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Increasing the success rate of rotator cuff healing remains a tremendous challenge for orthopedic surgeons, which encourage the development of new biological therapies. Among many approaches, activating resident progenitor cells with the Lipogems® product could be an easy, safe, practical and cost-effective new therapeutic strategy for increasing rotator cuff tendon healing.
The primary goal of this study is to evaluate efficacy of infiltration of autologous micro-fragmented adipose tissue in arthroscopic rotator cuff repair, in terms of gain in post-operative Constant score.
Increasing the success rate of rotator cuff healing remains a tremendous challenge for orthopedic surgeons, which encourage the development of new biological therapies. Among many approaches, the possibility of activating resident stem cells in situ, without the need of isolating them from biopsies and successive in vitro culturing, could represent a very promising therapeutic strategy. Along this line, it has been recently demonstrated that a lipoaspirate product, such as the Lipogems® product, contains and produces growth factors that may activate resident stem cells. Recently, it has been discovered that also the human rotator cuff contains a reservoir of progenitor cells, which can be isolated and expanded in vitro.
The primary goal of this study is to evaluate efficacy of infiltration of autologous micro-fragmented adipose tissue in arthroscopic rotator cuff repair, in terms of gain in post-operative Constant score.
Secondary goals are to evaluate efficacy of infiltration of autologous micro-fragmented adipose tissue in arthroscopic rotator cuff repairs, in terms of post-operative pain reduction, gain in post-operative strength in abduction and external rotation; estimate incidence of re-ruptures at 1 and 2 years post-operatively, quantify the amount of fatty degeneration of the supraspinatus at 1 and 2 years post-operatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | arthroscopic rotator cuff repair + injection of autologous micro-fragmented adipose tissue (10 mL) |
|
| control group | Other | arthroscopic rotator cuff repair only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| arthroscopic rotator cuff repair | Procedure | arthroscopic rotator cuff repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Constant score between the two groups at 6 months post-operatively | Hypothesis: in the treatment group, Constant score at 6 months post-operatively is at least 7 points HIGHER than Constant score in the control group. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Constant score between the two groups at 1, 3, 6, 12, 18, 24 months post-operatively | 1, 3, 6, 12, 18, 24 months | |
| Comparison of ASES score between the two groups at 1, 3, 6, 12, 18, 24 months post-operatively | 1, 3, 6, 12, 18, 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pietro Randelli, MD | U.O.C. 1a Divisione, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.O.C. 1a Divisione, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO | Milan | Milan | 20122 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35302901 | Derived | Randelli PS, Cucchi D, Fossati C, Boerci L, Nocerino E, Ambrogi F, Menon A. Arthroscopic Rotator Cuff Repair Augmentation With Autologous Microfragmented Lipoaspirate Tissue Is Safe and Effectively Improves Short-term Clinical and Functional Results: A Prospective Randomized Controlled Trial With 24-Month Follow-up. Am J Sports Med. 2022 Apr;50(5):1344-1357. doi: 10.1177/03635465221083324. Epub 2022 Mar 18. |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| autologous micro-fragmented adipose tissue | Procedure | injection of autologous micro-fragmented adipose tissue (10 mL) after arthroscopic rotator cuff repair, in dry arthroscopy condition |
|
| Comparison of Visual Analogue Scale (VAS) difference between the two groups at 1, 3, 7, 14, 30 days and 3, 6, 12, 18, 24 months post-operatively. | 1, 3, 7, 14, 30 days and 3, 6, 12, 18, 24 months |
| Comparison SST score (simple shoulder test) between the two groups at 1, 3, 6, 12, 18, 24 months post-operatively. | 1, 3, 6, 12, 18, 24 months |
| Comparison of strength in abduction and external rotation between the two groups at 1, 3, 6, 12, 18, 24 months post-operatively. | Strength will be measured with a dynamometer, using International System metrics. | 1, 3, 6, 12, 18, 24 months |
| Comparison of incidence of re-ruptures between the two groups at 18 months post-operatively, measured with magnetic resonance imaging. | 18 months |
| Comparison of development of fatty degeneration in the supraspinatus at 18 months post-operatively | degeneration is measured with magnetic resonance imaging and classified using the Fuchs classification (grading I-IV) | 18 months |
| Number of adverse events for any cause | 7 days, 45-90 days, 12-18 months |
| IRCCS Policlinico San Donato | San Donato Milanese | Milan | 20097 | Italy |