Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT01152658 |
| Other study ID # |
MMC10008-2010CTIL |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
Phase 1
|
| First received |
April 26, 2010 |
| Last updated |
January 28, 2013 |
| Start date |
April 2010 |
| Est. completion date |
June 2012 |
Study information
| Verified date |
March 2012 |
| Source |
Meir Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Israel: Ethics CommissionUnited States: Institutional Review Board |
| Study type |
Interventional
|
Clinical 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.
Speed of tendon healing of partial thickness tear of the supraspinatus tendon influenced by
local injection of platelets rich plasma
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.
