Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05824806
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2023-03-24
Brief Title:
Knee Osteoarthritis Treatment With Platelet-rich Plasma
Sponsor:
Instituto Nacional de Traumatologia e Ortopedia
Organization:
Instituto Nacional de Traumatologia e Ortopedia
Study Overview
Official Title:
Knee Osteoarthritis Treatment With Platelet-rich Plasma Prospective and Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Knee osteoarthritis KOA is a disease characterized by cartilage degeneration synovium inflammation bone remodeling osteophyte formation inflammations and loss of articular function Interest on biological therapies has increased due to the recent update on KOA and its natural history Viscosupplementation with hyaluronic acid aims to restore rheological properties of synovial fluid Platelet rich plasma PRP is an autologous blood product which contains an elevated platelet concentration above the one found in blood The goal of this study is to compare the clinical results of intra articular infiltration of hyaluronic and platelet rich plasma in the treatment of KOA and to establish a protocol for PRP obtaining and prepare Patients form the OA treating program will be selected and randomized into three groups treatment with hyaluronic acid or onte of the two PRP protocols PRP A and PRP B Evaluation will include subjective functional evaluation clinical evaluation radiological evaluation and radiological evaluation which will be performed before treatment and 3 weeks 3 months 6 months and 1 year after treatment Evaluation of PRP composition will be performed using ELISALUMINEX
Key words Knee osteoarthritis platelet rich plasma viscosupplementation
Key words Knee osteoarthritis platelet rich plasma viscosupplementation
Detailed Description:
The goal of the study is to compare the clinical results of infiltration with hyaluronic acid and platelet-rich plasma PRP in the conservative treatment of mild to moderate osteoarthritis of the knee Besides we want to standardize two protocols for obtaining and preparing PRP for use in the treatment of mild to moderate OA of the knee
The sample will consist of 90 patients with osteoarthritis of the knee being treated at the outpatient clinic of the Osteoarthritis Monitoring and Treatment Program
Patients will be randomized in blocks by simple drawing of opaque envelopes before application in 3 experimental groups and identified as described below
GROUP PRP Protocol A Composed of 30 patients who will receive an intra-articular injection of platelet-rich plasma PRP A once a week for three consecutive weeks GROUP PRP Protocol B Composed of 30 patients who will receive an intra-articular injection of platelet-rich plasma PRP B once a week for three consecutive weeks GROUP Hyaluronic acid Composed of 30 patients who will receive an intra-articular injection of 2 mL of intra-articular hyaluronic acid AHI once a week for three consecutive weeks
PRP A will be prepared according to the following technique published previously elsewhere
1 Collection of 50 mL of peripheral blood from the antecubital vein in sterile vacuum collection tubes of 5 mL with 10 sodium citrate An aliquot of collected whole blood will be used to evaluate microbiological contamination
2 Centrifuge the whole blood for 10 minutes at 1200 rpm at room temperature separating the material into two different layers erythrocytes in the lower layer and plasma in the upper layer in a 65 cm radius centrifuge
3 Separate and centrifuge the plasma for 5 minutes at 1200 rpm creating two new layers upper which will be removed lower containing the platelets Care must be taken to carefully aspirate the plasma from the closed tube using a syringe and needle and transfer it to a new collection tube carefully injecting it through the cap
4 Prepare the material for infiltration in the knee after preparation it is estimated that 5 mL of PRP will be obtained with half of the volume used for injection and the other half for composition analysis and microbiological analysis
he preparation of PRP B will be carried out according to the following technique published previously elsewhere
a Collection of 50 mL of peripheral blood from the antecubital vein in sterile vacuum collection tubes of 5 mL with 10 sodium citrate b Centrifuge the whole blood for 15 minutes at 1500 rpm at room temperature separating the material into two different layers red blood cells in the lower layer and plasma in the upper layer in a 65 cm radius centrifuge e Separate and centrifuge the plasma for 7 minutes at 3500 rpm creating two new layers upper which will be removed lower containing the platelets Care must be taken to carefully aspirate the plasma from the closed tube using a syringe and needle and transfer it to a new collection tube carefully injecting it through the cap f Prepare the material for infiltration in the knee after preparation it is estimated that 5 mL of PRP will be obtained with half of the volume used for injection and the other half for analysis of the composition
All infiltrations will be performed in the outpatient procedure room using aseptic technique The technique for application will follow the steps below
1 Patient sitting on the stretcher in a comfortable position with knees flexed and blindfolded blinding as to the treatment performed
2 Clean the area where the application will be performed with gauze moistened with degerming Clorhexidine
