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Cascade PRFM Study: The Evaluation of Cascade Platelet-Rich Fibrin Matrix (PRFM) on Rotator Cuff Healing

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ClinicalTrials.gov Identifier: NCT00198185
Recruitment Status : Withdrawn
First Posted : September 20, 2005
Last Update Posted : January 4, 2018
Information provided by (Responsible Party):

Study Description
Brief Summary:

Hypothesis: The use of cascade platelet-rich fibrin matrix (PRFM) on medium and large sized rotator cuff tears will improve patient results versus the control results by 50%.

The purpose of this study is to examine the effect of PRFM on rotator cuff repairs. Since locally applied platelet-derived growth factor (PDGF) has shown early promise in enhancing tendon and ligament healing in anterior cruciate ligament (ACL) and medial collateral ligament (MCL) reconstruction, the investigators believe that locally applied PRFM will enhance the quality of rotator cuff repairs.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tendon Injuries Procedure: Placement of Platelet Rich Fibrin Matrix During Arthroscopic Rotator Cuff Surgery Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Evaluation of Cascade PRFM on Rotator Cuff Healing
Study Start Date : January 2005
Estimated Primary Completion Date : January 2005
Estimated Study Completion Date : January 2005
Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. L'Insalata: preoperatively, 6 weeks, 3 months post-operatively, 12 months post-operatively
  2. American Shoulder and Elbow Surgery (ASES) Patient Survey: preoperatively, 6 weeks, 3 months post-operatively, 12 months post-operatively

Secondary Outcome Measures :
  1. Ultrasound (power Doppler imaging): 6 weeks, 3 months post-operatively
  2. Manual muscle testing using a dynamometer: preoperatively, 3 months post-operatively, 6 months post-operatively
  3. ASES Physician Survey: preoperatively, 3 months post-operatively, 12 months post-operatively

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients 45 years of age and older who have failed conservative treatment for rotator cuff pathology.
  • Patients in this study will have full thickness rotator cuff tears that are classified arthroscopically as medium (1 to 3 cm) or large (3 to 5 cm) and that are treated with arthroscopic repair.

Exclusion Criteria:

  • Patients who have undergone revision procedures, mini-open, or open procedures will be excluded.
Contacts and Locations

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): NCT00198185

United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Musculoskeletal Transplant Foundation
Principal Investigator: Russell F. Warren, MD Hospital for Special Surgery, New York
More Information

Mafulli, N, Benazzo F. Basic Sciences of Tendons. Sports Medicine and Arthroscopy Review, 8:1-5, 2000

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT00198185     History of Changes
Other Study ID Numbers: 24087
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018

Keywords provided by Hospital for Special Surgery, New York:
Full Thickness Tendon Defect of Rotator Cuff

Additional relevant MeSH terms:
Tendon Injuries
Wounds and Injuries