Clinical trial NCT01586351: Rotator Cuff Reconstruction With Xenologous Dermis-patch Augmentation and ACP® - Injection
Official title: Arthroscopic Rotator Cuff Reconstruction With Xenologous Dermis-patch Augmentation and ACP® - Injection in Patients Over 60 Years (ACP = Autologous Conditioned Plasma)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tears
Keywords: Rotator cuff tears
ACP
DX Reinforcement Matrix
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
Collaborators: name: Arthrex, Inc.
First posted: 2012-04-26
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The potential patients will be recruited from the operation list due to the inclusion and exclusion criteria.

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.

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

Primary outcomes:
measure: Oxford Shoulder Score (Questionnaire)
timeFrame: 3mo
Secondary outcomes:
measure: VAS Pain Scoring Tool
timeFrame: 10d
measure: QuickDASH Questionnaire (Short version of Disability of the Arm, Shoulder and Hand Questionnaire)
timeFrame: 3/6/24mo
measure: EQ-5D Questionnaire
timeFrame: 3/6/24 mo
measure: ROM (degrees)
timeFrame: 3/6/24mo
measure: Measurement of the abduction strength (Kilograms)
timeFrame: 3/6/24 mo
measure: ASES Score (American Shoulder And Elbow Surgeons Questionnaire)
timeFrame: 3/6/24mo
measure: Constant Murley Score (CMS)
timeFrame: 3/6/24 mo
measure: MRI/X-Ray/Ultrasonic Diagnostics (Objective Evaluation (Descriptive) of the healing process)
timeFrame: 6/24 mo
measure: Measurement of the external rotation strength (Kilograms)
timeFrame: 3/6/24 mo
measure: Oxford Shoulder Score (Questionnaire)
timeFrame: 6mo/24mo
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Schulthess Klinik
state: Canton Zürich
Study officials:
affiliation: Upper Extremities Department
name: Matthias Flury, Dr
role: PRINCIPAL_INVESTIGATOR
References: