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

This study has been completed.
Arthrex, Inc.
Information provided by (Responsible Party):
Matthias Flury, Schulthess Klinik Identifier:
First received: April 24, 2012
Last updated: April 21, 2016
Last verified: April 2016
The purpose of this study is to show that an augmentation with the DX Reinforcement Matrix from Arthrex is possible with the arthroscopic technique.

Condition Intervention
Rotator Cuff Tears
Device: Patch Augmentation and ACP injection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Arthroscopic Rotator Cuff Reconstruction With Xenologous Dermis-patch Augmentation and ACP® - Injection in Patients Over 60 Years (ACP = Autologous Conditioned Plasma)

Further study details as provided by Schulthess Klinik:

Primary Outcome Measures:
  • Oxford Shoulder Score (Questionnaire) [ Time Frame: 3mo ]
    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 Scoring Tool [ Time Frame: 10d ]
    Measuring of the pain with a VAS pain scale during 10 days post-operative

  • QuickDASH Questionnaire (Short version of Disability of the Arm, Shoulder and Hand Questionnaire) [ Time Frame: 3/6/24mo ]

    The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb.

    The QuickDASH is a shortened version of the DASH Outcome Measure. Instead of 30 items, the QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.

  • EQ-5D Questionnaire [ Time Frame: 3/6/24 mo ]
    EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal.Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys.

  • ROM (degrees) [ Time Frame: 3/6/24mo ]
    Range of motion refers to the distance and direction a joint can move.

  • Measurement of the abduction strength (Kilograms) [ Time Frame: 3/6/24 mo ]
  • ASES Score (American Shoulder And Elbow Surgeons Questionnaire) [ Time Frame: 3/6/24mo ]
    The ASES was developed to measure functional limitations and shoulder pain in people with musculoskeletal pathologies. Pain score was calculated from a single pain question on a visual analog scale (pain symptoms) and a function score from the sum of 10 questions addressing function using a 4-point ordinal scale (physical function). Pain and function are weighted equally and the total score ranges from 0 to 100 points, where 0 = worst and 100 = best.

  • Constant Murley Score (CMS) [ Time Frame: 3/6/24 mo ]
    The CMS is a 100-point scoring system that is divided into four subscales: pain (15 points), activities of daily living (20 points), range of motion (40 points) and strength (25 points).Pain and activities of daily living are self-reported by the patient using visual analog scales and ordinal categories. Range of motion is obtained during active painfree elevation in flexion and abduction (using a goniometer), and functional internal and external rotation of the shoulder (using ordinal scale). Strength testing was performed at 90° of abduction in the scapular plane.

  • MRI/X-Ray/Ultrasonic Diagnostics (Objective Evaluation (Descriptive) of the healing process) [ Time Frame: 6/24 mo ]
  • Measurement of the external rotation strength (Kilograms) [ Time Frame: 3/6/24 mo ]
  • Oxford Shoulder Score (Questionnaire) [ Time Frame: 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.

Enrollment: 20
Study Start Date: October 2012
Study Completion Date: March 2016
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patch and ACP Treatment
Patents who get an patch augmentation and ACP injection following an arthroscopic repair of the rotator cuff.
Device: Patch Augmentation and ACP injection
Patch augmentation and 4mL autologous conditioned plasma application under the footprint following an arthroscopic repair of the rotator cuff.
Other Names:
  • ACP
  • DX Reinforcement Matrix

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.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The potential patients will be recruited from the operation list due to the inclusion and exclusion 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01586351

Schulthess Klinik
Zürich, Canton Zürich, Switzerland
Sponsors and Collaborators
Schulthess Klinik
Arthrex, Inc.
Principal Investigator: Matthias Flury, Dr Upper Extremities Department
  More Information

Responsible Party: Matthias Flury, Principal Investigator (Department of Upper Extremity), Schulthess Klinik Identifier: NCT01586351     History of Changes
Other Study ID Numbers: ACP02
Study First Received: April 24, 2012
Last Updated: April 21, 2016

Keywords provided by Schulthess Klinik:
Rotator cuff tears
DX Reinforcement Matrix processed this record on May 23, 2017