A Prospective Comparison of Ultrasound-Guided Percutaneous Platelet-Rich Plasma Injection

Phase 2

Completed

• Conditions: Tendinosis; Tendinitis
• Interventions: Procedure: Tenotomy (no injection); Drug: Ultrasound guided platelet rich plasma injection

• Registration Number: NCT01600326
• Lead Sponsor: University of Michigan

Brief Summary

The purpose of this study is to determine the effectiveness of various treatment soft tendinosis also known as tendinitis.

Detailed Description

Currently there are three treatments that are considered standard of care; rest, tenotomy and tenotomy with injections of platelet-rich plasma (PRP). Tenotomy is performed by passing a needle through the abnormal tendon repeatedly until the needle has passed through all areas of the abnormal tendon with softening of the tendon. Tenotomy with PRP injections is performed in the same manner but includes an injection of platelet-rich plasma (PRP) into the tendon. This study will evaluate the effectiveness of tenotomy versus PRP treatment.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2012-05-01
• Study First Submitted QC: 2012-05-16
• Study First Posted: 2012-05-17
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2017-02
• Results First Submitted: 2017-02-20
• Results First Submitted QC: 2017-02-20
• Last Update Submitted: 2017-02-20
• Results First Posted: 2017-04-05
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Adult subjects with a diagnosis of tendinosis of the hip.
• Adult subjects who have been referred to Dr. Jacobson for the treatment of tendinosis by tenotomy.

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Exclusion Criteria

• pregnancy
• risk of bleeding due to anticoagulant medication
• presence of malignancy
• steroid injection less than 3 months before enrollment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tenotomy Group	Tenotomy (no injection)	Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.
Plasma Injection Group	Ultrasound guided platelet rich plasma injection	Treatment is Ultrasound guided platelet rich plasma injection.

Primary Outcome Measures

Name	Time	Method
Pain Level and Interference With Activity	Up to 23 days	Patient symptoms are measured on a 50 point scale where 0 is no pain or interference with activities and 50 is highest pain and interference.; A verbal evaluation and assessment of subject's pain and symptoms will be completed prior to treatment. After receiving medication a second evaluation will be taken to determine how well the medication has relieved and controlled the subject's pain and inflammation associated with tendinitis.; Subjects will be specifically asked to rate the level of pain and how the pain is affecting common activities of daily living. The outcomes will be assessed at 2 follow up periods, 1 and approximately 2 weeks after treatment (but no more than 23 days).

Secondary Outcome Measures

Name	Time	Method
Number of Participants Showing Symptomatic Improvement as Assessed in Patient Chart	15 to 555 days post treatment	Information from patient charts were retrospectively reviewed to determine if symptoms were reported as improved, worse, or no change over a time period (range 15 to 555 days post treatment).

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States