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 Withdrawn at 1 site in Israel.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
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
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
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
3rd visit: 1sr trimester control
4rd visit: 2nd trimester control
5th visit: 3rd trimester control
6th visit: 4th trimester control
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.
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.
Exclusion Criteria:
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
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
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
Nack 0.9 5 will be then injected to the control group group in sterile conditions under ultrasound control
Also known as: control group
partial tear of supraspinatus tendon
Time frame: one year
efficacy of platelets rich plasma (PRP \ PRGF)
Time frame: one year
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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Meir Medical Center