Platelet-Rich PlasmaNCT03176641
Platelet-rich Plasma for Meniscus Repair
A study testing platelet-rich plasma in people with Platelet-Rich Plasma and Knee Injuries, run by Pei-Yuan Lee, MD at 1 site in Taiwan.
Trial summary
This study aims to evaluate the effect of platelet-rich plasma (PRP) on meniscus injury by comparing the imaging and clinical outcomes between patients receiving PRP with meniscus repair surgery and those receiving meniscus repair surgery only. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Platelet-Rich Plasma, Knee Injuries, Meniscus Disorder
- What is being tested?
- platelet-rich plasma
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Aug 2016to 21 Nov 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20 and 60 years
- With diagnosis of meniscus injury
- With indications of meniscus repair surgery
Who cannot join
- Multiple ligaments injury
- with prior history of knee surgery
- Cancer patients
- Pregnancy
- Patients who will not cooperate with one-year followup
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Platelet-rich Plasma on Meniscus Repair- a Randomized Controlled Trial
This study aims to evaluate the effect of platelet-rich plasma (PRP) on meniscus injury by comparing the imaging and clinical outcomes between patients receiving PRP with meniscus repair surgery and those receiving meniscus repair surgery only.
Read the detailed description
Damage to meniscal tissue is challenging for orthopedic surgeons because of the absence of healing at the avascular zone. Additionally, the accelerated degeneration of articular cartilage and increased rate of knee osteoarthritis that can occur following a meniscal injury. 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. Several in vivo and in vitro studies have reported favorable outcomes of PRP on meniscal repair; however, the clinical results varied between studies.This clinical trial will investigate the effect of PRP on on meniscus injury. Eligible patients will be randomly assigned to receive PRP with meniscus repair surgery or to receive meniscus repair surgery only. The postoperative imaging and clinical outcomes will be compared and analyzed.
- Conditions
- Platelet-Rich Plasma, Knee Injuries, Meniscus Disorder
- Being tested
- platelet-rich plasma, control
- Keywords
- Platelet-Rich Plasma, Meniscus, Knee Injuries
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet-rich plasmaOther
Autologous platelet-rich plasma gel applied during meniscus repair surgery
controlOther
Meniscus repair surgery only
| Study group | Role | What they receive |
|---|---|---|
| PRP group | Active comparator | 30 patients will receive autologous platelet-rich plasma gel during meniscus repair surgery. Receives: Other: platelet-rich plasma |
| Control group | Placebo comparator | 30 patients will receive meniscus repair surgery only. Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-month postoperative knee function evaluated by IKDC
Knee function is evaluated using International Knee Documentation Committee (IKDC) score.
Measured: 3-month postoperative
Secondary outcomes (7)
6-month postoperative knee function evaluated by IKDC
Knee function is evaluated using International Knee Documentation Committee (IKDC) score.
Measured: 6-month postoperative
12-month postoperative knee function evaluated by IKDC
Knee function is evaluated using International Knee Documentation Committee (IKDC) score.
Measured: 12-month postoperative
3-month postoperative knee pain evaluated by VAS
Pain level is evaluated using visual analogue scale (VAS).
Measured: 3-month postoperative
6-month postoperative knee pain evaluated by VAS
Pain level is evaluated using visual analogue scale (VAS).
Measured: 6-month postoperative
12-month postoperative knee pain evaluated by VAS
Pain level is evaluated using visual analogue scale (VAS).
Measured: 12-month postoperative
Percentage of patients with healed meniscus 6-month postoperative
Healing of meniscus is evaluated by MRI
Measured: 6-month postoperative
Percentage of patients with healed meniscus 12-month postoperative
Healing of meniscus is evaluated by MRI
Measured: 12-month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start24 Aug 2016
- Primary completion8 May 2018
- Study completion21 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet-Rich PlasmaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 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
- NCT03176641
- Sponsor's protocol ID
- RA-16027-RD-105063
- Status last verified
- Dec 2018
- First submitted
- 13 Apr 2017
- Last updated
- 26 Dec 2018
- 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 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Platelet-rich Plasma on Meniscus Repair- a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03176641
- Acronym / sponsor ID
- RA-16027-RD-105063
- Conditions
- Platelet-Rich Plasma, Knee Injuries, Meniscus Disorder
- Keywords
- Platelet-Rich Plasma, Meniscus, Knee Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pei-Yuan Lee, MDUniversity, hospital or other
- Collaborators
- Aeon Biotechnology Corporation
- Study start
- 24 Aug 2016 (actual)
- Primary completion
- 8 May 2018 (actual)
- Study completion
- 21 Nov 2018 (actual)
- First posted
- 5 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 aims to evaluate the effect of platelet-rich plasma (PRP) on meniscus injury by comparing the imaging and clinical outcomes between patients receiving PRP with meniscus repair surgery and those receiving meniscus repair surgery only.
Detailed description
Damage to meniscal tissue is challenging for orthopedic surgeons because of the absence of healing at the avascular zone. Additionally, the accelerated degeneration of articular cartilage and increased rate of knee osteoarthritis that can occur following a meniscal injury. 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. Several in vivo and in vitro studies have reported favorable outcomes of PRP on meniscal repair; however, the clinical results varied between studies.This clinical trial will investigate the effect of PRP on on meniscus injury. Eligible patients will be randomly assigned to receive PRP with meniscus repair surgery or to receive meniscus repair surgery only. The postoperative imaging and clinical outcomes will be compared and analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP group | Active comparator | Other: platelet-rich plasma30 patients will receive autologous platelet-rich plasma gel during meniscus repair surgery. |
| Control group | Placebo comparator | Other: control30 patients will receive meniscus repair surgery only. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 20 and 60 years
- With diagnosis of meniscus injury
- With indications of meniscus repair surgery
Key exclusion criteria (5 listed)
- Multiple ligaments injury
- with prior history of knee surgery
- Cancer patients
- Pregnancy
- Patients who will not cooperate with one-year followup
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 plasmaAutologous platelet-rich plasma gel applied during meniscus repair surgery | Other | PRP group |
| controlMeniscus repair surgery only | Other | Control group |
Primary outcome
3-month postoperative knee function evaluated by IKDC
Time frame: 3-month postoperative
Knee function is evaluated using International Knee Documentation Committee (IKDC) score.
7 secondary outcomes
6-month postoperative knee function evaluated by IKDC
Time frame: 6-month postoperative
12-month postoperative knee function evaluated by IKDC
Time frame: 12-month postoperative
3-month postoperative knee pain evaluated by VAS
Time frame: 3-month postoperative
6-month postoperative knee pain evaluated by VAS
Time frame: 6-month postoperative
12-month postoperative knee pain evaluated by VAS
Time frame: 12-month postoperative
Percentage of patients with healed meniscus 6-month postoperative
Time frame: 6-month postoperative
Percentage of patients with healed meniscus 12-month postoperative
Time frame: 12-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 26 Dec 2018.
- 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 Platelet-Rich Plasma and Knee Injuries, 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 3 inclusion and 5 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 26 Dec 2018. 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.
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?
3-month postoperative knee function evaluated by IKDC (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 26 Dec 2018.