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Efficacy of Microfragmented Lipoaspirate Tissue in Arthroscopic Rotator Cuff Repair

Primary Purpose

Rotator Cuff Tears

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

arthroscopic rotator cuff repair

autologous micro-fragmented adipose tissue

About this trial

This is an interventional treatment trial for Rotator Cuff Tears

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

U.O.C. 1a Divisione, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
IRCCS Policlinico San Donato

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

treatment group

control group

Arm Description

arthroscopic rotator cuff repair + injection of autologous micro-fragmented adipose tissue (10 mL)

arthroscopic rotator cuff repair only

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Comparison of Constant score between the two groups at 1, 3, 6, 12, 18, 24 months post-operatively

Comparison of ASES score between the two groups at 1, 3, 6, 12, 18, 24 months post-operatively

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.

Comparison SST score (simple shoulder test) between the two groups at 1, 3, 6, 12, 18, 24 months post-operatively.

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.

Comparison of incidence of re-ruptures between the two groups at 18 months post-operatively, measured with magnetic resonance imaging.

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)

Number of adverse events for any cause

Full Information

NCT ID

NCT02783352

First Posted

March 9, 2016

Last Updated

June 10, 2021

Sponsor

University of Milan

1. Study Identification

Unique Protocol Identification Number

NCT02783352

Brief Title

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

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

February 2016 (undefined)

Primary Completion Date

April 19, 2020 (Actual)

Study Completion Date

April 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Milan

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotator Cuff Tears

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

treatment group

Arm Type

Experimental

Arm Description

arthroscopic rotator cuff repair + injection of autologous micro-fragmented adipose tissue (10 mL)

Arm Title

control group

Arm Type

Other

Arm Description

arthroscopic rotator cuff repair only

Intervention Type

Procedure

Intervention Name(s)

arthroscopic rotator cuff repair

Intervention Description

arthroscopic rotator cuff repair

Intervention Type

Procedure

Intervention Name(s)

autologous micro-fragmented adipose tissue

Intervention Description

injection of autologous micro-fragmented adipose tissue (10 mL) after arthroscopic rotator cuff repair, in dry arthroscopy condition

Primary Outcome Measure Information:

Title

Comparison of Constant score between the two groups at 6 months post-operatively

Description

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

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

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

Title

Comparison of strength in abduction and external rotation between the two groups at 1, 3, 6, 12, 18, 24 months post-operatively.

Description

Strength will be measured with a dynamometer, using International System metrics.

Time Frame

1, 3, 6, 12, 18, 24 months

Title

Comparison of incidence of re-ruptures between the two groups at 18 months post-operatively, measured with magnetic resonance imaging.

Time Frame

18 months

Title

Comparison of development of fatty degeneration in the supraspinatus at 18 months post-operatively

Description

degeneration is measured with magnetic resonance imaging and classified using the Fuchs classification (grading I-IV)

Time Frame

18 months

Title

Number of adverse events for any cause

Time Frame

7 days, 45-90 days, 12-18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pietro Randelli, MD

Organizational Affiliation

U.O.C. 1a Divisione, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO

Official's Role

Principal Investigator

Facility Information:

Facility Name

U.O.C. 1a Divisione, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO

City

Milano

State/Province

Milan

ZIP/Postal Code

20122

Country

Italy

Facility Name

IRCCS Policlinico San Donato

City

San Donato Milanese

State/Province

Milan

ZIP/Postal Code

20097

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35302901

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.

Results Reference

derived

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Efficacy of Microfragmented Lipoaspirate Tissue in Arthroscopic Rotator Cuff Repair

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