Muscle TearPhase 2/3NCT00726245
Plasma Rich in Growth Factors (PRGF) Treatment for Muscle Tear
A Phase 2/3 study testing PRGF in people with Muscle Tear, run by Meir Medical Center at 1 site in Israel.
Trial summary
the improvement of symptoms and disease progress by the treatment of OA of the knee with PRGF Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Muscle Tear
- What is being tested?
- PRGF
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2008to Mar 2011
- Phase
- Phase 2/3
- 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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- US diagnosed muscle tear
- age 15-40 years old
Who cannot join
- pregnancy
- mental or physical disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PRP as a Treatment for Acute Muscle Tears - Randomized-double-blind-placebo Control Trail.
the improvement of symptoms and disease progress by the treatment of OA of the knee with PRGF
- Conditions
- Muscle Tear
- Being tested
- PRGF, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRGFBiological
3-6mg IM (to area of muscle tear)
PlaceboBiological
3cc IM of physiological saline
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | PRGF Receives: Biological: PRGF |
| 2 | Placebo comparator | physiological saline Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of symptoms / disease progress
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2008 (estimated)
- Study startJan 2008
- Primary completionFeb 2009
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726245
- Sponsor's protocol ID
- 3000
- Status last verified
- Jul 2011
- First submitted
- 29 Jul 2008
- Last updated
- 12 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRP as a Treatment for Acute Muscle Tears - Randomized-double-blind-placebo Control Trail.
- ClinicalTrials.gov ID
- NCT00726245
- Acronym / sponsor ID
- 3000
- Conditions
- Muscle Tear
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 31 Jul 2008 (estimated)
- 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.
the improvement of symptoms and disease progress by the treatment of OA of the knee with PRGF
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: PRGFPRGF |
| 2 | Placebo comparator | Biological: Placebophysiological saline |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- US diagnosed muscle tear
- age 15-40 years old
Key exclusion criteria (2 listed)
- pregnancy
- mental or physical disabilities
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 |
|---|---|---|
| PRGF3-6mg IM (to area of muscle tear) | Biological | 1 |
| Placebo3cc IM of physiological saline | Biological | 2 |
Primary outcome
improvement of symptoms / disease progress
Time frame: 1 year
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 12 Jul 2011.
Related trials for Muscle Tear
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Recruiting
Thermal Therapies in the Treatment of Muscle Injuries
Hamstring Injuries, Hamstring Muscle Repair
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Not yet recruitingObservational study
Ultrasound and Shear Wave Elastography for Assessment of the Quality of Rotator Cuff Muscles
Rotator Cuff Injuries, Rotator Cuff Tear
Active, not recruitingObservational study
Perianchor Cyst Formation, Tendon Healing, and Clinical Outcomes Following Arthroscopic Rotator Cuff Repair
Rotator Cuff Tears, Tendon Thickening
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PRGF in people with Muscle Tear, run by Meir 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 2 inclusion and 2 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 12 Jul 2011. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
improvement of symptoms / disease progress (time frame: 1 year). 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 12 Jul 2011.