Arthroscopic Rotator Cuff RepairNCT06960343
Long Term Clinical Outcome After Arthroscopic Rotator Cuff Repair Augmentation With Autologous Microfragmented Lipoaspirate Tissue
An observational study of Arthroscopic Rotator Cuff Repair and Augmentation, run by University of Milan at 1 site in Italy.
Trial summary
Specific Aims : The aim of this prospective randomized controlled single-blind clinical trial was to evaluate the safety and efficacy of autologous microfragmented lipoaspirate tissue in arthroscopic rotator cuff repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroscopic Rotator Cuff Repair, Augmentation, Microfragmented Adipose Tissue
- What is being tested?
- magnetic resonance imaging (MRI) and VAS, SST, ASES, CMS scores, and strength measurements in external rotation and abduction
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 11 Apr 2025to 11 Oct 2026
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: This study is a prospective, randomized, double-blind, controlled clinical trial and represents the final follow-up of an our previous study with short follow-up (2 years). At least 5 years after surgery, all enrolled patients in the previous study will be call again and will be asked to complete the ASES, SST, and VAS questionnaire and they will undergo a clinical examination, including the CMS and measurement of isometric strength in shoulder forward flexion, abduction, and external rotation. All strength measures will be performed in triplicate with a dynamometer. During the same assessment day, the patients would be evaluated with MRI of the operated shoulder in order to assess tendon integrity and calculate rerupture rate according to the classification proposed by Sugaya (types IV and V defined as retears). Atrophy of the supraspinatus muscle belly was evaluated according to Warner and fatty degeneration was classified according to Fuchs.
Who may be able to join
- Age > 18 years
- Full-thickness supraspinatus and infraspinatus tendon tears (C1, C2, and C3 according to the SCOI classification)
- Indication for arthroscopic rotator cuff repair
- Informed consent to participate in the study
- Informed consent to participate for the duration of the study
Who cannot join
- Partial rotator cuff tendon tears (A1, A2, A3, B1, B2, and B3 according to the SCOI classification)
- Massive rotator cuff tear (C4 according to the SCOI classification)
- Subscapularis tendon tear (grade III, IV, or IV according to Lafosse classification)
- Associated anterior, posterior, or multidirectional shoulder instability
- Indication for repair of a SLAP lesion of the biceps anchor
- Grade III or IV muscle atrophy of the supraspinatus and infraspinatus tendons (according to Goutallier or Fuchs classification)
Show all 20Show fewer
- Intra-articular hyaluronic acid or corticosteroid infiltration within 3 mo from the planned surgical procedure
- Medical comorbidities contraindicating arthroscopic shoulder surgery
- Local (shoulder, abdominal region, gluteal region) or systemic infection, osteomyelitis, or sepsis
- Diabetes mellitus, untreated thyroid disease, chronic kidney disease, rheumatoid arthritis
- Immunodeficiency
- Chronic disorders involving coagulation, platelet aggregation, or severe coagulopathy
- Severe cardiovascular disease
- Stroke or acute cardiovascular event within 6 mo from the planned surgical procedure
- Weight loss for any cause .30 kg in 12 mo or .10 kg in 12 mo without a cause
- Eating disorders or body dysmorphic disorder
- Varices, phlebitis, or scars next to the planned adipose tissue harvesting site
- Alcohol/drug addiction or psychiatric disease compromising compliance with postoperative protocols
- Pregnancy or breastfeeding women
- Informed consent not accepted
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
ASST Gaetano Pini-CTO
Milan, Italy, 20122
Alessandra Menon, PhD, 3498694424, ale.menon@me.com
Pietro Simone Randelli, Prof., MD
About this study
Official title: Long Term Clinical Outcome After Arthroscopic Rotator Cuff Repair Augmentation With Autologous Microfragmented Lipoaspirate Tissue: a Prospective Randomized Controlled Trialin Question Won by Our Research Group.
Specific Aims :
The aim of this prospective randomized controlled single-blind clinical trial was to evaluate the safety and efficacy of autologous microfragmented lipoaspirate tissue in arthroscopic rotator cuff repair.
