Clinical trial NCT02783352: Efficacy of Microfragmented Lipoaspirate Tissue in Arthroscopic Rotator Cuff Repair
Official title: Efficacy of Microfragmented Lipoaspirate Tissue in Arthroscopic Rotator Cuff Repairs: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tears
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 18\< Age \< 75 years.
* a full-thickness tear of the supraspinatus and/or infraspinatus tendons (classified according to Snyder as degree C1, C2, C3).
* Indication for arthroscopic rotator cuff repair.
* Patients able to understand the study conditions and willing to participate for its entire duration.
* Patients who signed written informed consent.

Exclusion Criteria:

* Patients diagnosed with partial supraspinatus/infraspinatus tears (A1, A2, A3, A4, B1, B2, B3, B4 in Snyder classification system).
* Patients diagnosed with massive rotator cuff tears C4 in Snyder classification system).
* Patients diagnosed with subscapularis tears, of grade III, IV or V in Lafosse classification.
* Patients diagnosed with anterior, posterior or multidirectional shoulder instability.
* Patients diagnosed with Superior Labrum Anterior-to-Posterior (SLAP)-type long-head of the biceps tendon lesions.
* Patients presenting serious comorbidities, which represent contraindications to shoulder arthroscopy.
* Patients treated with hyaluronic acid or steroid intra-articular injections in the index shoulder less than 3 months before the procedure.
* Patients diagnosed with local (shoulder, site of fat tissue harvest or nearby tissues) or systemic infections, osteomyelitis, sepsis.
* Fatty degeneration/atrophy grade III or IV (Goutallier or Fuchs classification) in supraspinatus or infraspinatus muscle bellies.
* Patients diagnosed with diabetes
* Patients diagnosed with chronic kidney disease with Glomerular Filtration Rate (GFR) less than 60 mL/min.
* Patients diagnosed with any disease of coagulation or platelet aggregation systems, or treated with oral anti-coagulating or anti-aggregating agents for which no suspension is possible at the moment of intervention.
* Patients chronically treated with immune-suppressants agents.
* Patients affected by chronic heart failure.
* Patients diagnosed with acute coronary or cerebrovascular disease in the last 6 months.
* Patients who reported weight loss greater than 30 kg for any reasons in the last 12 months or, if the cause is unknown, greater than 10 kg in the last 12 months if the cause
* Patients diagnosed with eating disorders or body dysmorphic disorders.
* Patients with untreated hypo- or hyperthyroidism.
* Patients with varicose veins, phlebitis or scars near the fat tissue harvest area.
* Drug-addicted, alcohol-addicted patients, patients with psychiatric disorders or other clinical conditions, which could compromise the results of the surgical procedure or of the follow-up.
* Informed consent not accepted.
* Pregnant or breastfeeding women.

Primary outcomes:
measure: Comparison of Constant score between the two groups at 6 months post-operatively
timeFrame: 6 months
Secondary outcomes:
measure: Comparison of Constant score between the two groups at 1, 3, 6, 12, 18, 24 months post-operatively
timeFrame: 1, 3, 6, 12, 18, 24 months
measure: Comparison of ASES score between the two groups at 1, 3, 6, 12, 18, 24 months post-operatively
timeFrame: 1, 3, 6, 12, 18, 24 months
measure: 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.
timeFrame: 1, 3, 7, 14, 30 days and 3, 6, 12, 18, 24 months
measure: Comparison SST score (simple shoulder test) between the two groups at 1, 3, 6, 12, 18, 24 months post-operatively.
timeFrame: 1, 3, 6, 12, 18, 24 months
measure: Comparison of strength in abduction and external rotation between the two groups at 1, 3, 6, 12, 18, 24 months post-operatively.
timeFrame: 1, 3, 6, 12, 18, 24 months
measure: Comparison of incidence of re-ruptures between the two groups at 18 months post-operatively, measured with magnetic resonance imaging.
timeFrame: 18 months
measure: Comparison of development of fatty degeneration in the supraspinatus at 18 months post-operatively
timeFrame: 18 months
measure: Number of adverse events for any cause
timeFrame: 7 days, 45-90 days, 12-18 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: U.O.C. 1a Divisione, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
state: Milan
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Milan
Study officials:
affiliation: U.O.C. 1a Divisione, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
name: Pietro Randelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.