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

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

Treatments tested in this trial

  • Acellular Dermal Matrix
  • Acellular Dermal Matrix with autologous orthobiologics

Treatment groups

72 Participants
are divided into 2 treatment groups

Sponsors and collaborators