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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.

作者信息

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

机构信息

Academic Department of Trauma & Orthopaedics, School of Medicine, University of Leeds, Leeds, UK.

Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.

出版信息

Br Med Bull. 2025 Jan 16;153(1). doi: 10.1093/bmb/ldae023.


DOI:10.1093/bmb/ldae023
PMID:39821211
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11738167/
Abstract

INTRODUCTION: Surgical 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.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e4f/11738167/46f8ceceef86/ldae023f6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e4f/11738167/d645abd91e1d/ldae023f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e4f/11738167/c2cb1fe4541c/ldae023f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e4f/11738167/fe03d01ed047/ldae023f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e4f/11738167/559c355cb1c8/ldae023f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e4f/11738167/ee25647436f7/ldae023f5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e4f/11738167/46f8ceceef86/ldae023f6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e4f/11738167/d645abd91e1d/ldae023f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e4f/11738167/c2cb1fe4541c/ldae023f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e4f/11738167/fe03d01ed047/ldae023f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e4f/11738167/559c355cb1c8/ldae023f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e4f/11738167/ee25647436f7/ldae023f5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e4f/11738167/46f8ceceef86/ldae023f6.jpg

相似文献

[1]
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.

Br Med Bull. 2025-1-16

[2]
Reconstruction of iliac crest with bovine cancellous allograft after bone graft harvest for symphysis pubis arthrodesis.

Int Orthop. 2012-5-22

[3]
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[4]
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[5]
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Spine J. 2012-11-16

[6]
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[7]
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Spine (Phila Pa 1976). 2005-12-15

[8]
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J Spinal Disord Tech. 2005-2

[9]
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Skeletal Radiol. 2001-5

[10]
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本文引用的文献

[1]
Effect of collagen-based scaffolds with hydroxyapatite on the repair of cartilage defects in the rabbit knee joint.

J Orthop Surg Res. 2024-12-3

[2]
Osteoinductive potential of graphene and graphene oxide for bone tissue engineering: a comparative study.

J Orthop Surg Res. 2024-8-30

[3]
Comparative Efficacy of Clinical Interventions for Sacroiliac Joint Pain: Systematic Review and Network Meta-analysis With Preliminary Design of Treatment Algorithm.

Neurospine. 2023-9

[4]
Hypermobility prevalence, measurements, and outcomes in childhood, adolescence, and emerging adulthood: a systematic review.

Rheumatol Int. 2023-8

[5]
Ligament Advanced Reinforcement System (LARS) synthetic graft for PCL reconstruction: systematic review and meta-analysis.

Br Med Bull. 2022-9-22

[6]
Pelvic Girdle Pain, Hypermobility Spectrum Disorder and Hypermobility-Type Ehlers-Danlos Syndrome: A Narrative Literature Review.

J Clin Med. 2020-12-9

[7]
Minimally Invasive Sacroiliac Joint Fusion: The Current Evidence.

Int J Spine Surg. 2020-2-10

[8]
iFuse Implant System for Treating Chronic Sacroiliac Joint Pain: A NICE Medical Technology Guidance.

Appl Health Econ Health Policy. 2020-6

[9]
Randomized Trial of Sacroiliac Joint Arthrodesis Compared with Conservative Management for Chronic Low Back Pain Attributed to the Sacroiliac Joint.

J Bone Joint Surg Am. 2019-3-6

[10]
Reconstruction of iliac crest defect after autogenous harvest with bone cement and screws reduces donor site pain.

BMC Musculoskelet Disord. 2018-7-19

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