NCT00779415

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

February 27, 2015

Status Verified

February 1, 2015

Enrollment Period

3.8 years

First QC Date

October 22, 2008

Last Update Submit

February 26, 2015

Conditions

Keywords

Partial ThicknessRotator Cuff

Outcome Measures

Primary Outcomes (1)

  • Creation of a database of patients with partial rotator cuff tears documented by MRI.

    Retrospective review from 1/1/02 to 12/31/06, four years.

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (5)

  • 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.

    PMID: 12620544BACKGROUND
  • 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.

    PMID: 3958003BACKGROUND
  • 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.

    PMID: 8020236BACKGROUND
  • 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.

    PMID: 11408898BACKGROUND
  • 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.

    PMID: 16882890BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • April D Armstrong, MD

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 22, 2008

First Posted

October 24, 2008

Study Start

July 1, 2008

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

February 27, 2015

Record last verified: 2015-02

Locations