Clinical Trial Finder

Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)

Study Purpose

The objective of this study is to collect and evaluate long-term clinical outcomes data in order to better understand the safety and performance of the Equinoxe Humeral Reconstruction Prosthesis in shoulder arthroplasty over time. This study will follow subjects for a period of up to 10 years post-surgery.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 21 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patient is indicated for shoulder arthroplasty (or has previously undergone shoulder arthroplasty) - Patient is at least 21 years of age.
  • - 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, implentation should be delayed until infection is resolved.
  • - Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis.
  • - Neuromuscular disorders that do not allow control of the joint.
  • - SIgnigicant 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 adversely affect the function or longevity of the implant.
  • - Patient is pregnant.
  • - Patient is a prisoner.
- Patient has a physical or mental condition that would invalidate the results

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05615246
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Exactech
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Osteoarthritis Shoulder, Rheumatoid Arthritis, Oncology

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Denver, Colorado

Status

Recruiting

Address

Western Orthopaedics Research and Education Foundation

Denver, Colorado, 80218

Site Contact

Libby Mauter

[email protected]

303-321-1333

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