Knee OsteoarthritisEarly Phase 1NCT04454164
Platelet Rich Plasma Injection for Knee Osteoarthritis
A Early Phase 1 study testing PRP and Saline in people with Knee Osteoarthritis and Cartilage Degeneration, run by Ferhat Say at 1 site in Turkey (Türkiye).
Trial summary
The research questions of this study are; 1. Is platelet rich plasma (PRP) treatment effective in knee osteoarthritis (OA)? 2. What are the indications for PRP treatment? 3. Which patients are the most suitable for the PRP treatment method? 4. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Cartilage Degeneration
- What is being tested?
- PRP and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2018to 1 Jan 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stage 1-2-3 symptomatic OA patients according to Kellgren / Lawrence staging
- mean VAS pain score of >4 of 10 (worst possible pain) over the course of 7 days during the previous month
Who cannot join
- OA secondary to joint inflammatory diseases,
- generalized OA,
- metabolic diseases of the bone,
- coexisting backache,
- the presence of hematological disease (coagulopathy),
- bilateral symptomatic lesions and advanced stages (grade 4) of OA,
Show all 14Show fewer
- patients who had received intra-articular injections within 3 months or arthroscopic lavage in the previous 1 year,
- patients who were receiving immunosuppressive,
- patients with current use of anticoagulant medications,
- NSAIDs used in the 5 days before blood donation,
- major axis deviation (more than 15 degree of varus or more than 5 degree of valgus deviation),
- patients with a hemoglobin level less than 11.5 g/dL,
- platelets level less than 100,000/μL,
- associated comorbidities, infection, tumor, crystal arthropathies, anemia, tense joint effusion and pregnancy or possibility of pregnancy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Orthopedic and Trauma, Faculty of Medicine, Ondokuz Mayıs University
Samsun, Atakum, 55139
About this study
Official title: Platelet Rich Plasma In Knee Osteoarthritis: A Prospective, Double-Blind Randomized, Placebo Controlled Clinical Trial
The research questions of this study are;
- Is platelet rich plasma (PRP) treatment effective in knee osteoarthritis (OA)?
- What are the indications for PRP treatment?
- Which patients are the most suitable for the PRP treatment method?
- How does age, Body Mass Index (BMI), lower extremity mechanical axis angle and OA stages affect the success of the PRP treatment?
- Is there any advantage of multiple PRP doses?
- What is the therapeutic effect of placebo?
Read more
This study was designed to find answers of these questions.
The hypotheses of this study are; "PRP treatment is more effective than placebo; PRP treatment effectiveness decreases with age and advanced stages of OA; BMI is a factor that negatively affects the treatment effectiveness of the PRP; as the mechanical axis angle of the lower limb increases, it will adversely affect the effectiveness of PRP therapy; multiple dose of PRP affects the effectiveness and duration of PRP as positively compared to single dose of PRP".
The primary purpose of this study; to prove the effectiveness of PRP treatment on knee pain and functions in patients with knee OA by comparing it with the placebo control group. Secondary purposes of this study; to understand the effect of age, BMI, OA grade and lower limb mechanical axis angle on PRP effectiveness. This study, designed as a randomized, double-blind and placebo control group, with a high level of scientific evidence. Thus, it will be scientifically possible to find answers to the investigators research questions and to prove the investigators hypothesis.
Read the detailed description
The power analysis of this study was calculated based on the sample size studies of previous studies. The difference of d = 3 units between the two means is to have a standard deviation of 6 units. The sample size 200 required to detect with 95% power in the 95% confidence interval to detect.
This study covers 324 patients. All patients were selected according to predefined and established inclusion and exclusion criteria.
Inclusion criteria were: stage 1-2-3 symptomatic OA patients according to Kellgren / Lawrence staging, age between 18 and 80 years, mean Visual Analogue Score (VAS) of >4 of 10 (worst possible pain) over the course of 7 days during the previous month were included on a voluntary basis. Only one knee injection was made to the patients.
Exclusion criteria were OA secondary to joint inflammatory diseases; patients with generalized OA, metabolic diseases of the bone, coexisting backache, the presence of hematological disease (coagulopathy), bilateral symptomatic lesions and advanced stages (grade 4) of OA; patients who had received intra-articular injections within three months or arthroscopic lavage in the previous one year or who were receiving immunosuppressive; patients with current use of anticoagulant medications or NSAIDs used in the five days before blood donation, major axis deviation (more than 15 degree of varus or more than 5 degree of valgus deviation); and patients with a hemoglobin level less than 11.5 g/dL and platelets level less than 100,000/μL or associated co-morbidities, infection, tumor, crystal arthropathies, anemia, tense joint effusion and pregnancy or possibility of pregnancy.
