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 |
| Secondary identifying numbers | 2021-05-039 |
- 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
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
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 |
|---|---|
| md0713@hanmail.net |
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 |
| nathan0319@naver.com |
Study information
| Study design | Single center interventional non-randomized retrospective cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Treatment |
| Participant information sheet | Not applicable (retrospective study) |
| 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 | 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. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/12/2019 |
| Completion date | 01/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
Seongdong-gu
Seoul
04763
Korea, South
Sponsor information
Hospital/treatment centre
222 Wangsimni-ro
Seongdong-gu
Seoul
04763
Korea, South
| Phone | +82-2-2290-8485 |
|---|---|
| irb@hyumc.com | |
| Website | https://seoul.hyumc.com/ |
"ROR" |
https://ror.org/04n76mm80 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/04/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact journal |
| 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 |
Editorial Notes
28/02/2023: Trial's existence confirmed by Hanyang University Hospital Instituional review board.
