Osteo Arthritis KneeNCT03197441
Platelet Rich Plasma for Knee Osteoarthritis
A study testing Platelet-rich plasma in people with Osteo Arthritis Knee and Platelet-rich Plasma, run by Pei-Yuan Lee, MD at 1 site in Taiwan.
Trial summary
This study aimed to analyze the effect of platelet-rich plasma (PRP) on knee osteoarthritis. Eligible patients will undertake arthroscopic knee surgery plus intraoperative PRP and also receive second look surgery and intraoperative biopsy. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Osteo Arthritis Knee, Platelet-rich Plasma
- What is being tested?
- Platelet-rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Aug 2016to 28 Jun 2018
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 30 and 70 years
- With diagnosis of osteoarthritis, grade II~grade IV, II-III medial compartment
Who cannot join
- Lateral compartment and patellofemoral joint osteoarthritis
- With prior history of knee surgery
- Severe varus deformity
- With current or prior history of traum or infection at the knee
- With current or prior history of cancer
- With current or prior history of hematological disease
- Pregnancy
- Patients who will not cooperate with one-year followup
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Platelet Rich Plasma Injection in Arthroscopic Surgery for Osteoarthritis of the Knee
This study aimed to analyze the effect of platelet-rich plasma (PRP) on knee osteoarthritis. Eligible patients will undertake arthroscopic knee surgery plus intraoperative PRP and also receive second look surgery and intraoperative biopsy.
Read the detailed description
Osteoarthritis is a chronic disease defined by progressive degradation of the joint as well as loss of cartilage on joint surfaces. The degeneration that occurs in the joint leads to changes in the catabolic and anabolic activity of chondrocytes. Osteoarthritis may induce pain, stiffness and limitation in range of motion of the joint and also may impact the quality of life. Platelet-rich plasma (PRP) is a fraction of plasma that contains platelets and multiple growth factors concentrated at high level. Because activated platelets have the potential to release growth factors, PRP has been clinically used to accelerate wound healing and tissue regeneration in orthopedic and oral surgery. Although several studies have assessed the effects of PRP on knee osteoarthritis, a higher level of evidence has not been provided. This study aimed to analyze the effect of PRP on knee osteoarthritis. After performing arthroscopic knee surgery plus intraoperative PRP in eligible patients, a second look arthroscopic surgery with intraoperative biopsy will be arranged 6 months later. Pre- and post-operative imaging and clinical outcomes will also be compared.
- Conditions
- Osteo Arthritis Knee, Platelet-rich Plasma
- Being tested
- Platelet-rich plasma
- Keywords
- Platelet-rich plasma, Osteoarthritis Knee
- 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 plasmaOther
Intraoperative platelet-rich plasma injection during arthroscopic knee surgery
| Study group | Role | What they receive |
|---|---|---|
| PRP group | Experimental | Arthroscopic knee surgery plus intraoperative platelet-rich plasma Receives: Other: Platelet-rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knee function from baseline to postoperative 3 months
Knee function is evaluated using Oswestry Disability Index preoperatively and 3-month postoperatively.
Measured: 3-month postoperative
Secondary outcomes (7)
Change in knee function from baseline to postoperative 6 months
Knee function is evaluated using Oswestry Disability Index preoperatively and 6-month postoperatively.
Measured: 6-month postoperative
Change in knee function from baseline to postoperative 12 months
Knee function is evaluated using Oswestry Disability Index preoperatively and 12-month postoperatively.
Measured: 12-month postoperative
Change in knee pain from baseline to postoperative 3 months
Pain is evaluated using visual analogue scale preoperatively and 3-month postoperatively.
Measured: 3-month postoperative
Change in knee pain from baseline to postoperative 6 months
Pain is evaluated using visual analogue scale preoperatively and 6-month postoperatively.
Measured: 6-month postoperative
Change in knee pain from baseline to postoperative 12 months
Pain is evaluated using visual analogue scale preoperatively and 12-month postoperatively.
Measured: 12-month postoperative
Percentage of patients with regenerated cartilage
Cartilage regeneration is assessed by pathological biopsy during second look surgery at 12-month postoperative.
