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

Rotator Cuff Tears Clinical Trial

Official title:

Arthroscopic Rotator Cuff Reconstruction With Xenologous Dermis-patch Augmentation and ACP® - Injection in Patients Over 60 Years (ACP = Autologous Conditioned Plasma)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01586351
• Other study ID #: ACP02
• Status: Active, not recruiting
• Phase: N/A
• First received: April 24, 2012
• Last updated: December 18, 2015
• Start date: October 2012
• Est. completion date: January 2016

Study information

• Verified date: December 2015
• Source: Schulthess Klinik
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: January 2016
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Rotator Cuff Tears

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Schulthess Klinik	Zürich	Canton Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Schulthess Klinik	Arthrex, Inc.

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxford Shoulder Score (Questionnaire)	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.	3mo	No
Secondary	VAS Pain Scoring Tool	Measuring of the pain with a VAS pain scale during 10 days post-operative	10d	No
Secondary	QuickDASH Questionnaire (Short version of Disability of the Arm, Shoulder and Hand Questionnaire)	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.	3/6/24mo	No
Secondary	EQ-5D Questionnaire	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.	3/6/24 mo	No
Secondary	ROM (degrees)	Range of motion refers to the distance and direction a joint can move.	3/6/24mo	No
Secondary	Measurement of the abduction strength (Kilograms)		3/6/24 mo	No
Secondary	ASES Score (American Shoulder And Elbow Surgeons Questionnaire)	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.	3/6/24mo	No
Secondary	Constant Murley Score (CMS)	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.	3/6/24 mo	No
Secondary	MRI/X-Ray/Ultrasonic Diagnostics (Objective Evaluation (Descriptive) of the healing process)		6/24 mo	No
Secondary	Measurement of the external rotation strength (Kilograms)		3/6/24 mo	No
Secondary	Oxford Shoulder Score (Questionnaire)	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.	6mo/24mo	No