Evidence map›Paper›PMID 39821211›Full record

Trial reportBritish medical bulletin2025

Safety and performance of a novel synthetic biomimetic scaffold for iliac crest defect reconstruction during surgical treatment of pelvic girdle pain: a first-in-human trial.

Peter V Giannoudis, Paul Andrzejwski, George Chloros, Elizabeth M A Hensor

Abstract readClinical Trial
In one paragraph

Trial report in British medical bulletin, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

2 citing papers in PubMed.

  1. Review
  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

4 authors.

Peter V GiannoudisAcademic Department of Trauma & Orthopaedics, School of Medicine, University of Leeds, Leeds, UK.ORCID 0000-0002-5205-7696
Paul AndrzejwskiAcademic Department of Trauma & Orthopaedics, School of Medicine, University of Leeds, Leeds, UK.
George ChlorosAcademic Department of Trauma & Orthopaedics, School of Medicine, University of Leeds, Leeds, UK.
Elizabeth M A HensorLeeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.

Funding

Department of Health and Social CareLeeds Biomedical Research Centre NIHR 203331National Institute for Health and Care Research
6 · The paper itself

Abstract

introductionSurgical treatment of pelvic girdle pain (PGP) involves arthrodesis of sacroiliac (SI) and pubic symphysis joints. Fusion of pubic symphysis involves the implantation of an autologous iliac crest tricortical graft harvested from the iliac crest. The objective was to assess the safety of a novel synthetic graft substitute (b.Bone) for iliac crest reconstruction and to evaluate the results of PGP surgical treatment. SOURCES OF DATA: Consecutive participants undergoing pelvic fusion and requiring iliac crest reconstruction were enrolled and followed-up for 12 months in a prospective first-in-human clinical investigation. Adverse events were documented, and health-related quality of life was evaluated using EuroQol-5D-5L questionnaire. Iliac crest defect healing was evaluated by the Modified Lane and Sandhu radiological scoring system. In addition, relevant published peer-reviewed scientific articles identified from PubMed. AREAS OF AGREEMENT: The EQ-5D-5L scores improved steadily reaching the highest point at 365 days. By 365 days complete healing of the bone defect was observed. AREAS OF CONTROVERSY: The management of PGP remains challenging with mixed results reported in the literature. GROWING POINTS: While there is lack of consensus on how to manage PGP, the present study shows improved outcomes at one year following surgery. The synthetic b.Bone scaffold is a safe option with good healing outcomes for iliac crest defect reconstruction. AREAS TIMELY FOR DEVELOPING RESEARCH: Although b.Bone synthetic scaffold found to be safe, further studies reporting on surgical treatment of PGP are required to confirm the findings in comparative trials.

Indexed as

ArthrodesisBone SubstitutesBone TransplantationIliumPelvic Girdle PainTissue ScaffoldsAdultFemaleHumansMaleMiddle AgedProspective StudiesQuality of LifeSacroiliac JointTreatment OutcomeBone Substitutesb.Bone scaffoldhypermobilityLevel of evidence: Therapeutic level phase 0pelvic fusionpelvic pain

Identifiers

PMID39821211
PMCPMC11738167

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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.