Evidence map›Paper›PMID 39427182›Full record

ArticleTrials2024

Stem cell treatment for regeneration of the rotator cuff: study protocol for a prospective single-center randomized controlled trial (Lipo-cuff).

Mariana Bichuette Cartuliares, Eva Kildall Hejbøl, Henrik Daa Schrøder, Andreas Kristian Pedersen, Lars Henrik Frich

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06505135 (Stem Cell Treatment for Regeneration of the Rotator Cuff), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06505135 phase1enrolling by invitationnot on this map

Stem Cell Treatment for Regeneration of the Rotator Cuff (Lipo-Cuff Study)

TypeinterventionalSponsorUniversity of Southern DenmarkRan2024 to 2026Enrolled30ConditionsRotator Cuff Tears, Rotator Cuff Injuries, Rotator Cuff Tear ArthropathyArmsStem-cell treatment, Standard care
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Mariana Bichuette Cartuliares *Department of Orthopaedics, Hospital Soenderjylland, Kresten Philipsens Vej 15, Aabenraa, 6200, Denmark. mbc@rsyd.dk.ORCID http://orcid.org/0000-0003-0923-6960
Eva Kildall Hejbøl *Department of Regional Health Research, University of Southern Denmark, Campusvej 55, Odense M, 5230, Denmark.
Henrik Daa SchrøderDepartment of Pathology, Odense University Hospital, J. B. Winsløws Vej 15, Odense, 5000, Denmark.
Andreas Kristian PedersenDepartment of Clinical Research, University of Southern Denmark, Winsløwparken 19, Odense, 5000, Denmark.
Lars Henrik FrichDepartment of Orthopaedics, Hospital Soenderjylland, Kresten Philipsens Vej 15, Aabenraa, 6200, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRotator cuff tears (RCT) are a common musculoskeletal condition, especially in the aging population. The prevalence of rotator cuff tears varies based on factors like age, occupation, and activity level. In the general population, the prevalence of rotator cuff tears is estimated to be around 20 to 25%. Rotator cuff tears (RCT) have an impact in patients' pain level, shoulder function, sleep disturbance, and quality of life. Primary tendon surgery is in mostly cases necessary. This study aimed to examine if treatment of rotator cuff lesions with implantation of micro-fragmented adipose tissue can improve patients' reported pain and function compared to conventional surgery.

methodsThe study is a prospective superiority parallel-group single-center randomized controlled trial including 30 patients between 40 and 69 years of age in Denmark. Patients will be allocated 1:1 ratio to reconstruction of the supraspinatus tendon with an injection of micro-fragmented adipose tissue into the related muscle (stem cell treatment) or the standard of care (SOC), which is conventional surgery. Patients, project assistants, physicians, and outcome adjudicators are not blinded to randomization due to practical constraints. The radiologist and the statistician performing the analysis will be blinded. The primary outcome will be the Oxford shoulder score at 12 months post-surgery. DISCUSSION: This study will assess whether adding micro-fragmented adipose tissue therapy to conventional rotator cuff tear treatment can enhance recovery, accelerate return to daily activities, and improve functional outcomes. The research will also determine if this minimally invasive procedure could be standardized for routine patient care.

trial registrationClinicalTrials.gov NCT06505135. Registered on July 10, 2024.

Indexed as

Adipose TissueRandomized Controlled Trials as TopicRecovery of FunctionRotator CuffRotator Cuff InjuriesAdultAgedDenmarkEquivalence Trials as TopicFemaleHumansMaleMiddle AgedPain MeasurementProspective StudiesRegenerationOxford shoulder scorePatient-reported outcomeRandomized controlled trialRotator cuff tearStem cell treatment

Identifiers

PMID39427182
PMCPMC11492208

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.