Rotator Cuff TearNCT00923858
The Natural History of Asymptomatic Rotator Cuff Tears
An observational study of Rotator Cuff Tear, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rotator Cuff Tear
- How many people
- 495 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2005to Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients are recruited from orthopaedic surgeon's clinic.
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Asymptomatic Cuff Tears: A Model for Pain Development - Part B
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.
Read the detailed description
The specific aims of our study are:
- To determine the probability that an asymptomatic rotator cuff tear will become symptomatic over time.
- To determine which epidemiological factors correlate with symptomatic progression.
- To determine if symptomatic progression correlates with enlargement of the rotator cuff tear as determined at sonography.
- To determine the value of routine sonographic scanning of the asymptomatic shoulder.
- Conditions
- Rotator Cuff Tear
- Keywords
- Rotator Cuff, Ultrasound, Pain, Tear Progression
- Medical subject headings
- Rotator Cuff Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control - participants from cycles 1 & 2 | no intervention. Control group is composed of participants from Cohort I (recruited during our first grant cycle) and from Cohort II (recruited during our second grant cycle). Continued observation is planned for those controls, partial tears and full tears who enrolled in study at age 65 years or younger and have less than 11 years of follow up. | |
| Cuff Tear Cohort III | These participants are being recruited from our clinical population and have been scheduled to undergo a standard of care rotator cuff repair and post op therapy. One shoulder has been indicated for rotator cuff repair and the contralateral shoulder is asymptomatic. Both shoulders will be monitored. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Shoulder Ultrasound & Radiographs
The ultrasound involves measurement of rotator cuff tear (if present) and assessment of muscle degeneration. Radiographs will be used to document any bony changes.
Measured: Through study completion, an average of 1 per year
Secondary outcomes (3)
American Shoulder & Elbow Survey (ASES)
Assessment of patient-rated shoulder pain and function/disability. Questions involve activities of daily living that reflect the use of the shoulder \& elbow in different planes of motion. Pain and weakness with various activities are also addressed. (Range 0-100, higher scores indicate better outcomes)
Measured: Through study completion, an average of 1 per year
Western Ontario Rotator Cuff (WORC) Index
Disease-specific quality of life questionnaire, evaluating the change in symptoms and functional ability, specific to rotator cuff tendinopathy. (Range: 0-2100, normalized to 0-100, higher scores indicate worst possible symptoms)
Measured: Through study completion, an average of 1 per year
Short Form Health Survey (SF-12)
General health assessment composed of two scales, Physical Component Summary and Mental Component Summary (Range: 0-100, higher scores indicate better health)
Measured: Through study completion, an average of 1 per year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study start1 Jul 2005
- Primary completionJun 2022
- Study completionJun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (50)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 495 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Jay D Keener, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00923858
- Sponsor's protocol ID
- IRB# 201103230
- Other IDs
- 5R01AR051026
- Status last verified
- Aug 2022
- First submitted
- 16 Jun 2009
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 19283436Bright 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.
PubMed 9453105Codman 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.
PubMed 17866481COTTON 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.
PubMed 14167640Deutsch 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.
PubMed 8816337Dunn 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.
PubMed 16140812Galatz 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.
PubMed 14960664Goodman RS. Abnormal findings on magnetic resonance images of asymptomatic shoulders. J Bone Joint Surg Am. 1996 Apr;78(4):633. No abstract available.
PubMed 8609145Goutallier 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.
PubMed 8020238Harryman 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.
PubMed 1874784Hollister 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.
PubMed 7645478Kamath 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.
PubMed 19411453Kowalsky 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.
PubMed 21411687Keyes 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.
PubMed 17866987Kim 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.
PubMed 18287426
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asymptomatic Cuff Tears: A Model for Pain Development - Part B
- ClinicalTrials.gov ID
- NCT00923858
- Acronym / sponsor ID
- IRB# 201103230
- Conditions
- Rotator Cuff Tear
- Keywords
- Rotator Cuff, Ultrasound, Pain, Tear Progression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 495 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 1 Jul 2005 (actual)
- Primary completion
- Jun 2022 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 18 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the probability that an asymptomatic rotator cuff tear will become symptomatic over time.
- To determine which epidemiological factors correlate with symptomatic progression.
- To determine if symptomatic progression correlates with enlargement of the rotator cuff tear as determined at sonography.
- To determine the value of routine sonographic scanning of the asymptomatic shoulder.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control - participants from cycles 1 & 2 | – | –no intervention. Control group is composed of participants from Cohort I (recruited during our first grant cycle) and from Cohort II (recruited during our second grant cycle). Continued observation is planned for those controls, partial tears and full tears who enrolled in study at age 65 years or younger and have less than 11 years of follow up. |
| Cuff Tear Cohort III | – | –These participants are being recruited from our clinical population and have been scheduled to undergo a standard of care rotator cuff repair and post op therapy. One shoulder has been indicated for rotator cuff repair and the contralateral shoulder is asymptomatic. Both shoulders will be monitored. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are recruited from orthopaedic surgeon's clinic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Standardized Shoulder Ultrasound & Radiographs
Time frame: Through study completion, an average of 1 per year
The ultrasound involves measurement of rotator cuff tear (if present) and assessment of muscle degeneration. Radiographs will be used to document any bony changes.
3 secondary outcomes
American Shoulder & Elbow Survey (ASES)
Time frame: Through study completion, an average of 1 per year
Western Ontario Rotator Cuff (WORC) Index
Time frame: Through study completion, an average of 1 per year
Short Form Health Survey (SF-12)
Time frame: Through study completion, an average of 1 per year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Background: PubMed 19283436Baumgarten 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.
- Background: PubMed 9453105Bright 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.
- Background: PubMed 17866481Codman 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.
- Background: PubMed 14167640COTTON 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.
- Background: PubMed 8816337Deutsch 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.
- Background: PubMed 16140812Dunn 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.
- Background: PubMed 14960664Galatz 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.
- Background: PubMed 8609145Goodman RS. Abnormal findings on magnetic resonance images of asymptomatic shoulders. J Bone Joint Surg Am. 1996 Apr;78(4):633. No abstract available.
- Background: PubMed 8020238Goutallier 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.
- Background: PubMed 1874784Harryman 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.
- Background: PubMed 7645478Hollister 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.
- Background: PubMed 19411453Kamath 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay D Keener, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tear, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized Shoulder Ultrasound & Radiographs (time frame: Through study completion, an average of 1 per year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00923858, which also lists 50 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.