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Arthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears

Last updated on April 10, 2018

FOR MORE INFORMATION
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.
Show details

- 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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Arthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears
A Prospective Study To Evaluate Surgical Outcomes In Subjects With Full-Thickness Rotator Cuff Tears Treated By Means Of A Double-Row Arthroscopic Repair
This 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.
Subjects 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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Community Sample
  • Rotator Cuff
  • Arthroscopic Surgery
Other: 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.
1
Standard of Care
Intervention: Other: Observational study of the surgical outcome
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
July 2011
July 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00739947
3202V1-1000
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2014

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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Contact

[email protected]



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