Knee OsteoarthritisPhase 4NCT03086759
Intra-Articular Platelet Rich Plasm Use in Osteoarthritis of Knee.
A Phase 4 study testing platelet rich plasm, Triamcinolone Hexacetonide and Isotonic Saline Solution in people with Knee Osteoarthritis, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Osteoarthritis of the knee is a very prevalent disease. However, there are few therapeutic options for its patients. Platelet-rich plasma is a treatment option for chronic pain. If proven to be effective in its intra-articular use, Platelet-rich plasma may help in the treatment of these patients. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- platelet rich plasm, Triamcinolone Hexacetonide and Isotonic Saline Solution
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jan 2017to 2 Jun 2018
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary knee osteoarthritis
- degree II and II in Kellgren \& Lawrence classification
- pain duration: more than three months
- pain in the visual analogue scale between 4 and 8cm
- agree in participate and sign the consent form
Who cannot join
- secondary knee osteoarthritis
- skin lesion in knee
- intraarticular joint injection in the previous three months
- steroids use in the previous 30 days
- degree I or IV in Kellgren \& Lawrence classification
- inflammatory arthritis, gout and pseudo-gout
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- cancer
- previous surgery in knee
- cardiovascular and respiratory disease that change functional status
- pregnancy and breastfeed
- coagulation disturb
- bacterial infection
- handicapped
- NSAIDs and Platelet anticoagulant in the previous month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-Articular Use of Platelet Rich Plasma Versus Corticosteroid: A Clinical Trials in Osteoarthritis of Knee.
Osteoarthritis of the knee is a very prevalent disease. However, there are few therapeutic options for its patients. Platelet-rich plasma is a treatment option for chronic pain. If proven to be effective in its intra-articular use, Platelet-rich plasma may help in the treatment of these patients.
Goal:
Read more
Primary objective: To compare effectiveness in improving pain and function and the medium-term tolerance (12 weeks) of intra-articular injection of Platelet-rich plasma versus intraarticular injection of triamcinolone hexacetonide in patients with symptomatic primary knee osteoarthritis.
Secondary objective: To compare the medium-term effectiveness of intra-articular injection of Platelet-rich plasma versus intra-articular injection of triamcinolone hexacetonide to improve synovial hypertrophy and quality of life in these patients.
Methods: A prospective randomized controlled double-blind study with three groups (each with n = 33) of patients with symptomatic osteoarthritis of knees who will receive intra-articular infiltration in a single moment. Patients will be allocated to one of three groups: 1) Platelet-rich plasma group: patients who will receive plasma; 2) triamcinolone hexacetonide Group: patients who will receive 40mg of triamcinolone hexacetonide; And 3) Isotonic saline solution group: patients who will receive isotonic saline solution. The patients will be evaluated by "blind" evaluators in 4 assessment times up to 12 weeks of follow-up through clinical assessment instruments (rest and movement pain, joint edema, goniometry, clinical improvement scale, quality of life questionnaire as the SF36), functional (Womac questionnaire, M. Lequesne Functional Knee Index, 6 min walk test, Time up and go test), and ultrasound test (quantitative and semiquantitative measurement of synovial hypertrophy and semiquantitative Power Doppler).
Statistics: The following statistical tests will be used according to the need: Student's t test, Mann-whitney, Pearson's chi-square test and ANOVA for repeated measures. A statistical significance of 5% will be considered.
- Conditions
- Knee Osteoarthritis
- Being tested
- platelet rich plasm, Triamcinolone Hexacetonide, Isotonic Saline Solution
- 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 plasmProcedure or surgery
intra-articular infiltration with platelet rich plasm
Triamcinolone HexacetonideDrug
intra-articular infiltration withTriamcinolone Hexacetonide
Isotonic Saline SolutionProcedure or surgery
intra-articular infiltration with Isotonic Saline Solution
| Study group | Role | What they receive |
|---|---|---|
| Platelet rich plasm group | Experimental | Not described Receives: Procedure: platelet rich plasm |
| Triamcinolone Hexacetonide group | Active comparator | Not described Receives: Drug: Triamcinolone Hexacetonide |
| Isotonic Saline Solution group | Placebo comparator | Not described Receives: Procedure: Isotonic Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain
Evaluated using a visual analogue scale
Measured: Baseline, after 4, 8, 12 and 48 weeks
Secondary outcomes (9)
Change in joint edema
Evaluated using a visual analogue scale
Measured: Baseline, after 4, 8, 12 and 48 weeks
Change in range of motion
Evaluated using goniometry
Measured: Baseline, after 4, 8, 12 and 48 weeks
Change in a clinical improvement scale
Evaluated using an improvement scale
Measured: Baseline, after 4, 8, 12 and 48 weeks
Change in quality of life
Using the SF-36 questionnaire
Measured: Baseline, after 4, 8, 12 and 48 weeks
Change in functional capacity
Using the WOMAC questionnaire
Measured: Baseline, after 4, 8, 12 and 48 weeks
Change in functional capacity
Using the M Lequesne questionnaire
Measured: Baseline, after 4, 8, 12 and 56 weeks
Change in functional capacity
Using the six minute walk test
Measured: Baseline, after 4, 8, 12 and 48 weeks
Change in functional capacity
Using the time to up and go test
Measured: Baseline, after 4, 8, 12 and 48 weeks
Changing in quantitative and semiquantitative measurement of synovial hypertrophy and semiquantitative Power Doppler
Using an ultrasound exam
Measured: Baseline, after 4, 8, 12 and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start2 Jan 2017
- Primary completion2 Jun 2018
- Study completion2 Jun 2018
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Carlos Nunes Tamashiro, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086759
- Sponsor's protocol ID
- CEP UNIFESP 842 167/2014
- Status last verified
- Jan 2019
- First submitted
- 16 Mar 2017
- Last updated
- 18 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Articular Use of Platelet Rich Plasma Versus Corticosteroid: A Clinical Trials in Osteoarthritis of Knee.
