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Effect of ACP on Surgical Repair of Rotator Cuff Tears
This study has been completed.
Sponsor:
Schulthess Klinik
Collaborator:
Arthrex, Inc.
Information provided by (Responsible Party):
Matthias Flury, Schulthess Klinik
ClinicalTrials.gov Identifier:
NCT01266226
First received: December 22, 2010
Last updated: May 19, 2015
Last verified: May 2015
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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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
| Official Title: | Effect of Autologous Plasma (ACP) on Surgical Repair of Rotator Cuff Tears |
Resource links provided by NLM:
Further study details as provided by Matthias Flury, Schulthess Klinik:
Primary Outcome Measures:
- Oxford Shoulder Score [ Time Frame: 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 Outcome Measures:
- VAS Pain [ Time Frame: 10d po ]
- QuickDASH [ Time Frame: 3/6/24mo ]
- EQ-5D [ Time Frame: 3/6/24 mo ]
- ROM [ Time Frame: 3/6/24mo ]
- Measurement of the abduction strength [ Time Frame: 3/6/24 mo ]
- ASES Score [ Time Frame: 3/6/24mo ]
- Constant Murley Score [ Time Frame: 3/6/24 mo ]
- MRI/X-Ray/Ultrasonic Diagnostics [ Time Frame: 6/24 mo ]
- Measurement of the external rotation strenght [ Time Frame: 3/6/24 mo ]
| Enrollment: | 129 |
| Study Start Date: | December 2010 |
| Study Completion Date: | February 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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 Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01266226
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266226
Locations
| Switzerland | |
| Schulthess Klinik | |
| Zürich, Canton Zürich, Switzerland, 8008 | |
Sponsors and Collaborators
Schulthess Klinik
Arthrex, Inc.
Investigators
| Principal Investigator: | Matthias Flury, Dr | Upper Extremities Department |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 ( Other Identifier: Regional Ethics Committee of Zurich ) |
| Study First Received: | December 22, 2010 |
| Last Updated: | May 19, 2015 |
Keywords provided by Matthias Flury, Schulthess Klinik:
|
Rotator cuff tears ACP |
Additional relevant MeSH terms:
|
Polystyrene sulfonic acid Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 28, 2017