Read more
The primary goal of this study was to test the following hypothesis: an intraoperative injection of autologous microfragmented adipose tissue processed with an enzyme-free technology could improve the clinical outcomes of single-row arthroscopic rotator cuff repair in terms of points in the Constant-Murley score (CMS) collected at least 5 years after surgery.
Background and Significance:
Rotator cuff surgery was initially proposed at the end of the 19th century and evolved then from open to arthroscopic techniques, rising quickly from a minor niche to a fully recognized subspecialty.
To improve clinical and functional results and reduce the retear rate, new fixation techniques and biological solutions to enhance tendon healing are being developed at a fast pace, as shown by the dramatic increase in the number of articles published per year.
Biological solutions to enhance rotator cuff healing include growth factors and platelet-rich plasma, as well as mesenchymal stem cells (MSCs) and their derivatives.
MSCs are believed to enhance tissue healing mainly through stimulation of local cells via paracrine mechanisms and anti-inflammatory and/or immunomodulatory activity, thus creating a suitable microenvironment for tissue repair.
Autologous microfragmented lipoaspirate tissue has been recently introduced in orthopaedics as an easily available source of adipose derived MSCs (ADSCs) to support and accelerate tissue regeneration. Lipoaspirates contain human ADSCs and produce growth factors, such as platelet-derived growth factor, fibroblast growth factor, transforming growth factor beta, and vascular endothelial growth factor, which play important regulatory roles in cellular functions, including adhesion, chemotaxis, proliferation, migration, matrix synthesis, differentiation, and angiogenesis.
Herewith, autologous microfragmented lipoaspirate tissue is expected to optimize the microenvironment for tendon regeneration. Among many approaches, devices relying on nonenzymatic methods and avoiding the use of additives and other additional manipulations (eg, centrifugation) allow one to harvest, process, and obtain autologous microfragmented lipoaspirate tissue directly in the operative theatre under sterile conditions. This permits immediate use in the same surgical intervention without delays owing to the difficulty of an ex vivo cell expansion and the complexity of the current good manufacturing practice requirements for preparing cells for therapeutic use.
Although several animal studies have been published showing promising results for the use of ADSCs in enhancing the healing of rotator cuff tears, minimal evidence describing augmentation of rotator cuff treatment with lipoaspirate.
Preliminary Studies/Progress Report:
This study is a prospective, randomized, double-blind, controlled clinical trial and represents the final follow-up of an our previous study with short follow-up (2 years). The previous study demonstrated that the intraoperative injection of autologous microfragmented adipose tissue is safe and effective in improving short-term clinical and functional results after single-row arthroscopic rotator cuff repair.
Nevertheless, no significant differences emerged between the groups in terms of rerupture rate, complication rate, number of adverse events, and mid-term clinical outcomes.
A previous in vitro study showed that autologous microfragmented adipose tissue significantly increases the proliferation rate of human tendon stem cells without altering their stemness and differentiation capability. Moreover, treated cells increase the expression of VEGF, which is crucial for the neovascularization of the tissue during the healing process.
Research Design and Method:
At least 5 years after surgery, all enrolled patients in the previous study will be call again and will be asked to complete the ASES, SST, and VAS questionnaire and they will undergo a clinical examination, including the CMS and measurement of isometric strength in shoulder forward flexion, abduction, and external rotation. All strength measures will be performed in triplicate with a dynamometer.
During the same assessment day, the patients would be evaluated with MRI of the operated shoulder in order to assess tendon integrity and calculate rerupture rate according to the classification proposed by Sugaya (types IV and V defined as retears). Atrophy of the supraspinatus muscle belly was evaluated according to Warner and fatty degeneration was classified according to Fuchs.
- Being tested
- magnetic resonance imaging (MRI), VAS, SST, ASES, CMS scores, and strength measurements in external rotation and abduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imaging (MRI)Procedure or surgery
All enrolled patients will be contacted again at a minimum follow-up of 5 years, and an MRI of the operated shoulder will also be performed.
