PRPPhase 4NCT04586361
Prospective Analysis of Introperative RegenLab PRP and Hyaluronic Acid in Patients With Knee ACL Tear
A Phase 4 study testing RegenLab PRP, hyaluronic acid and normal saline in people with PRP and ACL, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial summary
Purpose: The purpose of this article is to examine the clinical application of PRP and PRP+hyaluronic acid in disorders in the knee. Methods: The study was conducted on 150 adult patients with age over 20 years old affected by unilateral ACL complete tear and receiving ACL reconstruction. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- PRP, ACL, Hyaluronic Acid
- What is being tested?
- RegenLab PRP, hyaluronic acid and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Oct 2020to 15 Sep 2022
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- receiving unilateral ACL reconstruction in our hospital
- postoperative follow-up over 3 month
Who cannot join
- postoperative follow-up less than 3 month
- possible pregnency
- with coagulation disease
- NSAIDs intake during study period
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Veterans General Hospital
Kaohsiung City, Kaohsiung, 813
Yi Ping Wei, MD, 073422121, xgoznas22@gmail.com
About this study
Purpose: The purpose of this article is to examine the clinical application of PRP and PRP+hyaluronic acid in disorders in the knee.
Methods:
The study was conducted on 150 adult patients with age over 20 years old affected by unilateral ACL complete tear and receiving ACL reconstruction. We divided the patients in three groups, and we treated the group A with perioperative injection of HHA, group B with perioperative HHA+PRP, group C with perioperative normal saline.
Follow-up:
Every 1,3,and 12months, we recheck physical exmianation at OPD and recheck MRI at postoperative 3 months.
- Conditions
- PRP, ACL, Hyaluronic Acid
- Being tested
- RegenLab PRP, hyaluronic acid, normal saline
- Keywords
- PRP; ACL reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegenLab PRPCombination product
PRP preparations also improved functional outcome scores compared to hyaluronic acid and placebo in patients affected by knee osteoarthritis (OA). Based on previous studys, we can conclude that the PRP treatment is a safe and efficacious procedure which can provide functional benefit.
hyaluronic acidCombination product
Also called RegenLab PRP
Few studies investigated the effects of HA+PRP combined treatment for knee osteoarthritis (OA). Numerous studies demonstrated the efficacy of HA injection therapy in knee OA for a clinical point of view, reducing the pain and improving the quality of life.
normal salineOther
In this study, we compare introperative PRP/PRP+HA/normal saline in ACL reconstruction patient.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group 1 | Experimental | Intraoperative1 kit of Platelet-rich plasma(PRP) injection into knee joint after anterior cruciate ligament (ACL) reconstruction. Receives: Combination Product: RegenLab PRP |
| Experimental group 2 | Experimental | Intraoperative1 kit of PRP+Hyaluronic acid(HA) injection into knee joint after ACL reconstruction. Receives: Combination Product: hyaluronic acid |
| Experimental group 3 | Placebo comparator | Intraoperative 20 ml normal saline injection into knee joint after ACL reconstruction. Receives: Other: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test
the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist
Measured: postoperative 1 month
150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test
the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist
Measured: postoperative 3 months
150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test
the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist
Measured: postoperative 12 months
150 of participants with preoperative and postoperative Magnetic Resonance Imaging are accessed
anterior cruciate ligament was accessed by MRI T1 and T2 image; MRI was checked by one orthopedist
Measured: postoperative 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start15 Oct 2020 (estimated)
- Primary completion15 Sep 2021 (estimated)
- Study completion15 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PRPStudies 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
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Ping Wei, Kaohsiung Veterans General Hospital.
- Investigators
- Yi Ping Wei, MD, Principal investigator, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586361
- Sponsor's protocol ID
- 200527-2
- Status last verified
- Oct 2020
- First submitted
- 13 Sep 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Introperative RegenLab PRP and Hyaluronic Acid in Patients With Knee ACL Tear
- ClinicalTrials.gov ID
- NCT04586361
- Acronym / sponsor ID
- 200527-2
- Conditions
- PRP, ACL, Hyaluronic Acid
- Keywords
- PRP; ACL reconstruction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- 15 Oct 2020 (estimated)
- Primary completion
- 15 Sep 2021 (estimated)
- Study completion
- 15 Sep 2022 (estimated)
- First posted
- 14 Oct 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.
Purpose: The purpose of this article is to examine the clinical application of PRP and PRP+hyaluronic acid in disorders in the knee.
Methods:
The study was conducted on 150 adult patients with age over 20 years old affected by unilateral ACL complete tear and receiving ACL reconstruction. We divided the patients in three groups, and we treated the group A with perioperative injection of HHA, group B with perioperative HHA+PRP, group C with perioperative normal saline.
Follow-up:
Every 1,3,and 12months, we recheck physical exmianation at OPD and recheck MRI at postoperative 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1 | Experimental | Combination Product: RegenLab PRPIntraoperative1 kit of Platelet-rich plasma(PRP) injection into knee joint after anterior cruciate ligament (ACL) reconstruction. |
| Experimental group 2 | Experimental | Combination Product: hyaluronic acidIntraoperative1 kit of PRP+Hyaluronic acid(HA) injection into knee joint after ACL reconstruction. |
| Experimental group 3 | Placebo comparator | Other: normal salineIntraoperative 20 ml normal saline injection into knee joint after ACL reconstruction. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- receiving unilateral ACL reconstruction in our hospital
- postoperative follow-up over 3 month
Key exclusion criteria (4 listed)
- postoperative follow-up less than 3 month
- possible pregnency
- with coagulation disease
- NSAIDs intake during study period
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 |
|---|---|---|
| RegenLab PRPPRP preparations also improved functional outcome scores compared to hyaluronic acid and placebo in patients affected by knee osteoarthritis (OA). Based on previous studys, we can conclude that the PRP treatment is a safe and efficacious procedure which can provide functional benefit. | Combination product | Experimental group 1 |
| hyaluronic acidAlso: RegenLab PRPFew studies investigated the effects of HA+PRP combined treatment for knee osteoarthritis (OA). Numerous studies demonstrated the efficacy of HA injection therapy in knee OA for a clinical point of view, reducing the pain and improving the quality of life. | Combination product | Experimental group 2 |
| normal salineIn this study, we compare introperative PRP/PRP+HA/normal saline in ACL reconstruction patient. | Other | Experimental group 3 |
Primary outcome
150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test
Time frame: postoperative 1 month
the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist
150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test
Time frame: postoperative 3 months
the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist
150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test
Time frame: postoperative 12 months
the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist
150 of participants with preoperative and postoperative Magnetic Resonance Imaging are accessed
Time frame: postoperative 3 month
anterior cruciate ligament was accessed by MRI T1 and T2 image; MRI was checked by one orthopedist
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
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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.
Yi Ping Wei, MD principal investigator
Kaohsiung Veterans General Hospital.
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 RegenLab PRP, hyaluronic acid and normal saline in people with PRP and ACL, run by Kaohsiung Veterans General Hospital. 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 4 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 14 Oct 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 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Ping Wei, MD (+886-7-342-2121, xgoznas22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test (time frame: postoperative 1 month). The study lists 4 primary outcomes in all. 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 14 Oct 2020.