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

NCT01600326 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: HUM00039445
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tendinosis; Tendinitis

Outcome Measures

Primary Outcomes (1)

• Pain Level and Interference With Activity

  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).

  Up to 23 days

Secondary Outcomes (1)

• Number of Participants Showing Symptomatic Improvement as Assessed in Patient Chart

  15 to 555 days post treatment

Study Arms (2)

Tenotomy Group

ACTIVE COMPARATOR

Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.

Procedure: Tenotomy (no injection)

Plasma Injection Group

ACTIVE COMPARATOR

Treatment is Ultrasound guided platelet rich plasma injection.

Drug: Ultrasound guided platelet rich plasma injection

Interventions

Tenotomy (no injection) PROCEDURE

Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy.

Tenotomy Group

Ultrasound guided platelet rich plasma injection DRUG

Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm. The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called "Ultrasound guided platelet rich plasma injection." Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study. Subjects will see their referring physician two weeks after treatment to begin physical therapy.

Plasma Injection Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Tendinopathy

Interventions

Tenotomy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative

Limitations and Caveats

Two limitations include the small sample size and the retrospective nature of the long term secondary patient outcome.

Results Point of Contact

• Title: Jon Jacobson
• Organization: University of Michigan

jjacobsn@umich.edu

734 936-4365

Study Officials

• Jon Jacobson, MD

  University of Michigan Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 1, 2012
• First Posted: May 17, 2012
• Study Start: July 1, 2010
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: April 5, 2017
• Results First Posted: April 5, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)