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Completed

NCT Number: NCT04851951

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

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.

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Key information

Conditions

Supraspinatus Tendinitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia

Bari, 70124, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Visual Analogic Scale

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

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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Other

Registry information

Official study title

Clinical Results Of Platelet Rich Plasma (PRP) One-Shot Injection For Supraspinatus Tendinosis, Our Experience At Short-Term Follow Up

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Apr 21, 2021
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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