VAS, SST, ASES, CMS scores, and strength measurements in external rotation and abductionOther
All enrolled patients will be contacted again at a minimum follow-up of 5 years, and a clinical evaluation will be performed using the following measurements and scores: VAS, SST, ASES, CMS scores, and strength measurements in external rotation and abduction.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Cohort of patients that receved a single-row arthroscopic rotator cuff repair, followed by intraoperative injection of autologous microfragmented adipose tissue processed with an enzyme-free technology, 5 years ago in our previous trial (NCT02783352). Receives: Procedure: magnetic resonance imaging (MRI); Other: VAS, SST, ASES, CMS scores, and strength measurements in external rotation and abduction | |
| Control group | Cohort of patients that received a single-row arthroscopic rotator cuff repair alone, 5 years ago in our previous trial (NCT02783352). Receives: Procedure: magnetic resonance imaging (MRI); Other: VAS, SST, ASES, CMS scores, and strength measurements in external rotation and abduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between the two groups of the incidence of retears at least 5 years after surgery
The primary goal of this study is to evaluate the long-term effecacy of the use of autologous microfragmented adipose tissue in arthroscopic rotator cuff repair, in terms of estimating the incidence of retears at least 5 years after surgery, as assessed by magnetic resonance imaging (MRI).
Measured: 5 years
Secondary outcomes (5)
Comparison of the Constant-Murley score (CMS) between the two groups at least 5 years after surgery.
A secondary objective is to assess the effecacy of microfragmented autologous adipose tissue in arthroscopic repairs of rotator cuff tears in terms of improvement in the postoperative CMS at the 5-year follow-up.
Measured: 5 years
Comparison between the two groups of the difference in the Visual Analogue Scale (VAS) score at least 5 years after surgery.
A secondary objective is to assess the effecacy of microfragmented autologous adipose tissue in arthroscopic repairs of rotator cuff tears in terms of pain reduction of pain, assessed by VAS, at the 5-year follow-up.
Measured: 5 years
Comparison between the two groups of abduction and external rotation strength at least 5 years after surgery.
A secondary objective is to assess the effecacy of microfragmented autologous adipose tissue in arthroscopic repairs of rotator cuff tears in terms of increase in abduction and external rotation strength after surgery at the 5-year follow-up.
Measured: 5 years
Comparison of the ASES (American Shoulder and Elbow Surgeons score) and SST (Simple Shoulder Test) between the two groups at least 5 years after surgery.
A secondary objective is to assess the effecacy of microfragmented autologous adipose tissue in arthroscopic repairs of rotator cuff tears in terms of improvement in the postoperative ASES and SST scores at the 5-year follow-up.
Measured: 5 years
Comparison between the two groups of the progression of supraspinatus fatty degeneration at least 5 years after surgery
A secondary objective is to assess the effecacy of microfragmented autologous adipose tissue in arthroscopic repairs of rotator cuff repair, as assessed by magnetic resonance imaging (MRI) and graded according to the Fuchs classification, at the 5-year follow-up.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start11 Apr 2025
- Primary completion11 Oct 2026 (estimated)
- Study completion11 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Arthroscopic Rotator Cuff RepairStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Collaborators
- International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine, ASST Gaetano Pini-CTO
- Responsible party
- Principal investigator, Pietro Randelli, MD, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960343
- Sponsor's protocol ID
- Lipotendon_LongFu
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
Publications
Vigano M, Lugano G, Perucca Orfei C, Menon A, Ragni E, Colombini A, De Luca P, Randelli P, de Girolamo L. Autologous microfragmented adipose tissue reduces inflammatory and catabolic markers in supraspinatus tendon cells derived from patients affected by rotator cuff tears. Int Orthop. 2021 Feb;45(2):419-426. doi: 10.1007/s00264-020-04693-9. Epub 2020 Jul 8.
PubMed 32642826Fuchs B, Weishaupt D, Zanetti M, Hodler J, Gerber C. Fatty degeneration of the muscles of the rotator cuff: assessment by computed tomography versus magnetic resonance imaging. J Shoulder Elbow Surg. 1999 Nov-Dec;8(6):599-605. doi: 10.1016/s1058-2746(99)90097-6.
PubMed 10633896Warner JJ, Higgins L, Parsons IM 4th, Dowdy P. Diagnosis and treatment of anterosuperior rotator cuff tears. J Shoulder Elbow Surg. 2001 Jan-Feb;10(1):37-46. doi: 10.1067/mse.2001.112022.
