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Arthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears

Last updated on November 16, 2019

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Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85027 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rotator Cuff, Arthroscopic Surgery
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Full thickness Rotator Cuff Tears ranging from 1cm to 4cm in size.

- Planned procedure for repair is tendon-to-bone repair by means of an arthroscopy

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Previous surgical intervention to the shoulder joint understudy

- Tears of the subscapularis or labral pathology requiring surgical repair

- Shoulder instability either shoulder

- Unable to complete functional evaluations in either shoulder

NCT00739947
Pfizer
Completed
Arthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears

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Descriptive Information
Brief TitleArthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears
Official TitleA Prospective Study To Evaluate Surgical Outcomes In Subjects With Full-Thickness Rotator Cuff Tears Treated By Means Of A Double-Row Arthroscopic Repair
Brief SummaryThis is an observational study that involves subjects with full-thickness rotator cuff tears treated by means of arthroscopy surgical repair, also known as arthroscopic surgery. The primary objective of this study is to observe the timing and rate of tendon retear in those subjects.
Detailed DescriptionSubjects will be recruited from each surgeon's surgical practice. They will be reviewed to assure they meet all eligibility criteria prior to enrolling them into the study.
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationCommunity Sample
Condition
  • Rotator Cuff
  • Arthroscopic Surgery
InterventionOther: Observational study of the surgical outcome
Subjects return for 7 follow-up visits following arthroscopic repair of their rotator cuff. During the follow-up visits subjects undergo imaging with MRI and ultrasound.
Study Groups/Cohorts1
Standard of Care
Intervention: Other: Observational study of the surgical outcome
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: July 19, 2010)
162
Original Estimated Enrollment
 (submitted: August 21, 2008)
160
Actual Study Completion DateJuly 2011
Actual Primary Completion DateJuly 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Full thickness Rotator Cuff Tears ranging from 1cm to 4cm in size.
  • Planned procedure for repair is tendon-to-bone repair by means of an arthroscopy

Exclusion Criteria:

  • Previous surgical intervention to the shoulder joint understudy
  • Tears of the subscapularis or labral pathology requiring surgical repair
  • Shoulder instability either shoulder
  • Unable to complete functional evaluations in either shoulder
Sex/Gender
Sexes Eligible for Study:All
Ages21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesUnited States
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00739947
Other Study ID Numbers3202V1-1000
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJuly 2014

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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