OsteoarthritisNCT02012530
PRP vs HA Intra-articular Knee Injections for Cartilage Defects
A study testing HA and PRP in people with Osteoarthritis, run by Shetty-Kim Research Foundation at 1 site in United Kingdom.
Trial summary
Study Title: A cohort comparison study Comparing Platelet Rich Plasma vs Hyaluronic Acid Intra-articular Knee Injections for Early Cartilage Defects in the knee. Study hypothesis: We start with the hypothesis that both treatments are equally effective. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- HA and PRP
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Jun 2017
- Phase
- Interventional
- 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
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Diagnosed with either early degenerative cartilage lesions (Grade 1-3) as determined by plain radiograph, MRI or intra-operatively (categorised as per Outerbridge/ICRS classification).
- The patient must have more than a four month history of knee pain or swelling whether continuous or intermittent.
Who cannot join
- Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
- Systemic disorders- DM, RA, SLE
- Major axial deviation (varus>5˚, valgus>5˚)
- Patients suffering from haematological disorders (coagulopathy)
- Patients with severe cardiovascular disease
- Active infection
Show all 11Show fewer
- Immuno-suppressed patients
- Patients taking anticoagulants such warfarin or low molecular weight heparin
- Haemoglobin levels below 11g/dl
- Platelet count below 150000/mmc
- Participants who have participated in another research study involving an investigational product in the past 12 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cohort Comparison Study Comparing Platelet Rich Plasma vs Hyaluronic Acid Intra-articular Knee Injections for Early Cartilage Defects in the Knee
Study Title: A cohort comparison study Comparing Platelet Rich Plasma vs Hyaluronic Acid Intra-articular Knee Injections for Early Cartilage Defects in the knee.
Study hypothesis: We start with the hypothesis that both treatments are equally effective.
Read more
Trial Design: The participating patients will be divided into two groups, each group receiving either one of the treatment modalities. This study will be randomised. Both procedures will be done at the Spire Alexandra Hospital by Professor A. A Shetty. The post-operative rehabilitation process will be the same for both groups.
Trial Participants: All participants will be from patients attending Professor Shetty's clinic at the Spire Alexandra Hospital.
Planned Sample Size: 50 patients in each group
Follow-up duration: The participating patients will be followed up at 2 weeks, 6 weeks, 3 months following the surgery by visits to the clinic and assessed clinically. The surgical outcomes will be measured by by IKDC, KOOS and Lysholm scores.
Planned Trial Period: Two to three years
Primary Objective: To establish superiority, if any, of either procedure over the other by studying pain relief, improvement in function.
Primary Endpoint: At the end of the 2 year follow up for all participating patients.
Read the detailed description
Osteoarthritis and early degenerative cartilage lesions has a significant impact on our society. People are both living and are more active for longer and so their demands are greater. This is having a direct effect on our economy from days missed off work and greater dependency on state resources.
The limited regenerative capacity of cartilage is part of this problem. Existing degenerative lesions lead to accelerated deterioration of the articular (joint) surface leading to end-stage arthritis. Any solution that can delay or reverse this process is therefore desirable. A number of non-invasive solutions do exist to treat painful knees that improve functionality but with varying rates of success. Two of the more promising agents are hyaluronic acid (HA) and platelet rich plasma (PRP). HA is widely applied in clinical practice with good results in many studies. HA forms part of the inflammatory process that can lead to the regeneration of cartilage in defective areas of the knee.
PRP uses reparative growth factors taken from the patient's own blood to create an environment in the knee conducive to wound healing that can fill cartilage defects. It's autologous origin, easy preparation and safety profile makes it a potentially ground breaking treatment option for knee cartilage defects and osteoarthritis.
These solutions work to improve the localised environment of morbidity and so for this reason are best administered as intra-articularly. As PRP is still in the earlier stages of its development, its exact dosage is still to be determined. HA has also recently been prepared as a higher concentration solution to test if there are any benefits to this.
Trials have compared these two products. No randomised controlled trials exist making our proposed research important.
Our null hypothesis is that there is no difference between HA and PRP in treating patients will articular lesions.
We will attempt to answer our research question by means of a randomised trial as there have been no trials to date that have proposed to clarify this clinical question. The reason for choosing a randomised trial is that it will take the quality of our research findings to a higher level than already exists in the literature. PRP will be compared with HA as these are two products with similar objectives. HA has been used for longer and has a more proven clinically successful track record. Selected participants will be randomised to receive either HA or PRP intra-articular injections.
Patients will be sourced from GP referrals to our knee unit clinic at the Alexandra Spire Hospital. Post-arthroscopy patients or existing follow up patients that satisfy the inclusion criteria will also be offered a place in our trial. Selected patients will be given a participant information sheet to read that will explain all about the trial. They will meet an investigator (doctor) to answer any queries and sign a consent form if they so wish.
