Clinical trial NCT00779415: Long Term Prognosis of MRI Diagnosed Partial Thickness Tears of the Rotator Cuff
Official title: Long Term Prognosis of MRI Diagnosed Partial Thickness Tears of the Rotator Cuff
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tear
Keywords: Partial Thickness
Rotator Cuff
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2008-10-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Full thickness tear of the rotator cuff, surgically repaired rotator cuff, and patients who do not fit criteria listed in inclusion criteria.

Primary outcomes:
measure: Creation of a database of patients with partial rotator cuff tears documented by MRI.
timeFrame: Retrospective review from 1/1/02 to 12/31/06, four years.
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: April D Armstrong, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ogilvie-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.
citation: Yamanaka 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.
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: 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.