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

Not Applicable

Recruiting

• Conditions: Rotator Cuff Tears
• Interventions: Other: Acellular Dermal Matrix with autologous orthobiologics; Other: Acellular Dermal Matrix

• Registration Number: NCT05855759
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-14
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-11
• Study Start: 2023-12-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-04
• Primary Completion: 2025-05-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acellular Dermal Matrix with autologous orthobiologics	Acellular Dermal Matrix with autologous orthobiologics	Enrolled patients will be randomly assigned to the suture-bridge technique with acellular dermal matrix with orthobiologics autologous: humeral bone marrow concentrate and subacromial bursa
Acellular Dermal Matrix	Acellular Dermal Matrix	Enrolled patients will be randomly assigned to the suture-bridge technique with acellular dermal matrix

Primary Outcome Measures

Name	Time	Method
re-tear rate	12 months after surgery	Presence/absence of re-tear on magnetic resonance imaging

Secondary Outcome Measures

Name	Time	Method
cell yeld	baseline	number of stromals cells contained in the humeral bone marrow concentrate
subacromial bursa	baseline	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

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, BO, Italy