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

NCT05703958 | Recruiting

• 1 other identifier: CR21-001
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

Proximal Humeral Fracture; Fracture Dislocation; Non-Union Fracture

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Exactech: lead

Study Sites (1)

NYU Grossman School of Medicine

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Shoulder Fractures; Fracture Dislocation; Fractures, Ununited

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Abhishek Ganta, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachael Craig

CONTACT

352-377-1140; rachael.craig@exac.com

Sandrine Angibaud

CONTACT

352-377-1140; sandrine.angbaud@exac.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: January 30, 2023
• Study Start: April 19, 2023
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): September 30, 2034
• Last Updated: October 24, 2024

Record last verified: 2024-10

Locations

US (1)