UnknownNot Applicable

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

Switzerland84 participantsStarted 2015-06

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Informed Consent as documented by signature (Appendix Informed Consent Form), * Symptomatic interstitial tear of the supraspinatus tendon, Exclusion Criteria: * Tear of infraspinatus or subscapularis tendons (same shoulder) * Frozen shoulder (antepulsion deficit \> 20%) * Corticosteroid shoulder infiltration in the 3 months prior the inclusion, * 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,

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Lesion healing

Timeframe: 6 months

Trial details

NCT IDNCT02672085

SponsorLa Tour Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-10

Contact for this trial

Schwitzguébel Adrien, MD

adrien.schwitzgueel@latour.ch

View on ClinicalTrials.gov More Supraspinatis Interstitial Partial-thickness Tears trials