The voluntary patients included in this study were divided into four different groups with a computer-assisted randomization program. This groups; group A (n:67) were given a single injection of PRP, group B (n:69) were given a single injection of normal saline (physiological control/placebo), group C (n:66) were given three injection (one per month) of PRP, group D (n:65) were given three injection of normal saline (one per month) (physiological control/placebo).
All patients were evaluated by a blinded researcher with VAS, Knee injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), KUJALA, knee range of motion (ROM) and knee circumference measurement at 1st, 3rd, 6th, 12th and 24th months after treatment.
- Conditions
- Knee Osteoarthritis, Cartilage Degeneration
- Being tested
- PRP, Saline
- Keywords
- platelet-rich plasma, placebo, growth factors, osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPBiological
Also called platelet rich plasma
platelet rich plasma
SalineDrug
Also called serum physiologic
serum physiologic
| Study group | Role | What they receive |
|---|---|---|
| PRP group | Experimental | Intraarticular 5 ml single PRP injection Receives: Biological: PRP |
| Saline group | Placebo comparator | Intraarticular 5 ml single saline injection Receives: Drug: Saline |
| Multiple PRP group | Experimental | Intraarticular 3 dose of 5 ml PRP injection (0, 1, 3 month injection) Receives: Biological: PRP |
| Multiple saline group | Placebo comparator | Intraarticular 3 dose of 5 ml saline injection (0, 1, 3 month injection) Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
Visual Analogue scale (0-10 higher scores mean a worse outcome)
Measured: Baseline VAS score
VAS
Visual Analogue scale (0-10 higher scores mean a worse outcome)
Measured: VAS score at 1st months
VAS
Visual Analogue scale (0-10 higher scores mean a worse outcome)
Measured: VAS score at 3th months
VAS
Visual Analogue scale (0-10 higher scores mean a worse outcome)
Measured: VAS score at 6th months
VAS
Visual Analogue scale (0-10 higher scores mean a worse outcome)
Measured: VAS score at 12th months
VAS
Visual Analogue scale (0-10 higher scores mean a worse outcome)
Measured: VAS score at 24th months
KOOS
Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)
Measured: Baseline KOOS score
KOOS
Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)
Measured: KOOS score at 1st months
KOOS
Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)
Measured: KOOS score at 3th months
KOOS
Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)
Measured: KOOS score at 6th months
KOOS
Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)
Measured: KOOS score at 12th months
KOOS
Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)
Measured: KOOS score at 24th months
WOMAC
Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)
Measured: Baseline WOMAC score
WOMAC
Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)
Measured: WOMAC score at 1st months
WOMAC
Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)
Measured: WOMAC score at 3th months
WOMAC
Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)
Measured: WOMAC score at 6th months
WOMAC
Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)
Measured: WOMAC score at 12th months
WOMAC
Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)
Measured: WOMAC score at 24th months
Kujala
Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)
Measured: Baseline Kujala score
Kujala
Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)
Measured: Kujala score at 1st months
Kujala
Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)
Measured: Kujala score at 3th months
Kujala
Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)
Measured: Kujala score at 6th months
Kujala
Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)
Measured: Kujala score at 12th months
Kujala
Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)
Measured: Kujala score at 24th months
Secondary outcomes (7)
Knee movement
knee joint range of motion (measured by goniometer as degree)
Measured: 1st, 3rd, 6th, 12th and 24th months
knee circumference
Knee Trans patella circumference
Measured: 1st, 3rd, 6th, 12th and 24th months
mechanical axis angle
angle measured from radiological axes graphs
Measured: baseline
age
age of the patient
Measured: baseline
stage
stage of the osteoarthritis
Measured: baseline
BMI
body mass index
Measured: baseline
patient global satisfaction
subjective satisfaction level of the patient
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start1 Jun 2018
- Primary completion23 Aug 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferhat Say
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ferhat Say, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454164
- Sponsor's protocol ID
- PRP2018
- Status last verified
- Jun 2020
- First submitted
- 24 Jun 2020
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin KY, Yang CC, Hsu CJ, Yeh ML, Renn JH. Intra-articular Injection of Platelet-Rich Plasma Is Superior to Hyaluronic Acid or Saline Solution in the Treatment of Mild to Moderate Knee Osteoarthritis: A Randomized, Double-Blind, Triple-Parallel, Placebo-Controlled Clinical Trial. Arthroscopy. 2019 Jan;35(1):106-117. doi: 10.1016/j.arthro.2018.06.035.
