Clinical trial NCT05855759: Acellular Matrix From Human Dermis in Combination With Orthobiologic Stimuli for Augmentation of Massive Rotator Cuff Tears
Official title: Acellular Matrix Homologous From Human Dermis in Combination With Orthobiologic Stimuli,Subacromial Bursa and Humeral Bone Marrow Concentrate, for Augmentation of Massiverotator Cuff Tears: Therapeutic Efficacy and Improvements for the Development of a Costeffective and Ready to Use Product
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Tears
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (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: 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

Primary outcomes:
measure: re-tear rate
timeFrame: 12 months after surgery
Secondary outcomes:
measure: cell yeld
timeFrame: baseline
measure: subacromial bursa
timeFrame: baseline
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
state: BO
Study officials:
References:
citation: Rotini R, Marinelli A, Guerra E, Bettelli G, Castagna A, Fini M, Bondioli E, Busacca M. Human dermal matrix scaffold augmentation for large and massive rotator cuff repairs: preliminary clinical and MRI results at 1-year follow-up. Musculoskelet Surg. 2011 Jul;95 Suppl 1:S13-23. doi: 10.1007/s12306-011-0141-8.
citation: Bondioli E, Fini M, Veronesi F, Giavaresi G, Tschon M, Cenacchi G, Cerasoli S, Giardino R, Melandri D. Development and evaluation of a decellularized membrane from human dermis. J Tissue Eng Regen Med. 2014 Apr;8(4):325-36. doi: 10.1002/term.1530. Epub 2012 Jun 11.