Platelet-rich Plasma (PRP) Clinical Trial
— PRP RandomizedOfficial title:
In Vivo Clinical and Radiological Effects of Platelet-rich Plasma on Interstitial Supraspinatus Lesion: Randomized Study
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
Status | Recruiting |
Enrollment | 84 |
Est. completion date | December 2017 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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, |
Country | Name | City | State |
---|---|---|---|
Switzerland | La Tour Hospital | Meyrin | Geneva |
Lead Sponsor | Collaborator |
---|---|
La Tour Hospital | Rive Droite SA |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lesion healing | After second PRP injection, tendon healing will be assessed by comparison of baseline MRI and control MRI | 6 months | |
Secondary | Single Assessment Numeric Evaluation (SANE) score | Changes from baseline will be compared between cases receiving two PRP injections and controls receiving tendon needling, 0,1,3, and 6 months after second injection. | 0,1,3, and 6 months, and last follow-up (12 months or more) | |
Secondary | Pain Scores on the Visual Analogue Scale | Changes from baseline will be compared between cases receiving two PRP injections and controls receiving tendon needling, 0,1,3, and 6 months after second injection. | 0,1,3, 6 months, and last follow-up (12 months or more) | |
Secondary | Constant score | Changes from baseline will be compared between cases receiving two PRP injections and controls receiving tendon needling, 0,1,3, and 6 months after second injection. | 0,1,3, and 6 months | |
Secondary | ASES score | Changes from baseline will be compared between cases receiving two PRP injections and controls receiving tendon needling, 0,1,3, and 6 months after second injection. | 0,1,3, and 6 months | |
Secondary | Shoulder Pain Disability Index score | Changes from baseline will be compared between cases receiving two PRP injections and controls receiving tendon needling, 0,1,3, and 6 months after second injection. | 0,1,3, and 6 months | |
Secondary | Correlation between the initial tear size and the percentage of tear size evolution | The tear size change will be evaluated between the 2 MRI, at the baseline and at the 6 months endpoints. This correlation will be separately evaluated in each study arm, and in the whole sample. | 6 months | |
Secondary | Lesion healing between interstitial lesions that englobes or not the bone-tendon interface | Tendon healing will be assessed by comparison of baseline MRI and control MRI | 6 months | |
Secondary | Time limit in months from the first intervention to the last follow-up | Will be measurerd in months | 12-36 months | |
Secondary | Treatements at the end of the 6 months of PRP/Saline follow-up: Occurence of surgery | The occurence of surgery will be reported in both groups: cases receiving two PRP injections and controls | between 6 months and the last follow-up | |
Secondary | Treatements at the end of the 6 months of PRP/Saline follow-up: Occurence of corticoid infiltrations | The number of infiltrations of the subacromial with corticosteroids bursa will be reported in both groups: cases receiving two PRP injections and controls | between 6 months and the last follow-up | |
Secondary | Treatements at the end of the 6 months of PRP/Saline follow-up: Occurence of other infiltrations | The nature number of infiltrations of the subacromial bursa with others substances (i.e. PRP, sclerosing agents, autologous blood, hyaluronic acid, ...) will be reported in both groups: cases receiving two PRP injections and controls | between 6 months and the last follow-up | |
Secondary | Histological changes of tendon samples in case of surgery: tendon cellularity | Cells count will be compared between cases receiving two PRP injections and controls | between 6 months and the last follow-up | |
Secondary | Histological changes of tendon samples in case of surgery: vascularity | Vascularity (CD34+ blood vessels count) will be compared between cases receiving two PRP injections and controls | between 6 months and the last follow-up | |
Secondary | Histological changes of tendon samples in case of surgery: apoptosis | Apoptosis (p53+ cells count) will be compared between cases receiving two PRP injections and controls | between 6 months and the last follow-up |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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