Status:

RECRUITING

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

Lead Sponsor:

Istituto Ortopedico Rizzoli

Conditions:

Rotator Cuff Tears

Eligibility:

All Genders

18-65 years

Phase:

NA

Brief Summary

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 ...

Eligibility Criteria

Inclusion Criteria:

  • 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,
  • pre-operative Magnetic Resonance Imaging,
  • ability to read, understand and complete outcome scores

Exclusion Criteria:

  • patients affected by osteoarthritic degeneration,
  • frozen shoulder,
  • symptomatic acromioclavicular arthritis,
  • revision surgeries,
  • inability to cope with post-operative rehabilitation regimen,
  • autoimmune connective tissue disease,
  • current or past hematologicaldisorders,
  • comorbidities affecting healing,
  • active infections,
  • cancers,
  • pregnancy and lactation

Key Trial Info

Start Date :

December 18 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 30 2026

Estimated Enrollment :

72 Patients enrolled

Trial Details

Trial ID

NCT05855759

Start Date

December 18 2023

End Date

May 30 2026

Last Update

February 19 2026

Active Locations (1)

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1

Istituto Ortopedico Rizzoli

Bologna, BO, Italy, 40136