Health TrialsbyHealthPanel

Acellular Matrix From Human Dermis in Combination With Orthobiologic Stimuli for Augmentation of Massive Rotator Cuff Tears

ConditionRotator Cuff Tears
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIstituto Ortopedico Rizzoli

About this trial

The use of biologic acellular matrices for the surgical augmentation of rotator cuff lesions has greatly expanded inrecent years. The study team patented a method for removing cells from human dermis (Acellular Dermal Matrix), maintaining unaltered biological and structural integrity. Acellular Dermal Matrix has been succesfully used for rotator cuff surgical repair augmentation beside in a limited number of patients. The aim of the project is to demonstrate the therapeutical efficacy of this strategy in patients affected by rotator cuff massive tears. Acellular Dermal Matrix will be also combined with autologous orthobiologics.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients affected by large to massive lesion according to Gerber involving supraspinatus and infraspinatus tendons

tendon retraction <=3 according to Thomazeau

fatty degeneration <=3 according to Goutallier

possibility to obtain tendon reduction,

Disqualifiers

patients affected by osteoarthritic degeneration,

frozen shoulder,

symptomatic acromioclavicular arthritis,

revision surgeries,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acellular Dermal Matrix

    Other intervention

    Patinets will be treated with acellular dermal matrix with standard arthroscopic technique performed as per normal clinical practice. For the tendon repair the acellular dermal matrix patch will be placed over the repaired tendon with dedicated sutures and anchors.

  • Acellular Dermal Matrix with autologous orthobiologics

    Other intervention

    Patinets will be treated with acellular dermal matrix enriched with autologous humeral bone marrow concentrate and subacromial bursa with standard arthroscopic technique. Humeral bone marrow concentrate will be harvested from the proximal humeral head inthe operating room and concentrated by an automatic close system.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Acellular Dermal MatrixActive comparator 1 intervention
Group B: Acellular Dermal Matrix with autologous orthobiologicsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

re-tear rate

Presence/absence of re-tear on magnetic resonance imaging

Time frame
12 months after surgery

Secondary outcomes

1

cell yeld

number of stromals cells contained in the humeral bone marrow concentrate

Time frame
baseline
2

subacromial bursa

Half of the subacromial bursal tissue wll be assessed for determining the cell yield (number of stromal cells contained for mg of tissue) and half for histological processing

Time frame
baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istituto Ortopedico Rizzoli

Lead sponsor

Source ClinicalTrials.gov
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