PubMed 11182734Sugaya H, Maeda K, Matsuki K, Moriishi J. Repair integrity and functional outcome after arthroscopic double-row rotator cuff repair. A prospective outcome study. J Bone Joint Surg Am. 2007 May;89(5):953-60. doi: 10.2106/JBJS.F.00512.
PubMed 17473131Randelli P, Menon A, Ragone V, Creo P, Bergante S, Randelli F, De Girolamo L, Alfieri Montrasio U, Banfi G, Cabitza P, Tettamanti G, Anastasia L. Lipogems Product Treatment Increases the Proliferation Rate of Human Tendon Stem Cells without Affecting Their Stemness and Differentiation Capability. Stem Cells Int. 2016;2016:4373410. doi: 10.1155/2016/4373410. Epub 2016 Jan 6.
PubMed 27057170Soleymaninejadian E, Pramanik K, Samadian E. Immunomodulatory properties of mesenchymal stem cells: cytokines and factors. Am J Reprod Immunol. 2012 Jan;67(1):1-8. doi: 10.1111/j.1600-0897.2011.01069.x. Epub 2011 Sep 23.
PubMed 21951555Shi M, Liu ZW, Wang FS. Immunomodulatory properties and therapeutic application of mesenchymal stem cells. Clin Exp Immunol. 2011 Apr;164(1):1-8. doi: 10.1111/j.1365-2249.2011.04327.x. Epub 2011 Feb 24.
PubMed 21352202Schmitt A, van Griensven M, Imhoff AB, Buchmann S. Application of stem cells in orthopedics. Stem Cells Int. 2012;2012:394962. doi: 10.1155/2012/394962. Epub 2012 Feb 23.
PubMed 22550505Mei SH, Haitsma JJ, Dos Santos CC, Deng Y, Lai PF, Slutsky AS, Liles WC, Stewart DJ. Mesenchymal stem cells reduce inflammation while enhancing bacterial clearance and improving survival in sepsis. Am J Respir Crit Care Med. 2010 Oct 15;182(8):1047-57. doi: 10.1164/rccm.201001-0010OC. Epub 2010 Jun 17.
PubMed 20558630Krasnodembskaya A, Song Y, Fang X, Gupta N, Serikov V, Lee JW, Matthay MA. Antibacterial effect of human mesenchymal stem cells is mediated in part from secretion of the antimicrobial peptide LL-37. Stem Cells. 2010 Dec;28(12):2229-38. doi: 10.1002/stem.544.
PubMed 20945332Gnecchi M, Zhang Z, Ni A, Dzau VJ. Paracrine mechanisms in adult stem cell signaling and therapy. Circ Res. 2008 Nov 21;103(11):1204-19. doi: 10.1161/CIRCRESAHA.108.176826.
PubMed 19028920Angeline ME, Rodeo SA. Biologics in the management of rotator cuff surgery. Clin Sports Med. 2012 Oct;31(4):645-63. doi: 10.1016/j.csm.2012.07.003.
PubMed 23040551Randelli P, Randelli F, Ragone V, Menon A, D'Ambrosi R, Cucchi D, Cabitza P, Banfi G. Regenerative medicine in rotator cuff injuries. Biomed Res Int. 2014;2014:129515. doi: 10.1155/2014/129515. Epub 2014 Aug 13.
PubMed 25184132McElvany MD, McGoldrick E, Gee AO, Neradilek MB, Matsen FA 3rd. Rotator cuff repair: published evidence on factors associated with repair integrity and clinical outcome. Am J Sports Med. 2015 Feb;43(2):491-500. doi: 10.1177/0363546514529644. Epub 2014 Apr 21.
PubMed 24753240Randelli P, Cucchi D, Ragone V, de Girolamo L, Cabitza P, Randelli M. History of rotator cuff surgery. Knee Surg Sports Traumatol Arthrosc. 2015 Feb;23(2):344-62. doi: 10.1007/s00167-014-3445-z. Epub 2014 Dec 2.
PubMed 25448135
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Clinical Outcome After Arthroscopic Rotator Cuff Repair Augmentation With Autologous Microfragmented Lipoaspirate Tissue: a Prospective Randomized Controlled Trialin Question Won by Our Research Group.
