Could a shot of your own fat make rotator cuff surgery last longer?
NCT ID NCT06960343
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether adding a small amount of a patient's own processed fat tissue during arthroscopic rotator cuff repair can improve healing and reduce the chance of the tendon tearing again. About 52 adults with full-thickness tears will be followed for at least 5 years after surgery. The main goal is to see if the fat injection lowers the re-tear rate on MRI and improves shoulder function and pain.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 52 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This study is a prospective, randomized, double-blind, controlled clinical trial and represents the final follow-up of an our previous study with short follow-up (2 years). At least 5 years after surgery, all enrolled patients in the previous study will be call again and will be asked to complete the ASES, SST, and VAS questionnaire and they will undergo a clinical examination, including the CMS and measurement of isometric strength in shoulder forward flexion, abduction, and external rotation. All strength measures will be performed in triplicate with a dynamometer. During the same assessment day, the patients would be evaluated with MRI of the operated shoulder in order to assess tendon integrity and calculate rerupture rate according to the classification proposed by Sugaya (types IV and V defined as retears). Atrophy of the supraspinatus muscle belly was evaluated according to Warner and fatty degeneration was classified according to Fuchs.
- Ages
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18 years and older
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age \> 18 years * Full-thickness supraspinatus and infraspinatus tendon tears (C1, C2, and C3 according to the SCOI classification) * Indication for arthroscopic rotator cuff repair * Informed consent to participate in the study * Informed consent to participate for the duration of the study Exclusion Criteria: * Partial rotator cuff tendon tears (A1, A2, A3, B1, B2, and B3 according to the SCOI classification) * Massive rotator cuff tear (C4 according to the SCOI classification) * Subscapularis tendon tear (grade III, IV, or IV according to Lafosse classification) * Associated anterior, posterior, or multidirectional shoulder instability * Indication for repair of a SLAP lesion of the biceps anchor * Grade III or IV muscle atrophy of the supraspinatus and infraspinatus tendons (according to Goutallier or Fuchs classification) * Intra-articular hyaluronic acid or corticosteroid infiltration within 3 mo from the planned surgical procedure * Medical comorbidities contraindicating arthroscopic shoulder surgery * Local (shoulder, abdominal region, gluteal region) or systemic infection, osteomyelitis, or sepsis * Diabetes mellitus, untreated thyroid disease, chronic kidney disease, rheumatoid arthritis * Immunodeficiency * Chronic disorders involving coagulation, platelet aggregation, or severe coagulopathy * Severe cardiovascular disease * Stroke or acute cardiovascular event within 6 mo from the planned surgical procedure * Weight loss for any cause .30 kg in 12 mo or .10 kg in 12 mo without a cause * Eating disorders or body dysmorphic disorder * Varices, phlebitis, or scars next to the planned adipose tissue harvesting site * Alcohol/drug addiction or psychiatric disease compromising compliance with postoperative protocols * Pregnancy or breastfeeding women * Informed consent not accepted
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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ASST Gaetano Pini-CTO
RECRUITINGMilan, Italy, 20122, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Stomach-Derived peptide help tendons heal faster after surgery?
- Can a patch make torn shoulder tendons heal stronger?
- Blood-derived injections may mend torn shoulder tendons without surgery
- Ultrasound 'Tissue Stiffness' test could reveal hidden rotator cuff healing problems
- Which painkiller wins for shoulder surgery? a Head-to-Head test
- Which shoulder repair works best for massive tears? a trial pits two techniques Head-to-Head