- ClinicalTrials.gov ID
- NCT03086759
- Acronym / sponsor ID
- CEP UNIFESP 842 167/2014
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 2 Jun 2018 (actual)
- Study completion
- 2 Jun 2018 (actual)
- First posted
- 22 Mar 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.
Osteoarthritis of the knee is a very prevalent disease. However, there are few therapeutic options for its patients. Platelet-rich plasma is a treatment option for chronic pain. If proven to be effective in its intra-articular use, Platelet-rich plasma may help in the treatment of these patients.
Goal:
Primary objective: To compare effectiveness in improving pain and function and the medium-term tolerance (12 weeks) of intra-articular injection of Platelet-rich plasma versus intraarticular injection of triamcinolone hexacetonide in patients with symptomatic primary knee osteoarthritis.
Secondary objective: To compare the medium-term effectiveness of intra-articular injection of Platelet-rich plasma versus intra-articular injection of triamcinolone hexacetonide to improve synovial hypertrophy and quality of life in these patients.
Methods: A prospective randomized controlled double-blind study with three groups (each with n = 33) of patients with symptomatic osteoarthritis of knees who will receive intra-articular infiltration in a single moment. Patients will be allocated to one of three groups: 1) Platelet-rich plasma group: patients who will receive plasma; 2) triamcinolone hexacetonide Group: patients who will receive 40mg of triamcinolone hexacetonide; And 3) Isotonic saline solution group: patients who will receive isotonic saline solution. The patients will be evaluated by "blind" evaluators in 4 assessment times up to 12 weeks of follow-up through clinical assessment instruments (rest and movement pain, joint edema, goniometry, clinical improvement scale, quality of life questionnaire as the SF36), functional (Womac questionnaire, M. Lequesne Functional Knee Index, 6 min walk test, Time up and go test), and ultrasound test (quantitative and semiquantitative measurement of synovial hypertrophy and semiquantitative Power Doppler).
Statistics: The following statistical tests will be used according to the need: Student's t test, Mann-whitney, Pearson's chi-square test and ANOVA for repeated measures. A statistical significance of 5% will be considered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Platelet rich plasm group | Experimental | Procedure: platelet rich plasm |
| Triamcinolone Hexacetonide group | Active comparator | Drug: Triamcinolone Hexacetonide |
| Isotonic Saline Solution group | Placebo comparator | Procedure: Isotonic Saline Solution |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- primary knee osteoarthritis
- degree II and II in Kellgren \& Lawrence classification
- pain duration: more than three months
- pain in the visual analogue scale between 4 and 8cm
- agree in participate and sign the consent form
Key exclusion criteria (14 listed)
- secondary knee osteoarthritis
- skin lesion in knee
- intraarticular joint injection in the previous three months
- steroids use in the previous 30 days
- degree I or IV in Kellgren \& Lawrence classification
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 plasmintra-articular infiltration with platelet rich plasm | Procedure or surgery | Platelet rich plasm group |
| Triamcinolone Hexacetonideintra-articular infiltration withTriamcinolone Hexacetonide | Drug | Triamcinolone Hexacetonide group |
| Isotonic Saline Solutionintra-articular infiltration with Isotonic Saline Solution | Procedure or surgery | Isotonic Saline Solution group |
Primary outcome
Change in pain
Time frame: Baseline, after 4, 8, 12 and 48 weeks
Evaluated using a visual analogue scale
9 secondary outcomes
Change in joint edema
Time frame: Baseline, after 4, 8, 12 and 48 weeks
Change in range of motion
Time frame: Baseline, after 4, 8, 12 and 48 weeks
Change in a clinical improvement scale
Time frame: Baseline, after 4, 8, 12 and 48 weeks
Change in quality of life
Time frame: Baseline, after 4, 8, 12 and 48 weeks
Change in functional capacity
Time frame: Baseline, after 4, 8, 12 and 48 weeks
Change in functional capacity
Time frame: Baseline, after 4, 8, 12 and 56 weeks
Change in functional capacity
Time frame: Baseline, after 4, 8, 12 and 48 weeks
Change in functional capacity
Time frame: Baseline, after 4, 8, 12 and 48 weeks
Changing in quantitative and semiquantitative measurement of synovial hypertrophy and semiquantitative Power Doppler
Time frame: Baseline, after 4, 8, 12 and 48 weeks
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 18 Jan 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing platelet rich plasm, Triamcinolone Hexacetonide and Isotonic Saline Solution in people with Knee Osteoarthritis, run by Federal University of São Paulo at 1 site in Brazil.
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 14 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 18 Jan 2019. 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 Brazil. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in pain (time frame: Baseline, after 4, 8, 12 and 48 weeks). 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 18 Jan 2019.