Reverse Shoulder Arthroplasty With or Without Concomitant Latissimus and Teres Major Transfer for Shoulder Pseudoparalysis With Teres Minor Dysfunction
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01697865|
Recruitment Status : Recruiting
First Posted : October 2, 2012
Last Update Posted : September 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis of the Shoulder||Procedure: Transfer group Procedure: Control group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Reverse Shoulder Arthroplasty With or Without Concomitant Latissimus and Teres Major Transfer for Shoulder Pseudoparalysis With Teres Minor Dysfunction: A Prospective, Randomized Investigation|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2019|
Active Comparator: Transfer group
The first surgical technique includes a concomitant latissimus and teres major transfer (transfer group).
|Procedure: Transfer group|
Active Comparator: Control group
The second technique does not include a concomitant latissimus and teres major transfer (control group).
|Procedure: Control group|
- ADLER Score [ Time Frame: 2 Year ]Activities of Daily Living and External Rotation (ADLER) Score: This tool measures patients' ability to do various tasks on a daily basis.
- DASH Score [ Time Frame: 1 Year, 2 Year ]Disabilities of the Arm, Shoulder, and Hand score
- ASES score [ Time Frame: 1 Year, 2 Year ]American Shoulder and Elbow Surgeons Score
- SF-12 Score [ Time Frame: 1 Year, 2 Year ]General Health Outcome score
- Range of Motion [ Time Frame: 1 Year, 2 Year ]Shoulder range of motion
- X-Ray Measurements [ Time Frame: 1 Year, 2 Year ]X-ray measurements from the anteroposterior (AP) and axillary views of the shoulder.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01697865
|Contact: Susan M Odum, MEd||704.323.2265||Susan.Odum@OrthoCarolina.com|
|United States, North Carolina|
|OrthoCarolina Research Institute||Recruiting|
|Charlotte, North Carolina, United States, 28207|
|Contact: Susan M Odum, MEd 704-323-2265 Susan.Odum@Orthocarolina.com|
|Principal Investigator: Nady Hamid, MD|