Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05703958

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Proximal Humeral Fracture Fracture Dislocation Fractures, Bone Fractures, Ununited Joint Diseases Joint Dislocations Musculoskeletal Diseases Non-Union Fracture Shoulder Fractures Shoulder Injuries Wounds and Injuries

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU Grossman School of Medicine

New York, 10016, United States

Location status: Recruiting

Location contact

CONTACT

718-206-6923

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Smart Score

    Time frame: 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

  2. Sane Score

    Time frame: 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

  3. ASES

    Time frame: 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

  4. Quick DASH

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Rachael Craig

CONTACT

[email protected]

352-377-1140

Sandrine Angibaud

CONTACT

[email protected]

352-377-1140

Sponsors and collaborators

Lead sponsor

Exactech

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2033
Study completion
2034
First posted
Jan 30, 2023
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.