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Completed

NCT Number: NCT00764504

Reverse Shoulder Prosthesis Study

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.

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Key information

Conditions

Rotator Cuff Arthropathy Failed Hemi-arthroplasty Failed Total Shoulder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Arthritis Orthopedics and Sports Medicine, Glendale, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Reverse Shoulder Prosthesis

Device

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

Primary outcomes

  1. American Shoulder and Elbow Surgeons Shoulder Score

    Time frame: 2-year

    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. Average Range of Motion

    Time frame: 2-year

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

  3. Subject Satisfaction With Surgery

    Time frame: 2-year

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

  4. Have Surgery Again?

    Time frame: 2-year

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

  5. Neer's "Limited Goals"

    Time frame: 2-year

    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.

  6. Radiographic Failures

    Time frame: Post-operative, 3-month, 6-month, 1-year, 2-year

    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.

  7. Safety Assessment

    Time frame: 2-year

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

Sponsors and collaborators

Lead sponsor

Encore Medical, L.P.

Industry

Registry information

Official study title

Encore Reverse Shoulder Prosthesis

Acronym: RSP

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Oct 2, 2008
Registry last updated
Apr 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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