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Exactech Proximal Humerus Fracture Plate System Study

This study is observing people who have received or will receive the Equinoxe Proximal Humerus Fracture Plate for a broken upper arm bone (proximal humeral fracture), a fracture with dislocation, or a fracture that isn't healing (non-union fracture). The main goal is to understand how safe and effective these plates are over a long period. Researchers will track your progress for up to 10 years, measuring your arm function and pain using scores like the Smart Score, Sane Score, and ASES. You can join if you are 21 or older, need this plate, or have already had surgery with it, and are willing to participate in follow-up visits.

Study design
This is an observational study, meaning researchers will watch and collect information from 151 participants over time. It is not testing a new treatment but rather observing the long-term use of an existing one.
What's involved
You would need to comply with pre- and post-operative visit requirements and agree to be followed for up to 10 years after your surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 10 years after their surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05703958

Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up

Recruiting
Not specifiedAges 21+Observational
Exactech
~151 participants
Updated 2024-10-24 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Smart Score
Measured over Through study completion, an average of 1 per year
+3 more outcomes measured

Conditions

Proximal Humeral Fracture
Fracture Dislocation
Non-Union Fracture

Explore related trials

Fracture DislocationFracture, ununitedShoulder Fracture

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Abhishek Ganta, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Rachael Craig
[email protected]
352-377-1140
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patient is indicated to receive Equinoxe Proximal Humerus Fracture Plate or has previously underwent primary surgery with Equioxe Proximal Humerus Fracture Plate
Patient is willing to participate by complying with pre- and postoperative visit requirements
Patient is willing to agree to be followed for up to 10 years following their index surgery
Patient is willing and able to review and sign a study informed consent form

Exclusion

Osteomyelitis of the proximal humerus or scapula
Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
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 has a physical or mental condition that would invalidate the results

What this trial measures

  • Smart ScoreThrough study completion, an average of 1 per year

    Shoulder Arthroplasty Smart (SAS) score - 6 questions based on 3 objective active range of motion and 3 subjective measures of pain and function. Score range of 0 to 100 where 100 indicates the best score

  • Sane ScoreThrough study completion, an average of 1 per year

    Single Assessment Numeric Evaluation (SANE) - Patient shoulder self-evaluation as a percentage of normal, 100% corresponds being normal

  • ASESThrough study completion, an average of 1 per year

    American Shoulder and Elbow Surgeons Score (ASES) - 100 points scale about shoulder pain and performance evaluation in activities of daily living where 100 indicates the best shoulder condition

  • Quick DASHThrough study completion, an average of 1 per year

    Shorten version of Disability of the Arm, Shoulder, and Hand (DASH) - 11 items to measure ability of a patient to perform certain upper extremity where 0 corresponds to no difficulty and 100 corresponds to unable