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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Hospital for Special Surgery, New York.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Musculoskeletal Transplant Foundation
Information provided by:
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT00198185
First received: September 12, 2005
Last updated: January 11, 2006
Last verified: September 2005
  Purpose

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 Intervention Phase
Rotator Cuff
Tendon Injuries
Procedure: Placement of Platelet Rich Fibrin Matrix During Arthroscopic Rotator Cuff Surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Evaluation of Cascade PRFM on Rotator Cuff Healing

Further study details as provided by Hospital for Special Surgery, New York:

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

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

Estimated Enrollment: 136
Study Start Date: January 2005
  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00198185

Contacts
Contact: Andrew D Pearle, MD 212 774 2333 pearlea@hss.edu
Contact: Cornelia Griggs, Bachelor's 212 774 7520 griggsc@hss.edu

Locations
United States, New York
Hospital for Special Surgery Recruiting
New York City, New York, United States, 10021
Contact: Andrew D Pearle, MD    212-774-2333    pearlea@hss.edu   
Contact: Cornelia Griggs, Bachelor's    212-774-7520    griggsc@hss.edu   
Sub-Investigator: Andrew D Pearle, MD         
Sponsors and Collaborators
Hospital for Special Surgery, New York
Musculoskeletal Transplant Foundation
Investigators
Principal Investigator: Russell F. Warren, MD Hospital for Special Surgery, New York
  More Information

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

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00198185     History of Changes
Other Study ID Numbers: 24087
Study First Received: September 12, 2005
Last Updated: January 11, 2006
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014