In Vivo Clinical and Radiological Effects of Platelet-rich Plasma on Interstitial Supraspinatus Lesion: Randomized Study

Summary

Background and Rationale:

Tedious PRP infiltrations are emerging treatments for tendinopathies and tendon tears. It has been showed effective in different parts of the body, but current evidences for rotator cuff PRP infiltration remains poor. Some studies that tested infiltrations on transfixing lesions showed no statistically significant effect of PRP on tendon healing. The investigators believe that this might be explained by a "flushing effect" of PRP into subacromial space or glenohumeral joint. Therefore, it was decided to focus this study on interstitial lesions, in which PRP is entrapped into the lesion for a long time.

Objective:

The purpose of this study is to evaluate whether intra-tear PRP infiltrations promotes tear repair better than needling procedures of torn tendon in participants with supraspinatus interstitial tears.

As secondary objective, we will study symptoms alleviation in same way. Primary outcome: Primary outcome: Supraspinatus tear size change from baseline will be compared between cases receiving two PRP injections and controls receiving torn tendon needling, 6 months after second injection.

Secondary outcomes: Single Assessment Numeric Evaluation score, Constant score, ASES score, Shoulder pain disability index, and Visual analogue scale changes from baseline will be compared between cases receiving two PRP injections and controls receiving torn tendon needling, 0,1,3, and 6 months after second injection.

Study design: This case-control study is randomized 1:1 between PRP (intervention group) and needling (Control group). It is a superiority trial that will include 84 patients suffering from interstitial supraspinatus tears. As adjuvant therapy, patients from each arm will beneficiate from standard physical therapy program. PRP and needling will be repeated 2 times, at one month interval. First injection will occur up to two months after recruitment. Clinical follow-up will occur from second injection to one year after second injection, with clinical parameters evaluation at 0,1,3, and 6 months after second injection, and control MRI 6 months after second injection.

Study Product / Intervention: Supraspinatus tendon needling with intralesional PRP injection. PRP will be extracted with Regenlab® extraction kit. No other medications used.

Control Intervention (if applicable): Supraspinatus tendon needling with intralesional saline water injection.

Number of Participants with Rationale: 84 patients will be needed (37 in each group). A 10% of dropout has been taken in consideration.

Study Duration: 24 months from recruitment of the first patient to the last follow-up visit. Scientific report will be written within the two months following recruitment of the last patient.

Study Schedule: First-Participant-In: 01.6.2015 Last-Participant-Out: 30.6.2017

Conditions

• Supraspinatis Interstitial Partial-thickness Tears
• Platelet-rich Plasma (PRP)

Interventions

PROCEDURE

PRP infiltraiton

Two time with 1 month interval, PRP will be extracted from own blood's patients with Regenlab® extraction kit, and injected into supraspinatus interstitial lesion.

PROCEDURE

Needling

Two time with 1 month interval, saline water will be injected into supraspinatus interstitial lesion.

Sponsors & Collaborators

• Rive Droite SA

  collaborator UNKNOWN

• La Tour Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-30

Primary Completion

2017-10-31

Completion

2017-12-31

Countries

• Switzerland

Study Locations