Rotator Cuff TearsMODANCT05855759
Acellular Matrix From Human Dermis in Combination With Orthobiologic Stimuli for Augmentation of Massive Rotator Cuff Tears
A study testing Acellular Dermal Matrix and Acellular Dermal Matrix with autologous orthobiologics in people with Rotator Cuff Tears, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Acellular Dermal Matrix and Acellular Dermal Matrix with autologous orthobiologics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- 18 Dec 2023to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients affected by osteoarthritic degeneration,
- frozen shoulder,
- symptomatic acromioclavicular arthritis,
- revision surgeries,
- inability to cope with post-operative rehabilitation regimen,
- autoimmune connective tissue disease,
Show all 11Show fewer
- current or past hematologicaldisorders,
- comorbidities affecting healing,
- active infections,
- cancers,
- pregnancy and lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Ortopedico Rizzoli
Bologna, BO, 40136
About this study
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
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.
- Conditions
- Rotator Cuff Tears
- Being tested
- Acellular Dermal Matrix, Acellular Dermal Matrix with autologous orthobiologics
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular Dermal MatrixOther
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 orthobiologicsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Acellular Dermal Matrix | Active comparator | Enrolled patients will be randomly assigned to the suture-bridge technique with acellular dermal matrix Receives: Other: Acellular Dermal Matrix |
| Acellular Dermal Matrix with autologous orthobiologics | Experimental | 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 Receives: Other: Acellular Dermal Matrix with autologous orthobiologics |
What is being measured
The primary outcome is the main question the study is designed to answer.
re-tear rate
Presence/absence of re-tear on magnetic resonance imaging
Measured: 12 months after surgery
Secondary outcomes (2)
cell yeld
number of stromals cells contained in the humeral bone marrow concentrate
Measured: baseline
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start18 Dec 2023
- Primary completion30 Jul 2025
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855759
- Sponsor's protocol ID
- MODA
- Acronym
- MODA
- Status last verified
- Feb 2026
- First submitted
- 14 Apr 2023
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21691735Bondioli 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.
PubMed 22689414Cavallo M, Solaro L, Tortorella F, Brunello V, Melandri D, Pagani S, Martini L, Guerra E, Tschon M. Acellular dermal matrix alone or in combination with subacromial bursa and humeral bone marrow concentrate for augmentation of massive rotator cuff tear repair: a double-blind randomized controlled trial protocol (MODA). Front Med (Lausanne). 2026 Mar 6;13:1724038. doi: 10.3389/fmed.2026.1724038. eCollection 2026.
PubMed 41868235
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05855759
- Acronym / sponsor ID
- MODA / MODA
- Conditions
- Rotator Cuff Tears
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acellular Dermal Matrix | Active comparator | Other: Acellular Dermal MatrixEnrolled patients will be randomly assigned to the suture-bridge technique with acellular dermal matrix |
| Acellular Dermal Matrix with autologous orthobiologics | Experimental | Other: Acellular Dermal Matrix with autologous orthobiologicsEnrolled patients will be randomly assigned to the suture-bridge technique with acellular dermal matrix with orthobiologics autologous: humeral bone marrow concentrate and subacromial bursa |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (11 listed)
- patients affected by osteoarthritic degeneration,
- frozen shoulder,
- symptomatic acromioclavicular arthritis,
- revision surgeries,
- inability to cope with post-operative rehabilitation regimen,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acellular Dermal MatrixPatinets 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. | Other | Acellular Dermal Matrix |
| Acellular Dermal Matrix with autologous orthobiologicsPatinets 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. | Other | Acellular Dermal Matrix with autologous orthobiologics |
Primary outcome
re-tear rate
Time frame: 12 months after surgery
Presence/absence of re-tear on magnetic resonance imaging
2 secondary outcomes
cell yeld
Time frame: baseline
subacromial bursa
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Results publication: PubMed 21691735Rotini 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.
- Results publication: PubMed 22689414Bondioli 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.
- Derived from this study: PubMed 41868235Cavallo M, Solaro L, Tortorella F, Brunello V, Melandri D, Pagani S, Martini L, Guerra E, Tschon M. Acellular dermal matrix alone or in combination with subacromial bursa and humeral bone marrow concentrate for augmentation of massive rotator cuff tear repair: a double-blind randomized controlled trial protocol (MODA). Front Med (Lausanne). 2026 Mar 6;13:1724038. doi: 10.3389/fmed.2026.1724038. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acellular Dermal Matrix and Acellular Dermal Matrix with autologous orthobiologics in people with Rotator Cuff Tears, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Cavallo, MD (0039.051.63.66 ext. 927, marco.cavallo@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
re-tear rate (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05855759, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.