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Study on Shoulder Surgery with or without Extra Support

This study is looking at how safe and good a new tool, called Bioenthesis™, is for fixing shoulder injuries. What we learn from this study might help doctors take better care of patients and could change how hospitals use resources.

Age & Gender

  • 18 years ~ 65 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

At each visit, you will meet a team member to talk about how you are doing. You will fill out surveys and do some strength tests. We will also ask about any medications you are taking. You will have 2 MRI scans, one at the start and one at the end of the study.

Incentives

You will receive a $50 online gift card for every study visit, adding up to a total of $200.

In-person visits:
3
Phone or online visits:
4
Total length of participation:
12 months

Looking for Specific Volunteers

Able to participate:

  • You have a rotator cuff tear that is indicated for surgical repair
  • are between the ages of 18-65
  • are able and willing to commit to study procedures for 12 months
  • are fluent in speaking, reading and comprehending English

Not eligible if:

  • you have had a previous shoulder surgery
  • are unwilling to remain tobacco free for the duration of the study
  • have any lower extremity injuries that require the use of a walking assist device
  • have systemic arthritis
  • are currently pregnant or plan to become pregnant during the duration of this study

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

Additional Study Information

Principal Investigator

Robert Creighton
Orthopaedics - Sports Medicine

Study Type

Clinical or Medical
Interventional

Study Topics

Bones, Joints, Muscles

IRB Number

24-0863

ClinicalTrials.gov

NCT06289686

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