Comparing the results of using strut bone graft from the iliac bone and cancellous bone graft from the iliac bone on large bone defects in the lower body

ISRCTN	ISRCTN99236054
DOI	https://doi.org/10.1186/ISRCTN99236054
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	2021-05-039
Sponsor	Hanyang University Seoul Hospital
Funder	Investigator initiated and funded

Submission date: 13/02/2023
Registration date: 15/03/2023
Last edited: 28/02/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
This study is looking at a new way to fix large bone defects in the lower body using bone graft from the iliac bone. In the past, using simple bone grafting has not been successful for fixing large bone defects. This study will compare using a strut-type bone graft from the iliac bone to using a cancellous bone graft from the iliac bone. The goal is to see if the strut-type bone graft is a good solution with fewer complications.

Who can participate?
Patients over 18 years of age with bone defects in the long bones of the lower extremity, treated by autogenous iliac bone graft (AIBG)

What does the study invlove?
Analyzing the outcomes of autogenous strut bone graft in large bone defects of ≥ 5 cm in the lower extremities and to compare it with the autogenous cancellous bone graft, which is accepted as the golden standard of treatment in bone defects of < 5 cm.

What are the possible benefits and risks of participating?
You can receive specialized treatment for bone defects in the lower limbs. Complications may occur during treatment, including infection, bleeding, pain, and damage to nerves and blood vessels.

Where is the study run from?
Hanyang University Seoul Hospital, 222-1 Wangsimni-ro, Seongdong-gu, Seoul 04763 KOREA

When is the study starting and how long is it expected to run for?
This study is a retrospective study, and all data collection and analysis were completed in December 2021, starting with the study design plan in December 2019.

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Professor Kyu Tae Hwang, M.D, Ph.D.
md0713@hanmail.net

Contact information

Prof Kyu Tae Hwang
Principal investigator

Department of Orthopaedic Surgery
Hanyang University College of Medicine
222 Wangsimni-ro
Seongdong-gu
Seoul
04763
Korea, South

Phone	+82-2-2290-8485
Email	md0713@hanmail.net

Dr Incheol Kook
Public

Department of Orthopaedic Surgery
Hanyang University College of Medicine
222 Wangsimni-ro
Seongdong-gu
Seoul
04763
Korea, South

ORCID ID	0000-0001-8691-5495
Phone	+82-2-2290-8485
Email	nathan0319@naver.com

Study information

Primary study design	Interventional
Study design	Single center interventional non-randomized retrospective cohort study
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	The impact of autogenous iliac strut bone graft on large bone defect of lower extremity compared with autogenous iliac cancellous bone graft: a retrospective cohort study
Study acronym	Strut AIBG
Study objectives	Autogenous bone graft in strut form might show favorable union rate in large bone defects of ≥ 5 cm with minimal complications
Ethics approval(s)	Approved 02/05/2021, Hanyang University Hospital Instituional review board (222-1 Wangsimni-ro, Seongdong-gu, Seoul, 04763, South KOREA; +82 (2)2290 9651; icshin@hanyang.ac ), ref: HYUH 2021-05-039
Health condition(s) or problem(s) studied	Performing autogenous strut bone graft in patients with large bone defects of ≥ 5 cm in the lower extremities.
Intervention	Based on the types of the grafted bone, the patients were classified into two groups: strut bone graft group and cancellous bone graft group. All bone grafts were harvested along the anterior iliac crest through the anterior approach. The strut-type corticocancellous bone graft was harvested using an osteotome, and a cortical window was used for harvesting the cancellous bone graft. Strut bone graft was performed only when the bone defect length was ≥ 5 cm. All of the bone graft procedures were performed by a single orthopedic trauma surgeon.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Union and time to union were evaluated using a Radiographic Union Scale of Tibial Fractures (RUST) at 1, 2, 3, 6, 9, and 12 months postoperatively.
Key secondary outcome measure(s)	1. Complications measured retrospective medical record review over admission and outpatient follow-up period 2. Reoperations measured using retrospective medical record review over admission and outpatient follow-up period
Completion date	01/12/2021

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	50
Total final enrolment	50
Key inclusion criteria	1. Bone defects in the long bones of the lower extremity 2. Bone defects treated by autogenous iliac bone graft 3. Age over 18 years
Key exclusion criteria	1. Age younger than 18 years 2. Bone defects caused by pathologic fracture or tumor resection 3. Less than 12 months of follow-up period
Date of first enrolment	23/03/2011
Date of final enrolment	02/04/2020

Locations

Countries of recruitment

Korea, South

Study participating centre

Hanyang University Soeul Hospital

222-1 Wangsimni-ro
Seongdong-gu
Seoul
04763
Korea, South

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and analysed during the current study will be available upon request from Kyu Tae Hwang, M.D., Ph.D, e-mail: md0713@hanmail.net

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

28/02/2023: Trial's existence confirmed by Hanyang University Hospital Instituional review board.