Reverse Shoulder Prosthesis Study

NCT00764504 | Completed Phase 3 Results

• 1 other identifier: Study 300
• Study Type: interventional
• Target: 516
• Locations: 1 country
• Sites: 25

Brief Summary

The objective of this clinical study is to evaluate the safety and efficacy of the Encore Reverse Shoulder Prosthesis (RSP). The clinical results of the RSP will be compared to clinical results published in literature for rotator cuff arthropathy and salvage procedures.

Conditions

Rotator Cuff Arthropathy; Failed Total Shoulder; Failed Hemi-arthroplasty

Outcome Measures

Primary Outcomes (7)

• American Shoulder and Elbow Surgeons Shoulder Score

  The patient self-report section of the ASES is a condition specific scale which is intended to measure functional limitations and pain of the shoulder. On a scale of 0 to 100, the use of their shoulder is measured with 0 = no use and 100 = full use. The assessment is done in two sections. One Pain (measured by the Visual Analog Pain Scale) and the second is a list of 10 questions referred to as the Activities of Daily Living. The results are calculated with the following equation: \[(10 - Visual analog scale pain score) x 5\] + \[(5/3) x Cumulative ADL score\]

  2-year

• Average Range of Motion

  Physician's assessment of a subject's range of motion in degrees.

  2-year

• Subject Satisfaction With Surgery

  Each subject had a chance to rate their satisfaction with surgery at each study interval.

  2-year

• Have Surgery Again?

  Subject satisfaction: subject's willingness to have surgery performed again if necessary.

  2-year

• Neer's "Limited Goals"

  To meet Neer's limited goals, a subject must report: none, slight or moderate pain with unusual activity and exhibit \>90 degrees active forward elevation and exhibit \>20 degrees of active external rotation.

  2-year

• Radiographic Failures

  Radiographic failure is defined as a shift in the position of the component \>3mm or 3 degrees, a fracture of the cement mantle, a fracture of the component, or a \>2mm radiolucency completely around either prosthesis.

  Post-operative, 3-month, 6-month, 1-year, 2-year

• Safety Assessment

  Number of device related adverse events and device failures at the 2 year time frame.

  2-year

Study Arms (3)

Primary

EXPERIMENTAL

Primary shoulder

Device: Reverse Shoulder Prosthesis

Revision

EXPERIMENTAL

Revision shoulder

Device: Reverse Shoulder Prosthesis

Continued Access

EXPERIMENTAL

Primary shoulder subjects enrolled at a later date in order to collect more data.

Device: Reverse Shoulder Prosthesis

Interventions

Reverse Shoulder Prosthesis DEVICE

For subjects with rotator cuff arthropathy and no previous shoulder device implanted.

Continued Access; Primary

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Irreparable rotator cuff or failed hemi or total shoulder arthroplasty with irreparable rotator cuff
• Evidence of upward displacement of the humeral head with respect to the glenoid
• Loss of glenohumeral joint space
• Functional deltoid muscle
• Patient is likely to be available for evaluation for the duration of the study
• Visual Analog Pain Scale 5 or greater

You may not qualify if:

• Non functional deltoid muscle
• Active sepsis
• Excessive glenoid bone loss
• Pregnancy
• Neurological abnormalities, which could hinder patient's ability or willingness to follow study procedures. For example, any that may restrict physical activities such as Parkinson's, Multiple Sclerosis, or previous stroke, which affects upper extremity.
• Mental conditions that may interfere with ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the patient cannot understand the informed consent process, global dementia, prior strokes that interfere with the patient's cognitive abilities, senile dementia, and Alzheimer's Disease.
• Prisoners
• Conditions that place excessive demand on the implant (i.e. Charcot's joints, muscle deficiencies, refusal to modify postoperative physical activities, skeletal immaturity).
• Known metal allergy (i.e., jewelry).
• Visual Analog Pain Scale \<5.

Sponsors & Collaborators

• Encore Medical, L.P.: lead

Study Sites (25)

Arthritis Orthopedics and Sports Medicine

Glendale, California, 91206, United States

Location

Orthopaedic Specialty Institute

Orange, California, 92868, United States

Location

University of Colorado

Denver, Colorado, 80054, United States

Location

Orthopedic Center of the Rockies

Fort Collins, Colorado, 80525, United States

Location

Advanced Orthopedic and Sports Medicine Specialists, P.C.

Lonetree, Colorado, 80124, United States

Location

Steadman Hawkins SPT Medical Foundation

Vail, Colorado, 81657, United States

Location

Atlantis Orthopaedics

Atlantis, Florida, 33462, United States

Location

Orthopaedic Surgery & Sports Medicine

Jupiter, Florida, 33458, United States

Location

Palm Beach Orthopaedic Institute

Palm Beach Gardens, Florida, 33410, United States

Location

Florida Orthopedic Institute

Temple Terrace, Florida, 33637, United States

Location

Unknown Facility

Atlanta, Georgia, 30342, United States

Location

Cincinnati Sports Medicine & Orthopaedic Center

Crestview, Kentucky, 41017, United States

Location

Unknown Facility

Lutherville, Maryland, 21093, United States

Location

Orthopedic Specialists

Towson, Maryland, 21204, United States

Location

TRIA Orthopaedic Center

Bloomington, Minnesota, 55431, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

UNC School of Medicine

Chapel Hill, North Carolina, 27599, United States

Location

Crystal Clinic

Akron, Ohio, 44333, United States

Location

Bone & Joint Hospital, LLC

Oklahoma City, Oklahoma, 73103, United States

Location

Orthopedic Research Foundation of the Carolinas

Spartanburg, South Carolina, 29307, United States

Location

The Carrell Clinic

Dallas, Texas, 75231, United States

Location

Orthopedic Associates of Dallas

Dallas, Texas, 75246, United States

Location

Orthopedic Specialty Associates, P.A.

Fort Worth, Texas, 76104, United States

Location

Unlimited Research

San Antonio, Texas, 78217, United States

Location

Orthopedic Institute

Tyler, Texas, 75701, United States

Location

Related Links

• Sponsor company home page

Results Point of Contact

• Title: Manager of Clinical Affairs
• Organization: DJO Surgical

jane.jacob@djosurgical.com

512-832-9500

Study Officials

• Mark Frankle, M.D.

  Florida Orthopedic Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 2, 2008
• Study Start: October 1, 2002
• Primary Completion: June 1, 2008
• Study Completion: August 1, 2008
• Last Updated: April 19, 2011
• Results First Posted: April 19, 2011

Record last verified: 2011-03

Locations

US (25)