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Completed

NCT Number: NCT00719771

Global® AP™ Total Shoulder Arthroplasty

This study will evaluate the clinical performance of DePuy Global® AP™ Shoulder prosthesis using the anchor pegged glenoid component and clinical and radiographic evaluations.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The CORE Institute, Phoenix, Arizona, United States

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About this study

The purpose of the study is to determine the difference between pre-operative and post-operative levels of patient satisfaction, shoulder function, radiographic alignment, shoulder pain and patient satisfaction in patients receiving a Global® AP™ shoulder prosthesis for glenohumeral arthritis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients selected for inclusion will present for primary shoulder arthroplasty with a diagnosis of osteoarthritis and will consent to participate.

Exclusion criteria

  • Are under 18 years of age or over 70
  • Diagnosis of AVN, Inflammatory Arthritis, Fracture or Malunion.
  • Have a hemi-arthroplasty
  • Have destruction of the proximal humerus that precludes rigid fixation of the humeral component
  • Have arthritis with insufficient cuff tissue
  • Have had a failed rotator cuff surgery
  • Have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified
  • Have evidence of active infection
  • Present with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachial plexus injury with a flail shoulder joint) - Have a known active metastatic or neoplastic disease
  • Are unwilling or unable to comply with a rehabilitation program or would fail to return for the postoperative follow-up visits prescribed by the protocol
  • Are skeletally immature.
  • Have a known allergic reaction to implant metals, polyethylene or a tissue reaction to corrosion or wear products
  • Have other conditions such as central nervous system disturbances, alcohol or drug addiction, etc. that may make effective evaluation of the joint replacement difficult or impossible
  • Are currently participating in another clinical study
  • Are taking > 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery
  • Are currently involved in any personal injury litigation, medical legal or worker's compensation claims.

Treatment and study plan

Global® AP™ Total shoulder arthroplasty

Device

Total shoulder arthroplasty

Other names: Global® AP™ Shoulder

Primary outcomes

  1. Constant Shoulder Score

    Time frame: Pre-op, 6, 12, 24 months

Secondary outcomes

  1. SF-12

    Time frame: Pre-op, 6,12, 24 months

  2. Penn/ASES

    Time frame: Pre-Op, 6, 12, and 24 months

  3. Radiographic Data

    Time frame: Pre-Op, 6 weeks, 6, 12, and 24 months

  4. Quality of Life Survey

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

DePuy Orthopaedics

Industry

Registry information

Official study title

A Multi-center Clinical Study of the Global® AP™ Shoulder in Total Shoulder Arthroplasty

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jul 22, 2008
Registry last updated
May 22, 2014

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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