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

Proximal Humeral Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05703958
• Other study ID #: CR21-001
• Status: Recruiting
• Start date: April 19, 2023
• Est. completion date: September 30, 2034

Study information

• Verified date: September 2023
• Source: Exactech
• Contact: Rachael Craig
• Phone: 352-377-1140
• Email: rachael.craig[@]exac.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 151
• Est. completion date: September 30, 2034
• Est. primary completion date: December 31, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fracture Dislocation
• Fractures, Bone
• Fractures, Ununited
• Humeral Fractures
• Non-Union Fracture
• Proximal Humeral Fracture
• Shoulder Fractures

Locations

Country	Name	City	State
United States	NYU Grossman School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Exactech

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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