- ClinicalTrials.gov ID
- NCT06960343
- Acronym / sponsor ID
- Lipotendon_LongFu
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Collaborators
- International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine, ASST Gaetano Pini-CTO
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 11 Oct 2026 (estimated)
- Study completion
- 11 Oct 2026 (estimated)
- First posted
- 7 May 2025 (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.
Specific Aims :
The aim of this prospective randomized controlled single-blind clinical trial was to evaluate the safety and efficacy of autologous microfragmented lipoaspirate tissue in arthroscopic rotator cuff repair.
The primary goal of this study was to test the following hypothesis: an intraoperative injection of autologous microfragmented adipose tissue processed with an enzyme-free technology could improve the clinical outcomes of single-row arthroscopic rotator cuff repair in terms of points in the Constant-Murley score (CMS) collected at least 5 years after surgery.
Background and Significance:
Rotator cuff surgery was initially proposed at the end of the 19th century and evolved then from open to arthroscopic techniques, rising quickly from a minor niche to a fully recognized subspecialty.
To improve clinical and functional results and reduce the retear rate, new fixation techniques and biological solutions to enhance tendon healing are being developed at a fast pace, as shown by the dramatic increase in the number of articles published per year.
Biological solutions to enhance rotator cuff healing include growth factors and platelet-rich plasma, as well as mesenchymal stem cells (MSCs) and their derivatives.
MSCs are believed to enhance tissue healing mainly through stimulation of local cells via paracrine mechanisms and anti-inflammatory and/or immunomodulatory activity, thus creating a suitable microenvironment for tissue repair.
Autologous microfragmented lipoaspirate tissue has been recently introduced in orthopaedics as an easily available source of adipose derived MSCs (ADSCs) to support and accelerate tissue regeneration. Lipoaspirates contain human ADSCs and produce growth factors, such as platelet-derived growth factor, fibroblast growth factor, transforming growth factor beta, and vascular endothelial growth factor, which play important regulatory roles in cellular functions, including adhesion, chemotaxis, proliferation, migration, matrix synthesis, differentiation, and angiogenesis.
Herewith, autologous microfragmented lipoaspirate tissue is expected to optimize the microenvironment for tendon regeneration. Among many approaches, devices relying on nonenzymatic methods and avoiding the use of additives and other additional manipulations (eg, centrifugation) allow one to harvest, process, and obtain autologous microfragmented lipoaspirate tissue directly in the operative theatre under sterile conditions. This permits immediate use in the same surgical intervention without delays owing to the difficulty of an ex vivo cell expansion and the complexity of the current good manufacturing practice requirements for preparing cells for therapeutic use.
Although several animal studies have been published showing promising results for the use of ADSCs in enhancing the healing of rotator cuff tears, minimal evidence describing augmentation of rotator cuff treatment with lipoaspirate.
Preliminary Studies/Progress Report:
This study is a prospective, randomized, double-blind, controlled clinical trial and represents the final follow-up of an our previous study with short follow-up (2 years). The previous study demonstrated that the intraoperative injection of autologous microfragmented adipose tissue is safe and effective in improving short-term clinical and functional results after single-row arthroscopic rotator cuff repair.
Nevertheless, no significant differences emerged between the groups in terms of rerupture rate, complication rate, number of adverse events, and mid-term clinical outcomes.
A previous in vitro study showed that autologous microfragmented adipose tissue significantly increases the proliferation rate of human tendon stem cells without altering their stemness and differentiation capability. Moreover, treated cells increase the expression of VEGF, which is crucial for the neovascularization of the tissue during the healing process.
Research Design and Method:
At least 5 years after surgery, all enrolled patients in the previous study will be call again and will be asked to complete the ASES, SST, and VAS questionnaire and they will undergo a clinical examination, including the CMS and measurement of isometric strength in shoulder forward flexion, abduction, and external rotation. All strength measures will be performed in triplicate with a dynamometer.
