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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
arthroscopic rotator cuff repair
injection of autologous micro-fragmented adipose tissue (10 mL) after arthroscopic rotator cuff repair, in dry arthroscopy condition
U.O.C. 1a Divisione, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
Milan, Milan, Italy
IRCCS Policlinico San Donato
San Donato Milanese, Milan, Italy
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.
Time frame: 6 months
Comparison of Constant score between the two groups at 1, 3, 6, 12, 18, 24 months post-operatively
Time frame: 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
Time frame: 1, 3, 6, 12, 18, 24 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 18 months
Comparison of development of fatty degeneration in the supraspinatus at 18 months post-operatively
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degeneration is measured with magnetic resonance imaging and classified using the Fuchs classification (grading I-IV)
Time frame: 18 months
Number of adverse events for any cause
Time frame: 7 days, 45-90 days, 12-18 months