Status:

RECRUITING

Exactech Shoulder Post Market Clinical Follow-up Study

Lead Sponsor:

Exactech

Conditions:

Osteo Arthritis Shoulders

Osteonecrosis

Eligibility:

All Genders

21+ years

Brief Summary

The objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time...

Eligibility Criteria

Inclusion Criteria:

  • Patient is indicated for shoulder arthroplasty (or has previously undergone shoulder arthroplasty)
  • Patient is skeletelly mature
  • Patient is expected to survive at least 2 years beyond surgery
  • Patient is willing to participate by complying with pre- and postoperative visit requirements
  • Patient is willing and able to read and sign a study informed consent form

Exclusion Criteria:

  • Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implantation should be delayed until infection is resolved
  • Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
  • Medial humeral bone loss resulting in compromised humeral stem fixation
  • Proximal humeral bone loss extending distal to the surgical neck where there is compromised humeral stem fixation
  • Neuromuscular disorders that do not allow control of the joint
  • Significant injury to the brachial plexus
  • Non-functional deltoid muscles
  • Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system
  • The patient is unwilling or unable to comply with the post-operative care instructions
  • Alcohol, drug, or other subtance abuse
  • Any disease state that could adversaly affect the function or longevity of the implant
  • Patient is pregnant
  • Patient is a prisoner
  • Patient is contraindicated for the surgery
  • Revision cases in which a stemmed humeral component was used (Stemless Shoulder System)
  • Metal allergy or sensitivity to the implants materials (Stemless Shoulder System)
  • Acute fracture of the proximal humerus and displacement of the tuberosities, displaced three or four part fractures of the proximal humerus (hemi-arthroplasty), or acture fracture of the proximal humerus with failure of the glenohumeral joint (total anatomic shoulder arthroplasty) (Stemless Shoulder System)
  • Acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty) (Stemless Shoulder System)

Key Trial Info

Start Date :

July 19 2007

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2031

Estimated Enrollment :

20000 Patients enrolled

Trial Details

Trial ID

NCT05603728

Start Date

July 19 2007

End Date

December 31 2031

Last Update

December 15 2025

Active Locations (38)

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Page 1 of 10 (38 locations)

1

South County Orthopedic Specialists

Laguna Woods, California, United States, 92637

2

Stanford Health Care

Redwood City, California, United States, 94063

3

Alpine Orthopaedic Medical Group

Stockton, California, United States, 95204-5508

4

Western Orthopaedics

Denver, Colorado, United States, 80218