Knee OsteoarthritisNCT04852380
Platelet Rich Plasma (PRP) Injections For Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
Trial summary
It was conducted a prospective study with a series of 153 patients treated with PRP injections in patient affected by knee osteoarthritis. One independent observer performed clinical and functional evaluations at T0 (recruitment), T1 (one month after the injection), T2 (three months after the last injection) and T3… Read more about this study
- Who is it for?
- Ages 40 to 81 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- PRP injections
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 153 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: One hundred and fiftythree patients referring to the Orthopaedic and Trauma Unit of the local University Hospital between January 2018 and January 2020 with knee osteoarthritis
Who may be able to join
- Age between 40 and 81;
- Body mass index (BMI) between 21.5 and 29.3;
- Chronic history (for at least 4 months) of knee joint pain;
- Radiographically documented knee osteoarthritis of grades 1 to 3 (Kellgren-Lawrence (K-L) radiographic classification scale)
Who cannot join
- Radiographically severe documented knee osteoarthritis of grade 4 (K-L radiographic classification scale);
- Previous femur and tibia fractures;
- Knee previous surgical treatment (e.g., arthroscopy);
- Hyaluronic acid infiltration within the previous six months;
- Hemoglobin levels <10 g/dL;
- History of oncohematological disease, infections, or immunodepression
Trial locations and contacts
1 site in 1 country.
Italy1 site
AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia
Bari, 70124
About this study
Official title: Clinical Results Of Platelet Rich Plasma (PRP) Injections For Knee Osteoarthritis (KOA), Our Experience At Midterm Follow Up
It was conducted a prospective study with a series of 153 patients treated with PRP injections in patient affected by knee osteoarthritis. One independent observer performed clinical and functional evaluations at T0 (recruitment), T1 (one month after the injection), T2 (three months after the last injection) and T3 (six months after the last injection).
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Knee Score Society (KSS) score and the Visual Analogue Scale (VAS) were evaluated and recorded for each patient at each follow up.
- Conditions
- Knee Osteoarthritis
- Being tested
- PRP injections
- Keywords
- knee osteoarthritis (KOA); Platelet-rich plasma (PRP);
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP injectionsProcedure or surgery
The 5 mL PRP concentrate was injected every week for three times, starting from recruitment. The patient was placed supine whit a knee flexion of 90°.All the procedures were carried out in an aseptic condition, injected in the knee soft spot through an anterior approach, using a 21-gauge needle.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated by PRP injection | Not described Receives: Procedure: PRP injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analogic Scale
The knee pain was quantified using the Visual Analogic Scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: Day 0; Month 1; Month 3; Month 6 (after the injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start1 Jan 2018
- Primary completion1 Jan 2020
- Study completion1 Apr 2021
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852380
- Sponsor's protocol ID
- PRP-Knee Osteoarthritis
- Status last verified
- Apr 2021
- First submitted
- 15 Apr 2021
- Last updated
- 27 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Results Of Platelet Rich Plasma (PRP) Injections For Knee Osteoarthritis (KOA), Our Experience At Midterm Follow Up
- ClinicalTrials.gov ID
- NCT04852380
- Acronym / sponsor ID
- PRP-Knee Osteoarthritis
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis (KOA); Platelet-rich plasma (PRP);
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 21 Apr 2021 (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.
It was conducted a prospective study with a series of 153 patients treated with PRP injections in patient affected by knee osteoarthritis. One independent observer performed clinical and functional evaluations at T0 (recruitment), T1 (one month after the injection), T2 (three months after the last injection) and T3 (six months after the last injection).
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Knee Score Society (KSS) score and the Visual Analogue Scale (VAS) were evaluated and recorded for each patient at each follow up.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated by PRP injection | – | Procedure: PRP injections |
Who may qualify
- Ages
- 40 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One hundred and fiftythree patients referring to the Orthopaedic and Trauma Unit of the local University Hospital between January 2018 and January 2020 with knee osteoarthritis
Key inclusion criteria (4 listed)
- Age between 40 and 81;
- Body mass index (BMI) between 21.5 and 29.3;
- Chronic history (for at least 4 months) of knee joint pain;
- Radiographically documented knee osteoarthritis of grades 1 to 3 (Kellgren-Lawrence (K-L) radiographic classification scale)
Key exclusion criteria (6 listed)
- Radiographically severe documented knee osteoarthritis of grade 4 (K-L radiographic classification scale);
- Previous femur and tibia fractures;
- Knee previous surgical treatment (e.g., arthroscopy);
- Hyaluronic acid infiltration within the previous six months;
- Hemoglobin levels <10 g/dL;
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 |
|---|---|---|
| PRP injectionsThe 5 mL PRP concentrate was injected every week for three times, starting from recruitment. The patient was placed supine whit a knee flexion of 90°.All the procedures were carried out in an aseptic condition, injected in the knee soft spot through an anterior approach, using a 21-gauge needle. | Procedure or surgery | Patients treated by PRP injection |
Primary outcome
Change in Visual Analogic Scale
Time frame: Day 0; Month 1; Month 3; Month 6 (after the injection)
The knee pain was quantified using the Visual Analogic Scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
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: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Visual Analogic Scale (time frame: Day 0; Month 1; Month 3; Month 6 (after the injection)). 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 27 Apr 2021.