During the same assessment day, the patients would be evaluated with MRI of the operated shoulder in order to assess tendon integrity and calculate rerupture rate according to the classification proposed by Sugaya (types IV and V defined as retears). Atrophy of the supraspinatus muscle belly was evaluated according to Warner and fatty degeneration was classified according to Fuchs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Procedure: magnetic resonance imaging (MRI), Other: VAS, SST, ASES, CMS scores, and strength measurements in external rotation and abductionCohort of patients that receved a single-row arthroscopic rotator cuff repair, followed by intraoperative injection of autologous microfragmented adipose tissue processed with an enzyme-free technology, 5 years ago in our previous trial (NCT02783352). |
| Control group | – | Procedure: magnetic resonance imaging (MRI), Other: VAS, SST, ASES, CMS scores, and strength measurements in external rotation and abductionCohort of patients that received a single-row arthroscopic rotator cuff repair alone, 5 years ago in our previous trial (NCT02783352). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study is a prospective, randomized, double-blind, controlled clinical trial and represents the final follow-up of an our previous study with short follow-up (2 years). At least 5 years after surgery, all enrolled patients in the previous study will be call again and will be asked to complete the ASES, SST, and VAS questionnaire and they will undergo a clinical examination, including the CMS and measurement of isometric strength in shoulder forward flexion, abduction, and external rotation. All strength measures will be performed in triplicate with a dynamometer. During the same assessment day, the patients would be evaluated with MRI of the operated shoulder in order to assess tendon integrity and calculate rerupture rate according to the classification proposed by Sugaya (types IV and V defined as retears). Atrophy of the supraspinatus muscle belly was evaluated according to Warner and fatty degeneration was classified according to Fuchs.
Key inclusion criteria (5 listed)
- Age > 18 years
- Full-thickness supraspinatus and infraspinatus tendon tears (C1, C2, and C3 according to the SCOI classification)
- Indication for arthroscopic rotator cuff repair
- Informed consent to participate in the study
- Informed consent to participate for the duration of the study
Key exclusion criteria (20 listed)
- Partial rotator cuff tendon tears (A1, A2, A3, B1, B2, and B3 according to the SCOI classification)
- Massive rotator cuff tear (C4 according to the SCOI classification)
- Subscapularis tendon tear (grade III, IV, or IV according to Lafosse classification)
- Associated anterior, posterior, or multidirectional shoulder instability
- Indication for repair of a SLAP lesion of the biceps anchor
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 |
|---|---|---|
| magnetic resonance imaging (MRI)All enrolled patients will be contacted again at a minimum follow-up of 5 years, and an MRI of the operated shoulder will also be performed. | Procedure or surgery | Control group, Treatment group |
| VAS, SST, ASES, CMS scores, and strength measurements in external rotation and abductionAll enrolled patients will be contacted again at a minimum follow-up of 5 years, and a clinical evaluation will be performed using the following measurements and scores: VAS, SST, ASES, CMS scores, and strength measurements in external rotation and abduction. | Other | Control group, Treatment group |
Primary outcome
Comparison between the two groups of the incidence of retears at least 5 years after surgery
Time frame: 5 years
The primary goal of this study is to evaluate the long-term effecacy of the use of autologous microfragmented adipose tissue in arthroscopic rotator cuff repair, in terms of estimating the incidence of retears at least 5 years after surgery, as assessed by magnetic resonance imaging (MRI).
5 secondary outcomes
Comparison of the Constant-Murley score (CMS) between the two groups at least 5 years after surgery.
Time frame: 5 years
Comparison between the two groups of the difference in the Visual Analogue Scale (VAS) score at least 5 years after surgery.
Time frame: 5 years
Comparison between the two groups of abduction and external rotation strength at least 5 years after surgery.
Time frame: 5 years
Comparison of the ASES (American Shoulder and Elbow Surgeons score) and SST (Simple Shoulder Test) between the two groups at least 5 years after surgery.
Time frame: 5 years
Comparison between the two groups of the progression of supraspinatus fatty degeneration at least 5 years after surgery
Time frame: 5 years
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 28 Apr 2026.
- Results publication: PubMed 32642826Vigano M, Lugano G, Perucca Orfei C, Menon A, Ragni E, Colombini A, De Luca P, Randelli P, de Girolamo L. Autologous microfragmented adipose tissue reduces inflammatory and catabolic markers in supraspinatus tendon cells derived from patients affected by rotator cuff tears. Int Orthop. 2021 Feb;45(2):419-426. doi: 10.1007/s00264-020-04693-9. Epub 2020 Jul 8.
