Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06520059
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Optimal Articular Solutions With Intraosseous and Synovial Platelet-Rich Plasma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Efficacy of Intraosseous vs Intra-articular Injections of PRP for Advanced Knee OA
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OASIS-PRP
Brief Summary:
This is a prospective cohort clinical study Due to logistic constraints at the sites of implementation a randomized allocation will not be feasible private clinic Patients will be selected with the aim of matching for important confounders sex and age the grade of knee OA will be restricted to advance stages
Detailed Description:
A prospective cohort clinical study The matched sample will be divided into two groups Group 1 will receive two intraosseous injections of PRP and another intra-articular injection of PRP on the same day
Group 2 will only receive two intra-articular injections of PRP separated by one week One week before the PRP injection both groups will receive an intra-articular injection of 20 mg triamcinolone hexacetonide
The PRP is obtained from an autologous blood sample PRP production consists of a 54 mL PRP intra-articular and 80 mL PRP intraosseous sample of venous blood from the cubital vein of the patients upper limb using 6 x 9 ml tubes containing a 32 sodium citrate solution The tubes will be centrifuged at 2400 rpm for 12 minutes at room temperature It is obtained a suspended concentration of PRP that is carefully extracted using a pipette to avoid aspiration of leukocytes from the buffy coat leukocyte-poor PRP LP-PRP For group 1 it will be injected 4 mL intraosseous and 8 mL intra-articular Group 2 will be injected 8 ml of PRP twice one each week A total of 8 ml of PRP will be injected into the knee
A hemogram will be used to analyze the blood sample and the PRP to evaluate their characteristics concentration of red blood cells concentration of white blood cells concentration of platelets and mean platelet volume with this analysis it will be also calculated the platelet concentration growth factor between baseline blood sample and PRP Besides concentration it will also be calculated the total volume of platelets injected into the knee
All procedures will be carried out in a laminar flow chamber 034 ms to avoid contamination Following preparation the PRP will be injected with the minimum time elapsed since its preparation maximum 30 minutes
The PRP is injected after the skin is prepared and draped If needed synovial fluid aspiration will be done before injections With the patient lying in a supine position on the examination table with the knees fully extended the PRP intra-articular injection is performed in a sterile manner via a superolateral patellar approach under ultrasound guidance Logiq E R8 GE Healthcare
Regarding intraosseous injections the location and exploration of the joint line tibial plateau and femoral condyle will be done with ultrasound Following the identification of the articular line through ultrasound examination the two insertion points for the intraosseous infiltrations in the knee are marked 2 cm below the tibiofemoral joint line for the tibial plateau and 2 cm above the tibiofemoral joint line for the femoral condyle The procedure is done for the affected knee compartment medial or lateral
To ensure effective and safe analgesia during the intraosseous infiltration procedure a solution of 1 lidocaine 10 mgmL In summary a 10 mL syringe will be filled with the previously mentioned specified solution and then injected at the marked points-the tibial plateau and femoral condyle Approximately 4-5 mL will be injected along the path until contact is made with the periosteum where the trocar will be inserted An additional 4-5 mL will be injected after the insertion of the trocar A 10-20 minute time interval will be observed before proceeding with the intraosseous infiltrations The tibial plateau and femoral condyle will be targeted and a 15-G trocar-biopsy needle system 18 mm diameter 90 mm length Arrow OnControl Aspiration needle set Teleflex Medical Europe Ltd Dublin Ireland will be placed on the tibial and condyle entry mark points Subsequently the trocar will be attached to a power driver Arrow OnControl Powered Bone Access System Teleflex Medical Europe Ltd Dublin Ireland encased in a sterile plastic sleeve The trocar will be advanced with precision while its placement is verified using ultrasound imaging It will be positioned 2 cm below the articular line at a 45-degree angle in the tibial plateau and 2 cm above the articular line at a 30-degree angle penetrating 15-2 cm into the bone Accurate depth measurement is made with laser marks on the trocar spaced 1 cm apart Once the correct position is confirmed the power driver will be detached and the needle core removed Afterward 6 mL of activated PRP will be injected through the trocar Following the injection the needle core will be reinserted and reattached to the power driver and the trocar will be withdrawn Intraosseous infiltration will be consistently performed at the same site in all procedures as PRP is expected to distribute uniformly across the subchondral area regardless of tissue lesions
