Long Term Clinical Outcome After Arthroscopic Rotator Cuff Repair Augmentation With Autologous Microfragmented Lipoaspirate Tissue
NCT ID: NCT06960343
Last Updated: 2025-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
52 participants
OBSERVATIONAL
2025-04-11
2026-04-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of Microfragmented Lipoaspirate Tissue in Arthroscopic Rotator Cuff Repair
NCT02783352
Arthroscopic Surgical Outcome Study In Subjects With Rotator Cuff Tears
NCT00739947
Evaluation of Tendon-to-Bone Healing Potential in Arthroscopic Rotator Cuff Repair Through Biological Stimulation
NCT03060928
Arthroscopic Treatment of Massive Rotator Cuff Tears With Debridement and Biodegradable Spacer.
NCT04571918
Performance and Safety Evaluation of MD-Shoulder Collagen Medical Device in the Treatment of Rotator Cuff Syndrome
NCT05489484
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
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.
VAS, SST, ASES, CMS scores, and strength measurements in external rotation and abduction
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.
Control group
Cohort of patients that received a single-row arthroscopic rotator cuff repair alone, 5 years ago in our previous trial (NCT02783352).
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.
VAS, SST, ASES, CMS scores, and strength measurements in external rotation and abduction
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
VAS, SST, ASES, CMS scores, and strength measurements in external rotation and abduction
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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)
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine (ISAKOS)
UNKNOWN
ASST Gaetano Pini-CTO
OTHER
University of Milan
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pietro Randelli, MD
Prof., MD
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
ASST Gaetano Pini-CTO
Milan, Italy, Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Fuchs 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.
Warner 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.
Sugaya 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.
Randelli 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.
Soleymaninejadian 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.
Shi 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.
Schmitt 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.
Mei 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.
Krasnodembskaya 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.
Gnecchi 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.
Angeline 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.
Randelli 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.
McElvany 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.
Randelli 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Lipotendon_LongFu
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.