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Exactech Shoulder Post Market Clinical Follow-up Study

StatusRecruiting
PhaseNot specified
SponsorExactech
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoints: details revised at 2 of 5 entries
    • Study sites: 38 to 40
    • Eligibility criteria expanded, about 23 words
  2. Start date: Jan 2010 to Jul 19, 2007v5
  3. Study sites: 34 to 38
    • Study completion date: Sep 30, 2031 to Dec 31, 2031
    • Eligibility criteria shortened, about 4 words
    v4
  4. 2 versions Re-verified since Jan 27, 2023, no change to tracked fieldsv2-v3
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. This study will follow subjects long-term for a minimum of 10-years, without an early-term restriction on the amount of time they will be followed.
Trial Details
NCT Number NCT05603728
Lead Sponsor Exactech
Conditions
(from sponsor)		 Osteo Arthritis Shoulders, Osteonecrosis, Rotator Cuff Tears, Rotator Cuff Tear Arthropathy, Ankylosing Spondylitis, Post-traumatic Osteoarthritis, Rheumatoid Arthritis, Fracture +1 more
Related terms Arthritis, Rheumatoid, Fractures, Bone, Infections, Osteonecrosis, Rotator Cuff Injuries, Rotator Cuff Tear Arthropathy, Spondylitis, Ankylosing
Enrollment 20,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov