Knee OsteoarthritisPhase 4OASIS-PRPNCT06520059
Optimal Articular Solutions With Intraosseous and Synovial Platelet-Rich Plasma
A Phase 4 study testing Platelet rich-plasma - PRP - intraosseous and intra-articular admnistration in people with Knee Osteoarthritis, run by Universidade do Porto at 2 sites in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Platelet rich-plasma - PRP - intraosseous and intra-articular admnistration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesPortugal
- Study dates
- 1 Jan 2025to 31 Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult individuals with unilateral or bilateral symptomatic knee OA diagnosis according to the American College of Rheumatology
- with symptoms for more than 3 months
- confirmed with radiologic diagnosis (Kellgren-Lawrence grades III or IV).
- Patients must be able to walk with a painful knee.
Who cannot join
- previous history of knee surgery
- systemic autoimmune or rheumatic disease
- platelet diseases
- use of NSAIDs 3 days prior the injections
- previous history (last 3 months) of systematic use of corticosteroids
- or other intra-articular injections in the knee in the past 6 months
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal2 sites
Faculdade de Medicina da Universidade do Porto
Porto, 4200 - 319
Faculdade de Medicina da Universidade do Porto
Porto, 4200-319
About this study
Official title: Comparison of Efficacy of Intraosseous vs Intra-articular Injections of PRP for Advanced Knee OA
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.
Read the 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 patient's upper limb, using 6 x 9 ml tubes, containing a 3.2% 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 (0.34 m/s) 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 mg/mL). 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 (1.8 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 1.5-2 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 gm/day) will be allowed in the management of pain during the post-intervention period.
- Conditions
- Knee Osteoarthritis
- Being tested
- Platelet rich-plasma - PRP - intraosseous and intra-articular admnistration
- Keywords
- Injections, Intra-Articula;, Regenerative Medicine;, Cartilage Repair
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich-plasma - PRP - intraosseous and intra-articular admnistrationCombination product
Group 1 will receive two intraosseous injections of PRP and a subsequent/synchronous intra-articular injection of PRP on the same day.
Group 2 will only receive two intra-articular injections of PRP, separated by one week.
| Study group | Role | What they receive |
|---|---|---|
| Intraosseous and intra-articular PRP | Active comparator | Two intraosseous injections of PRP and another intra-articular injection of PRP on the same day. Receives: Combination Product: Platelet rich-plasma - PRP - intraosseous and intra-articular admnistration |
| Intra-articular PRP | Active comparator | Patients submited to two intra-articular injections of PRP, separated by one week. Receives: Combination Product: Platelet rich-plasma - PRP - intraosseous and intra-articular admnistration |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROM - Knee related Qol
Knee injury and Osteoarthritis Outcome Score (KOOS) - absolute value from the score (units). Min-Max (0-100) higher scores indicate better outcomes and a higher quality of life related to the knee
Measured: baseline, and at follow-up of 3 months, 6 months and 12 months
PROM - PAIN
Visual analogic Score - PAIN (VAS) -absolute value from the score (units). Min-Max (0-10) higher scores indicate worse outcomes
Measured: baseline, and at follow-up of 3 months, 6 months and 12 months
Secondary outcomes (2)
bone marrow edema -MRI
first scored dichotomous (yes/no)
Measured: 1 month prior to the injection; 1 month to one year after intervention
bone marrow edema -MRI
BME will be classified using the criteria defined in the Whole-Organ Magnetic Resonance Imaging Score (WORMS). Range 0-3 Higher scores mean more medular edema.
