Partial Supraspinatus TearPhase 1PrgfRC001ILNCT01152658
Partial Tear of Supraspinatus (SSP) and Treatment With Plasma Rich in Growth Factors (PRGF)
A Phase 1 study testing PRGF and NACL in people with Partial Supraspinatus Tear, run by Meir Medical Center at 1 site in Israel.
Trial summary
The objective of this clinical trial is to evaluate the impact and symptomatic efficacy of platelets rich plasma (PRP \ PRGF) in the treatment of partial tears of supraspinatus tendon of rotator cuff. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Partial Supraspinatus Tear
- What is being tested?
- PRGF and NACL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2010to Jun 2012
- Phase
- Phase 1
- 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
Who may be able to join
- Male or female patients aged between 18 and 60
- Patients suffering from partial tear of supraspinatus tendon on echography.
- Patients who are willing to participate in the trial, to come to all scheduled visits and to sign the informed consent forms.
Who cannot join
- Patients receiving other methods of treatment to this area, who had concomitant other injury of the Rotator Cuff tendons.
- Non cooperative patient with the basic rehab program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind Prospective Randomize Trail of Partial Tear of SSP and Treatment With PRGF
The objective of this clinical trial is to evaluate the impact and symptomatic efficacy of platelets rich plasma (PRP \ PRGF) in the treatment of partial tears of supraspinatus tendon of rotator cuff.
Speed of tendon healing of partial thickness tear of the supraspinatus tendon influenced by local injection of platelets rich plasma
Read the detailed description
Primary endpoint: evaluate functional changes after treatment with local infection with platelets rich plasma. This functional changes will be evaluate with Constant Score (questionnaire of shoulder function) and clinical examination.
Secondary endpoint: evaluate the healing effect of the platelets rich plasma locally injected on partial tear of SSP tendon. These morphologic changes will be evaluated by echography
Selection and withdrawal of subjects 40 patients with partial tear of supraspinatus tendon diagnosed by echography. INCLUSION CRITERIA Male or female patients aged between 18 and 60 Patients suffering from partial tear of supraspinatus tendon on echography. Patients who are willing to participate in the trial, to come to all scheduled visits and to sign the informed consent forms.
EXCLUSION CRITERIA Patients receiving other methods of treatment to this area, who had concomitant other injury of the Rotator Cuff tendons.
Non cooperative patient with the basic rehab program.
Trial design
1st visit: Enrollment of patient
- The patient will be given a full verbal and written explanation regarding the trial and treatment. The patient will sign the informed consent form and will be given a serial number.
- The screening forms will be completed.
- Demographic data: date of birth, sex, age and complete medical history, height and previous treatments will be recorded.
- Fill out questionnaire of shoulder function. Constant score. SST ( Simple shoulder test)
- Clinical examination will be performed. The results will be recorded in the CRF.
- Radiology studies: RX Shoulder AP+LAT+ SSP OUTLET VIEW (as required in normal examination of RC injury)
- Each patient will receive a physiotherapy treatment order according to the protocol of each social work
Randomized separation of the patients in two groups: Control group and the trail group. Patients and medical staff do not know to which group they belong. Double blind trial. (Outside the physician in charge of preparing the blood and the principal investigator)
2nd visit: autologous platelet-rich plasma
- Blood samples (4 test tubes) will be extracted from control groups and 8 test tubes for the trial group. The blood of the trial group will be centrifuged and the platelet fraction extracted and counted (only 4 test tubes).
- The enriched plasma fraction will be then injected to the trial group in sterile conditions under ultrasound control. The control group will receive NACL0.9% solution under the same conditions.
3rd visit: 1sr trimester control
- Fill out questionnaire of shoulder function. Constant score. SST ( Simple shoulder test)
- Clinical examination will be performed. . Constant score The results will be recorded in the CRF
- Ultrasound shoulder examination
4rd visit: 2nd trimester control
- Fill out questionnaire of shoulder function. Constant score. SST (simple shoulder test)
- Clinical examination will be performed. . Constant score The results will be recorded in the CRF
- Ultrasound shoulder examination
5th visit: 3rd trimester control
- Fill out questionnaire of shoulder function. Constant score. STT ( simple shoulder test)
- Clinical examination will be performed. . Constant score The results will be recorded in the CRF
- Ultrasound shoulder examination
6th visit: 4th trimester control
- Fill out questionnaire of shoulder function. Constant score. SST ( simple shoulder test)
- Clinical examination will be performed. . Constant score The results will be recorded in the CRF
- Ultrasound shoulder examination
- End of trial
After one year if treatment if PRGF is proved to be significantly effective on the result of the trail the medical staff is committed to provide treatment, with rich plasma to control patients at no cost.
