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

Recruiting

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

• Registration Number: NCT05703958
• Lead Sponsor: Exactech

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-19
• Study First Submitted QC: 2023-01-19
• Study First Posted: 2023-01-30
• Study Start: 2023-04-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-24
• Primary Completion: 2033-12-31
• Study Completion: 2034-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 151

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sane Score	Through 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
ASES	Through 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 DASH	Through 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
Smart Score	Through 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

Trial Locations

Locations (1)

NYU Grossman School of Medicine; 🇺🇸 New York, New York, United States