Subscapularis Indocyanine Green Perfusion Pilot Study

NCT05179941 | Completed

• 1 other identifier: STUDY02001327
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The Purpose of this pilot study is to evaluate the feasibility of open wide-field imaging of indocyanine green ingress and egress during total shoulder arthroplasty. This study also hopes to characterize the relationship between tissue perfusion measured with DCE-FI and different approaches and techniques used in total shoulder arthroplasty. The long term goal of this study is to determine if there is a potential relationship between perfusion and patient reported outcomes and subscapularis failure.

Conditions

Shoulder Pain; Shoulder Arthritis; Shoulder Arthroplasty

Keywords

Orthopaedic; Shoulder; Joint Replacement; ICG; Indocyanine green

Outcome Measures

Primary Outcomes (1)

• measurement of change to tendon blood supply during total shoulder arthroplasty

  The primary study outcome is to evaluate the ingress and egress in tendon and tissue blood flow in patients undergoing a total shoulder repair.

  Baseline, up to 2 hours

Secondary Outcomes (1)

• measurement of change to tendon blood supply using different techniques used in total shoulder arthroplasty

  Baseline, up to 2 hours

Study Arms (1)

patients requiring a shoulder arthroplasty

EXPERIMENTAL

Patients will be administered Food and Drug Administration (FDA) approved Indocyanine green (ICG) through intravenous injection and imaged by a FDA approved surgical fluorescence imaging device. Both ICG fluorescence and the imaging system have been used for routine clinical practice for many years. ICG fluorescence imaging utilizes intravenously injected ICG, which is a fluorescent dye that is FDA approved for clinical use, illuminated with near-infrared light. The ICG dye is indirectly activated and the dynamic fluorescence due to meniscal perfusion can be captured by an FDA approved imaging system.

Procedure: Perfusion with Indocyanine green

Interventions

Perfusion with Indocyanine green PROCEDURE

Infusion of Indocyanine green to determine perfusion of the subscapularis tendon change after tenotomy vs peel technique and subsequent intra-operative repair.

patients requiring a shoulder arthroplasty

Eligibility Criteria

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

You may qualify if:

• \- Participant must be 18 years of age or older
• \- Meet clinical and radiographic parameters necessary to undergo shoulder arthroplasty
• \- Subscapularis tendon intact clinically on exam or via advanced imaging
• \- Subject has the ability to have their shoulder arthroplasty completed using either the tenotomy or peel technique.

You may not qualify if:

• \- Inability of patient to provide informed consent
• \- Iodine allergy
• \- Subscapularis tendon tear or concern for tear
• \- Incarceration
• \- Pregnant women
• \- Patients less than 18 years of age
• \- Prior deltopectoral approach to the ipsilateral shoulder

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Perfusion; Indocyanine Green

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• John-Erik Bell, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedics staff physician

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 6, 2022
• Study Start: February 11, 2022
• Primary Completion: December 13, 2022
• Study Completion: December 13, 2022
• Last Updated: August 4, 2023

Record last verified: 2023-08

Locations

US (1)