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WithdrawnNCT01152658PrgfRC001ILUpdated Jan 29, 2013

Partial Tear of Supraspinatus (SSP) and Treatment With Plasma Rich in Growth Factors (PRGF)

A Phase 1 interventional study of PRGF and NACL in Partial Supraspinatus Tear, sponsored by Meir Medical Center. Withdrawn at 1 site in Israel. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-01-29.

Sponsored by Meir Medical Center · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Partial Supraspinatus Tear

Keywords

  • Partial supraspinatus tear
  • partial tear ssp per echo
03

In context

Lead sponsor

Meir Medical Center is the lead sponsor of 389 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Placebo comparator
    Nacl Injection

    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 .

    Other: NACL

  • Experimental
    PRGF

    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.

    Biological: PRGF

Interventions

  • BiologicalPRGF

    enriched plasma fraction will be then injected to the trial group in sterile conditions under ultrasound control in the ssp gap

    Also known as: trial group

  • OtherNACL

    Nack 0.9 5 will be then injected to the control group group in sterile conditions under ultrasound control

    Also known as: control group

06

What researchers measure

Primary outcomes

  1. partial tear of supraspinatus tendon

    Time frame: one year

Secondary outcomes

  1. efficacy of platelets rich plasma (PRP \ PRGF)

    Time frame: one year

07

Study locations

1 site
  • Orthopedic Department - Meir Medical Center
    Kfar-saba, 44281, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01152658
Lead sponsor
Meir Medical Center
Responsible party
Sponsor
First posted
Jun 29, 2010
Start date
Apr 2010
Primary completion
May 2012
Completion
Jun 2012
Last update
Jan 29, 2013

Study contacts

Ezequiel Palmanovich, MD
principal investigator · Meir Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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