Could a shot of your own fat make rotator cuff surgery last longer?

NCT ID NCT06960343

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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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

About 52 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Show 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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • ASST Gaetano Pini-CTO

    RECRUITING

    Milan, Italy, 20122, Italy

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