Clinical Outcome Comparison Between Medial and Lateral Offset Reverse Shoulder Arthroplasty
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|ClinicalTrials.gov Identifier: NCT01086202|
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : September 15, 2016
|Condition or disease|
|Rotator Cuff Tear Proximal Humerus Fractures Malunions Chronic Proximal Humerus Dislocations|
The combination of shoulder arthritis and rotator cuff deficiency presents quite a surgical challenge. The reverse prosthesis offers a treatment option for subset of patients as previous attempts to treat with soft tissue reconstruction or conventional arthroplasty have provided sub-optimal clinical results. Numerous reports in the literature have validated the effectiveness of the reverse design.
Patients meeting criteria must be between the ages of 50 and 95 years of age and are a candidate for a reverse shoulder arthroplasty. This is includes patients with rotator cuff tear arthroplasty, irreparable rotator cuff tears, significant proximal humerus fractures and malunions, and chronic proximal humerus dislocators. A total of 40 patients will be enrolled and randomized to either one of two groups; 20 patients will be randomized to the Tornier Reversed shoulder Arthroplasty Medial offset, and 20 will receive the Lateral offset design. Both implants are FDA approved. The patients will be followed for 24 months and will follow-up will be at 6 weeks, 3 months, 6 months, 12 months and 24 months questionnaires will be completed at each visit, x-rays will be done at pre-op, 3 month, 6 months 12 and 24 months.
|Study Type :||Observational|
|Actual Enrollment :||37 participants|
|Official Title:||Clinical Outcome Comparison Between Medial and Lateral Offset Reverse Shoulder Arthroplasty|
|Study Start Date :||May 2010|
|Primary Completion Date :||September 2014|
|Study Completion Date :||October 2014|
|Tornier Reversed Shoulder Arthroplasty Medial Offset|
|Lateral offset arthroplasty|
- Clinical Outcome Comparison Between Medical Lateral Offset Reverse Shoulder Arthroplasty [ Time Frame: 36 Months ]We would like to follow these patients for two years after implantation of the reverse shoulder and evaluate their radiographs, pain scores, and shoulder functional scores. this would be the first randomized prospective single blinded study of its kind.
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): NCT01086202
|United States, California|
|Loma Linda University Health Care Dept. of Orthopaedic Surgery|
|Loma Linda, California, United States, 92354|
|Principal Investigator:||Wesley Phipatanakul, MD||Loma Linda University Health Dept. Orthopaedic Surgery|