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

Primary Purpose

Rotator Cuff, Tendon Injuries

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Placement of Platelet Rich Fibrin Matrix During Arthroscopic Rotator Cuff Surgery
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff focused on measuring Full Thickness Tendon Defect of Rotator Cuff

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital for Special Surgery

Outcomes

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

Full Information

First Posted
September 12, 2005
Last Updated
January 2, 2018
Sponsor
Hospital for Special Surgery, New York
Collaborators
Musculoskeletal Transplant Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00198185
Brief Title
Cascade PRFM Study: The Evaluation of Cascade Platelet-Rich Fibrin Matrix (PRFM) on Rotator Cuff Healing
Official Title
The Evaluation of Cascade PRFM on Rotator Cuff Healing
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Withdrawn
Study Start Date
January 2005 (undefined)
Primary Completion Date
January 2005 (undefined)
Study Completion Date
January 2005 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
Collaborators
Musculoskeletal Transplant Foundation

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff, Tendon Injuries
Keywords
Full Thickness Tendon Defect of Rotator Cuff

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Placement of Platelet Rich Fibrin Matrix During Arthroscopic Rotator Cuff Surgery
Primary Outcome Measure Information:
Title
L'Insalata: preoperatively, 6 weeks, 3 months post-operatively, 12 months post-operatively
Title
American Shoulder and Elbow Surgery (ASES) Patient Survey: preoperatively, 6 weeks, 3 months post-operatively, 12 months post-operatively
Secondary Outcome Measure Information:
Title
Ultrasound (power Doppler imaging): 6 weeks, 3 months post-operatively
Title
Manual muscle testing using a dynamometer: preoperatively, 3 months post-operatively, 6 months post-operatively
Title
ASES Physician Survey: preoperatively, 3 months post-operatively, 12 months post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell F. Warren, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11550856
Citation
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Citation
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PubMed Identifier
9486332
Citation
Tauro JC. Arthroscopic rotator cuff repair: analysis of technique and results at 2- and 3-year follow-up. Arthroscopy. 1998 Jan-Feb;14(1):45-51. doi: 10.1016/s0749-8063(98)70119-7.
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PubMed Identifier
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Citation
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PubMed Identifier
11830806
Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Citation
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Citation
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Results Reference
derived

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

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