OsteoarthritisPhase 3NCT01926327
The Effect of Platelet-rich Plasma in Patients With Osteoarthritis of the Knee
A Phase 3 study testing PRP injection in people with Osteoarthritis, run by Royan Institute at 1 site in Iran.
Trial summary
Osteoarthritis is the most common type of arthritis. The prevalence of osteoarthritis of the knee has significantly elevated in the elderly population and youth due to age and sport activities respectively. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- PRP injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteIran
- Study dates
- Jan 2013to Apr 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years
- Body mass index (BMI) ≤33 kg/m2
- Grade 2And above imaging of osteoarthritis
- History of knee pain or swelling should have at least 4 months
Who cannot join
- treated with steroids and Anti-coagulant or anti-platelet aggregation
- history of infectious, systemic diseases, Immune deficiency and coagulation disorders
- Patients with Hb ≤11, Plt ≤ 150000
- Varus > 10 , valgus > 10
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Intraarticular Injection of Platelet-rich Plasma in Patients With Osteoarthritis of the Knee (in a Clinical Trial Phase III)
Osteoarthritis is the most common type of arthritis. The prevalence of osteoarthritis of the knee has significantly elevated in the elderly population and youth due to age and sport activities respectively. Our aims to treat the knee osteoarthritis are including; reduce knee pain and improve its function; return patients to normal daily activities and reduce health care costs.
The current treatments which are already being used for osteoarthritis of the knee patients include:
Read more
- Symptomatic therapy: conservative therapies, physiotherapy, analgesics and non-steroidal anti-inflammatory drugs.
- Intra-articular injections of corticosteroids and hyaluronic acid.
- Current Surgical Therapy: knee arthroplasty, osteotomy, arthrodesis and debridement.
As the low mitotic activity and lack of blood supply cause little ability for the articular cartilage to repair itself, so injection of platelet-rich plasma (PRP) has recently received much more attention due to its capacity to do self-healing in treatment of osteoarthritis of the knee.
PRP consists of several concentrated growth factors in platelets of autologous blood that are applied to the different parts of medicine such as reconstruction of damaged tissue. Although platelets are well-known to involve in the blood clots formation, but current studies have shown that they secrete many bio-proteins which attract macrophages, mesenchymal stem cells and osteoblasts to remove necrotic tissue in addition to participate in healing procedure.
This study is a prospective, randomized, controlled trial to assess The positive effects of platelet-rich plasma injection in 244 patients with osteoarthritis of the knee
Read the detailed description
In this study all eligible patients (Based on the inclusion and exclusion criteria) were randomly allocated into two study groups by a Stratified Permuted Block randomization method: group A received platelet rich plasma, group B (control group) received only placebo.
All of the patients underwent a standard long protocol for knee osteoarthritis. All patients with grade II,III and IV of radiographic knee OA are selected. On average, in each instance, the amount of platelets in the peripheral blood is 4 to 6 times the baseline level.
Group A: 1-3 cc injection of placebo Group B: 1-3 cc injection of PRP All patients received monthly injection for 3 times.
- Conditions
- Osteoarthritis
- Being tested
- PRP injection, Placebo
- Keywords
- PRP PRGF Osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP injectionBiological
Injection of PRP in patients with knee osteoarthritis.
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| platelet reach plasma | Active comparator | The patients with osteoarthritis who underwent PRP injection. Receives: Biological: PRP injection |
| placebo | Placebo comparator | The patients with osteoarthritis who underwent Normal Saline injection. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
pain reduction by VAS scoring before injection of PRP and 3,6 and 12 months after last injection
Measured: 3 months
physical activity
physical activity of patients which is measured by WOMAC scoring , before injection of PRP\& 3,6 and 12 months after last injection.
Measured: 3months
cartilage repair
The repair of knee cartilage that is evaluated by MRI,before and 12months after injection.
Measured: 12months
Secondary outcomes (2)
quality of life
Evaluation the quality of life that is measured by SF36,before,3,6 and 12months after injection.
Measured: 3months
joint replacement
Evaluation the need for joint replacement 12months after injection.
