Clinical Outcome Comparison Between Medial and Lateral Offset Reverse Shoulder Arthroplasty

Rotator Cuff Tear Clinical Trial

Official title:

Clinical Outcome Comparison Between Medial and Lateral Offset Reverse Shoulder Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01086202
• Other study ID #: 59247
• Status: Completed
• Phase: N/A
• First received: March 11, 2010
• Last updated: September 14, 2016
• Start date: May 2010
• Est. completion date: October 2014

Study information

• Verified date: June 2011
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to prospectively evaluate two FDA approved implant designs for the Tornier Reverse Shoulder arthroplasty. The small difference in design is the amount of offset each implant has. This offset may improve clinical outcomes in the patient population. There have been no clinical comparative studies between these two designs in the literature to date. 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Any patient that is a candidate for reverse shoulder arthroplasty this includes:

• rotator cuff tear arthroplasty,

• irreparable rotator cuff tear,

• significant proximal humerus fracture and malunions,

• chronic proximal humerus dislocation.

Exclusion Criteria:

1. Any patient with previous arthroplasty on affected shoulder.

2. Patient who will need additional procedures including: bone grafting of the glenoid and muscle transfer.

3. Patients who do not want to participate or participate in follow-ups.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Proximal Humerus Dislocations
• Dislocations
• Humeral Fractures
• Malunions
• Proximal Humerus Fractures
• Rotator Cuff Tear

Locations

Country	Name	City	State
United States	Loma Linda University Health Care Dept. of Orthopaedic Surgery	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Outcome Comparison Between Medical Lateral Offset Reverse Shoulder Arthroplasty	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.	36 Months	No