PubMed 30611335Smith PA. Intra-articular Autologous Conditioned Plasma Injections Provide Safe and Efficacious Treatment for Knee Osteoarthritis: An FDA-Sanctioned, Randomized, Double-blind, Placebo-controlled Clinical Trial. Am J Sports Med. 2016 Apr;44(4):884-91. doi: 10.1177/0363546515624678. Epub 2016 Feb 1.
PubMed 26831629Patel S, Dhillon MS, Aggarwal S, Marwaha N, Jain A. Treatment with platelet-rich plasma is more effective than placebo for knee osteoarthritis: a prospective, double-blind, randomized trial. Am J Sports Med. 2013 Feb;41(2):356-64. doi: 10.1177/0363546512471299. Epub 2013 Jan 8.
PubMed 23299850Gormeli G, Gormeli CA, Ataoglu B, Colak C, Aslanturk O, Ertem K. Multiple PRP injections are more effective than single injections and hyaluronic acid in knees with early osteoarthritis: a randomized, double-blind, placebo-controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017 Mar;25(3):958-965. doi: 10.1007/s00167-015-3705-6. Epub 2015 Aug 2.
PubMed 26233594Di Martino A, Di Matteo B, Papio T, Tentoni F, Selleri F, Cenacchi A, Kon E, Filardo G. Platelet-Rich Plasma Versus Hyaluronic Acid Injections for the Treatment of Knee Osteoarthritis: Results at 5 Years of a Double-Blind, Randomized Controlled Trial. Am J Sports Med. 2019 Feb;47(2):347-354. doi: 10.1177/0363546518814532. Epub 2018 Dec 13.
PubMed 30545242Filardo G, Di Matteo B, Di Martino A, Merli ML, Cenacchi A, Fornasari P, Marcacci M, Kon E. Platelet-Rich Plasma Intra-articular Knee Injections Show No Superiority Versus Viscosupplementation: A Randomized Controlled Trial. Am J Sports Med. 2015 Jul;43(7):1575-82. doi: 10.1177/0363546515582027. Epub 2015 May 7.
PubMed 25952818Yurtbay A, Say F, Cinka H, Ersoy A. Multiple platelet-rich plasma injections are superior to single PRP injections or saline in osteoarthritis of the knee: the 2-year results of a randomized, double-blind, placebo-controlled clinical trial. Arch Orthop Trauma Surg. 2022 Oct;142(10):2755-2768. doi: 10.1007/s00402-021-04230-2. Epub 2021 Oct 27.
PubMed 34705072
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich Plasma In Knee Osteoarthritis: A Prospective, Double-Blind Randomized, Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04454164
- Acronym / sponsor ID
- PRP2018
- Conditions
- Knee Osteoarthritis, Cartilage Degeneration
- Keywords
- platelet-rich plasma, placebo, growth factors, osteoarthritis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Ferhat SayUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 23 Aug 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 1 Jul 2020 (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 research questions of this study are;
- Is platelet rich plasma (PRP) treatment effective in knee osteoarthritis (OA)?
- What are the indications for PRP treatment?
- Which patients are the most suitable for the PRP treatment method?
- How does age, Body Mass Index (BMI), lower extremity mechanical axis angle and OA stages affect the success of the PRP treatment?
- Is there any advantage of multiple PRP doses?
- What is the therapeutic effect of placebo?
This study was designed to find answers of these questions.
The hypotheses of this study are; "PRP treatment is more effective than placebo; PRP treatment effectiveness decreases with age and advanced stages of OA; BMI is a factor that negatively affects the treatment effectiveness of the PRP; as the mechanical axis angle of the lower limb increases, it will adversely affect the effectiveness of PRP therapy; multiple dose of PRP affects the effectiveness and duration of PRP as positively compared to single dose of PRP".
The primary purpose of this study; to prove the effectiveness of PRP treatment on knee pain and functions in patients with knee OA by comparing it with the placebo control group. Secondary purposes of this study; to understand the effect of age, BMI, OA grade and lower limb mechanical axis angle on PRP effectiveness. This study, designed as a randomized, double-blind and placebo control group, with a high level of scientific evidence. Thus, it will be scientifically possible to find answers to the investigators research questions and to prove the investigators hypothesis.
