Efficacy of Microfragmented Lipoaspirate Tissue in Arthroscopic Rotator Cuff Repair

Efficacy of Microfragmented Lipoaspirate Tissue in Arthroscopic Rotator Cuff Repairs: a Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Procedure: arthroscopic rotator cuff repair; Procedure: autologous micro-fragmented adipose tissue

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan
    • Milano, Milan, Italy, 20122
      • U.O.C. 1a Divisione, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
    • San Donato Milanese, Milan, Italy, 20097
      • IRCCS Policlinico San Donato

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment group; arthroscopic rotator cuff repair + injection of autologous micro-fragmented adipose tissue (10 mL)	Procedure: arthroscopic rotator cuff repair; arthroscopic rotator cuff repair; Procedure: autologous micro-fragmented adipose tissue; injection of autologous micro-fragmented adipose tissue (10 mL) after arthroscopic rotator cuff repair, in dry arthroscopy condition
Other: control group; arthroscopic rotator cuff repair only	Procedure: arthroscopic rotator cuff repair; arthroscopic rotator cuff repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Milan
• Investigators: Principal Investigator: Pietro Randelli, MD, U.O.C. 1a Divisione, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): April 19, 2020
• Study Completion (Actual): April 27, 2021

Study Registration Dates

• First Submitted: March 9, 2016
• First Submitted That Met QC Criteria: May 23, 2016
• First Posted (Estimate): May 26, 2016

Study Record Updates

• Last Update Posted (Actual): June 15, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: LipoTendon01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No