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

An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Equinoxe Proximal Humerus Fracture Plates Clinical and Radiographic Outcomes

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.

Study Overview

• Status: Recruiting
• Conditions: Fracture Dislocation; Proximal Humeral Fracture; Non-Union Fracture

• Study Type: Observational
• Enrollment (Estimated): 151

Contacts and Locations

• Study Contact: Name: Sandrine Angibaud; Phone Number: 352-377-1140; Email: sandrine.angbaud@exac.com
• Study Contact Backup: Name: Rachael Craig; Phone Number: 352-377-1140; Email: rachael.craig@exac.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Grossman School of Medicine
      • Contact: Phone Number: 718-206-6923

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• 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

Description

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 informed consent form

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Through study completion, an average of 1 per year
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	Through study completion, an average of 1 per year
Sane Score	Single Assessment Numeric Evaluation (SANE) - Patient shoulder self-evaluation as a percentage of normal, 100% corresponds being normal	Through study completion, an average of 1 per year
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	Through study completion, an average of 1 per year

Collaborators and Investigators

• Sponsor: Exactech
• Investigators: Principal Investigator: Abhishek Ganta, MD, NYU Grossman School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2023
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): September 30, 2034

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Arm Injuries; Fractures, Bone; Fractures, Ununited; Humeral Fractures; Shoulder Fractures; Fracture Dislocation
• Other Study ID Numbers: CR21-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No