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Completed

NCT Number: NCT00765037

Retrospective Encore Reverse Shoulder Prosthesis Study

The purpose of this study is to evaluate the survivorship and efficacy of the Encore Reverse Shoulder Prosthesis in a group of no more than 50 subjects for whom data collection has already begun.

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Key information

Conditions

Rotator Cuff Deficiency Glenohumeral Arthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nashville Orthopedic Specialists

Nashville, Tennessee, 37203, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The RSP is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.
  • The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
  • The glenoid baseplate is intended for Cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

Exclusion criteria

  • Infection or sepsis
  • Insufficient bone quality which may affect the stability of the implant, as determined by the physician
  • Muscular, neurological, or vascular deficiencies, which compromise the affected extremity
  • Alcoholism or other addictions
  • Materials (metals, etc) sensitivity
  • Loss of ligamentous structures
  • High levels of physical activity
  • Non-functional deltoid muscle

Treatment and study plan

Encore Reverse Shoulder Prosthesis

Device

rotator cuff deficiency and glenohumeral arthritis

Primary outcomes

  1. Survivorship of the Encore Reverse Shoulder Prosthesis

    Time frame: 1 year

    Number of subjects who completed all study visits through the 1 year visit.

Sponsors and collaborators

Lead sponsor

Encore Medical, L.P.

Industry

Registry information

Official study title

Post Market Study on the Efficacy of the Encore Reverse Shoulder Prosthesis in a Small Group of Subjects

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 2, 2008
Registry last updated
Aug 25, 2010

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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