Knee Surgery Clinical Trial
— ICGOfficial title:
Differential Subchondral Perfusion Mapping Using Indocyanin Green Laser Angiography
NCT number | NCT02918383 |
Other study ID # | 5160045 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2016 |
Est. completion date | December 2017 |
Verified date | January 2020 |
Source | Loma Linda University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Laser Angiography using indocyanin green (ICG) is a relatively new technique and has been
utilized to assess the viability of soft tissue, most prominently in the general surgery and
plastic surgery literature. This technique has been used for prediction of soft tissue
viability by assessing the perfusion status. There is currently no Orthopaedic literature
regarding the use of this device for assessment of subchondral perfusion of articular
surfaces such as the distal femur or other chondral surfaces.
In this pilot study, the use of ICG to detect the perfusion status of a distal femur and
proximal tibia during a surgical approach to the knee and correlating this to visible signs
of arthritis. For example, due to the difference visible with ICG angiography correlate to
gross changes in the cartilage health visible to the naked eye with radiographic imaging.
Status | Terminated |
Enrollment | 2 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility |
Inclusion Criteria: - Patients undergoing elective orthopedic intervention in which the distal femoral or proximal tibial articular surface is visualized through arthroscopic or open technique - Patients not meeting exclusion criteria Exclusion Criteria: - Iodine allergy - Intolerance to indocyanine green dye - Active infection at surgical site - Known pregnancy - Inability to comprehend consent process - Age <18 or > 89 - Significant blood loss risk without tourniquet inflation |
Country | Name | City | State |
---|---|---|---|
United States | Loma Linda University Healthcare Department of Orthopaedic Surgery | Loma Linda | California |
Lead Sponsor | Collaborator |
---|---|
Loma Linda University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Differential Subchondral Perfusion Mapping using Indocyanin Green Laser Angiography | Visible grade of chondromalacia from the 6 points mentioned above. Video will be acquired using the Spy Elite or Pinpoint system of the distal femur or proximal tibial surface. Currently, the software with the SPY elite is able to quantify the degree of dye uptake, and this dye uptake number from the 6 points will also be recorded. Video data will be given a key that corresponds to the subject, thus no videos will be labelled with patient data or information chondromalacia ondromalacia from the 6 points mentioned above. Video will be acquired using the Spy Elite or Pinpoint system of the distal femur or proximal tibial surface. Currently, the software with the SPY elite is able to quantify the degree of dye uptake, and this dye uptake number from the 6 points will also be recorded. Video data will be given a key that corresponds to the subject, thus no videos will be labelled with patient data or information |
15 months |
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