Clinical trial NCT05615246: Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
Official title: An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoarthritis Shoulder
Rheumatoid Arthritis
Oncology
Lead sponsor: Exactech
Sponsor class: INDUSTRY
First posted: 2022-11-14
Enrollment: 4
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patients who meet eligibility criteria
* Patients who consent to participate to return for follow-up visits out to 10 years or longer

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: SST-12
timeFrame: Through study completion, an average of 1 per year
measure: SPADI
timeFrame: Through study completion, an average of 1 per year
measure: Constant
timeFrame: Through study completion, an average of 1 per year
measure: ASES
timeFrame: Through study completion, an average of 1 per year
measure: UCLA
timeFrame: Through study completion, an average of 1 per year
measure: TESS
timeFrame: Through study completion, an average of 1 per year
measure: MSTS
timeFrame: Through study completion, an average of 1 per year
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Western Orthopaedics Research and Education Foundation
state: Colorado
Study officials:
References: