Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT01152658
Status:
WITHDRAWN
Last Update Posted:
2013-01-29
First Post:
2010-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Partial Tear of Supraspinatus (SSP) and Treatment With Plasma Rich in Growth Factors (PRGF)
Sponsor:
Meir Medical Center
Organization:
Study Overview
Official Title:
Double Blind Prospective Randomize Trail of Partial Tear of SSP and Treatment With PRGF
Status:
WITHDRAWN
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PrgfRC001IL
Brief 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
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
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: