deltatrials
Completed NA INTERVENTIONAL 2-arm NCT02783352

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

Updated 13 times since 2017 Last updated: Jun 10, 2021 Started: Feb 29, 2016 Primary completion: Apr 19, 2020 Completion: Apr 27, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jun 2017 · 4 months · monthly snapshot~Jun 2017 – ~Jun 2018 · 12 months · monthly snapshot~Jun 2018 – ~Feb 2020 · 20 months · monthly snapshot~Feb 2020 – ~Jun 2020 · 4 months · monthly snapshot~Jun 2020 – ~Dec 2020 · 6 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Jul 2024 · 34 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 7 months · monthly snapshot~Jan 2026 – present · 3 months · monthly snapshot

Change History

13 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed NA

  2. Sep 2025 — Present [monthly]

    Completed NA

  3. Sep 2024 — Sep 2025 [monthly]

    Completed NA

  4. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  5. Sep 2021 — Jul 2024 [monthly]

    Completed NA

    Status: Active Not RecruitingCompleted

Show 8 earlier versions
  1. Jan 2021 — Sep 2021 [monthly]

    Active Not Recruiting NA

  2. Dec 2020 — Jan 2021 [monthly]

    Active Not Recruiting NA

  3. Jun 2020 — Dec 2020 [monthly]

    Active Not Recruiting NA

  4. Feb 2020 — Jun 2020 [monthly]

    Active Not Recruiting NA

  5. Jun 2018 — Feb 2020 [monthly]

    Active Not Recruiting NA

    Status: RecruitingActive Not Recruiting

  6. Jun 2017 — Jun 2018 [monthly]

    Recruiting NA

  7. Feb 2017 — Jun 2017 [monthly]

    Recruiting NA

  8. 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

Sponsor contact:
  • University of Milan
Data source: University of Milan

For direct contact, visit the study record on ClinicalTrials.gov .