Rotator Cuff TearsNCT02783352
Efficacy of Microfragmented Lipoaspirate Tissue in Arthroscopic Rotator Cuff Repair
A study testing arthroscopic rotator cuff repair and autologous micro-fragmented adipose tissue in people with Rotator Cuff Tears, run by University of Milan at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- arthroscopic rotator cuff repair and autologous micro-fragmented adipose tissue
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesItaly
- Study dates
- Feb 2016to 27 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 22Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
U.O.C. 1a Divisione, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
Milan, Milan, 20122
IRCCS Policlinico San Donato
San Donato Milanese, Milan, 20097
About this study
Official title: 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.
Read the 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.
- Conditions
- Rotator Cuff Tears
- Being tested
- arthroscopic rotator cuff repair, autologous micro-fragmented adipose tissue
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroscopic rotator cuff repairProcedure or surgery
arthroscopic rotator cuff repair
autologous micro-fragmented adipose tissueProcedure or surgery
injection of autologous micro-fragmented adipose tissue (10 mL) after arthroscopic rotator cuff repair, in dry arthroscopy condition
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | arthroscopic rotator cuff repair + injection of autologous micro-fragmented adipose tissue (10 mL) Receives: Procedure: arthroscopic rotator cuff repair; Procedure: autologous micro-fragmented adipose tissue |
| control group | Other | arthroscopic rotator cuff repair only Receives: Procedure: arthroscopic rotator cuff repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (8)
Comparison of Constant score between the two groups at 1, 3, 6, 12, 18, 24 months post-operatively
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 18 months
Number of adverse events for any cause
Measured: 7 days, 45-90 days, 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startFeb 2016
- Primary completion19 Apr 2020
- Study completion27 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pietro Randelli, MD, University of Milan
- Investigators
- Pietro Randelli, MD, Principal investigator, U.O.C. 1a Divisione, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783352
- Sponsor's protocol ID
- LipoTendon01
- Status last verified
- Jun 2021
- First submitted
- 9 Mar 2016
- Last updated
- 15 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 35302901
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Microfragmented Lipoaspirate Tissue in Arthroscopic Rotator Cuff Repairs: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02783352
- Acronym / sponsor ID
- LipoTendon01
- Conditions
- Rotator Cuff Tears
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- 19 Apr 2020 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 26 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Procedure: arthroscopic rotator cuff repair, Procedure: autologous micro-fragmented adipose tissuearthroscopic rotator cuff repair + injection of autologous micro-fragmented adipose tissue (10 mL) |
| control group | Other | Procedure: arthroscopic rotator cuff repairarthroscopic rotator cuff repair only |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arthroscopic rotator cuff repairarthroscopic rotator cuff repair | Procedure or surgery | control group, treatment group |
| autologous micro-fragmented adipose tissueinjection of autologous micro-fragmented adipose tissue (10 mL) after arthroscopic rotator cuff repair, in dry arthroscopy condition | Procedure or surgery | treatment group |
Primary outcome
Comparison of Constant score between the two groups at 6 months post-operatively
Time frame: 6 months
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.
8 secondary outcomes
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.
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
Time frame: 18 months
Number of adverse events for any cause
Time frame: 7 days, 45-90 days, 12-18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Derived from this study: PubMed 35302901Randelli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pietro Randelli, MD principal investigator
U.O.C. 1a Divisione, Azienda Socio Sanitaria Territoriale Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing arthroscopic rotator cuff repair and autologous micro-fragmented adipose tissue in people with Rotator Cuff Tears, run by University of Milan at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Constant score between the two groups at 6 months post-operatively (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02783352, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2021.