Rotator Cuff Reconstruction With Xenologous Dermis-patch Augmentation and ACP® - Injection

NCT ID: NCT01586351

Last Updated: 2016-04-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2016-03-31

Brief Summary

The purpose of this study is to show that an augmentation with the DX Reinforcement Matrix from Arthrex is possible with the arthroscopic technique.

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.

The patients in this study have 60 years or more. The tissue of these patients isn't as good as in young patients. The patch will be used to improve the strength of the tendon at the insertion site and the ingrowth process of the new tissue at this area. Additionally the investigators can boost the healing process with a selective use of PRP (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.

Conditions

Rotator Cuff Tears

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patch and ACP Treatment

Patents who get an patch augmentation and ACP injection following an arthroscopic repair of the rotator cuff.

Patch Augmentation and ACP injection

Intervention Type: DEVICE

Patch augmentation and 4mL autologous conditioned plasma application under the footprint following an arthroscopic repair of the rotator cuff.

Interventions

Patch Augmentation and ACP injection

Patch augmentation and 4mL autologous conditioned plasma application under the footprint following an arthroscopic repair of the rotator cuff.

Intervention Type: DEVICE

Other Intervention Names

ACP; DX Reinforcement Matrix

Eligibility Criteria

Inclusion Criteria

• Arthroscopic rotator cuff reconstructions of degenerative or traumatic full thickness rotatorcuff tears (supraspinatus should be affected)performed by Dr. Flury
• Age: 60 years or more
• Suture bridge technique
• Women: No longer of childbearing age (at menopause and last menstrual period more than 12 months, prevented surgically Ovaries and/or uterus removed surgically)
• 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arthrex, Inc.

INDUSTRY

Sponsor Role: collaborator

Schulthess Klinik

OTHER

Sponsor Role: lead

Responsible Party

Matthias Flury

Principal Investigator (Department of Upper Extremity)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthias Flury, Dr

Role: PRINCIPAL_INVESTIGATOR

Upper Extremities Department

Locations

Schulthess Klinik

Zurich, Canton Zürich, Switzerland

Countries

Switzerland

Other Identifiers

ACP02

Identifier Type: -

Identifier Source: org_study_id