Clinical trial NCT00719771: Global® AP™ Total Shoulder Arthroplasty
Official title: A Multi-center Clinical Study of the Global® AP™ Shoulder in Total Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Glenohumeral joint
Glenoid
Shoulder arthroplasty
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2008-07-22
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Constant Shoulder Score
timeFrame: Pre-op, 6, 12, 24 months
Secondary outcomes:
measure: SF-12
timeFrame: Pre-op, 6,12, 24 months
measure: Penn/ASES
timeFrame: Pre-Op, 6, 12, and 24 months
measure: Radiographic Data
timeFrame: Pre-Op, 6 weeks, 6, 12, and 24 months
measure: Quality of Life Survey
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: The CORE Institute
state: Arizona
city: Asheville
country: United States
facility: Mission Hospitals Research Institute
state: North Carolina
city: Cincinnati
country: United States
facility: Wellington Orthopaedics and Sports Medicine
state: Ohio
city: Park City
country: United States
facility: Rosenberg Cooley Metcalf Clinic
state: Utah
Study officials:
affiliation: DePuy Orthopaedics
name: Sam Himden, BA
role: STUDY_DIRECTOR
References: