Efficacy of Microfragmented Lipoaspirate Tissue in Arthroscopic Rotator Cuff Repair
Efficacy of Microfragmented Lipoaspirate Tissue in Arthroscopic Rotator Cuff Repairs: a Randomized Controlled Study
Sponsor: University of Milan
This NA trial investigates Rotator Cuff Tears and is currently completed. University of Milan leads this study, which shows 13 recorded versions since 2016 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)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.
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.
Status Flow
Change History
13 versions recorded-
Jan 2026 — Present [monthly]
Completed NA
-
Sep 2025 — Present [monthly]
Completed NA
-
Sep 2024 — Sep 2025 [monthly]
Completed NA
-
Jul 2024 — Sep 2024 [monthly]
Completed NA
-
Sep 2021 — Jul 2024 [monthly]
Completed NA
Status: Active Not Recruiting → Completed
▶ Show 8 earlier versions
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Jan 2021 — Sep 2021 [monthly]
Active Not Recruiting NA
-
Dec 2020 — Jan 2021 [monthly]
Active Not Recruiting NA
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Jun 2020 — Dec 2020 [monthly]
Active Not Recruiting NA
-
Feb 2020 — Jun 2020 [monthly]
Active Not Recruiting NA
-
Jun 2018 — Feb 2020 [monthly]
Active Not Recruiting NA
Status: Recruiting → Active Not Recruiting
-
Jun 2017 — Jun 2018 [monthly]
Recruiting NA
-
Feb 2017 — Jun 2017 [monthly]
Recruiting NA
-
Jan 2017 — Feb 2017 [monthly]
Recruiting NA
First recorded
Feb 2016
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- University of Milan
For direct contact, visit the study record on ClinicalTrials.gov .