- Results publication: PubMed 10633896Fuchs B, Weishaupt D, Zanetti M, Hodler J, Gerber C. Fatty degeneration of the muscles of the rotator cuff: assessment by computed tomography versus magnetic resonance imaging. J Shoulder Elbow Surg. 1999 Nov-Dec;8(6):599-605. doi: 10.1016/s1058-2746(99)90097-6.
- Results publication: PubMed 11182734Warner JJ, Higgins L, Parsons IM 4th, Dowdy P. Diagnosis and treatment of anterosuperior rotator cuff tears. J Shoulder Elbow Surg. 2001 Jan-Feb;10(1):37-46. doi: 10.1067/mse.2001.112022.
- Results publication: PubMed 17473131Sugaya H, Maeda K, Matsuki K, Moriishi J. Repair integrity and functional outcome after arthroscopic double-row rotator cuff repair. A prospective outcome study. J Bone Joint Surg Am. 2007 May;89(5):953-60. doi: 10.2106/JBJS.F.00512.
- Results publication: PubMed 27057170Randelli P, Menon A, Ragone V, Creo P, Bergante S, Randelli F, De Girolamo L, Alfieri Montrasio U, Banfi G, Cabitza P, Tettamanti G, Anastasia L. Lipogems Product Treatment Increases the Proliferation Rate of Human Tendon Stem Cells without Affecting Their Stemness and Differentiation Capability. Stem Cells Int. 2016;2016:4373410. doi: 10.1155/2016/4373410. Epub 2016 Jan 6.
- Results publication: PubMed 21951555Soleymaninejadian E, Pramanik K, Samadian E. Immunomodulatory properties of mesenchymal stem cells: cytokines and factors. Am J Reprod Immunol. 2012 Jan;67(1):1-8. doi: 10.1111/j.1600-0897.2011.01069.x. Epub 2011 Sep 23.
- Results publication: PubMed 21352202Shi M, Liu ZW, Wang FS. Immunomodulatory properties and therapeutic application of mesenchymal stem cells. Clin Exp Immunol. 2011 Apr;164(1):1-8. doi: 10.1111/j.1365-2249.2011.04327.x. Epub 2011 Feb 24.
- Results publication: PubMed 22550505Schmitt A, van Griensven M, Imhoff AB, Buchmann S. Application of stem cells in orthopedics. Stem Cells Int. 2012;2012:394962. doi: 10.1155/2012/394962. Epub 2012 Feb 23.
- Results publication: PubMed 20558630Mei SH, Haitsma JJ, Dos Santos CC, Deng Y, Lai PF, Slutsky AS, Liles WC, Stewart DJ. Mesenchymal stem cells reduce inflammation while enhancing bacterial clearance and improving survival in sepsis. Am J Respir Crit Care Med. 2010 Oct 15;182(8):1047-57. doi: 10.1164/rccm.201001-0010OC. Epub 2010 Jun 17.
- Results publication: PubMed 20945332Krasnodembskaya A, Song Y, Fang X, Gupta N, Serikov V, Lee JW, Matthay MA. Antibacterial effect of human mesenchymal stem cells is mediated in part from secretion of the antimicrobial peptide LL-37. Stem Cells. 2010 Dec;28(12):2229-38. doi: 10.1002/stem.544.
- Results publication: PubMed 19028920Gnecchi M, Zhang Z, Ni A, Dzau VJ. Paracrine mechanisms in adult stem cell signaling and therapy. Circ Res. 2008 Nov 21;103(11):1204-19. doi: 10.1161/CIRCRESAHA.108.176826.
- Results publication: PubMed 23040551Angeline ME, Rodeo SA. Biologics in the management of rotator cuff surgery. Clin Sports Med. 2012 Oct;31(4):645-63. doi: 10.1016/j.csm.2012.07.003.
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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?
An observational study of Arthroscopic Rotator Cuff Repair and Augmentation, run by University of Milan 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 5 inclusion and 20 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 28 Apr 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 Alessandra Menon, PhD (+393498694424, ale.menon@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between the two groups of the incidence of retears at least 5 years after surgery (time frame: 5 years). 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 NCT06960343, which also lists 15 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 28 Apr 2026.