Upon inclusion they will fill out a scoring questionnaire, be randomised and receive their corresponding injection. PRP recipients will have a sample of blood taken as is the requirement for the procedure.
They will then be followed up in clinic at 6 weeks, 3, 6, and 12 months where they will have to fill in a scoring questionnaire each time. The trial will therefore last from inclusion of our first patient until the last patient is followed up for one year.
- Conditions
- Osteoarthritis
- Being tested
- HA, PRP
- Keywords
- Articular cartilage, Hyaluronic Acid (HA), Platelet rich plasma (PRP)
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAProcedure or surgery
HA is widely applied in clinical practice with good results in many studies. HA forms part of the inflammatory process that can lead to the regeneration of cartilage in defective areas of the knee.
PRPProcedure or surgery
PRP uses reparative growth factors taken from the patient's own blood to create an environment in the knee conducive to wound healing that can fill cartilage defects. It's autologous origin, easy preparation and safety profile makes it a potentially ground breaking treatment option for knee cartilage defects and osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| HA | Active comparator | Patients in this arm will have hyaluronic acid (HA) injected into their knee along with 3 ml local anaesthetic. The HA injection is in the form of 2 ml aqueous sodium hyaluronate. The exact constituents of the HA change in a proprietary manner. All HA injections used will have the CE marking on them. Receives: Procedure: HA |
| PRP | Active comparator | Patients in this arm will have platelet rich plasma (PRP) injected into their knee. The PRP sample will be produced at the time of the injection. 30 ml of blood is drawn fro the patient a few minutes before the injection. Using a CE marked differential centrifugation device, the platelets are isolated. This concentrated sample of platelets is injected into the knee after the skin around the injection site is anaesthetised with local anaesthetic. Receives: Procedure: PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome
The participating patients will be followed up at 2 weeks, 6 weeks and finally at 3 months following the injection by visits to the clinic and assessed clinically. The surgical outcomes will be measured by by KOOS score.
Measured: 3 months
Secondary outcomes (1)
Change in VAS Score at 3 months
The Participants will be followed at at 2 weeks, 6 weeks and finally at 3 months following the injection and will be asked to score a Visual Analogue Scale for pain at every visit. These scores will be compared to pre-operative values.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionNov 2016 (estimated)
- Study completionJun 2017 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shetty-Kim Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asode A Shetty, MD, MCh, PhD, FRCS, Principal investigator, Canterbury Christ Church University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012530
- Sponsor's protocol ID
- SKRF 003
- Status last verified
- Dec 2013
- First submitted
- 11 Oct 2013
- Last updated
- 16 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Comparison Study Comparing Platelet Rich Plasma vs Hyaluronic Acid Intra-articular Knee Injections for Early Cartilage Defects in the Knee
- ClinicalTrials.gov ID
- NCT02012530
- Acronym / sponsor ID
- SKRF 003
- Conditions
- Osteoarthritis
- Keywords
- Articular cartilage, Hyaluronic Acid (HA), Platelet rich plasma (PRP)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shetty-Kim Research FoundationUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 16 Dec 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.
Study Title: A cohort comparison study Comparing Platelet Rich Plasma vs Hyaluronic Acid Intra-articular Knee Injections for Early Cartilage Defects in the knee.
Study hypothesis: We start with the hypothesis that both treatments are equally effective.
Trial Design: The participating patients will be divided into two groups, each group receiving either one of the treatment modalities. This study will be randomised. Both procedures will be done at the Spire Alexandra Hospital by Professor A. A Shetty. The post-operative rehabilitation process will be the same for both groups.
Trial Participants: All participants will be from patients attending Professor Shetty's clinic at the Spire Alexandra Hospital.
Planned Sample Size: 50 patients in each group
Follow-up duration: The participating patients will be followed up at 2 weeks, 6 weeks, 3 months following the surgery by visits to the clinic and assessed clinically. The surgical outcomes will be measured by by IKDC, KOOS and Lysholm scores.
Planned Trial Period: Two to three years
Primary Objective: To establish superiority, if any, of either procedure over the other by studying pain relief, improvement in function.
Primary Endpoint: At the end of the 2 year follow up for all participating patients.
Detailed description
Osteoarthritis and early degenerative cartilage lesions has a significant impact on our society. People are both living and are more active for longer and so their demands are greater. This is having a direct effect on our economy from days missed off work and greater dependency on state resources.
