Osteoarthritis, KneeEarly Phase 1NCT03329235
Intraosseous With Intra-articular Injection of Platelet Rich Plasma in Treatment of Knee Osteoarthritis
A Early Phase 1 study testing PRP and HA in people with Osteoarthritis, Knee, run by Cangzhou Central Hospital.
Trial summary
The aim of this study was to compare the efficacy of treatment in three groups of patients with knee osteoarthritis (OA) given a combination of intraosseous with intra-articular injection of platelet rich plasma (PRP), intra-articular injection of PRP and a single application of hyaluronic acid (HA). Read more about this study
- Who is it for?
- Ages 40 to 73 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- PRP and HA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Jan 2017
- Phase
- Early Phase 1
- 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 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral symptomatic knee with pain for at least 1 month or swelling.
- Radiographic findings of knee degeneration (Kellgren-Lawrence score of II - III).
- Age 40-73 years.
- Body mass index (BMI) 18-32.5).
- Knee stability without a severe trauma history.
Who cannot join
- Bilateral knee osteoarthritis indicative of treatment for both knees.
- Kellgren-Lawrence score greater than III.
- BMI >32.
- Age >73 years.
- Systemic autoimmune rheumatic diseases and blood disorders.
- Active immunosuppressive or anticoagulant therapy.
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- Intra-articular injection to the knee within the previous 1 year or previous joint infection.
- use of corticosteroids for 3 weeks before the procedure.
- use of nonsteroidal anti-inflammatory drugs (NSAIDs) in the 3 weeks before treatment.
About this study
Official title: Intraosseous With Intra-articular Injection of Platelet Rich Plasma Versus Hyaluronic Acid in Treatment of Knee Osteoarthritis
The aim of this study was to compare the efficacy of treatment in three groups of patients with knee osteoarthritis (OA) given a combination of intraosseous with intra-articular injection of platelet rich plasma (PRP), intra-articular injection of PRP and a single application of hyaluronic acid (HA).
Read the detailed description
Methods Eighty-six patients from January 2015 to June 2015 with grade II to grade III knee osteoarthritis according to the Kellgren-Lawrence classification were randomly divided into 3 groups to receive either PRP or HA. Group A received intra-articular injection of PRP 2 ml combination with medial tibial plateau and medial femoral condyle injection of PRP 2 ml (once more 2 weeks later). Group B were treated with 2 ml of PRP intra-articular injection every 14 days for a total of two injections. Group C received intra-articular injection of hyaluronic acid 2 ml every 7 days for five injections. All patients were evaluated by the Visual Analogue Scale (VAS) and the Western Ontario and McMaster Universities (WOMAC) score before the treatment and at 1st, 3rd, 6th, 12th and 18th months.
- Conditions
- Osteoarthritis, Knee
- Being tested
- PRP, HA
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPDrug
platelet rich plasma
HADrug
hyaluronic acid
| Study group | Role | What they receive |
|---|---|---|
| Intraosseous and intra-articular | Experimental | injection of PRP 2 ml Receives: Drug: PRP |
| intra-articular PRP | Active comparator | injection PRP 2 ml Receives: Drug: PRP |
| Intra-articular injection of HA | Active comparator | injection of HA 2 ml Receives: Drug: HA |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC scores
The evaluation was performed with WOMAC, which were recorded on a five-point Likert scale scoring, with a response of "none" scored as 0, "mild" as 1, "moderate" as 2, "severe" as 3 and "extreme" as 4.
Measured: At the 18th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start1 Jan 2015
- Primary completion30 Jun 2015
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cangzhou Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329235
- Sponsor's protocol ID
- Cangzhou Central Hospital
- Status last verified
- Oct 2017
- First submitted
- 3 Mar 2017
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraosseous With Intra-articular Injection of Platelet Rich Plasma Versus Hyaluronic Acid in Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03329235
- Acronym / sponsor ID
- Cangzhou Central Hospital
- Conditions
- Osteoarthritis, Knee
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Cangzhou Central HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 1 Nov 2017 (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.
The aim of this study was to compare the efficacy of treatment in three groups of patients with knee osteoarthritis (OA) given a combination of intraosseous with intra-articular injection of platelet rich plasma (PRP), intra-articular injection of PRP and a single application of hyaluronic acid (HA).
Detailed description
Methods Eighty-six patients from January 2015 to June 2015 with grade II to grade III knee osteoarthritis according to the Kellgren-Lawrence classification were randomly divided into 3 groups to receive either PRP or HA. Group A received intra-articular injection of PRP 2 ml combination with medial tibial plateau and medial femoral condyle injection of PRP 2 ml (once more 2 weeks later). Group B were treated with 2 ml of PRP intra-articular injection every 14 days for a total of two injections. Group C received intra-articular injection of hyaluronic acid 2 ml every 7 days for five injections. All patients were evaluated by the Visual Analogue Scale (VAS) and the Western Ontario and McMaster Universities (WOMAC) score before the treatment and at 1st, 3rd, 6th, 12th and 18th months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intraosseous and intra-articular | Experimental | Drug: PRPinjection of PRP 2 ml |
| intra-articular PRP | Active comparator | Drug: PRPinjection PRP 2 ml |
| Intra-articular injection of HA | Active comparator | Drug: HAinjection of HA 2 ml |
Who may qualify
- Ages
- 40 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unilateral symptomatic knee with pain for at least 1 month or swelling.
- Radiographic findings of knee degeneration (Kellgren-Lawrence score of II - III).
- Age 40-73 years.
- Body mass index (BMI) 18-32.5).
- Knee stability without a severe trauma history.
Key exclusion criteria (9 listed)
- Bilateral knee osteoarthritis indicative of treatment for both knees.
- Kellgren-Lawrence score greater than III.
- BMI >32.
- Age >73 years.
- Systemic autoimmune rheumatic diseases and blood disorders.
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 |
|---|---|---|
| PRPplatelet rich plasma | Drug | Intraosseous and intra-articular, intra-articular PRP |
| HAhyaluronic acid | Drug | Intra-articular injection of HA |
Primary outcome
WOMAC scores
Time frame: At the 18th month
The evaluation was performed with WOMAC, which were recorded on a five-point Likert scale scoring, with a response of "none" scored as 0, "mild" as 1, "moderate" as 2, "severe" as 3 and "extreme" as 4.
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 1 Nov 2017.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PRP and HA in people with Osteoarthritis, Knee, run by Cangzhou Central Hospital.
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 5 inclusion and 9 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 1 Nov 2017. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
WOMAC scores (time frame: At the 18th month). 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 1 Nov 2017.