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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01152658
First received: April 26, 2010
Last updated: January 28, 2013
Last verified: March 2012
  Purpose

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 Intervention Phase
Partial Supraspinatus Tear
Biological: PRGF
Other: NACL
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double Blind Prospective Randomize Trail of Partial Tear of SSP and Treatment With PRGF

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • partial tear of supraspinatus tendon [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • efficacy of platelets rich plasma (PRP \ PRGF) [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: April 2010
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01152658     History of Changes
Other Study ID Numbers: MMC10008-2010CTIL
Study First Received: April 26, 2010
Last Updated: January 28, 2013
Health Authority: Israel: Ethics Commission
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 22, 2014