Reverse Shoulder Prosthesis Prospective Multi-Center Study

Shoulder Arthropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01005446
• Other study ID #: PS - 901
• Status: Completed
• Start date: December 2009
• Est. completion date: June 2018

Study information

• Verified date: March 2021
• Source: Encore Medical, L.P.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: June 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Failed Shoulder Replacement
• Joint Diseases
• Rotator Cuff Deficiency
• Shoulder Arthropathy

Intervention

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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Encore Medical, L.P.	DJO Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Radiologic Success	Changes in radiolucency compared with Baseline	5 year
Secondary	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
Secondary	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
Secondary	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
Secondary	Subject Satisfaction Survey	Patient Related Outcome of Device Satisfaction (score 1-5 with 1 = best and 5 = worst) Device satisfaction	5 year

External Links

•   Sponsor website