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Completed

NCT Number: NCT01586351

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

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

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Key information

Conditions

Rotator Cuff Tears Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Schulthess Klinik

Zurich, Canton Zürich, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patch Augmentation and ACP injection

Device

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

Primary outcomes

  1. 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 outcomes

  1. VAS Pain Scoring Tool

    Time frame: 10d

    Measuring of the pain with a VAS pain scale during 10 days post-operative

  2. 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.

  3. 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.

  4. ROM (degrees)

    Time frame: 3/6/24mo

    Range of motion refers to the distance and direction a joint can move.

  5. Measurement of the abduction strength (Kilograms)

    Time frame: 3/6/24 mo

  6. 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.

  7. 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.

  8. MRI/X-Ray/Ultrasonic Diagnostics (Objective Evaluation (Descriptive) of the healing process)

    Time frame: 6/24 mo

  9. Measurement of the external rotation strength (Kilograms)

    Time frame: 3/6/24 mo

  10. 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.

Sponsors and collaborators

Lead sponsor

Schulthess Klinik

Other

Collaborators

  • Arthrex, Inc.

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Apr 26, 2012
Registry last updated
Apr 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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