NCT02783352

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 9, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2021

Completed
Last Updated

June 15, 2021

Status Verified

June 1, 2021

Enrollment Period

4.2 years

First QC Date

March 9, 2016

Last Update Submit

June 10, 2021

Conditions

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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.

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

  • +3 more secondary outcomes

Study Arms (2)

treatment group

EXPERIMENTAL

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

Procedure: arthroscopic rotator cuff repairProcedure: autologous micro-fragmented adipose tissue

control group

OTHER

arthroscopic rotator cuff repair only

Procedure: arthroscopic rotator cuff repair

Interventions

arthroscopic rotator cuff repairPROCEDURE

arthroscopic rotator cuff repair

control grouptreatment group
autologous micro-fragmented adipose tissuePROCEDURE

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

treatment group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \< 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.

You may not qualify if:

  • 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.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Milan, Milan, 20122, Italy

Location

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

Location

Related Publications (1)

  • 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.

    PMID: 35302901DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Pietro Randelli, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

March 9, 2016

First Posted

May 26, 2016

Study Start

February 1, 2016

Primary Completion

April 19, 2020

Study Completion

April 27, 2021

Last Updated

June 15, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)