Platelet Rich Plasma (PRP) One-Shot Injection For Supraspinatus Tendinosis

NCT04851951 | Completed

• 1 other identifier: PRP-shoulder
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

It was conducted a prospective study with a series of 50 patients treated with PRP one-shot injection in patient affected by Supraspinatus Tendinosis. One independent observer performed clinical and functional evaluations at T0 (recruitment), T1 (one month after the injection), T2 (three months after the last injection) and T3 (six months after the last injection). Constant Score, The Disabilites of the Arm,Shoulder and Hand Score (DASH) And Visual Analogue Scale (VAS) were administered at each evaluation.

Conditions

Supraspinatus Tendinitis

Keywords

Supraspinatus tendinosis; PRP; Shoulder;

Outcome Measures

Primary Outcomes (1)

• Change in Visual Analogic Scale

  The shoulder pain was quantified using the Visual Analogic Scale ranging from 0 (no pain) to 10 (worst imaginable pain).

  Day 0; Month 1; Month 3; Month 6 (after the injection)

Study Arms (1)

patients treated by one-shot PRP injection

Procedure: one-shot PRP injection

Interventions

one-shot PRP injection PROCEDURE

A single injection of PRP (7% concentrate) ml 4 was made in the Supraspinatus tendon and in the Subacromial space under ultrasound guidance.

patients treated by one-shot PRP injection

Eligibility Criteria

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

Study Population

Fifty (50) patients referring to the Orthopaedic and Trauma Unit of the local University Hospital between January 2018 and July 2020 with Supraspinatus tendinosis were prospectively recruited.

You may qualify if:

• Age \> 18 years old;
• Supraspinatus tendinosis detected by MRI.

You may not qualify if:

• Supraspinatus rupture;
• Previous shoulder surgery;
• Rotator cuff tears secondary to fracture;
• Hemoglobin \<7 g/dL or Platelets \< 30,000 microL;
• Active infection;
• Pregnant patients;
• Patients with hematologic and oncologic diseases.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: lead

Study Sites (1)

AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia

Bari, 70124, Italy

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: April 21, 2021
• Study Start: January 1, 2018
• Primary Completion: July 1, 2020
• Study Completion: April 1, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

IT (1)