Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05179941 |
| Other study ID # |
STUDY02001327 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 11, 2022 |
| Est. completion date |
December 13, 2022 |
Study information
| Verified date |
August 2023 |
| Source |
Dartmouth-Hitchcock Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Shoulder arthroplasty is a commonly utilized and routinely successful surgery performed for
management of glenohumeral joint arthritis. Upwards of 90% of primary anatomic total shoulder
arthroplasty surgeries are considered successful. Albeit rare, complications do occur.
Complications include glenoid or humeral component loosening, periprosthetic fracture,
infection and rotator cuff failure. Of the four muscles that comprise the rotator cuff, the
subscapularis is of particular concern in total shoulder arthroplasty surgery due to the
approach used to access the glenohumeral joint. The deltopectoral approach is the standard
approach used for shoulder arthroplasty and necessitates performing a subscapularis takedown
in order to obtain adequate visualization of the glenohumeral joint. Three techniques to
perform a subscapularis takedown are common, with an absence of consensus in the literature
as to which technique is superior. The techniques include a subscapularis peel, and a
subscapularis tenotomy.
Each subscapularis takedown technique requires repair at the conclusion of the procedure when
performing shoulder arthroplasty. Repair is crucial for proper force coupling of the shoulder
to keep the humeral head implant centered on the glenoid component. Takedown is still
performed in a reverse total shoulder arthroplasty but repair is not required to maintain
stability. Each takedown technique is reliant on a tendon to tendon interface for healing.
Failure of the subscapularis tendon repair can result in pain, instability, decreased
functional outcomes and ultimately the need for revision surgery. Subscapularis tendon
failure can sometimes be asymptomatic, however it can also be symptomatic and present with
the aforementioned signs. Subscapularis failure rates may approach 50% in long term studies
although symptomatic cases likely occur in less than 1% of total shoulder arthroplasties .
Due to the devastating impact on patients with symptomatic subscapularis failure, there is
interest in investigating which subscapularis takedown technique produces the best outcomes.
Prior randomized controlled trials as well as systematic reviews have previously been
conducted looking at these different takedown techniques, but demonstrated no statistically
significant difference in primary endpoints of subscapularis strength at various time
endpoint and no statistically significant difference in patient reported outcomes. These
prior studies did not evaluate subscapularis perfusion post repair, adequate perfusion is
necessary for healing to occur with any subscapularis takedown technique.
The takedown method of the subscapularis has previously been shown to have no statistically
significant differences with regards to strength, or patient reported outcomes, however if
there was a difference noted in tendon perfusion post repair this may provide rationale to
choose one technique over another as improved perfusion may correlate to lower risk of repair
failure.
The data acquired using the SPY Elite or SPY PHI or EleVision will be deanonymized and
exported to a secure PC for additional analysis and processing. The analysis techniques will
be more sophisticated than the current commercial system, and involve a correction for the
patient-specific arterial input function (AIF) -the cardiac and circulatory variations that
can modify the time and manner in which the ICG dye arrives in the imaging field-of-view.
Indocyanine green (ICG) is a well-studied water soluble, light absorbing tracer that has been
used in other capacities to help quantify tissue perfusion during surgery. ICG is able to be
injected into a patient intravenously and subsequently circulate systemically while bound to
albumin, quickly undergoing hepatic metabolism in just several minutes. The concentration of
ICG in specific tissue is able to be quantified as a surrogate for tissue perfusion. ICG due
to its IV administration and quick metabolism is able to help quantify perfusion in real
time, such as intra-operatively. Systemic reviews as well as case studies, most commonly in
plastic surgery, have been performed showing its utility to determine adequate or inadequate
perfusion in downstream tissue in situations where microanastomoses are performed, such as
with flaps and in hand surgery. Other studies have also been conducted showing the ability to
use ICG as a surrogate for tissue perfusion in the achilles paratenon in humans and in
rabbits who had undergone rotator cuff repair to determine tissue perfusion after different
types of repair. The use of ICG imaging in orthopaedic surgery is relatively nascent, and our
institution as well as other collaborators have demonstrated its promise in these
applications.
