Clinical Outcome Comparison Between Medial and Lateral Offset Reverse Shoulder Arthroplasty

NCT01086202 | Completed DMC

• 1 other identifier: 59247
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rotator Cuff Tear; Proximal Humerus Fractures; Malunions; Chronic Proximal Humerus Dislocations

Keywords

irreparable rotator cuff tears

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Tornier Reversed Shoulder Arthroplasty Medial Offset

Lateral offset arthroplasty

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly/aged, Inpatient and outpatient, healthy patients, females, males physically handicapped, Seventh-day Adventist cohort.

You may qualify if:

• \. 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.

You may not qualify if:

• Any patient with previous arthroplasty on affected shoulder.
• Patient who will need additional procedures including: bone grafting of the glenoid and muscle transfer.
• Patients who do not want to participate or participate in follow-ups.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health Care Dept. of Orthopaedic Surgery

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Wesley Phipatanakul, MD

  Loma Linda University Health Dept. Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Asscoaite Professor

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 15, 2010
• Study Start: May 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: September 15, 2016

Record last verified: 2011-06

Locations

US (1)