Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorExactech
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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 year2
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 year3
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 year4
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 Source ClinicalTrials.gov