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

NCT02672085 | Unknown

• 1 other identifier: RCPT PRP
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Lesion healing

  After second PRP injection, tendon healing will be assessed by comparison of baseline MRI and control MRI

  6 months

Secondary Outcomes (14)

• Single Assessment Numeric Evaluation (SANE) score

  0,1,3, and 6 months, and last follow-up (12 months or more)

• Pain Scores on the Visual Analogue Scale

  0,1,3, 6 months, and last follow-up (12 months or more)

• Constant score

  0,1,3, and 6 months

• ASES score

  0,1,3, and 6 months

• Shoulder Pain Disability Index score

  0,1,3, and 6 months

Study Arms (2)

PRP infiltration

EXPERIMENTAL

Supraspinatus interstitial lesion needling and infiltration with PRP

Procedure: PRP infiltraiton

Needling

ACTIVE COMPARATOR

Supraspinatus interstitial lesion needling and infiltration with NaCl

Procedure: Needling

Interventions

PRP infiltraiton PROCEDURE

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.

PRP infiltration

Needling PROCEDURE

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

Needling

Eligibility Criteria

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

You may qualify if:

• Informed Consent as documented by signature (Appendix Informed Consent Form),
• Symptomatic interstitial tear of the supraspinatus tendon,

You may not qualify if:

• Tear of infraspinatus or subscapularis tendons (same shoulder)
• Frozen shoulder (antepulsion deficit \> 20%)
• Patients suffering from symptomatic anaemia, or patients with severe cardiorespiratory insufficiency,
• Known or suspected non-compliance, drug or alcohol abuse,
• Patients incapable of judgement or under tutelage,
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
• Previous enrolment into the current study,
• Enrolment of the investigator, his/her family members, employees and other dependent persons,

Sponsors & Collaborators

• La Tour Hospital: lead
• Rive Droite SA: collaborator

Study Sites (1)

La Tour Hospital

Meyrin, Canton of Geneva, 1217, Switzerland

RECRUITING

Related Publications (1)

• Schwitzguebel AJ, Kolo FC, Tirefort J, Kourhani A, Nowak A, Gremeaux V, Saffarini M, Ladermann A. Efficacy of Platelet-Rich Plasma for the Treatment of Interstitial Supraspinatus Tears: A Double-Blinded, Randomized Controlled Trial. Am J Sports Med. 2019 Jul;47(8):1885-1892. doi: 10.1177/0363546519851097. Epub 2019 Jun 4.

  PMID: 31161947 DERIVED

Central Study Contacts

Schwitzguébel Adrien, MD

CONTACT

adrien.schwitzgueel@latour.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 5, 2015
• First Posted: February 3, 2016
• Study Start: June 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 22, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)