CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
platelet rich plasma injection +1 morebiological
Likely dose
platelet rich plasma injection 45 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT01123889
NCT01123889N/ACompleted

Treatment of Rotator Cuff Syndrome With Injection of Autologous Platelet Rich Plasma

Loma Linda University·interventional·Posted May 14, 2010·Updated Feb 11, 2014

In Brief

A clinical study evaluating platelet rich plasma injection and corticosteroid injection for Subacromial Impingement Syndrome and Partial Thickness Rotator Cuff Tear. Completed, enrolled 12 participants across 1 site.

Detailed Summary

The purpose of this investigator initiated study is to clinically evaluate the efficacy of a new treatment for subacromial impingement syndrome and partial thickness rotator cuff tears. This treatment consists of a platelet rich plasma injection into and around the rotator cuff. It is thought that this treatment will dramatically improve outcomes for patients suffering from these two conditions. Subjects will be randomized by choosing a slip of paper from an envelope. This process will randomize 25 patients to the experimental group, and 25 patients to the control. The experimental group will undergo a blood draw, allowing for an injection of platelet rich plasma around the rotator cuff. The control group will undergo a corticosteroid injection into the subacromial space surrounding the rotator cuff as sole treatment. Patients will be followed for three months for pain, and will fill out questionnaires at six weeks and three months post injection, which will give insight into functionality and pain changes that the rotator cuff is experiencing due to treatment. Subjects will be outpatients. Subjects may include employees, students, minorities, and elderly, although no subsets of these will be formed. Subjects will be between 18 and 89 years of age. In total, subject participation will last approximately 3 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 14, 2010
Enrollment StartMay 1, 2010
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 16.1 years ago

Interventions

platelet rich plasma injectionbiological

45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions.

corticosteroid injectiondrug

Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions.