Reverse Shoulder Prosthesis Prospective Multi-Center Study

PS-901: Prospective Multicenter Open Label Study of the Encore Reverse® Shoulder Prosthesis

The purpose of this study is to evaluate the use and efficacy of the Reverse® Shoulder Prosthesis for treatment of rotator cuff deficiency in subjects who are candidates for a total shoulder replacement (primary and revision subjects).

Study Overview

• Status: Completed
• Conditions: Shoulder Arthropathy; Rotator Cuff Deficiency; Failed Shoulder Replacement
• Intervention / Treatment: Device: Encore Reverse Shoulder Prosthesis (RSP®)

Detailed Description

Reverse shoulder arthroplasty for the treatment of rotator cuff deficiency and glenohumeral arthritis have shown favorable outcomes in pain and function over the short and medium term. A prospective, multi-center study on the outcomes of subjects treated with the RSP would be a valuable addition to the literature and give important information regarding an ever-increasing treatment option for subjects with rotator cuff deficiency. The study will take place at multiple sites across the United States and will be managed by the DJO Surgical Clinical Affairs Department. The study will include only subjects who meet the indications for use criteria for the Reverse® Shoulder Prosthesis and who are candidates for total shoulder replacement surgery.

• Study Type: Observational
• Enrollment (Actual): 245

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Stanford University - Dept. of Orthopedics
  • Florida
    • Bradenton, Florida, United States, 34209
      • Coastal Orthopedics & Sports Medicine
    • Fort Lauderdale, Florida, United States, 33334
      • Orthopaedic Institute at Holy Cross Hospital
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush-Presbyterian-St. Luke's Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Norton Orthopaedic & Sports Medicine Specialists
  • New York
    • Amherst, New York, United States, 14226
      • Excelsior Orthopaedics
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Cincinnati Sports Medicine and Orthopeadic Center
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
  • Texas
    • Plano, Texas, United States, 75093
      • Texas Center for Joint Replacement
  • Utah
    • Saint George, Utah, United States, 84790
      • Rimrock Orthopedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects who are 60 years of age or older at the time of consent and are suffering from a grossly rotator cuff deficient shoulder joints with severe arthropathy or have a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.

Description

Inclusion Criteria:

• Subject must be a candidate for a total shoulder joint replacement
• Subject must be diagnosed with one or more of the following conditions:

Irreparable rotator cuff tear with gleno-humeral arthritis; Failed rotator cuff surgery with gleno-humeral instability or antero- superior escape; Failed shoulder replacement surgery

• Subject has a functional deltoid muscle
• Subject's joint must be anatomically and functionally suited to receive the selected implant
• Subject is 60 years of age or older (≥ 60 yrs of age) at time of consent
• Subject is likely to be available for all study visits
• Subject is able and willing to sign the informed consent and follow study procedures
• Subject is not pregnant

Exclusion Criteria:

• Subject has a non-functional deltoid muscle
• Subject has a mental condition(s) that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
• Subject is a prisoner
• Subject has high levels of physical activity (ex. competitive sports, heavy physical labor)
• Subject is pregnant
• Subject has an active infection or sepsis
• Subject has loss of ligamentous structures
• Subject has a history of alcoholism or other addictions (current or past)
• Subject has muscular, neurological or vascular deficiencies which compromise the affected extremity (i.e., Parkinson's Disease, Syringomyelia and Multiple Sclerosis, Charcot joints)
• Subject has severe glenoid bone loss
• Subject has known materials sensitivity (to metals)
• Subject is younger than 60 years of age (< 60 years of age) at consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RSP Device; Post Market Study	Device: Encore Reverse Shoulder Prosthesis (RSP®); The RSP is indicated for use in subjects with grossly rotator cuff deficient shoulder joints with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.; Other Names: RSP®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in American Shoulder and Elbow Surgeons Score (ASES) from Baseline	Improvement in American Shoulder and Elbow Surgeons Score (ASES) from Baseline. Assessments include: 1) Pain score where 0=no pain at all and 10=pain as bad as it can be 2) Function score where 0=my should is useless and 10=my shoulder is normal 3) Activity score where 0=unable to do and 3=Normal.	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiologic Success	Changes in radiolucency compared with Baseline	5 year
Change in ASES score from Baseline	Improvement in American Shoulder and Elbow Surgeons Score (ASES) from Baseline. Assessments include: 1) Pain score where 0=no pain at all and 10=pain as bad as it can be 2) Function score where 0=my should is useless and 10=my shoulder is normal 3) Activity score where 0=unable to do and 3=Normal.	5 year
SF36- (Short Form 36)Health Survey	Change from baseline using the SF36-Health Status. There are multiple scales for general health, pain and activities of daily living	5 year
Change in Simple Shoulder Test from Baseline	Change in Simple Shoulder Test from Baseline. Twelve questions about pain and functionality with responses being yes or no	5 year
Subject Satisfaction Survey	Patient Related Outcome of Device Satisfaction (score 1-5 with 1 = best and 5 = worst) Device satisfaction	5 year

Collaborators and Investigators

• Sponsor: Encore Medical, L.P.
• Collaborators: DJO Incorporated
• Investigators: Principal Investigator: Samer S. Hasan, M.D., Cincinnati Sports Medicine and Orthopaedic Center

Publications and helpful links

Helpful Links

• Sponsor website

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: October 30, 2009
• First Submitted That Met QC Criteria: October 30, 2009
• First Posted (Estimate): November 1, 2009

Study Record Updates

• Last Update Posted (Actual): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: PS - 901