Detailed description
The power analysis of this study was calculated based on the sample size studies of previous studies. The difference of d = 3 units between the two means is to have a standard deviation of 6 units. The sample size 200 required to detect with 95% power in the 95% confidence interval to detect.
This study covers 324 patients. All patients were selected according to predefined and established inclusion and exclusion criteria.
Inclusion criteria were: stage 1-2-3 symptomatic OA patients according to Kellgren / Lawrence staging, age between 18 and 80 years, mean Visual Analogue Score (VAS) of >4 of 10 (worst possible pain) over the course of 7 days during the previous month were included on a voluntary basis. Only one knee injection was made to the patients.
Exclusion criteria were OA secondary to joint inflammatory diseases; patients with generalized OA, metabolic diseases of the bone, coexisting backache, the presence of hematological disease (coagulopathy), bilateral symptomatic lesions and advanced stages (grade 4) of OA; patients who had received intra-articular injections within three months or arthroscopic lavage in the previous one year or who were receiving immunosuppressive; patients with current use of anticoagulant medications or NSAIDs used in the five days before blood donation, major axis deviation (more than 15 degree of varus or more than 5 degree of valgus deviation); and patients with a hemoglobin level less than 11.5 g/dL and platelets level less than 100,000/μL or associated co-morbidities, infection, tumor, crystal arthropathies, anemia, tense joint effusion and pregnancy or possibility of pregnancy.
The voluntary patients included in this study were divided into four different groups with a computer-assisted randomization program. This groups; group A (n:67) were given a single injection of PRP, group B (n:69) were given a single injection of normal saline (physiological control/placebo), group C (n:66) were given three injection (one per month) of PRP, group D (n:65) were given three injection of normal saline (one per month) (physiological control/placebo).
All patients were evaluated by a blinded researcher with VAS, Knee injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), KUJALA, knee range of motion (ROM) and knee circumference measurement at 1st, 3rd, 6th, 12th and 24th months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PRP group | Experimental | Biological: PRPIntraarticular 5 ml single PRP injection |
| Saline group | Placebo comparator | Drug: SalineIntraarticular 5 ml single saline injection |
| Multiple PRP group | Experimental | Biological: PRPIntraarticular 3 dose of 5 ml PRP injection (0, 1, 3 month injection) |
| Multiple saline group | Placebo comparator | Drug: SalineIntraarticular 3 dose of 5 ml saline injection (0, 1, 3 month injection) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- stage 1-2-3 symptomatic OA patients according to Kellgren / Lawrence staging
- mean VAS pain score of >4 of 10 (worst possible pain) over the course of 7 days during the previous month
Key exclusion criteria (14 listed)
- OA secondary to joint inflammatory diseases,
- generalized OA,
- metabolic diseases of the bone,
- coexisting backache,
- the presence of hematological disease (coagulopathy),
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 |
|---|---|---|
| PRPAlso: platelet rich plasmaplatelet rich plasma | Biological | Multiple PRP group, PRP group |
| SalineAlso: serum physiologicserum physiologic | Drug | Multiple saline group, Saline group |
Primary outcome
VAS
Time frame: Baseline VAS score
Visual Analogue scale (0-10 higher scores mean a worse outcome)
VAS
Time frame: VAS score at 1st months
Visual Analogue scale (0-10 higher scores mean a worse outcome)
VAS
Time frame: VAS score at 3th months
Visual Analogue scale (0-10 higher scores mean a worse outcome)
VAS
Time frame: VAS score at 6th months
Visual Analogue scale (0-10 higher scores mean a worse outcome)
VAS
Time frame: VAS score at 12th months
Visual Analogue scale (0-10 higher scores mean a worse outcome)
VAS
Time frame: VAS score at 24th months
Visual Analogue scale (0-10 higher scores mean a worse outcome)
KOOS
Time frame: Baseline KOOS score
Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)
KOOS
Time frame: KOOS score at 1st months
Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)
KOOS
Time frame: KOOS score at 3th months
Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)
KOOS
Time frame: KOOS score at 6th months
Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)
KOOS
Time frame: KOOS score at 12th months
Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)
KOOS
Time frame: KOOS score at 24th months
Knee injury and Osteoarthritis Outcome Score (0-100 higher scores mean a better outcome)
WOMAC
Time frame: Baseline WOMAC score
Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)
WOMAC
Time frame: WOMAC score at 1st months
Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)
WOMAC
Time frame: WOMAC score at 3th months
Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)
WOMAC
Time frame: WOMAC score at 6th months
Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)
WOMAC
Time frame: WOMAC score at 12th months
Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)
WOMAC
Time frame: WOMAC score at 24th months
Western Ontario and McMaster Universities Arthritis Index (0-100 higher scores mean a better outcome)
Kujala
Time frame: Baseline Kujala score
Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)
Kujala
Time frame: Kujala score at 1st months
Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)
Kujala
Time frame: Kujala score at 3th months
Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)
Kujala
Time frame: Kujala score at 6th months
Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)
Kujala
Time frame: Kujala score at 12th months
Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)
Kujala
Time frame: Kujala score at 24th months
Kujala Patellofemoral Score (0-100 higher scores mean a better outcome)
7 secondary outcomes
Knee movement
Time frame: 1st, 3rd, 6th, 12th and 24th months
knee circumference
Time frame: 1st, 3rd, 6th, 12th and 24th months
mechanical axis angle
Time frame: baseline
age
Time frame: baseline
stage
Time frame: baseline
BMI
Time frame: baseline
patient global satisfaction
Time frame: 24 months
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 Jul 2020.
