Evidence map›Paper›PMID 41146252›Full record

ArticleTrials2025

The effect of low-intensity pulsed ultrasound (LIPUS) for the treatment of upper and lower extremity non-union compared to surgical intervention (PiNGUin): study protocol for a national, prospective, randomized controlled, open-label, multicenter, non-inferiority study.

Eva Simone Steinhausen, Andreas Stang, Anika Hüsing, Eva-Maria Huessler, Marcus Brinkmann, Bernadette Schröder, Verena Schröder, Hannah Hohberg-Piel, Marcel Dudda

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

9 authors.

Eva Simone SteinhausenDepartment of Trauma, Hand and Reconstructive Surgery, University Hospital Essen, Hufelandstr. 55, 45147, Essen, Germany. evasimone.steinhausen@bg-klinikum-duisburg.de.
Andreas StangInstitute for Medical Informatics, Biometry and Epidemiology, University Hospital Essen, Hufelandstr. 55, 45147, Essen, Germany.
Anika HüsingInstitute for Medical Informatics, Biometry and Epidemiology, University Hospital Essen, Hufelandstr. 55, 45147, Essen, Germany.
Eva-Maria HuesslerInstitute for Medical Informatics, Biometry and Epidemiology, University Hospital Essen, Hufelandstr. 55, 45147, Essen, Germany.
Marcus BrinkmannInstitute for Medical Informatics, Biometry and Epidemiology/Center for Clinical Trials, University Hospital Essen, Hufelandstr. 55, 45147, Essen, Germany.
Bernadette SchröderInstitute for Medical Informatics, Biometry and Epidemiology/Center for Clinical Trials, University Hospital Essen, Hufelandstr. 55, 45147, Essen, Germany.
Verena SchröderInstitute for Medical Informatics, Biometry and Epidemiology/Center for Clinical Trials, University Hospital Essen, Hufelandstr. 55, 45147, Essen, Germany.
Hannah Hohberg-PielInstitute for Medical Informatics, Biometry and Epidemiology/Center for Clinical Trials, University Hospital Essen, Hufelandstr. 55, 45147, Essen, Germany.
Marcel DuddaDepartment of Trauma, Hand and Reconstructive Surgery, University Hospital Essen, Hufelandstr. 55, 45147, Essen, Germany.

Funding

G-BA PiNGUin
6 · The paper itself

Abstract

backgroundNon-unions, defined as fractures not healed after at least 6 months, are a multifactorial complication occurring in 2-10% of all fractures and in up to 30% of patients with certain risk factors. Treatment costs are markedly higher than those associated with normal fracture healing and patients often suffer from pain and loss of function. Surgical revision is the gold standard for treatment; however, the disadvantages are re-hospitalization, possible secondary diseases and side effects such as post-operative infections, complications of anesthesia and embolisms. Low-intensity pulsed ultrasound (LIPUS) is a low-risk procedure, with skin reactions being the only side effect experienced by a very small number of patients. Patients can use the treatment independently at home, eliminating the need for repeated hospital visits. This study aims to show that LIPUS treatment is not inferior to surgical intervention by a threshold of -25 percentage points in terms of fracture healing in non-unions of the upper or lower extremity.

methodsPiNGUin will be a five-year national, prospective, controlled, randomized, open-label, multicenter study with a medical device. Patients are randomized into one of two groups: patients in the intervention group will receive daily 20-min LIPUS treatment for 200 days or undergo standard surgical intervention in the control group. Follow-up for both groups will be 12 months. The primary endpoint is fracture healing 12 months after treatment start, defined as bony consolidation of at least 3 out of 4 cortices and functional recovery. Secondary endpoints include time to fracture healing and to full weight bearing, incidence and intensity of pain, functional complaints/activities of daily living, health-related quality of life, complications, adverse events, re-operations or re-osteosyntheses and (re-) hospitalizations, hospital stays, duration and reasons for inability to work. With a one-sided significance level of 2.5%, a power of 90% and an assumed drop-out rate of 10% 184 patients will be required per treatment group. DISCUSSION: As LIPUS is a low-complication procedure with good results to date, this treatment is considered a potential alternative to surgery. If non-inferiority is proven, patients will have a choice of both invasive and non-invasive procedures in the future.

trial registrationDRKS00034357 (German Clinical Trials Register, registered March 11th, 2025).

Indexed as

Fracture HealingFractures, UnunitedLower ExtremityUltrasonic TherapyUltrasonic WavesUpper ExtremityEquivalence Trials as TopicHumansMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeFracture healingLow-intensity pulsed ultrasound (LIPUS)Medical deviceNon-inferiority studyNon-unionRandomized controlled trial (RCT)

Identifiers

PMID41146252
PMCPMC12560377

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Registered trials

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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.