Meniscal TearNCT03059706
The Effect of Intra-Articular Injection of RegenoGel-OSP™(Self-Plasma) to Treat Pain Following Arthroscopic Surgery
A study testing RegenoGel-OSP™ and saline in people with Meniscal Tear, run by Kaplan Medical Center at 1 site in Israel.
Trial summary
This study evaluates the efficacy of intra-articular administration of RegenoGel-OSP™ to treat pain and the safety and efficacy on subject's activity and quality of life following arthroscopic surgery due to degenerative or traumatic meniscal tear. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Meniscal Tear
- What is being tested?
- RegenoGel-OSP™ and saline
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteIsrael
- Study dates
- 23 Mar 2017to May 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has signed and dated the informed consent form.
- Subject is a male or female over the age of 45.
- Patients scheduled for knee arthroscopic surgery due to degenerative or traumatic meniscal tear.
Who cannot join
- Subject had any intra-articular injections to the intended study knee within 3 months prior to Screening.
- Subject is unable to stop chronic administration of pain medications (including paracetamol), from the day before each study visit through completion of the study visit.
- Subject has a history of Psoriatic Arthritis, Rheumatoid Arthritis,or any other inflammatory condition associated with arthritis.
- Subject has a superficial wound in the area of the intended study knee.
- Subject is scheduled for knee ligaments reconstructive surgery.
- Subject has fever signs or symptoms of systemic infection or infection of the intended study knee.
Show all 14Show fewer
- Subject has known sensitivity to any of the treatment components, egg, rubber or latex.
- Subject has a history of anaphylactic shock or other severe systemic response or other adverse event to human blood products.
- Subject has a clinically significant abnormal finding (e.g., laboratory result or ECG).
- Subject has known Human Immunodeficiency Virus / Acquired Immunodeficiency Syndrome (HIV/AIDS), Hepatitis B or C viral infections, or acute or chronic liver disease.
- Subject has ever had cellulitis of the lower extremities, a superficial or deep vein thrombosis, or a family history of a clotting disorders.
- Subject receives any investigational device or product within 30 days of Visit l.
- Subject is receiving an oral or injected anticoagulant.
- Subject ever abused drugs or alcohol (self-reported).
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Kaplan Medical Center
Rehovot, 76100
Philip Rosinsky, MD, 0508990006, prosinsky@gmail.com
About this study
Official title: Randomized, Open-Labal, Placebo-Controlled Trial of the Effect of Intra-Articular Injection of RegenoGel-OSP™ (Slef-Plasma) to Treat Pain Following Arthroscopic Surgery
This study evaluates the efficacy of intra-articular administration of RegenoGel-OSP™ to treat pain and the safety and efficacy on subject's activity and quality of life following arthroscopic surgery due to degenerative or traumatic meniscal tear. adult subjects will be randomized and sequentially assigned to RegenoGel-OSP™ or placebo treatment on a 1:1 basis.
- Conditions
- Meniscal Tear
- Being tested
- RegenoGel-OSP™, saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegenoGel-OSP™Device
intra-articular injection of RegenoGel-OSP™ after arthroscopic surgery
salineOther
intra-articular injection of saline after arthroscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| RegenoGel-OSP™ | Experimental | Not described Receives: Device: RegenoGel-OSP™ |
| Placebo | Placebo comparator | Not described Receives: Other: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of RegenoGel-OSP to treat pain following arthroscopic surgery
The subjects will answer VAS (Visual Analog Score) questionnaire for grading of their pain level
Measured: The questionnaires will filled for 6 months after surgery
Efficacy of RegenoGel-OSP on function following arthroscopic surgery
The subjects will answer three questionnaires for grading of their symptoms and overall functional performance
Measured: The questionnaires will filled for 6 months after surgery.
Efficacy of RegenoGel-OSP on function following arthroscopic surgery
Radiograph of the terget knee will be obtained.
Measured: Change from baseline at 6 months after surgery.
Secondary outcomes (3)
Incidence of treatment-emergent adverse events.
Self reported adverse events
Measured: self-reported adverse events will be evaluated for 6 months follow-up.
