AzTrials
AzTrials

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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

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.

Israel1 site
  • Orthopedic Department - Meir Medical Center

    Kfar Saba, 44281

Other trials in Israel

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

  1. 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.
  2. The screening forms will be completed.
  3. Demographic data: date of birth, sex, age and complete medical history, height and previous treatments will be recorded.
  4. Fill out questionnaire of shoulder function. Constant score. SST ( Simple shoulder test)
  5. Clinical examination will be performed. The results will be recorded in the CRF.
  6. Radiology studies: RX Shoulder AP+LAT+ SSP OUTLET VIEW (as required in normal examination of RC injury)
  7. 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

  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. The control group will receive NACL0.9% solution under the same conditions.

3rd visit: 1sr trimester control

  1. Fill out questionnaire of shoulder function. Constant score. SST ( Simple shoulder test)
  2. Clinical examination will be performed. . Constant score The results will be recorded in the CRF
  3. Ultrasound shoulder examination

4rd visit: 2nd trimester control

  1. Fill out questionnaire of shoulder function. Constant score. SST (simple shoulder test)
  2. Clinical examination will be performed. . Constant score The results will be recorded in the CRF
  3. Ultrasound shoulder examination

5th visit: 3rd trimester control

  1. Fill out questionnaire of shoulder function. Constant score. STT ( simple shoulder test)
  2. Clinical examination will be performed. . Constant score The results will be recorded in the CRF
  3. Ultrasound shoulder examination

6th visit: 4th trimester control

  1. Fill out questionnaire of shoulder function. Constant score. SST ( simple shoulder test)
  2. Clinical examination will be performed. . Constant score The results will be recorded in the CRF
  3. Ultrasound shoulder examination
  4. 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.

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 groups in NCT01152658
Study groupRoleWhat they receive
Nacl InjectionPlacebo comparator1. 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
PRGFExperimental1. 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.

  1. partial tear of supraspinatus tendon

    Measured: one year

Secondary outcomes (1)
  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.

  1. First posted29 Jun 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionMay 2012
  4. Study completionJun 2012

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in