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hamid Gourabi, PhD, Study chair, Head of Royan InstituteNasser Aghdami, MD,PhD, Study director, Head of Department of Regenerative Medicine Of Royan Institute & cell therapy centerMohsen Emadedin, MD, Study director, Orthoped scientist in Royan InstituteAli Mirazimi Bafghi, MD, Principal investigator, Regenerative Medicine Department of Royan Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926327
- Sponsor's protocol ID
- royan-Bone-011
- Status last verified
- Sep 2012
- First submitted
- 17 Aug 2013
- Last updated
- 25 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intraarticular Injection of Platelet-rich Plasma in Patients With Osteoarthritis of the Knee (in a Clinical Trial Phase III)
- ClinicalTrials.gov ID
- NCT01926327
- Acronym / sponsor ID
- royan-Bone-011
- Conditions
- Osteoarthritis
- Keywords
- PRP PRGF Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Jan 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 20 Aug 2013 (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.
Osteoarthritis is the most common type of arthritis. The prevalence of osteoarthritis of the knee has significantly elevated in the elderly population and youth due to age and sport activities respectively. Our aims to treat the knee osteoarthritis are including; reduce knee pain and improve its function; return patients to normal daily activities and reduce health care costs.
The current treatments which are already being used for osteoarthritis of the knee patients include:
- Symptomatic therapy: conservative therapies, physiotherapy, analgesics and non-steroidal anti-inflammatory drugs.
- Intra-articular injections of corticosteroids and hyaluronic acid.
- Current Surgical Therapy: knee arthroplasty, osteotomy, arthrodesis and debridement.
As the low mitotic activity and lack of blood supply cause little ability for the articular cartilage to repair itself, so injection of platelet-rich plasma (PRP) has recently received much more attention due to its capacity to do self-healing in treatment of osteoarthritis of the knee.
PRP consists of several concentrated growth factors in platelets of autologous blood that are applied to the different parts of medicine such as reconstruction of damaged tissue. Although platelets are well-known to involve in the blood clots formation, but current studies have shown that they secrete many bio-proteins which attract macrophages, mesenchymal stem cells and osteoblasts to remove necrotic tissue in addition to participate in healing procedure.
This study is a prospective, randomized, controlled trial to assess The positive effects of platelet-rich plasma injection in 244 patients with osteoarthritis of the knee
Detailed description
In this study all eligible patients (Based on the inclusion and exclusion criteria) were randomly allocated into two study groups by a Stratified Permuted Block randomization method: group A received platelet rich plasma, group B (control group) received only placebo.
All of the patients underwent a standard long protocol for knee osteoarthritis. All patients with grade II,III and IV of radiographic knee OA are selected. On average, in each instance, the amount of platelets in the peripheral blood is 4 to 6 times the baseline level.
Group A: 1-3 cc injection of placebo Group B: 1-3 cc injection of PRP All patients received monthly injection for 3 times.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| platelet reach plasma | Active comparator | Biological: PRP injectionThe patients with osteoarthritis who underwent PRP injection. |
| placebo | Placebo comparator | Biological: PlaceboThe patients with osteoarthritis who underwent Normal Saline injection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 65 years
- Body mass index (BMI) ≤33 kg/m2
- Grade 2And above imaging of osteoarthritis
- History of knee pain or swelling should have at least 4 months
Key exclusion criteria (4 listed)
- treated with steroids and Anti-coagulant or anti-platelet aggregation
- history of infectious, systemic diseases, Immune deficiency and coagulation disorders
- Patients with Hb ≤11, Plt ≤ 150000
- Varus > 10 , valgus > 10
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 injectionInjection of PRP in patients with knee osteoarthritis. | Biological | platelet reach plasma |
| Placebo | Biological | placebo |
Primary outcome
pain
Time frame: 3 months
pain reduction by VAS scoring before injection of PRP and 3,6 and 12 months after last injection
physical activity
Time frame: 3months
physical activity of patients which is measured by WOMAC scoring , before injection of PRP\& 3,6 and 12 months after last injection.
cartilage repair
Time frame: 12months
The repair of knee cartilage that is evaluated by MRI,before and 12months after injection.
2 secondary outcomes
quality of life
Time frame: 3months
joint replacement
Time frame: 12months
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 25 Apr 2014.
- Related InfoLink provided by the sponsor.
Related trials for Osteoarthritis
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Holistic Healing for Knee Osteoarthritis
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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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
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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.
Hamid Gourabi, PhD study chair
Head of Royan Institute
Nasser Aghdami, MD,PhD study director
Head of Department of Regenerative Medicine Of Royan Institute & cell therapy center
Mohsen Emadedin, MD study director
Orthoped scientist in Royan Institute
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 PRP injection in people with Osteoarthritis, run by Royan Institute at 1 site in Iran.
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 4 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 25 Apr 2014. 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 Iran. 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. Some participants in this study may receive a placebo. 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?
pain (time frame: 3 months). The study lists 3 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 25 Apr 2014.