Evidence map›Paper›PMID 29151232›Full record

Trial reportMusculoskeletal surgery2018

Early promising outcome following arthroscopic implantation of the subacromial balloon spacer for treating massive rotator cuff tear.

R S M Piekaar, I C E Bouman, P M van Kampen, F van Eijk, P E Huijsmans

Abstract readClinical TrialComparative Study
PubMed Publisher
In one paragraph

Trial report in Musculoskeletal surgery, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 3 pooled it
6.2field-weighted citation impact, top 3% of its field
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

27 citing papers in PubMed, 3 syntheses or guidelines pooled it, 68 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Rotator cuff repair protected with subacromial balloon spacer shows a low rate of non-healing.Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA · 2022
    Article
  13. Article
  14. Article
  15. Observational
  16. Article
  17. Article
  18. Review
  19. Subacromial Balloon Spacer Implantation.Current reviews in musculoskeletal medicine · 2020
    Review
  20. 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

5 authors at 3 institutions in 1 country.

R S M PiekaarDepartment of Orthopaedic Surgery, Spaarne Gasthuis, Spaarnepoort 1, 2134 TM, Hoofddorp, The Netherlands. roderickpiekaar@gmail.com.
I C E BoumanDepartment of Orthopaedic Surgery, Haga Hospital The Hague, Sportlaan 600, 2566 MJ, The Hague, The Netherlands.
P M van KampenDepartment of Orthopaedic Surgery, Bergman Clinics, Laan van Oversteen 20, 2289 CX, Rijswijk, The Netherlands.
F van EijkDepartment of Orthopaedic Surgery, Bergman Clinics, Laan van Oversteen 20, 2289 CX, Rijswijk, The Netherlands.
P E HuijsmansDepartment of Orthopaedic Surgery, Bergman Clinics, Laan van Oversteen 20, 2289 CX, Rijswijk, The Netherlands.
Bergman Clinics · NLHaga Hospital · NLSpaarne Ziekenhuis · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMassive rotator cuff tear (RCT) can result in disability and severe pain. When conservative treatment fails, surgical treatment should be considered, as various surgical options can provide relatively satisfactory results. However, choosing an optimal treatment remains controversial. A relatively new treatment for irreparable RCT is the arthroscopic implantation of a biodegradable balloon spacer into the subacromial space. Here, we examined whether placement of this balloon spacer reduces pain and improves functional outcome in patients with an irreparable RCT. Patients were followed for 1 year following implantation.

methodsIn this prospective single-arm study, a biodegradable balloon spacer was implanted into the subacromial space of patients with a massive RCT. Pain was evaluated using a numeric rating scale (NRS), and functional outcome was evaluated using the Oxford shoulder score (OSS) and the Constant-Murley shoulder score (CMS). Five follow-up visits were performed during the first postoperative year.

resultsForty-six shoulders in 44 patients with massive RCT were treated by surgical implantation of the subacromial balloon spacer. The mean reduction in NRS score was 3.5 points (95% CI 2.5-4.4), and 74% of patients achieved the minimal clinically important difference of 2 points by the 1-year follow-up visit. Functional outcome improved significantly based on OSS and CMS scores, and 80% of patients reported that they were satisfied with their outcome. No surgical or postoperative medical complications due to implantation of the balloon spacer were reported.

conclusionsOur results suggest that arthroscopic implantation of a biodegradable balloon spacer in the subacromial space significantly reduces pain and improves activities of daily living in patients with massive RCT during 1 year of follow-up. The specific contribution of the balloon with respect to improved clinical outcome needs further study, ideally in a randomized controlled trial.

Indexed as

Absorbable ImplantsActivities of Daily LivingAgedArthroscopyDebridementFemaleFollow-Up StudiesHumansImmobilizationMaleMiddle AgedPostoperative PainProspective StudiesProsthesis DesignProsthesis ImplantationRange of Motion, ArticularArthroscopic surgeryBalloon spacerFunctional outcomeMassive rotator cuff tearPain reductionSubacromial spacer

Identifiers

PMID29151232
OpenAlexW2770421393

What OpenQuestion holds

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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.