Viewing Study NCT00290888



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Study NCT ID: NCT00290888
Status: COMPLETED
Last Update Posted: 2015-03-27
First Post: 2006-02-10

Brief Title: Arthroscopic Rotator Cuff Repair of Full Thickness Tears With and Without Arthroscopic Acromioplasty
Sponsor: Panam Clinic
Organization: Panam Clinic

Study Overview

Official Title: Arthroscopic Rotator Cuff Repair With and Without Arthroscopic Acromioplasty in the Treatment of Full Thickness Rotator Cuff
Status: COMPLETED
Status Verified Date: 2015-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Surgical repair of full thickness tears of the rotator cuff is a controversial issue with several procedures currently being used to treat the tear The two most common treatments at this point in time are arthroscopic cuff repair with and without acromioplasty However an arthroscopic cuff repair without acromioplasty may offer the same degree of improvement as one that includes acromioplasty but without threatening the shoulder stability that is provided by the acromion and coracoacromial ligament This prospective study examines the hypothesis that appropriate shoulder function can be restored through the execution of the traditional arthroscopic cuff repair without acromioplasty
Detailed Description: There exists some controversy in the current trend in repair of full thickness tears of the rotator cuff The two most common treatments at this point in time are arthroscopic cuff repair with and without acromioplasty The purpose of acromioplasty is to create adequate space for the rotator cuff tendons Arthroscopic acromioplasty involves the removal of the subacromial bursa resection of the coracoacromial ligament and anteroinferior portion of the acromion and resection of any osteophytes from the acromioclavicular joint that are thought to be contributing to impingement However acromioplasty without cuff repair has been reported to have both good and poor results showing that the technique may be suspect in repair of full thickness tears alone

The purpose of this study is to compare the effectiveness of arthroscopic cuff repair with acromioplasty to arthroscopic cuff repair without acromioplasty in repair of full thickness tears of the rotator cuff

We hypothesize that there will be a significant clinical improvement in quality of life in patients who receive a rotator cuff repair without acromioplasty compared to those who receive a cuff repair with acromioplasty

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None