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

NCT01152658 | Withdrawn Phase 1

• 1 other identifier: MMC10008-2010CTIL
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Partial Supraspinatus Tear

Keywords

Partial supraspinatus tear; partial tear ssp per echo

Outcome Measures

Primary Outcomes (1)

• partial tear of supraspinatus tendon

  one year

Secondary Outcomes (1)

• efficacy of platelets rich plasma (PRP \ PRGF)

  one year

Study Arms (2)

Nacl Injection

PLACEBO COMPARATOR

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

PRGF

EXPERIMENTAL

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

Interventions

PRGF BIOLOGICAL

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

PRGF

NACL OTHER

Nack 0.9 5 will be then injected to the control group group in sterile conditions under ultrasound control

Also known as: control group

Nacl Injection

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Orthopedic Department - Meir Medical Center

Kfar Saba, 44281, Israel

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ezequiel Palmanovich, MD

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2010
• First Posted: June 29, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: January 29, 2013

Record last verified: 2012-03

Locations

IL (1)