3 Let the chlorhexidine act for one minute and then remove it with gauze moistened with 70 alcohol
4 Palpation of the knee for unguided infiltration through the anterolateral approach to the knee
5 Perform anesthetic button on the skin and subcutaneous tissue at the infiltration site with 1 mL of 2 lidocaine without vasoconstrictor
6 Insert the needle attached to the syringe of the product used through the chosen path
7 Inject the treatment according to randomization AHIPRP APRP B
8 Remove the needle and empty syringe from the joint
9 Perform 30 knee flexion-extension cycles to distribute the product over the joint
10 Finalize the procedure with a simple dressing
The patient should not consume fatty foods or alcoholic beverages 48 hours before the procedure
If joint effusion is present it must be aspirated before infiltration
The patient should be advised to return to the hospital in case of exacerbated pain swelling or redness in the knee
NSAIDs should not be used in the week following application
The clinical evaluation will consist of the following steps
1 Subjective functional assessment based on WOMAC questionnaires Knee Society Score KSS and visual analogue scale for pain function and satisfaction analysis before infiltration on the day of the third infiltration three months six months and one year after infiltration according to knee center follow-up protocol
2 Clinical assessment consisting of 1 registration of demographic data age gender weight height severity of osteoarthritis 2 range of motion measurement 3 assessment of the axis of the lower limbs before infiltration on the day of the third infiltration three months six months and one year after the infiltration according to the knee cernter follow-up protocol Radiographic evaluation with panoramic anteroposterior and profile radiographs of the knees with load aiming to detect alterations in the axis and joint space before infiltration 6 months and 1 year after infiltration according to the knee center follow-up protocol
Patients will be evaluated by an observer independent of the one who applied the selected treatment
The study of PRP composition will be carried out at the Cellular Technology Center following technique published previously elsewhere
Peripheral blood samples from groups A and B will be processed to obtain PRP with part of this product used in the application and part used to analyze the composition of the generated product
Soon after preparation a part of the product will be evaluated for hematological composition total cell count leukocytes and platelets and mean platelet volume The rest of the PRP will be stored in aliquots of about 200ul at the Cellular Technology Center where it will remain frozen in a freezer at -80C until the proteomic analysis specified below and the quantification of the factors and cytokines through enzime linked immunoabsorbant assay and Luminex Kits interleukin-1β interleukin-6 interleukin-8 tumor necrosis factor-α interferon-γ interleukin-2 interleukin-2R interleukin-7 interleukin-15 interleukin-17 interleukin-12p40 pro-inflammatory cytokines interleukin-1RA interleukin-4 interleukin-5 interleukin-10 interleukin-13 interferon-α anti-inflammatory cytokines eotaxin Interferon-gamma inducible Protein 10kDa Membrane cofactor protein-1 interferon-γ-induced monokine Macrophage inflammatory protein-1α Macrophage inflammatory protein-1β chemokines endothelium growth factor b-fibroblast growth factor G-colony stimulating factor vascular endotelium growth factor transforming growth factor-β1 transforming growth factor-β2 transforming growth factor-β3 platelet derived growth factor-AB platelet derived growth factor-BB insulin growth factor-1 growth factors
The sample will consist of 90 patients with osteoarthritis of the knee being treated at the outpatient clinic of the Osteoarthritis Monitoring and Treatment Program
Patients will be randomized in blocks by simple drawing of opaque envelopes before application in 3 experimental groups and identified as described below
GROUP PRP Protocol A Composed of 30 patients who will receive an intra-articular injection of platelet-rich plasma PRP A once a week for three consecutive weeks GROUP PRP Protocol B Composed of 30 patients who will receive an intra-articular injection of platelet-rich plasma PRP B once a week for three consecutive weeks GROUP Hyaluronic acid Composed of 30 patients who will receive an intra-articular injection of 2 mL of intra-articular hyaluronic acid AHI once a week for three consecutive weeks
PRP A will be prepared according to the following technique published previously elsewhere
1 Collection of 50 mL of peripheral blood from the antecubital vein in sterile vacuum collection tubes of 5 mL with 10 sodium citrate An aliquot of collected whole blood will be used to evaluate microbiological contamination
2 Centrifuge the whole blood for 10 minutes at 1200 rpm at room temperature separating the material into two different layers erythrocytes in the lower layer and plasma in the upper layer in a 65 cm radius centrifuge
3 Separate and centrifuge the plasma for 5 minutes at 1200 rpm creating two new layers upper which will be removed lower containing the platelets Care must be taken to carefully aspirate the plasma from the closed tube using a syringe and needle and transfer it to a new collection tube carefully injecting it through the cap