- Conditions
- Partial Supraspinatus Tear
- Being tested
- PRGF, NACL
- Keywords
- Partial supraspinatus tear, partial tear ssp per echo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRGFBiological
Also called trial group
enriched plasma fraction will be then injected to the trial group in sterile conditions under ultrasound control in the ssp gap
NACLOther
Also called control group
Nack 0.9 5 will be then injected to the control group group in sterile conditions under ultrasound control
| Study group | Role | What they receive |
|---|---|---|
| Nacl Injection | Placebo comparator | 1. Blood samples (4 test tubes) will be extracted from control groups and 8 test tubes for the trial group. The blood of the trial group will be centrifuged and the platelet fraction extracted and counted (only 4 test tubes).
2. NACL0.9% solution will be then injected to the control group in sterile conditions under ultrasound control
double blind procedure
. Receives: Other: NACL |
| PRGF | Experimental | 1. Blood samples (4 test tubes) will be extracted from control groups and 8 test tubes for the trial group. The blood of the trial group will be centrifuged and the platelet fraction extracted and counted (only 4 test tubes).2. The enriched plasma fraction will be then injected to the trial group in sterile conditions under ultrasound control. Receives: Biological: PRGF |
What is being measured
The primary outcome is the main question the study is designed to answer.
partial tear of supraspinatus tendon
Measured: one year
Secondary outcomes (1)
efficacy of platelets rich plasma (PRP \ PRGF)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Supraspinatus 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ezequiel Palmanovich, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152658
- Sponsor's protocol ID
- MMC10008-2010CTIL
- Acronym
- PrgfRC001IL
- Status last verified
- Mar 2012
- First submitted
- 26 Apr 2010
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Prospective Randomize Trail of Partial Tear of SSP and Treatment With PRGF
- ClinicalTrials.gov ID
- NCT01152658
- Acronym / sponsor ID
- PrgfRC001IL / MMC10008-2010CTIL
- Conditions
- Partial Supraspinatus Tear
- Keywords
- Partial supraspinatus tear, partial tear ssp per echo
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 29 Jun 2010 (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 objective of this clinical trial is to evaluate the impact and symptomatic efficacy of platelets rich plasma (PRP \ PRGF) in the treatment of partial tears of supraspinatus tendon of rotator cuff.
Speed of tendon healing of partial thickness tear of the supraspinatus tendon influenced by local injection of platelets rich plasma
Detailed description
Primary endpoint: evaluate functional changes after treatment with local infection with platelets rich plasma. This functional changes will be evaluate with Constant Score (questionnaire of shoulder function) and clinical examination.
Secondary endpoint: evaluate the healing effect of the platelets rich plasma locally injected on partial tear of SSP tendon. These morphologic changes will be evaluated by echography
Selection and withdrawal of subjects 40 patients with partial tear of supraspinatus tendon diagnosed by echography. INCLUSION CRITERIA Male or female patients aged between 18 and 60 Patients suffering from partial tear of supraspinatus tendon on echography. Patients who are willing to participate in the trial, to come to all scheduled visits and to sign the informed consent forms.
EXCLUSION CRITERIA Patients receiving other methods of treatment to this area, who had concomitant other injury of the Rotator Cuff tendons.
Non cooperative patient with the basic rehab program.
Trial design
1st visit: Enrollment of patient
- The patient will be given a full verbal and written explanation regarding the trial and treatment. The patient will sign the informed consent form and will be given a serial number.
- The screening forms will be completed.
- Demographic data: date of birth, sex, age and complete medical history, height and previous treatments will be recorded.
- Fill out questionnaire of shoulder function. Constant score. SST ( Simple shoulder test)
- Clinical examination will be performed. The results will be recorded in the CRF.
