Evidence map›Paper›PMID 26612576›Full record

Trial reportBMC musculoskeletal disorders2015

Complete twelve month bone remodeling with a bi-phasic injectable bone substitute in benign bone tumors: a prospective pilot study.

Jacek Kaczmarczyk, Piotr Sowinski, Maciej Goch, Katarzyna Katulska

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in BMC musculoskeletal disorders, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02567084 (A Prospective, Longitudinal Patient Study on CERAMENT™|BONE VOID FILLER in Benign Bone Tumors), which is not on this map. Cited by 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed
3.0field-weighted citation impact, top 10% 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.

NCT02567084 nacompletednot on this map

A Prospective, Longitudinal Patient Study on CERAMENT™|BONE VOID FILLER in Benign Bone Tumors

TypeinterventionalSponsorPoznan University of Medical SciencesRan2011 to 2014Enrolled14ConditionsBone CystArmsCERAMENT™, BONE VOID FILLER
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 42 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Article
  19. Article
  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

4 authors at 1 institution in 1 country.

Jacek KaczmarczykDepartment of Orthopedics and Traumatology, Poznań University of Medical Sciences, Poznan, Poland. dr.kaczmarczyk@gmail.com.
Piotr SowinskiDepartment of Orthopedics and Traumatology, Poznań University of Medical Sciences, Poznan, Poland. psowinski78@tlen.pl.
Maciej GochDepartment of Orthopedics and Traumatology, Poznań University of Medical Sciences, Poznan, Poland. ortopediapoznanska@gmail.com.
Katarzyna KatulskaDepartment of Radiology, Poznań University of Medical Sciences, Poznan, Poland. katarzyna_katulska@op.pl.
Poznan University of Medical Sciences · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBenign primary bone tumors are commonly treated by surgery involving bone grafts or synthetic bone void fillers. Although synthetic bone grafts may provide early mechanical support while minimizing the risk of donor-site morbidity and disease transmission, difficult handling properties and less than optimal transformation to bone have limited their use.

methodsIn a prospective series, patients with benign bone tumors were treated by minimal invasive intervention with a bi-phasic and injectable ceramic bone substitute (CERAMENT™ BONE VOID FILLER, BoneSupport, Sweden) with the hypothesis that open surgery with bone grafting might be avoided. The defects were treated by either mini-invasive surgery (solid tumors) or percutaneous injection (cysts) and followed clinically and radiologically for 12 months. CT scan was performed after 12 months to confirm bone remodeling of the bone substitute. All patients were allowed full weight bearing immediately after surgery.

resultsFourteen patients with a median age of 13 years (range 7-75) were consecutively recruited during 11 months. Eleven lesions were bone cysts (eight unicameral and three post-traumatic) and three were solid benign tumors. The median size of the lesions was 40 mL (range 1-152). The most common location was humerus (n = 10). After 12 months the defects completely or partially filled with median 18 mL (range 5-28) of bone substitute demonstrated full resolution (Neer Classification grade I) in 11 patients, partial resolution (Neer II) in 2 patients and in 1 patient the cyst persisted (Neer III). No lesions required recurrent surgery during the observation period. No post-operative fracture or infection was recorded.

conclusionsMinimal invasive treatment with a bi-phasic and injectable ceramic bone substitute might offer an alternative to regular bone grafting due to convenient handling properties and rapid bone remodeling.

trial registrationClinicalTrials NCT02567084 Release Date 10/01/2015.

Indexed as

AdolescentAdultAgedBone NeoplasmsBone RemodelingBone SubstitutesChildFemaleHumansMaleMiddle AgedMinimally Invasive Surgical ProceduresPilot ProjectsProspective StudiesRadiographyTime FactorsBone Substitutes

Identifiers

PMID26612576
PMCPMC4661983
OpenAlexW2174421392

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.