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Partial Tear of Supraspinatus (SSP) and Treatment With Plasma Rich in Growth Factors (PRGF) (PrgfRC001IL)

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ClinicalTrials.gov Identifier: NCT01152658
Recruitment Status : Withdrawn
First Posted : June 29, 2010
Last Update Posted : January 29, 2013
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

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


Condition or disease Intervention/treatment Phase
Partial Supraspinatus Tear Biological: PRGF Other: NACL Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Double Blind Prospective Randomize Trail of Partial Tear of SSP and Treatment With PRGF
Study Start Date : April 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Arm Intervention/treatment
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
Nack 0.9 5 will be then injected to the control group group in sterile conditions under ultrasound control
Other Name: control group
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
enriched plasma fraction will be then injected to the trial group in sterile conditions under ultrasound control in the ssp gap
Other Name: trial group



Primary Outcome Measures :
  1. partial tear of supraspinatus tendon [ Time Frame: one year ]

Secondary Outcome Measures :
  1. efficacy of platelets rich plasma (PRP \ PRGF) [ Time Frame: one year ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01152658


Locations
Israel
Orthopedic Department - Meir Medical Center
Kfar-saba, Israel, 44281
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Ezequiel Palmanovich, MD Meir Medical Center

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01152658     History of Changes
Other Study ID Numbers: MMC10008-2010CTIL
First Posted: June 29, 2010    Key Record Dates
Last Update Posted: January 29, 2013
Last Verified: March 2012

Keywords provided by Meir Medical Center:
Partial supraspinatus tear
partial tear ssp per echo