The limited regenerative capacity of cartilage is part of this problem. Existing degenerative lesions lead to accelerated deterioration of the articular (joint) surface leading to end-stage arthritis. Any solution that can delay or reverse this process is therefore desirable. A number of non-invasive solutions do exist to treat painful knees that improve functionality but with varying rates of success. Two of the more promising agents are hyaluronic acid (HA) and platelet rich plasma (PRP). HA is widely applied in clinical practice with good results in many studies. HA forms part of the inflammatory process that can lead to the regeneration of cartilage in defective areas of the knee.
PRP uses reparative growth factors taken from the patient's own blood to create an environment in the knee conducive to wound healing that can fill cartilage defects. It's autologous origin, easy preparation and safety profile makes it a potentially ground breaking treatment option for knee cartilage defects and osteoarthritis.
These solutions work to improve the localised environment of morbidity and so for this reason are best administered as intra-articularly. As PRP is still in the earlier stages of its development, its exact dosage is still to be determined. HA has also recently been prepared as a higher concentration solution to test if there are any benefits to this.
Trials have compared these two products. No randomised controlled trials exist making our proposed research important.
Our null hypothesis is that there is no difference between HA and PRP in treating patients will articular lesions.
We will attempt to answer our research question by means of a randomised trial as there have been no trials to date that have proposed to clarify this clinical question. The reason for choosing a randomised trial is that it will take the quality of our research findings to a higher level than already exists in the literature. PRP will be compared with HA as these are two products with similar objectives. HA has been used for longer and has a more proven clinically successful track record. Selected participants will be randomised to receive either HA or PRP intra-articular injections.
Patients will be sourced from GP referrals to our knee unit clinic at the Alexandra Spire Hospital. Post-arthroscopy patients or existing follow up patients that satisfy the inclusion criteria will also be offered a place in our trial. Selected patients will be given a participant information sheet to read that will explain all about the trial. They will meet an investigator (doctor) to answer any queries and sign a consent form if they so wish.
Upon inclusion they will fill out a scoring questionnaire, be randomised and receive their corresponding injection. PRP recipients will have a sample of blood taken as is the requirement for the procedure.
They will then be followed up in clinic at 6 weeks, 3, 6, and 12 months where they will have to fill in a scoring questionnaire each time. The trial will therefore last from inclusion of our first patient until the last patient is followed up for one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HA | Active comparator | Procedure: HAPatients in this arm will have hyaluronic acid (HA) injected into their knee along with 3 ml local anaesthetic. The HA injection is in the form of 2 ml aqueous sodium hyaluronate. The exact constituents of the HA change in a proprietary manner. All HA injections used will have the CE marking on them. |
| PRP | Active comparator | Procedure: PRPPatients in this arm will have platelet rich plasma (PRP) injected into their knee. The PRP sample will be produced at the time of the injection. 30 ml of blood is drawn fro the patient a few minutes before the injection. Using a CE marked differential centrifugation device, the platelets are isolated. This concentrated sample of platelets is injected into the knee after the skin around the injection site is anaesthetised with local anaesthetic. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Diagnosed with either early degenerative cartilage lesions (Grade 1-3) as determined by plain radiograph, MRI or intra-operatively (categorised as per Outerbridge/ICRS classification).
- The patient must have more than a four month history of knee pain or swelling whether continuous or intermittent.
Key exclusion criteria (11 listed)
- Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
- Systemic disorders- DM, RA, SLE
- Major axial deviation (varus>5˚, valgus>5˚)
- Patients suffering from haematological disorders (coagulopathy)
- Patients with severe cardiovascular disease
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 |
|---|---|---|
| HAHA is widely applied in clinical practice with good results in many studies. HA forms part of the inflammatory process that can lead to the regeneration of cartilage in defective areas of the knee. | Procedure or surgery | HA |
| PRPPRP uses reparative growth factors taken from the patient's own blood to create an environment in the knee conducive to wound healing that can fill cartilage defects. It's autologous origin, easy preparation and safety profile makes it a potentially ground breaking treatment option for knee cartilage defects and osteoarthritis. | Procedure or surgery | PRP |
Primary outcome
Clinical outcome
Time frame: 3 months
The participating patients will be followed up at 2 weeks, 6 weeks and finally at 3 months following the injection by visits to the clinic and assessed clinically. The surgical outcomes will be measured by by KOOS score.
1 secondary outcome
Change in VAS Score at 3 months
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2013.
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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.
Asode A Shetty, MD, MCh, PhD, FRCS principal investigator
Canterbury Christ Church University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HA and PRP in people with Osteoarthritis, run by Shetty-Kim Research Foundation at 1 site in United Kingdom.
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 11 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: status not confirmed, as of the sponsor's last update on 16 Dec 2013. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asode A Shetty, MD, PhD, MCh, FRCS (01634 662813, aashetty@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcome (time frame: 3 months). 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 16 Dec 2013.