After injection patients are allowed to mobilize the knee joint walk as desired and are instructed to apply ice over the injected area for the next 24-48 hours Patients will be requested to avoid vigorous activity for a minimum of 10 days and to avoid taking NSAIDs for 7 days after injection Consumption of acetaminophen max 3 gmday will be allowed in the management of pain during the post-intervention period
Group 2 will only receive two intra-articular injections of PRP separated by one week One week before the PRP injection both groups will receive an intra-articular injection of 20 mg triamcinolone hexacetonide
The PRP is obtained from an autologous blood sample PRP production consists of a 54 mL PRP intra-articular and 80 mL PRP intraosseous sample of venous blood from the cubital vein of the patients upper limb using 6 x 9 ml tubes containing a 32 sodium citrate solution The tubes will be centrifuged at 2400 rpm for 12 minutes at room temperature It is obtained a suspended concentration of PRP that is carefully extracted using a pipette to avoid aspiration of leukocytes from the buffy coat leukocyte-poor PRP LP-PRP For group 1 it will be injected 4 mL intraosseous and 8 mL intra-articular Group 2 will be injected 8 ml of PRP twice one each week A total of 8 ml of PRP will be injected into the knee
A hemogram will be used to analyze the blood sample and the PRP to evaluate their characteristics concentration of red blood cells concentration of white blood cells concentration of platelets and mean platelet volume with this analysis it will be also calculated the platelet concentration growth factor between baseline blood sample and PRP Besides concentration it will also be calculated the total volume of platelets injected into the knee
All procedures will be carried out in a laminar flow chamber 034 ms to avoid contamination Following preparation the PRP will be injected with the minimum time elapsed since its preparation maximum 30 minutes
The PRP is injected after the skin is prepared and draped If needed synovial fluid aspiration will be done before injections With the patient lying in a supine position on the examination table with the knees fully extended the PRP intra-articular injection is performed in a sterile manner via a superolateral patellar approach under ultrasound guidance Logiq E R8 GE Healthcare
Regarding intraosseous injections the location and exploration of the joint line tibial plateau and femoral condyle will be done with ultrasound Following the identification of the articular line through ultrasound examination the two insertion points for the intraosseous infiltrations in the knee are marked 2 cm below the tibiofemoral joint line for the tibial plateau and 2 cm above the tibiofemoral joint line for the femoral condyle The procedure is done for the affected knee compartment medial or lateral
To ensure effective and safe analgesia during the intraosseous infiltration procedure a solution of 1 lidocaine 10 mgmL In summary a 10 mL syringe will be filled with the previously mentioned specified solution and then injected at the marked points-the tibial plateau and femoral condyle Approximately 4-5 mL will be injected along the path until contact is made with the periosteum where the trocar will be inserted An additional 4-5 mL will be injected after the insertion of the trocar A 10-20 minute time interval will be observed before proceeding with the intraosseous infiltrations The tibial plateau and femoral condyle will be targeted and a 15-G trocar-biopsy needle system 18 mm diameter 90 mm length Arrow OnControl Aspiration needle set Teleflex Medical Europe Ltd Dublin Ireland will be placed on the tibial and condyle entry mark points Subsequently the trocar will be attached to a power driver Arrow OnControl Powered Bone Access System Teleflex Medical Europe Ltd Dublin Ireland encased in a sterile plastic sleeve The trocar will be advanced with precision while its placement is verified using ultrasound imaging It will be positioned 2 cm below the articular line at a 45-degree angle in the tibial plateau and 2 cm above the articular line at a 30-degree angle penetrating 15-2 cm into the bone Accurate depth measurement is made with laser marks on the trocar spaced 1 cm apart Once the correct position is confirmed the power driver will be detached and the needle core removed Afterward 6 mL of activated PRP will be injected through the trocar Following the injection the needle core will be reinserted and reattached to the power driver and the trocar will be withdrawn Intraosseous infiltration will be consistently performed at the same site in all procedures as PRP is expected to distribute uniformly across the subchondral area regardless of tissue lesions
After injection patients are allowed to mobilize the knee joint walk as desired and are instructed to apply ice over the injected area for the next 24-48 hours Patients will be requested to avoid vigorous activity for a minimum of 10 days and to avoid taking NSAIDs for 7 days after injection Consumption of acetaminophen max 3 gmday will be allowed in the management of pain during the post-intervention period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None