ClinicalTrials.gg
RecruitingNCT05703958Updated Sep 16, 2026

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

An observational study in Proximal Humeral Fracture, Fracture Dislocation and Non-Union Fracture, sponsored by Exactech. Recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Exactech · Observational

From the registry’s dates

  • Started Apr 2023; still recruiting 3 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
151
Ages
21 Years and older
Sex
All
01

Study 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 Proximal Humerus Fracture Plates over time. This study will follow subjects for a period of up to 10 years post-surgery.

02

Conditions studied

  • Proximal Humeral Fracture
  • Fracture Dislocation
  • Non-Union Fracture
03

In context

Shoulder Fractures

113 studies on the registry are indexed under Shoulder Fractures; 30 are open to participants now.

This study's planned enrollment of 151 is above the median of 97 across 60 observational studies indexed under Shoulder Fractures.

Browse Shoulder Fractures studies →

Lead sponsor

Exactech is the lead sponsor of 17 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing ORIF surgery who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years or longer

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 form

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
151 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Smart Score

    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

    Time frame: Through study completion, an average of 1 per year

  2. Sane Score

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

    Time frame: Through study completion, an average of 1 per year

  3. ASES

    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

    Time frame: Through study completion, an average of 1 per year

  4. Quick DASH

    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

    Time frame: Through study completion, an average of 1 per year

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05703958
Lead sponsor
Exactech
Responsible party
Sponsor
First posted
Jan 30, 2023
Start date
Apr 19, 2023
Primary completion
Dec 31, 2033 (estimated)
Completion
Sep 30, 2034 (estimated)
Last update
Sep 16, 2026

Study contacts

Rachael Craig
Contact
rachael.craig@advita.com
1-833-423-8482
Sandrine Angibaud
Contact
sandrine.angibaud@advita.com
1-833-423-8482
Abhishek Ganta, MD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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