RSP® Prospective Multi-Center Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
DJO Incorporated
Information provided by (Responsible Party):
Encore Medical, L.P.
ClinicalTrials.gov Identifier:
NCT01005446
First received: October 30, 2009
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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).


Condition Intervention Phase
Rotator Cuff Deficiency
Shoulder Arthropathy
Failed Shoulder Replacement
Device: Encore Reverse Shoulder Prosthesis (RSP®)
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PS-901: Prospective Multicenter Open Label Study of the Encore Reverse® Shoulder Prosthesis

Resource links provided by NLM:


Further study details as provided by Encore Medical, L.P.:

Primary Outcome Measures:
  • Improvement in American Shoulder and Elbow Surgeons (ASES) Score from Baseline [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Radiologic Success [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • Change in ASES score from Baseline [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • Change in SF36-Health Status from Baseline [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • Change in Simple Shoulder Test from Baseline [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • Subject Satisfaction Survey [ Time Frame: 5 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 224
Study Start Date: December 2009
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  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: NCT01005446

Locations
United States, California
Stanford University - Dept. of Orthopedics
Redwood City, California, United States, 94063
United States, Florida
Coastal Orthopedics & Sports Medicine
Bradenton, Florida, United States, 34209
Orthopaedic Institute at Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33334
United States, Illinois
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612
United States, Kentucky
Norton Orthopaedic & Sports Medicine Specialists
Louisville, Kentucky, United States, 40241
United States, New York
Excelsior Orthopaedics
Amherst, New York, United States, 14226
United States, Ohio
Cincinnati Sports Medicine and Orthopeadic Center
Cincinnati, Ohio, United States, 45242
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
United States, Texas
Texas Center for Joint Replacement
Plano, Texas, United States, 75093
United States, Utah
Rimrock Orthopedics
St. George, Utah, United States, 84790
Sponsors and Collaborators
Encore Medical, L.P.
DJO Incorporated
Investigators
Principal Investigator: Samer S. Hasan, M.D. Cincinnati Sports Medicine and Orthopaedic Center
  More Information

Additional Information:
No publications provided

Responsible Party: Encore Medical, L.P.
ClinicalTrials.gov Identifier: NCT01005446     History of Changes
Other Study ID Numbers: PS - 901
Study First Received: October 30, 2009
Last Updated: February 4, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 22, 2014