Knee OsteoarthritisPhase 3NCT02448407
Intraarticular Injections of Platelet-rich Plasma in Pain's Treatment of the Osteoarthritic Knee
A Phase 3 study testing Platelet rich plasma and Hyaluronic acid in people with Knee Osteoarthritis, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud.
Trial summary
Platelet-rich plasma (PRP), due to its high content of cytokines, bioactive proteins and platelet growth factors, may contribute to diminish the pain of arthritic knee. It was also recently recognized a regenerative cell potential improving the concentration of hyaluronic acid and stabilizing angiogenesis in arthritic… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Platelet rich plasma and Hyaluronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Nov 2014
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Arthritis in the knee rated I, II, or III (Kellgren-Lawrence Grading Scale)
- VAS greater than 5
- Between 40and 80 years of age
Who cannot join
- Level IV arthritis of the knee
- Either surgery, corticoid infiltration, or viscosupplementation in the knee in the previous three months
- Frontal deformity greater than 10 degrees
- Ipsilateral pathology of the knee or ankle
- Range of motion or flexibility of the knee less than 90 degrees
- Deficit of knee extension greater than 15 degrees
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- Anticoagulation treatment, antiplatelet treatment
- Hepatopathy
- Hematological neoplastic pathology
- Active infection
- Fibromyalgia
- Chronic fatigue syndrome
About this study
Platelet-rich plasma (PRP), due to its high content of cytokines, bioactive proteins and platelet growth factors, may contribute to diminish the pain of arthritic knee. It was also recently recognized a regenerative cell potential improving the concentration of hyaluronic acid and stabilizing angiogenesis in arthritic knees
This study therefore seeks to assess the analgesic power of PRP in osteoarthritic knees intraarticularly infiltrated, and which patients would benefit most from treatment, eliminating false expectations in the rest.
Read the detailed description
This is the first clinical trial developed following the report of the Spanish Competent Authority on May 23, 2013, considering the PRP as a medicinal product for human use and establishing minimum guarantees required of the product and the process of manufacturing. It has been conducted from the perspective of both the trauma and the specialized treatment of chronic pain anesthesiologist, and manufacturing the PRP on the premises of a Regional Centre for Transfusions, all belonging to the Public Health System and therefore without commercial interests.
- Conditions
- Knee Osteoarthritis
- Being tested
- Platelet rich plasma, Hyaluronic acid
- Keywords
- Knee osteoarthritis, Platelet-rich plasma, Pain's treatment
- 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 plasmaBiological
Also called PRP, Platelet Concentrate
Three intraarticular injections of platelet-rich plasma, one each fifteen days
Hyaluronic acidDrug
Also called Adant
Infiltrations of Hyaluronic acid as Hyaluronate 2,5 ml, 1% solution, administered by intraarticular injections (three doses, one each fifteen days)
| Study group | Role | What they receive |
|---|---|---|
| Platelet rich plasma | Experimental | Three intraarticular injection, one each fifteen days Receives: Biological: Platelet rich plasma |
| Hyaluronic acid | Active comparator | Infiltrations of Hyaluronic acid as Hyaluronate 2,5 ml, 1 % solution, administered by intraarticular injection (3 doses, one each fifteen days) Receives: Drug: Hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline Visual Analogue Scale (VAS) value
The main objective of this study is to determine the clinical value of intraarticular injections of platelet-rich plasma (PRP) in the reduction of perceived pain in patients with osteoarthritic knees
Measured: Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
Secondary outcomes (3)
Changes from baseline Knee and Osteoarthritis Outcome System (KOOS) scale value
KOOS is an instrument to assess the patient's opinion about their knee and associated problems. It includes 5 subscales which measure respectively the pain, symptoms, activities of daily living, sporting activity and quality of life
Measured: Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
Effects on quality of life
EUROQOL (European Quality of Life) for the evaluation of function and quality of life
Measured: Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
All reported adverse events
Measured: Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startJan 2014
- Primary completionJun 2014
- Study completionNov 2014
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elvira Montañez Heredia, MD, PhD, Principal investigator, Hospital Universitario Virgen de la Victoria. Málaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448407
- Sponsor's protocol ID
- EMH-PRP-2013
- Other IDs
- 2013-001303-36
- Status last verified
- Feb 2015
- First submitted
- 27 Apr 2015
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraarticular Injections of Platelet-rich Plasma in Pain's Treatment of the Osteoarthritic Knee
- ClinicalTrials.gov ID
- NCT02448407
- Acronym / sponsor ID
- EMH-PRP-2013
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee osteoarthritis, Platelet-rich plasma, Pain's treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 19 May 2015 (estimated)
- 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.
Platelet-rich plasma (PRP), due to its high content of cytokines, bioactive proteins and platelet growth factors, may contribute to diminish the pain of arthritic knee. It was also recently recognized a regenerative cell potential improving the concentration of hyaluronic acid and stabilizing angiogenesis in arthritic knees
This study therefore seeks to assess the analgesic power of PRP in osteoarthritic knees intraarticularly infiltrated, and which patients would benefit most from treatment, eliminating false expectations in the rest.
Detailed description
This is the first clinical trial developed following the report of the Spanish Competent Authority on May 23, 2013, considering the PRP as a medicinal product for human use and establishing minimum guarantees required of the product and the process of manufacturing. It has been conducted from the perspective of both the trauma and the specialized treatment of chronic pain anesthesiologist, and manufacturing the PRP on the premises of a Regional Centre for Transfusions, all belonging to the Public Health System and therefore without commercial interests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet rich plasma | Experimental | Biological: Platelet rich plasmaThree intraarticular injection, one each fifteen days |
| Hyaluronic acid | Active comparator | Drug: Hyaluronic acidInfiltrations of Hyaluronic acid as Hyaluronate 2,5 ml, 1 % solution, administered by intraarticular injection (3 doses, one each fifteen days) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Arthritis in the knee rated I, II, or III (Kellgren-Lawrence Grading Scale)
- VAS greater than 5
- Between 40and 80 years of age
Key exclusion criteria (12 listed)
- Level IV arthritis of the knee
- Either surgery, corticoid infiltration, or viscosupplementation in the knee in the previous three months
- Frontal deformity greater than 10 degrees
- Ipsilateral pathology of the knee or ankle
- Range of motion or flexibility of the knee less than 90 degrees
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 plasmaAlso: PRP, Platelet ConcentrateThree intraarticular injections of platelet-rich plasma, one each fifteen days | Biological | Platelet rich plasma |
| Hyaluronic acidAlso: AdantInfiltrations of Hyaluronic acid as Hyaluronate 2,5 ml, 1% solution, administered by intraarticular injections (three doses, one each fifteen days) | Drug | Hyaluronic acid |
Primary outcome
Changes from baseline Visual Analogue Scale (VAS) value
Time frame: Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
The main objective of this study is to determine the clinical value of intraarticular injections of platelet-rich plasma (PRP) in the reduction of perceived pain in patients with osteoarthritic knees
3 secondary outcomes
Changes from baseline Knee and Osteoarthritis Outcome System (KOOS) scale value
Time frame: Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
Effects on quality of life
Time frame: Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
All reported adverse events
Time frame: Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration
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 19 May 2015.
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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.
Elvira Montañez Heredia, MD, PhD principal investigator
Hospital Universitario Virgen de la Victoria. Málaga
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Platelet rich plasma and Hyaluronic acid in people with Knee Osteoarthritis, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud.
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 3 inclusion and 12 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 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes from baseline Visual Analogue Scale (VAS) value (time frame: Evaluation will be conducted at 28 days,3 months and 6 months after first infiltration). 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 19 May 2015.