Clinical Outcome Comparison Between Medial and Lateral Offset Reverse Shoulder Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wesley P. Phipatanakul, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01086202
First received: March 11, 2010
Last updated: September 3, 2015
Last verified: June 2011
  Purpose
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.

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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Outcome Comparison Between Medial and Lateral Offset Reverse Shoulder Arthroplasty

Resource links provided by NLM:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • Clinical Outcome Comparison Between Medial and Lateral Offset Reverse Shoulder Arthroplasty [ Time Frame: 36 months ] [ Designated as safety issue: No ]

    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.

    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.

    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.

    Pending



Enrollment: 37
Study Start Date: May 2010
Study Completion Date: October 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Tornier Reversed Shoulder Arthroplasty Medial Offset
Lateral offset arthroplasty

Detailed 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.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Elderly/aged, Inpatient and outpatient, healthy patients, females, males physically handicapped, Seventh-day Adventist cohort.
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01086202

Locations
United States, California
Loma Linda University Health Care Dept. of Orthopaedic Surgery
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Wesley Phipatanakul, MD Loma Linda University Health Dept. Orthopaedic Surgery
  More Information

Responsible Party: Wesley P. Phipatanakul, M.D. Asscoaite Professor, Loma Linda University
ClinicalTrials.gov Identifier: NCT01086202     History of Changes
Other Study ID Numbers: 59247 
Study First Received: March 11, 2010
Last Updated: September 3, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
irreparable rotator cuff tears

Additional relevant MeSH terms:
Dislocations
Humeral Fractures
Arm Injuries
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on May 05, 2016