The Effect of Platelet Rich Plasma (PRP) Application on Rotator Cuff Tear.
Overview
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Movin score
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
PRP group
The experimental group includes patients to whom the PRP intervention will be applied.
Intervention: Platelet Rich Plasma (Biological)
Control group
The control group includes patients to whom a normal saline injection will be applied.
Intervention: Normal saline (Other)
Outcomes
Primary Outcomes
Movin score
Time Frame: 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 Outcomes
- Bonar score(Immediately after surgery.)
- Collagen I gene expression(Immediately after surgery.)
- Collagen II expression(Immediately after surgery.)
- Collagen III gene expression(Immediately after surgery.)
- Metalloproteinase 3 gene expression(Immediately after surgery.)
- Metalloproteinase 13 gene expression(Immediately after surgery.)
- Interleukin 1β gene expression(Immediately after surgery.)
- Interleukin 6 gene expression(Immediately after surgery.)