Knee OsteoarthritisPhase 3NCT01381081
Platelet-rich Plasma Intra-articular Knee Injections for Knee Osteoarthritis
A Phase 3 study testing platelet-rich plasma and Corticosteroid in people with Knee Osteoarthritis, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
The benefit of using platelet rich plasma (PRP) in cartilage injuries, and specifically in degenerative ones, has not been assessed yet. Current studies on the PRP healing or repairing effect on knee cartilage degenerative injuries are not conclusive to establish a standard of behavior, although PRP has shown to… 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 Corticosteroid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2011to Jan 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
- Degenerative osteoarthritis of the knee confirmed radiologically
- Degenerative osteoarthritis of the knee replacement candidate
- Walking ability in patients with or without external support
- Baseline in pain VAS greater than 60
Who cannot join
- Neoplastic disease
- Immunosuppressive States
- Patients who received intra-articular injections of steroids, anesthetic and / or hyaluronic acid in the last 3 months.
- Patients who have undergone arthroscopic surgery on the last 3 months
- Patients with involvement of bone metabolism except osteoporosis (Paget's disease, renal osteodystrophy, osteomalacia)
- Fibromyalgia or chronic fatigue syndrome
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- Liver disease
- Deficit coagulation (blood dyscrasia)
- Thrombocytopenia
- Anticoagulant treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Double-blinded, Clinical Trial, Comparing Platelet-rich Plasma Intra-articular Knee Injections Versus Corticosteroid Intra-articular Knee Injections for Knee Osteoarthritis
The benefit of using platelet rich plasma (PRP) in cartilage injuries, and specifically in degenerative ones, has not been assessed yet. Current studies on the PRP healing or repairing effect on knee cartilage degenerative injuries are not conclusive to establish a standard of behavior, although PRP has shown to improve joint functionality and reduce pain.
Hypothesis: PRP intra-articular injections in osteoarthritic knees reduces pain and leads to a more effective and lasting functional recovering than corticosteroid intra-articular injections.
- Conditions
- Knee Osteoarthritis
- Being tested
- platelet-rich plasma, Corticosteroid
- Keywords
- knee osteoarthritis, comparing platelet-rich plasma, intra-articular knee injections
- 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
a single intra-articular injection
CorticosteroidDrug
A single betamethasone and bupivacaine intra-articular injection
| Study group | Role | What they receive |
|---|---|---|
| platelet-rich plasma intra-articular knee injections | Experimental | a single intra-articular injection of PRP in knee osteoarthritis Receives: Biological: platelet-rich plasma |
| Corticosteroid intra-articular knee injections | Active comparator | a betamethasone and bupivacaine intra-articular injection Receives: Drug: Corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The value of the visual analogue scale pain (VAS)
The difference between the baseline and the value of the scale one month after treatment
Measured: one month after the treatment
Secondary outcomes (4)
the value of pain visual analog scale according to
Measured: 4 weeks, 3 and 6 months after treatment
the functional level of the knee KOOS
Measured: 4 weeks, 3 and 6 months after treatment
All reported adverse events
Measured: 4 weeks, 3 and 6 months after treatment
Scale of the SF36 quality of life
Measured: 4 weeks, 3 and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionJan 2014
- Study completionJan 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.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nayana Joshi, MD, Principal investigator, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381081
- Sponsor's protocol ID
- PRP2010
- Other IDs
- 2010-023977-21
- Status last verified
- Feb 2015
- First submitted
- 23 Jun 2011
- Last updated
- 24 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blinded, Clinical Trial, Comparing Platelet-rich Plasma Intra-articular Knee Injections Versus Corticosteroid Intra-articular Knee Injections for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01381081
- Acronym / sponsor ID
- PRP2010
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, comparing platelet-rich plasma, intra-articular knee injections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 27 Jun 2011 (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.
The benefit of using platelet rich plasma (PRP) in cartilage injuries, and specifically in degenerative ones, has not been assessed yet. Current studies on the PRP healing or repairing effect on knee cartilage degenerative injuries are not conclusive to establish a standard of behavior, although PRP has shown to improve joint functionality and reduce pain.
Hypothesis: PRP intra-articular injections in osteoarthritic knees reduces pain and leads to a more effective and lasting functional recovering than corticosteroid intra-articular injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| platelet-rich plasma intra-articular knee injections | Experimental | Biological: platelet-rich plasmaa single intra-articular injection of PRP in knee osteoarthritis |
| Corticosteroid intra-articular knee injections | Active comparator | Drug: Corticosteroida betamethasone and bupivacaine intra-articular injection |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Degenerative osteoarthritis of the knee confirmed radiologically
- Degenerative osteoarthritis of the knee replacement candidate
- Walking ability in patients with or without external support
- Baseline in pain VAS greater than 60
Key exclusion criteria (10 listed)
- Neoplastic disease
- Immunosuppressive States
- Patients who received intra-articular injections of steroids, anesthetic and / or hyaluronic acid in the last 3 months.
- Patients who have undergone arthroscopic surgery on the last 3 months
- Patients with involvement of bone metabolism except osteoporosis (Paget's disease, renal osteodystrophy, osteomalacia)
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 plasmaa single intra-articular injection | Biological | platelet-rich plasma intra-articular knee injections |
| CorticosteroidA single betamethasone and bupivacaine intra-articular injection | Drug | Corticosteroid intra-articular knee injections |
Primary outcome
The value of the visual analogue scale pain (VAS)
Time frame: one month after the treatment
The difference between the baseline and the value of the scale one month after treatment
4 secondary outcomes
the value of pain visual analog scale according to
Time frame: 4 weeks, 3 and 6 months after treatment
the functional level of the knee KOOS
Time frame: 4 weeks, 3 and 6 months after treatment
All reported adverse events
Time frame: 4 weeks, 3 and 6 months after treatment
Scale of the SF36 quality of life
Time frame: 4 weeks, 3 and 6 months after treatment
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 24 Feb 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.
Nayana Joshi, MD principal investigator
Hospital Vall d'Hebron
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing platelet-rich plasma and Corticosteroid in people with Knee Osteoarthritis, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 10 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 24 Feb 2015. 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 Spain. 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 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?
The value of the visual analogue scale pain (VAS) (time frame: one month after the treatment). 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 24 Feb 2015.