- Background: PubMed 30611335Lin KY, Yang CC, Hsu CJ, Yeh ML, Renn JH. Intra-articular Injection of Platelet-Rich Plasma Is Superior to Hyaluronic Acid or Saline Solution in the Treatment of Mild to Moderate Knee Osteoarthritis: A Randomized, Double-Blind, Triple-Parallel, Placebo-Controlled Clinical Trial. Arthroscopy. 2019 Jan;35(1):106-117. doi: 10.1016/j.arthro.2018.06.035.
- Background: PubMed 26831629Smith PA. Intra-articular Autologous Conditioned Plasma Injections Provide Safe and Efficacious Treatment for Knee Osteoarthritis: An FDA-Sanctioned, Randomized, Double-blind, Placebo-controlled Clinical Trial. Am J Sports Med. 2016 Apr;44(4):884-91. doi: 10.1177/0363546515624678. Epub 2016 Feb 1.
- Background: PubMed 23299850Patel S, Dhillon MS, Aggarwal S, Marwaha N, Jain A. Treatment with platelet-rich plasma is more effective than placebo for knee osteoarthritis: a prospective, double-blind, randomized trial. Am J Sports Med. 2013 Feb;41(2):356-64. doi: 10.1177/0363546512471299. Epub 2013 Jan 8.
- Background: PubMed 26233594Gormeli G, Gormeli CA, Ataoglu B, Colak C, Aslanturk O, Ertem K. Multiple PRP injections are more effective than single injections and hyaluronic acid in knees with early osteoarthritis: a randomized, double-blind, placebo-controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017 Mar;25(3):958-965. doi: 10.1007/s00167-015-3705-6. Epub 2015 Aug 2.
- Background: PubMed 30545242Di Martino A, Di Matteo B, Papio T, Tentoni F, Selleri F, Cenacchi A, Kon E, Filardo G. Platelet-Rich Plasma Versus Hyaluronic Acid Injections for the Treatment of Knee Osteoarthritis: Results at 5 Years of a Double-Blind, Randomized Controlled Trial. Am J Sports Med. 2019 Feb;47(2):347-354. doi: 10.1177/0363546518814532. Epub 2018 Dec 13.
- Background: PubMed 25952818Filardo G, Di Matteo B, Di Martino A, Merli ML, Cenacchi A, Fornasari P, Marcacci M, Kon E. Platelet-Rich Plasma Intra-articular Knee Injections Show No Superiority Versus Viscosupplementation: A Randomized Controlled Trial. Am J Sports Med. 2015 Jul;43(7):1575-82. doi: 10.1177/0363546515582027. Epub 2015 May 7.
- Derived from this study: PubMed 34705072Yurtbay A, Say F, Cinka H, Ersoy A. Multiple platelet-rich plasma injections are superior to single PRP injections or saline in osteoarthritis of the knee: the 2-year results of a randomized, double-blind, placebo-controlled clinical trial. Arch Orthop Trauma Surg. 2022 Oct;142(10):2755-2768. doi: 10.1007/s00402-021-04230-2. Epub 2021 Oct 27.
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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 Early Phase 1 study testing PRP and Saline in people with Knee Osteoarthritis and Cartilage Degeneration, run by Ferhat Say at 1 site in Turkey (Türkiye).
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 2 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 1 Jul 2020. 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 Turkey (Türkiye). 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?
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?
VAS (time frame: Baseline VAS score). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04454164, which also lists 7 linked publications.
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 Jul 2020.