PRP, Supraspinatus Injury, Tendon Injuries
Conditions
Keywords
Supraspinatus tendon, Biology, Collagen, Metalloproteinase, Tenocyte, PRP, Platelet Rich Plasma, Gene expression, Shoulder injection
Brief summary
The aim of this randomized control trial is to evaluate the impact and effectiveness of PRP on tenocyte metabolism and tendon tissue properties in rotator cuff tear.
Detailed description
The refractory to conservative treatment rotator cuff tears are mainly treated with arthroscopic repair. Intraoperative or postoperative platelet rich plasma (PRP) injections have been widely used to enhance the tendon healing and the repair process. Additionally, subacromial PRP injections are related to favorable outcomes in case of partial rotator cuff tears even one month after their application. Laboratory and clinical trials have correlated PRP with an increase in tenocyte metabolic activity, based on the up- or downregulation of specific gene expression. Patients with rotator cuff tear who will be treated surgically will be included in the current study. After obtaining a signed consent form to participate in this trial, the patients will be randomly divided in two groups; the experimental group, where the PRP intervention will be applied, and the control group, where the patients will receive a placebo injection. The included patients will undergo an ultrasound-assisted PRP or saline subacromial injection, four to six weeks prior to the scheduled surgery. During the arthroscopic rotator cuff repair procedure, a tendon biopsy will be performed and the sample will be sent for further analysis. The samples will be sent for histologic analysis and quantification of specific gene expression. The gene analysis will contain the collagen I, collagen III, metalloproteinase 3 and metalloproteinase 13 genes, which are related to tendon repair and remodeling in cases of rupture and/or injury. Furthermore, the two groups will be compared in terms of the MRI imaging findings. After statistical analysis, a conclusion regarding the effect of PRP on the enhancement of biological properties of the ruptured tendon and, consecutively, tendon healing process will be extracted.
Interventions
BIOLOGICALPlatelet Rich Plasma
The injection of PRP in the subacromial space.
OTHERNormal saline
The injection of normal saline in the subacromial space.
Sponsors
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Patients with rotator cuff tear who will be treated surgically will be included in the current study. After obtaining a signed consent form to participate in this trial, the patients will be randomly divided in two groups; the experimental group, where the PRP intervention will be applied, and the control group, where the patients will receive a placebo injection.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Full thickness rotator cuff tear treated with arthroscopic repair * Age of 18 to 65 years * Chronic shoulder pain due to rotator cuff tear * Magnetic resonance imaging study within 6 months prior to arthroscopy * Goutallier grade 1 or 2 muscle fatty infiltration
Exclusion criteria
* Comorbidities, including coagulopathy, liver disease, cancer, nutritional disorder * Goutallier grade 3 or 4 muscle fatty infiltration * Shoulder osteoarthritis, rotator cuff arthropathy, rheumatoid arthritis * History oof shoulder injection within the last 12 months * History of prior shoulder surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Movin score | Immediately after surgery. | The Movin score qualifies the characteristics of tendon structure, including : fiber arrangement, fiber structure, rounding of the nuclei, inflammation, angiogenesis and cell density. The scores of the experimental and control groups will be compared. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bonar score | Immediately after surgery. | The Bonar score qualifies the characteristics of tendon structure, including : tenocytes, collagen, ground substance and vascularity. The scores of the experimental and control groups will be compared. |
| Collagen I gene expression | Immediately after surgery. | Collagen I gene expression will be measured using real-time PCR. The scores of the experimental and control groups will be compared. |
| Collagen II expression | Immediately after surgery. | Collagen II expression will be measured using real-time PCR. The scores of the experimental and control groups will be compared. |
| Collagen III gene expression | Immediately after surgery. | Collagen IIII expression will be measured using real-time PCR. The scores of the experimental and control groups will be compared. |
| Metalloproteinase 3 gene expression | Immediately after surgery. | Metalloproteinase 3 gene expression will be measured using real-time PCR. The scores of the experimental and control groups will be compared. |
| Metalloproteinase 13 gene expression | Immediately after surgery. | Metalloproteinase 13 gene expression will be measured using real-time PCR. The scores of the experimental and control groups will be compared. |
| Interleukin 1β gene expression | Immediately after surgery. | Interleukin 1β gene expression will be measured using real-time PCR. The scores of the experimental and control groups will be compared. |
| Interleukin 6 gene expression | Immediately after surgery. | Interleukin 6 gene expression will be measured using real-time PCR. The scores of the experimental and control groups will be compared. |
Countries
Greece
Contacts
PRINCIPAL_INVESTIGATORCharalampos Pitsilos, MSc
Aristotle University Of Thessaloniki
STUDY_CHAIRPericles Papadopoulos, PhD
Aristotle University Of Thessaloniki
STUDY_DIRECTORIoannis Gigis, PhD
Aristotle University Of Thessaloniki
STUDY_DIRECTORByron Chalidis, PhD
Aristotle University Of Thessaloniki
Outcome results
None listed