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

The Evaluation of Cascade PRFM on Rotator Cuff Healing

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00198185

Enrollment

Registered

2005-09-20

Start date

2005-01-31

Completion date

2005-01-31

Last updated

2018-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff, Tendon Injuries

Keywords

Full Thickness Tendon Defect of Rotator Cuff

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.

Interventions

PROCEDUREPlacement of Platelet Rich Fibrin Matrix During Arthroscopic Rotator Cuff Surgery

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026