Rotator Cuff TearNCT00779415
Long Term Prognosis of MRI Diagnosed Partial Thickness Tears of the Rotator Cuff
An observational study of Rotator Cuff Tear, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
Patients diagnosed with partial thickness tears of the rotator cuff are sometimes surgically repaired, while other cases are not. It is unknown how patients fare over time without electing surgical repair and how outcomes differ by type of injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tear
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Apr 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who presented from 1/1/02 to 12/31/06 to Hershey Medical Center with complaint of shoulder pain and were treated by the Orthopaedic Department.
Who may be able to join
- Patients examined at the Hershey Medical Center from 1/1/02-12/31/06 with a documented MRI report of a partial thickness tear of the rotator cuff that was treated non-operatively.
Who cannot join
- Full thickness tear of the rotator cuff, surgically repaired rotator cuff, and patients who do not fit criteria listed in inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Patients diagnosed with partial thickness tears of the rotator cuff are sometimes surgically repaired, while other cases are not. It is unknown how patients fare over time without electing surgical repair and how outcomes differ by type of injury.
Read the detailed description
We plan to conduct a retrospective cohort study to assemble a research database of all patients with shoulder pain from 1/1/02-12/31/06 presenting at the Hershey Medical Center. Participants will be identified using billing codes in the medical records office, with inclusion/exclusion criteria as described above. Data extraction will include medical record number, demographic data (age, race/ethnicity, sex, insurance type), pre-fracture functional status, pre-admission residence, medical co-morbidities, prior hospitalization within 30 days, abnormal clinical findings on admission, shoulder score, pain score, range of motion score, type of diagnosis (partial tear, full thickness tear, tendonitis, shoulder pain), occupation, past medical history, physical therapy and duration of physical therapy, cigarette/cigar use, drug use, alcohol use, treatment protocols (anti-inflammatory medication, injections, etc.), and complaints by patient of pain status.
- Conditions
- Rotator Cuff Tear
- Keywords
- Partial Thickness, Rotator Cuff
- Medical subject headings
- Rotator Cuff Injuries
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 |
|---|---|---|
| Partial Rotator Cuff Tear | Patients who presented from 1/1/02 to 12/31/06 to Hershey Medical Center with complaint of shoulder pain and were treated by the Orthopaedic Department |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of a database of patients with partial rotator cuff tears documented by MRI.
Measured: Retrospective review from 1/1/02 to 12/31/06, four years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startJul 2008
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 Milton S. Hershey Medical CenterThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, April Armstrong, Milton S. Hershey Medical Center
- Investigators
- April D Armstrong, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779415
- Sponsor's protocol ID
- IRB26682EP
- Status last verified
- Feb 2015
- First submitted
- 22 Oct 2008
- Last updated
- 27 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Nakatani T, Fujita K, Iwasaki Y, Sakai H, Kurosaka M. MRI-negative rotator cuff tears. Magn Reson Imaging. 2003 Jan;21(1):41-5. doi: 10.1016/s0730-725x(02)00630-6.
PubMed 12620544Ogilvie-Harris DJ, Wiley AM. Arthroscopic surgery of the shoulder. A general appraisal. J Bone Joint Surg Br. 1986 Mar;68(2):201-7. doi: 10.1302/0301-620X.68B2.3958003.
PubMed 3958003Yamanaka K, Matsumoto T. The joint side tear of the rotator cuff. A followup study by arthrography. Clin Orthop Relat Res. 1994 Jul;(304):68-73.
PubMed 8020236Yamaguchi 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.
PubMed 11408898Yamaguchi 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.
PubMed 16882890
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Prognosis of MRI Diagnosed Partial Thickness Tears of the Rotator Cuff
- ClinicalTrials.gov ID
- NCT00779415
- Acronym / sponsor ID
- IRB26682EP
- Conditions
- Rotator Cuff Tear
- Keywords
- Partial Thickness, Rotator Cuff
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 24 Oct 2008 (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.
Patients diagnosed with partial thickness tears of the rotator cuff are sometimes surgically repaired, while other cases are not. It is unknown how patients fare over time without electing surgical repair and how outcomes differ by type of injury.
Detailed description
We plan to conduct a retrospective cohort study to assemble a research database of all patients with shoulder pain from 1/1/02-12/31/06 presenting at the Hershey Medical Center. Participants will be identified using billing codes in the medical records office, with inclusion/exclusion criteria as described above. Data extraction will include medical record number, demographic data (age, race/ethnicity, sex, insurance type), pre-fracture functional status, pre-admission residence, medical co-morbidities, prior hospitalization within 30 days, abnormal clinical findings on admission, shoulder score, pain score, range of motion score, type of diagnosis (partial tear, full thickness tear, tendonitis, shoulder pain), occupation, past medical history, physical therapy and duration of physical therapy, cigarette/cigar use, drug use, alcohol use, treatment protocols (anti-inflammatory medication, injections, etc.), and complaints by patient of pain status.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Partial Rotator Cuff Tear | – | –Patients who presented from 1/1/02 to 12/31/06 to Hershey Medical Center with complaint of shoulder pain and were treated by the Orthopaedic Department |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who presented from 1/1/02 to 12/31/06 to Hershey Medical Center with complaint of shoulder pain and were treated by the Orthopaedic Department.
Key inclusion criteria (1 listed)
- Patients examined at the Hershey Medical Center from 1/1/02-12/31/06 with a documented MRI report of a partial thickness tear of the rotator cuff that was treated non-operatively.
Key exclusion criteria (1 listed)
- Full thickness tear of the rotator cuff, surgically repaired rotator cuff, and patients who do not fit criteria listed in inclusion criteria.
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
Creation of a database of patients with partial rotator cuff tears documented by MRI.
Time frame: Retrospective review from 1/1/02 to 12/31/06, four years.
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 27 Feb 2015.
- Background: PubMed 12620544Nakatani T, Fujita K, Iwasaki Y, Sakai H, Kurosaka M. MRI-negative rotator cuff tears. Magn Reson Imaging. 2003 Jan;21(1):41-5. doi: 10.1016/s0730-725x(02)00630-6.
- Background: PubMed 3958003Ogilvie-Harris DJ, Wiley AM. Arthroscopic surgery of the shoulder. A general appraisal. J Bone Joint Surg Br. 1986 Mar;68(2):201-7. doi: 10.1302/0301-620X.68B2.3958003.
- Background: PubMed 8020236Yamanaka K, Matsumoto T. The joint side tear of the rotator cuff. A followup study by arthrography. Clin Orthop Relat Res. 1994 Jul;(304):68-73.
- Background: PubMed 11408898Yamaguchi 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.
- Background: PubMed 16882890Yamaguchi 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.
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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.
April D Armstrong, MD principal investigator
Milton S. Hershey Medical Center
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 Milton S. Hershey Medical Center 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 27 Feb 2015. 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?
Creation of a database of patients with partial rotator cuff tears documented by MRI. (time frame: Retrospective review from 1/1/02 to 12/31/06, four years.). 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 NCT00779415, which also lists 5 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 27 Feb 2015; AzTrials last refreshed its copy on 7 Nov 2026.