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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Arthrex, Inc.
Information provided by (Responsible Party):
Matthias Flury, Schulthess Klinik
ClinicalTrials.gov Identifier:
NCT01586351
First received: April 24, 2012
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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)

Resource links provided by NLM:


Further study details as provided by Schulthess Klinik:

Primary Outcome Measures:
  • Oxford Shoulder Score (Questionnaire) [ Time Frame: 3mo ] [ 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.


Secondary Outcome Measures:
  • VAS Pain Scoring Tool [ Time Frame: 10d ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • ASES Score (American Shoulder And Elbow Surgeons Questionnaire) [ Time Frame: 3/6/24mo ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Measurement of the external rotation strength (Kilograms) [ Time Frame: 3/6/24 mo ] [ Designated as safety issue: No ]
  • Oxford Shoulder Score (Questionnaire) [ Time Frame: 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.


Enrollment: 20
Study Start Date: October 2012
Estimated Study Completion Date: November 2015
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01586351

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

No publications provided

Responsible Party: Matthias Flury, Principal Investigator (Department of Upper Extremity), Schulthess Klinik
ClinicalTrials.gov Identifier: NCT01586351     History of Changes
Other Study ID Numbers: ACP02
Study First Received: April 24, 2012
Last Updated: August 8, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by Schulthess Klinik:
Rotator cuff tears
ACP
DX Reinforcement Matrix

ClinicalTrials.gov processed this record on October 21, 2014