The efficacy of RegenoGel-OSP on subject's activity and quality of life.
The subjects will answer four questionnaires for grading of their symptoms, pain level and overall functional performance.
Measured: The questionnaires will be filled for 6 months follow-up after surgery.
Incidence, relatedness and severity of treatment-emergent adverse events.
physical examination of the study knee by the investigator.
Measured: Physical examination will be evaluated for 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start23 Mar 2017
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscal TearStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ProCore Ltd.
- Responsible party
- Principal investigator, Philip Rosinsky, Kaplan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059706
- Sponsor's protocol ID
- PROC-3
- Status last verified
- Aug 2017
- First submitted
- 7 Feb 2017
- Last updated
- 23 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-Labal, Placebo-Controlled Trial of the Effect of Intra-Articular Injection of RegenoGel-OSP™ (Slef-Plasma) to Treat Pain Following Arthroscopic Surgery
- ClinicalTrials.gov ID
- NCT03059706
- Acronym / sponsor ID
- PROC-3
- Conditions
- Meniscal Tear
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- Collaborators
- ProCore Ltd.
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 23 Feb 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 evaluates the efficacy of intra-articular administration of RegenoGel-OSP™ to treat pain and the safety and efficacy on subject's activity and quality of life following arthroscopic surgery due to degenerative or traumatic meniscal tear. adult subjects will be randomized and sequentially assigned to RegenoGel-OSP™ or placebo treatment on a 1:1 basis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RegenoGel-OSP™ | Experimental | Device: RegenoGel-OSP™ |
| Placebo | Placebo comparator | Other: saline |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject has signed and dated the informed consent form.
- Subject is a male or female over the age of 45.
- Patients scheduled for knee arthroscopic surgery due to degenerative or traumatic meniscal tear.
Key exclusion criteria (14 listed)
- Subject had any intra-articular injections to the intended study knee within 3 months prior to Screening.
- Subject is unable to stop chronic administration of pain medications (including paracetamol), from the day before each study visit through completion of the study visit.
- Subject has a history of Psoriatic Arthritis, Rheumatoid Arthritis,or any other inflammatory condition associated with arthritis.
- Subject has a superficial wound in the area of the intended study knee.
- Subject is scheduled for knee ligaments reconstructive surgery.
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 |
|---|---|---|
| RegenoGel-OSP™intra-articular injection of RegenoGel-OSP™ after arthroscopic surgery | Device | RegenoGel-OSP™ |
| salineintra-articular injection of saline after arthroscopic surgery | Other | Placebo |
Primary outcome
Efficacy of RegenoGel-OSP to treat pain following arthroscopic surgery
Time frame: The questionnaires will filled for 6 months after surgery
The subjects will answer VAS (Visual Analog Score) questionnaire for grading of their pain level
Efficacy of RegenoGel-OSP on function following arthroscopic surgery
Time frame: The questionnaires will filled for 6 months after surgery.
The subjects will answer three questionnaires for grading of their symptoms and overall functional performance
Efficacy of RegenoGel-OSP on function following arthroscopic surgery
Time frame: Change from baseline at 6 months after surgery.
Radiograph of the terget knee will be obtained.
3 secondary outcomes
Incidence of treatment-emergent adverse events.
Time frame: self-reported adverse events will be evaluated for 6 months follow-up.
The efficacy of RegenoGel-OSP on subject's activity and quality of life.
Time frame: The questionnaires will be filled for 6 months follow-up after surgery.
Incidence, relatedness and severity of treatment-emergent adverse events.
Time frame: Physical examination will be evaluated for 6 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
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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?
A study testing RegenoGel-OSP™ and saline in people with Meniscal Tear, run by Kaplan Medical Center at 1 site in Israel.
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 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: status not confirmed, as of the sponsor's last update on 23 Aug 2017. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip Rosinsky (0508990006, prosinsky@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of RegenoGel-OSP to treat pain following arthroscopic surgery (time frame: The questionnaires will filled for 6 months after surgery). The study lists 3 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 23 Aug 2017.