4 Prepare the material for infiltration in the knee after preparation it is estimated that 5 mL of PRP will be obtained with half of the volume used for injection and the other half for composition analysis and microbiological analysis
he preparation of PRP B will be carried out according to the following technique published previously elsewhere
a Collection of 50 mL of peripheral blood from the antecubital vein in sterile vacuum collection tubes of 5 mL with 10 sodium citrate b Centrifuge the whole blood for 15 minutes at 1500 rpm at room temperature separating the material into two different layers red blood cells in the lower layer and plasma in the upper layer in a 65 cm radius centrifuge e Separate and centrifuge the plasma for 7 minutes at 3500 rpm creating two new layers upper which will be removed lower containing the platelets Care must be taken to carefully aspirate the plasma from the closed tube using a syringe and needle and transfer it to a new collection tube carefully injecting it through the cap f Prepare the material for infiltration in the knee after preparation it is estimated that 5 mL of PRP will be obtained with half of the volume used for injection and the other half for analysis of the composition
All infiltrations will be performed in the outpatient procedure room using aseptic technique The technique for application will follow the steps below
1 Patient sitting on the stretcher in a comfortable position with knees flexed and blindfolded blinding as to the treatment performed
2 Clean the area where the application will be performed with gauze moistened with degerming Clorhexidine
3 Let the chlorhexidine act for one minute and then remove it with gauze moistened with 70 alcohol
4 Palpation of the knee for unguided infiltration through the anterolateral approach to the knee
5 Perform anesthetic button on the skin and subcutaneous tissue at the infiltration site with 1 mL of 2 lidocaine without vasoconstrictor
6 Insert the needle attached to the syringe of the product used through the chosen path
7 Inject the treatment according to randomization AHIPRP APRP B
8 Remove the needle and empty syringe from the joint
9 Perform 30 knee flexion-extension cycles to distribute the product over the joint
10 Finalize the procedure with a simple dressing
The patient should not consume fatty foods or alcoholic beverages 48 hours before the procedure
If joint effusion is present it must be aspirated before infiltration
The patient should be advised to return to the hospital in case of exacerbated pain swelling or redness in the knee
NSAIDs should not be used in the week following application
The clinical evaluation will consist of the following steps
1 Subjective functional assessment based on WOMAC questionnaires Knee Society Score KSS and visual analogue scale for pain function and satisfaction analysis before infiltration on the day of the third infiltration three months six months and one year after infiltration according to knee center follow-up protocol
2 Clinical assessment consisting of 1 registration of demographic data age gender weight height severity of osteoarthritis 2 range of motion measurement 3 assessment of the axis of the lower limbs before infiltration on the day of the third infiltration three months six months and one year after the infiltration according to the knee cernter follow-up protocol Radiographic evaluation with panoramic anteroposterior and profile radiographs of the knees with load aiming to detect alterations in the axis and joint space before infiltration 6 months and 1 year after infiltration according to the knee center follow-up protocol
Patients will be evaluated by an observer independent of the one who applied the selected treatment
The study of PRP composition will be carried out at the Cellular Technology Center following technique published previously elsewhere
Peripheral blood samples from groups A and B will be processed to obtain PRP with part of this product used in the application and part used to analyze the composition of the generated product
Soon after preparation a part of the product will be evaluated for hematological composition total cell count leukocytes and platelets and mean platelet volume The rest of the PRP will be stored in aliquots of about 200ul at the Cellular Technology Center where it will remain frozen in a freezer at -80C until the proteomic analysis specified below and the quantification of the factors and cytokines through enzime linked immunoabsorbant assay and Luminex Kits interleukin-1β interleukin-6 interleukin-8 tumor necrosis factor-α interferon-γ interleukin-2 interleukin-2R interleukin-7 interleukin-15 interleukin-17 interleukin-12p40 pro-inflammatory cytokines interleukin-1RA interleukin-4 interleukin-5 interleukin-10 interleukin-13 interferon-α anti-inflammatory cytokines eotaxin Interferon-gamma inducible Protein 10kDa Membrane cofactor protein-1 interferon-γ-induced monokine Macrophage inflammatory protein-1α Macrophage inflammatory protein-1β chemokines endothelium growth factor b-fibroblast growth factor G-colony stimulating factor vascular endotelium growth factor transforming growth factor-β1 transforming growth factor-β2 transforming growth factor-β3 platelet derived growth factor-AB platelet derived growth factor-BB insulin growth factor-1 growth factors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None