Measured: 1 month prior to the injection; 1 month to one year after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study is a prospective cohort, parallel design clinical trial comparing the efficacy of intraosseous versus intra-articular injections of PRP for treating advanced knee osteoarthritis. Patients are matched for sex and age, and outcomes are assessed using VAS scores, KOOS, and MRI evaluations over a 12-month period. The study aims to determine which injection method provides superior pain relief and functional improvement.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, João Rocha Neves, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520059
- Sponsor's protocol ID
- 001-2024
- Acronym
- OASIS-PRP
- Status last verified
- Aug 2024
- First submitted
- 15 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This experimental study is safe for patients and will be carried out according to the principles of the Declaration of Helsinki and the European Union General Data Protection Regulation (GDPR). All data processing will be anonymous.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Intraosseous vs Intra-articular Injections of PRP for Advanced Knee OA
- ClinicalTrials.gov ID
- NCT06520059
- Acronym / sponsor ID
- OASIS-PRP / 001-2024
- Conditions
- Knee Osteoarthritis
- Keywords
- Injections, Intra-Articula;, Regenerative Medicine;, Cartilage Repair
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 patient's upper limb, using 6 x 9 ml tubes, containing a 3.2% 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 (0.34 m/s) 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 mg/mL). 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 (1.8 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 1.5-2 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 gm/day) will be allowed in the management of pain during the post-intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This study is a prospective cohort, parallel design clinical trial comparing the efficacy of intraosseous versus intra-articular injections of PRP for treating advanced knee osteoarthritis. Patients are matched for sex and age, and outcomes are assessed using VAS scores, KOOS, and MRI evaluations over a 12-month period. The study aims to determine which injection method provides superior pain relief and functional improvement.
| Arm | Type | Receives |
|---|---|---|
| Intraosseous and intra-articular PRP | Active comparator | Combination Product: Platelet rich-plasma - PRP - intraosseous and intra-articular admnistrationTwo intraosseous injections of PRP and another intra-articular injection of PRP on the same day. |
| Intra-articular PRP | Active comparator | Combination Product: Platelet rich-plasma - PRP - intraosseous and intra-articular admnistrationPatients submited to two intra-articular injections of PRP, separated by one week. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult individuals with unilateral or bilateral symptomatic knee OA diagnosis according to the American College of Rheumatology
- with symptoms for more than 3 months
- confirmed with radiologic diagnosis (Kellgren-Lawrence grades III or IV).
- Patients must be able to walk with a painful knee.
Key exclusion criteria (6 listed)
- previous history of knee surgery
- systemic autoimmune or rheumatic disease
- platelet diseases
- use of NSAIDs 3 days prior the injections
- previous history (last 3 months) of systematic use of corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet rich-plasma - PRP - intraosseous and intra-articular admnistrationGroup 1 will receive two intraosseous injections of PRP and a subsequent/synchronous intra-articular injection of PRP on the same day. Group 2 will only receive two intra-articular injections of PRP, separated by one week. | Combination product | Intra-articular PRP, Intraosseous and intra-articular PRP |
Primary outcome
PROM - Knee related Qol
Time frame: baseline, and at follow-up of 3 months, 6 months and 12 months
Knee injury and Osteoarthritis Outcome Score (KOOS) - absolute value from the score (units). Min-Max (0-100) higher scores indicate better outcomes and a higher quality of life related to the knee
PROM - PAIN
Time frame: baseline, and at follow-up of 3 months, 6 months and 12 months
Visual analogic Score - PAIN (VAS) -absolute value from the score (units). Min-Max (0-10) higher scores indicate worse outcomes
2 secondary outcomes
bone marrow edema -MRI
Time frame: 1 month prior to the injection; 1 month to one year after intervention
bone marrow edema -MRI
Time frame: 1 month prior to the injection; 1 month to one year after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No. This experimental study is safe for patients and will be carried out according to the principles of the Declaration of Helsinki and the European Union General Data Protection Regulation (GDPR). All data processing will be anonymous.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Platelet rich-plasma - PRP - intraosseous and intra-articular admnistration in people with Knee Osteoarthritis, run by Universidade do Porto at 2 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROM - Knee related Qol (time frame: baseline, and at follow-up of 3 months, 6 months and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.