- Radiology studies: RX Shoulder AP+LAT+ SSP OUTLET VIEW (as required in normal examination of RC injury)
- Each patient will receive a physiotherapy treatment order according to the protocol of each social work
Randomized separation of the patients in two groups: Control group and the trail group. Patients and medical staff do not know to which group they belong. Double blind trial. (Outside the physician in charge of preparing the blood and the principal investigator)
2nd visit: autologous platelet-rich plasma
- Blood samples (4 test tubes) will be extracted from control groups and 8 test tubes for the trial group. The blood of the trial group will be centrifuged and the platelet fraction extracted and counted (only 4 test tubes).
- The enriched plasma fraction will be then injected to the trial group in sterile conditions under ultrasound control. The control group will receive NACL0.9% solution under the same conditions.
3rd visit: 1sr trimester control
- Fill out questionnaire of shoulder function. Constant score. SST ( Simple shoulder test)
- Clinical examination will be performed. . Constant score The results will be recorded in the CRF
- Ultrasound shoulder examination
4rd visit: 2nd trimester control
- Fill out questionnaire of shoulder function. Constant score. SST (simple shoulder test)
- Clinical examination will be performed. . Constant score The results will be recorded in the CRF
- Ultrasound shoulder examination
5th visit: 3rd trimester control
- Fill out questionnaire of shoulder function. Constant score. STT ( simple shoulder test)
- Clinical examination will be performed. . Constant score The results will be recorded in the CRF
- Ultrasound shoulder examination
6th visit: 4th trimester control
- Fill out questionnaire of shoulder function. Constant score. SST ( simple shoulder test)
- Clinical examination will be performed. . Constant score The results will be recorded in the CRF
- Ultrasound shoulder examination
- End of trial
After one year if treatment if PRGF is proved to be significantly effective on the result of the trail the medical staff is committed to provide treatment, with rich plasma to control patients at no cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nacl Injection | Placebo comparator | Other: NACL1. Blood samples (4 test tubes) will be extracted from control groups and 8 test tubes for the trial group. The blood of the trial group will be centrifuged and the platelet fraction extracted and counted (only 4 test tubes). 2. NACL0.9% solution will be then injected to the control group in sterile conditions under ultrasound control double blind procedure . |
| PRGF | Experimental | Biological: PRGF1. Blood samples (4 test tubes) will be extracted from control groups and 8 test tubes for the trial group. The blood of the trial group will be centrifuged and the platelet fraction extracted and counted (only 4 test tubes).2. The enriched plasma fraction will be then injected to the trial group in sterile conditions under ultrasound control. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female patients aged between 18 and 60
- Patients suffering from partial tear of supraspinatus tendon on echography.
- Patients who are willing to participate in the trial, to come to all scheduled visits and to sign the informed consent forms.
Key exclusion criteria (2 listed)
- Patients receiving other methods of treatment to this area, who had concomitant other injury of the Rotator Cuff tendons.
- Non cooperative patient with the basic rehab program.
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 |
|---|---|---|
| PRGFAlso: trial groupenriched plasma fraction will be then injected to the trial group in sterile conditions under ultrasound control in the ssp gap | Biological | PRGF |
| NACLAlso: control groupNack 0.9 5 will be then injected to the control group group in sterile conditions under ultrasound control | Other | Nacl Injection |
Primary outcome
partial tear of supraspinatus tendon
Time frame: one year
1 secondary outcome
efficacy of platelets rich plasma (PRP \ PRGF)
Time frame: one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2013.
Related trials for Partial Supraspinatus Tear
Recruiting
Intralesional Versus Perilesional 5% Dextrose Injection in Partial Rotator Cuff Tears
Partial Rotator Cuff Tears, Rotator Cuff Tendinopathy
Not yet recruiting
Platelet-Rich Plasma for Partial Rotator Cuff Tears
Partial Supraspinatus Tear, Rotator Cuff Tears (RCTs)
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.
Ezequiel Palmanovich, MD principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRGF and NACL in people with Partial Supraspinatus 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 3 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: withdrawn, as of the sponsor's last update on 29 Jan 2013. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
partial tear of supraspinatus tendon (time frame: one 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 29 Jan 2013; AzTrials last refreshed its copy on 8 Nov 2026.