Platelet-Rich PlasmaNCT04040283
Platelet-rich Plasma for Menical Tear
An observational study of Platelet-Rich Plasma and Meniscus Lesion, run by University of Malaga at 1 site in Spain.
Trial summary
Meniscal injuries are a common pathology among athletes, and have an impact on the daily or sporting practice of patients. Surgical approach implies sometimes heavy consequences. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Platelet-Rich Plasma, Meniscus Lesion
- What is being tested?
- Platelet-rich plasma (PRP) therapy
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2014to Nov 2019
- Phase
- Observational
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Skeletally mature patients aged between 18 and 70 years with imaging and clinical diagnosis of meniscus injury and no indication of meniscus repair surgery
Who may be able to join
- Skeletally mature patients 18-70 years of age
- With diagnosis of meniscus injury
- Single tear of the medial and/or lateral meniscus
- With no indication of meniscus repair surgery
Who cannot join
- Prior history of multiple ligaments injury, associated significant ligament instability: Grade III MCL, Grade III PCL, or ACL deficient knee
- Prior history of knee surgery
- Discoid meniscus
- Osteoarthritic changes (Kellgren Lawrence scale >2)
- Inflammatory diseases (i.e. rheumatoid arthritis)
- Underlying bleeding disorder or coagulopathy
Show all 10Show fewer
- Concominant chondral defects (> 2 ICRS)
- Cancer patients
- Pregnancy
- Patients who will not cooperate with six-month followup
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Ivan Medina-Porqueres
Málaga
Ivan Medina-Porqueres, Professor, 0034951952858, imp@uma.es
About this study
Meniscal injuries are a common pathology among athletes, and have an impact on the daily or sporting practice of patients. Surgical approach implies sometimes heavy consequences. Platelet-rich-plasma (PRP) has been shown to be effective in accelerating wound healing and tissue regeneration in orthopedic and oral surgery. This clinical trial aims to investigate the safety and efficacy of intraarticular and periferal PRP injection in patients with stable meniscal injury. The pre- and post-interventional clinical outcomes will be compared.
- Conditions
- Platelet-Rich Plasma, Meniscus Lesion
- Being tested
- Platelet-rich plasma (PRP) therapy
- Keywords
- Growth factors, Meniscal injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich plasma (PRP) therapyProcedure or surgery
Platelet rich plasma (PRP) describes a technique in which platelets are isolated from a sample of a person's own blood using simple cell-separating systems such as centrifugation in order to obtain highly concentrated samples of platelets that can be re-injected into an injury site to promote healing.
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee injury and Osteoarthritis Outcome Score scale
Measured: 6months post procedure
Visual Analog Scale
Measured: 6months post procedure
Secondary outcomes (2)
International Knee Documentation Committee - Subjective Knee Evaluation Form
Measured: 6months post procedure
Satisfaction Level
Measured: 6months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study startJan 2014
- Primary completionJan 2019
- Study completionNov 2019 (estimated)
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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Medina-Porqueres, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040283
- Sponsor's protocol ID
- UMalaga21
- Status last verified
- Jul 2019
- First submitted
- 29 Jul 2019
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet-rich Plasma for Menical Tear
- ClinicalTrials.gov ID
- NCT04040283
- Acronym / sponsor ID
- UMalaga21
- Conditions
- Platelet-Rich Plasma, Meniscus Lesion
- Keywords
- Growth factors, Meniscal injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Nov 2019 (estimated)
- First posted
- 31 Jul 2019 (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.
Meniscal injuries are a common pathology among athletes, and have an impact on the daily or sporting practice of patients. Surgical approach implies sometimes heavy consequences. Platelet-rich-plasma (PRP) has been shown to be effective in accelerating wound healing and tissue regeneration in orthopedic and oral surgery. This clinical trial aims to investigate the safety and efficacy of intraarticular and periferal PRP injection in patients with stable meniscal injury. The pre- and post-interventional clinical outcomes will be compared.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Skeletally mature patients aged between 18 and 70 years with imaging and clinical diagnosis of meniscus injury and no indication of meniscus repair surgery
Key inclusion criteria (4 listed)
- Skeletally mature patients 18-70 years of age
- With diagnosis of meniscus injury
- Single tear of the medial and/or lateral meniscus
- With no indication of meniscus repair surgery
Key exclusion criteria (10 listed)
- Prior history of multiple ligaments injury, associated significant ligament instability: Grade III MCL, Grade III PCL, or ACL deficient knee
- Prior history of knee surgery
- Discoid meniscus
- Osteoarthritic changes (Kellgren Lawrence scale >2)
- Inflammatory diseases (i.e. rheumatoid arthritis)
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 plasma (PRP) therapyPlatelet rich plasma (PRP) describes a technique in which platelets are isolated from a sample of a person's own blood using simple cell-separating systems such as centrifugation in order to obtain highly concentrated samples of platelets that can be re-injected into an injury site to promote healing. | Procedure or surgery | – |
Primary outcome
Knee injury and Osteoarthritis Outcome Score scale
Time frame: 6months post procedure
Visual Analog Scale
Time frame: 6months post procedure
2 secondary outcomes
International Knee Documentation Committee - Subjective Knee Evaluation Form
Time frame: 6months post procedure
Satisfaction Level
Time frame: 6months post procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Platelet-Rich Plasma and Meniscus Lesion, run by University of Malaga at 1 site in Spain.
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 4 inclusion and 10 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 31 Jul 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee injury and Osteoarthritis Outcome Score scale (time frame: 6months post procedure). The study lists 2 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 31 Jul 2019.