Recruiting

Proximal Humerus Fracture Plate

Sponsor:

Exactech

Code:

NCT05703958

Conditions

Proximal Humeral Fracture

Fracture Dislocation

Non-Union Fracture

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05703958

Start date

Apr 19, 2023

Status verified date

Oct, 2024

Completion date

Sep 30, 2034

Anticipated

Primary completion date

Dec 31, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Enrollment

151 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Smart Score [ Time Frame: Through study completion, an average of 1 per year ]
  • Sane Score [ Time Frame: Through study completion, an average of 1 per year ]
  • ASES [ Time Frame: Through study completion, an average of 1 per year ]
  • Quick DASH [ Time Frame: Through study completion, an average of 1 per year ]

Central Contacts and Locations

Central contacts

Rachael Craig

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

Sandrine Angibaud

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

Locations

NYU Grossman School of Medicine

Recruiting

New York, New York, United States, 10016

Contacts

718-206-6923

More Information

Sponsor

Exactech

Last update posted

Oct 24, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Exactech on 2024-10-24.