Rotator Cuff: Does the Vascularity Matter and the Role for PINPOINT

NCT03001050 | Withdrawn FDA Device

• 1 other identifier: 5160379
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of doing this study is to improve long term patient function and outcomes in the healing rates of Rotator Cuffs. The investigators would also like to see if this method can be more cost effective and time efficient for Rotator Cuff evaluation during arthroscopy.

Conditions

Rotator Cuff Tear

Outcome Measures

Primary Outcomes (1)

• PINPOINT System-ASES

  American Shoulder and Elbow Surgeons questionnaire this will be used for scoring

  Change from baseline at 24 months

Secondary Outcomes (4)

• PINPOINT System-UCLA

  Change from baseline at 24 months

• PINPOINT System-DASH

  Change from baseline at 24 months

• PINPOINT System-SF-36

  Change from baseline at 24 months

• PINPOINT System-SF-12

  Change from baseline at 24 months

Study Arms (1)

PINPOINT system

OTHER

The operative intervention will proceed as current standard protocol dictates for the described procedure. No changes in the operative technique will be undertaken apart from injection of the dye and visualization with the camera. The idea would be to place the Pinpoint probe within the subacromial space, to check the vascular status of the tendon, and then take a bite of the tendon and place the pinpoint back to check if the vascularity has decreased. The Indocyanine Green dye kit will be used along with the PINPOINT system .

Device: PINPOINT System

Interventions

PINPOINT System DEVICE

To use the camera probe and identify the tendon and footprint vascularity at the time of surgery

PINPOINT system

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of requiring Rotator Cuff repair surgical treatment
• Willingness and ability to comply with the requirements of the protocol including follow-up requirements.
• Willing and able to sign a study specific informed consent form to participate.
• Age range of ≥ 30 years old and ≤ 80 years old at time of surgery.
• Male or female.

You may not qualify if:

• Previous Rotator cuff repair or shoulder surgery.
• Active systemic infection or infection at the operative site.
• Co-morbid medical conditions of the upper extremities that may affect the neurological and/or pain assessment.
• History of an osteoporotic fracture.
• History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism.
• Taking medications that may interfere with bony/soft tissue healing including chronic steroid use.
• Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia.
• Insulin-dependent type 1 or type 2 diabetes.
• Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion.
• Pregnant, or intend to become pregnant, during the course of the study.
• Severe obesity (Body Mass Index \> 40).

Sponsors & Collaborators

• Nirav Amin, MD: lead

Study Sites (1)

Loma Linda University Health, Department of Orthopaedic Surgery

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Nirav H Amin, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D. Associate Professor

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 22, 2016
• Study Start: December 20, 2017
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: February 26, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)