Effect of ACP on Surgical Repair of Rotator Cuff Tears
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Rotator Cuff Tears |
Device: Autologous conditioned plasma Device: Control group |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Effect of Autologous Plasma (ACP) on Surgical Repair of Rotator Cuff Tears |
- Oxford Shoulder Score [ Time Frame: 3mo (6mo/24mo) ] [ Designated as safety issue: No ]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.
- VAS Pain [ Time Frame: 10d po ] [ Designated as safety issue: No ]
- QuickDASH [ Time Frame: 3/6/24mo ] [ Designated as safety issue: No ]
- EQ-5D [ Time Frame: 3/6/24 mo ] [ Designated as safety issue: No ]
- ROM [ Time Frame: 3/6/24mo ] [ Designated as safety issue: No ]
- Measurement of the abduction strength [ Time Frame: 3/6/24 mo ] [ Designated as safety issue: No ]
- ASES Score [ Time Frame: 3/6/24mo ] [ Designated as safety issue: No ]
- Constant Murley Score [ Time Frame: 3/6/24 mo ] [ Designated as safety issue: No ]
- MRI/X-Ray/Ultrasonic Diagnostics [ Time Frame: 6/24 mo ] [ Designated as safety issue: No ]
- Measurement of the external rotation strenght [ Time Frame: 3/6/24 mo ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | January 2015 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ACP treated
The patients are going to get an injection of 4mL autologous conditioned plasma under the footprint following an arthroscopic repair of the rotator cuff.
|
Device: Autologous conditioned plasma
4mL autologous conditioned plasma application under the footprint following an arthroscopic repair of the rotator cuff.
Other Name: ACP Arthrex
|
|
Placebo Comparator: Control group
The patients are going to get an injection of 4mL saline solution under the footprint following an arthroscopic repair of the rotator cuff.
|
Device: Control group
4mL saline application under the footprint following an arthroscopic repair of the rotator cuff.
Other Name: ACP Arthrex
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01266226
| Switzerland | |
| Schulthess Klinik | |
| Zürich, Canton Zürich, Switzerland, 8008 | |
| Principal Investigator: | Matthias Flury, Dr | Upper Extremities Department |
More Information
No publications provided
| Responsible Party: | Matthias Flury, Principal Investigator, Schulthess Klinik |
| ClinicalTrials.gov Identifier: | NCT01266226 History of Changes |
| Other Study ID Numbers: | ACP01, KEK-ZH-Nr. 2010-0309/4 |
| Study First Received: | December 22, 2010 |
| Last Updated: | November 17, 2014 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by Schulthess Klinik:
|
Rotator cuff tears ACP |
ClinicalTrials.gov processed this record on March 01, 2015