahiya N, Teefey SA, Middleton WD, Stobbs G, Steger-May K, Yamaguchi K, Keener JD. Location and initiation of degenerative rotator cuff tears: an analysis of three hundred and sixty shoulders. J Bone Joint Surg Am. 2010 May;92(5):1088-96. doi: 10.2106/JBJS.I.00686.
citation: Kim HM, Teefey SA, Zelig A, Galatz LM, Keener JD, Yamaguchi K. Shoulder strength in asymptomatic individuals with intact compared with torn rotator cuffs. J Bone Joint Surg Am. 2009 Feb;91(2):289-96. doi: 10.2106/JBJS.H.00219.
citation: Wall LB, Teefey SA, Middleton WD, Dahiya N, Steger-May K, Kim HM, Wessell D, Yamaguchi K. Diagnostic performance and reliability of ultrasonography for fatty degeneration of the rotator cuff muscles. J Bone Joint Surg Am. 2012 Jun 20;94(12):e83. doi: 10.2106/JBJS.J.01899.
citation: Roztocil K, Oliva I, Prerovsky I, Linhart J. The effect of hydroxyethylrutoside and its combination with acetylsalicylic acid in patients with obliterative atherosclerosis. Cor Vasa. 1989;31(2):128-33.