Rotator Cuff Tears
Conditions
Keywords
Rotator cuff tears, ACP
Brief summary
The purpose of this study is to determine if autologous plasma (ACP) is beneficial for better and faster healing following an arthroscopic repair of the rotator cuff.
Detailed description
The shoulder joint, specially the rotator cuff, is one of the most complicated joints of the human body. If the tendon has to be fixed at the bone during surgery, the weak point in obtaining a successful surgery is the fixation of the tendon at the bone insertion site. Tendon belongs to the bradytrophic tissue conditional on the reduced blood flow, deep mitosis rate and lowered healing potential. We can boost the healing process with a selective use of PRP (platelet rich plasma). In this process, the healing site is delivered with an elevated concentration of thrombocytes and also growth factors which are constituent parts of them. In this study, we will test the Arthrex® Double Syringe System. With this system it is possible to obtain ACP (Autologous conditioned plasma) in one centrifugation step. The supernatant contains a concentration of thrombocytes which is twice as high as in the native blood. The concentration of the growth factors is 5-25x higher according to this. We also want to test if one application of ACP is enough to get a short- and long-term benefit in healing following a rotator cuff tear.
Interventions
4mL autologous conditioned plasma application under the footprint following an arthroscopic repair of the rotator cuff.
DEVICEControl group
4mL saline application under the footprint following an arthroscopic repair of the rotator cuff.
Sponsors
Arthrex, Inc.
Schulthess Klinik
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Arthroscopic rotator cuff reconstructions of degenerative or traumatic full thickness rotator cuff tears (supraspinatus and/or infraspinatus tendon) performed by Dr. Flury and Dr. Schwyzer * Suture bridge technique * No pregnancy at the date of the surgery for women of childbearing potential * Signed consent form
Exclusion criteria
* Partial reconstruction of the rotator cuff (PASTA) * Open reconstruction * Tendon transfer (latissimus dorsi or pectoralis major) * Revision surgery * Omarthrosis (Level ≥ 2 Samilson & Prieto) * Systemic arthritis * Rheumatoid arthritis * Diabetes (insulin treated) * Requiring surgery in reconstruction of the subscapularis tendon * Progressive fat inclusion (fatty infiltration of the rotator cuff musculature Goutallier level IV * Acute or chronic infection * Pathological bone metabolism * Insufficient perfusion in the affected arm * Neuromuscular disease in the affected arm * Non compliance of the patient * Disorders which handicap or inhibit the patient to follow the orders of the clinical testers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Shoulder Score | 3mo (6mo/24mo) | The Oxford Shoulder Score used after 3 months is the primary parameter. The Score tests the ability to participate in the patients' normal life before they got injured. |
Secondary
| Measure | Time frame |
|---|---|
| QuickDASH | 3/6/24mo |
| EQ-5D | 3/6/24 mo |
| ROM | 3/6/24mo |
| Measurement of the abduction strength | 3/6/24 mo |
| VAS Pain | 10d po |
| Constant Murley Score | 3/6/24 mo |
| MRI/X-Ray/Ultrasonic Diagnostics | 6/24 mo |
| Measurement of the external rotation strenght | 3/6/24 mo |
| ASES Score | 3/6/24mo |
Countries
Switzerland
Outcome results
None listed