Measured: 12-month postoperative
Change in cartilage thickness from baseline to postoperative 6 months
Cartilage thickness is assessed by MRI preoperatively and 6-month postoperatively.
Measured: 6-month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start29 Aug 2016
- Primary completion28 Jun 2018
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pei-Yuan Lee, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Aeon Biotechnology Corporation
- Responsible party
- Sponsor-investigator, Pei-Yuan Lee, MD, Show Chwan Memorial Hospital
- Investigators
- Pei-Yuan Lee, MD, Study chair, Show Chwan Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197441
- Sponsor's protocol ID
- RA-16028-RD-105065
- Status last verified
- Sep 2019
- First submitted
- 13 Apr 2017
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Platelet Rich Plasma Injection in Arthroscopic Surgery for Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT03197441
- Acronym / sponsor ID
- RA-16028-RD-105065
- Conditions
- Osteo Arthritis Knee, Platelet-rich Plasma
- Keywords
- Platelet-rich plasma, Osteoarthritis Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Pei-Yuan Lee, MDUniversity, hospital or other
- Collaborators
- Aeon Biotechnology Corporation
- Study start
- 29 Aug 2016 (actual)
- Primary completion
- 28 Jun 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 23 Jun 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.
This study aimed to analyze the effect of platelet-rich plasma (PRP) on knee osteoarthritis. Eligible patients will undertake arthroscopic knee surgery plus intraoperative PRP and also receive second look surgery and intraoperative biopsy.
Detailed description
Osteoarthritis is a chronic disease defined by progressive degradation of the joint as well as loss of cartilage on joint surfaces. The degeneration that occurs in the joint leads to changes in the catabolic and anabolic activity of chondrocytes. Osteoarthritis may induce pain, stiffness and limitation in range of motion of the joint and also may impact the quality of life. Platelet-rich plasma (PRP) is a fraction of plasma that contains platelets and multiple growth factors concentrated at high level. Because activated platelets have the potential to release growth factors, PRP has been clinically used to accelerate wound healing and tissue regeneration in orthopedic and oral surgery. Although several studies have assessed the effects of PRP on knee osteoarthritis, a higher level of evidence has not been provided. This study aimed to analyze the effect of PRP on knee osteoarthritis. After performing arthroscopic knee surgery plus intraoperative PRP in eligible patients, a second look arthroscopic surgery with intraoperative biopsy will be arranged 6 months later. Pre- and post-operative imaging and clinical outcomes will also be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRP group | Experimental | Other: Platelet-rich plasmaArthroscopic knee surgery plus intraoperative platelet-rich plasma |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 30 and 70 years
- With diagnosis of osteoarthritis, grade II~grade IV, II-III medial compartment
Key exclusion criteria (8 listed)
- Lateral compartment and patellofemoral joint osteoarthritis
- With prior history of knee surgery
- Severe varus deformity
- With current or prior history of traum or infection at the knee
- With current or prior history of cancer
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 plasmaIntraoperative platelet-rich plasma injection during arthroscopic knee surgery | Other | PRP group |
Primary outcome
Change in knee function from baseline to postoperative 3 months
Time frame: 3-month postoperative
Knee function is evaluated using Oswestry Disability Index preoperatively and 3-month postoperatively.
7 secondary outcomes
Change in knee function from baseline to postoperative 6 months
Time frame: 6-month postoperative
Change in knee function from baseline to postoperative 12 months
Time frame: 12-month postoperative
Change in knee pain from baseline to postoperative 3 months
Time frame: 3-month postoperative
Change in knee pain from baseline to postoperative 6 months
Time frame: 6-month postoperative
Change in knee pain from baseline to postoperative 12 months
Time frame: 12-month postoperative
Percentage of patients with regenerated cartilage
Time frame: 12-month postoperative
Change in cartilage thickness from baseline to postoperative 6 months
Time frame: 6-month postoperative
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 6 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Pei-Yuan Lee, MD study chair
Show Chwan Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-rich plasma in people with Osteo Arthritis Knee and Platelet-rich Plasma, run by Pei-Yuan Lee, MD at 1 site in Taiwan.
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 8 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 6 Sep 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 Taiwan. 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?
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 knee function from baseline to postoperative 3 months (time frame: 3-month postoperative). 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 6 Sep 2019.