Assessing the efficacy of a modified surgical technique in the treatment of unstable sacral fracture
| ISRCTN | ISRCTN81077281 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81077281 |
| Secondary identifying numbers | 201008002 |
- Submission date
- 30/12/2018
- Registration date
- 24/01/2019
- Last edited
- 27/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
It remains a complex and challenging problem to stabilize vertical unstable sacral fractures. Here, we describe a modified triangular osteosynthesis protocol to fix the sacral fractures. Our aim was to evaluate clinical effects by using this modified technique.
Who can participate?
Patients with sacral fractures
What does the study involve?
All participants received the same treatment, the modified triangular osteosynthesis protocol was applied in every case and done by one doctor team; data before and after operation for every case was collected and compared.
What are the possible benefits and risks of participating?
The technique can fix vertical unstable sacral fractures that have achieved faster and sufficient stability and reduce the discomfort of patients. There are risks associated with the operation and anaesthesia.
Where is the study run from?
Department of Orthopedics, Affiliated Dongfeng Hospital, Hubei University of Medicine.
When is the study starting and how long is it expected to run for?
The overall trial started on June 10, 2010. We observed the cases from Oct 7, 2010 to Dec 30, 2017.
Who is funding the study?
The cost for the study was in part paid by the local medical insurance and the grants from the grants from the Jingchu Program for Excellent Talents, the Provincial Educational Board of Hubei in 2017 (NO. 54), the Scientific and Technological Project of Shiyan City of Hubei Province (NO.14K72) and Teach & Research Program of Hubei University of Medicine (NO. 2017036).
Who is the main contact?
Min Xiong
minxiong1975@yahoo.com
Contact information
Scientific
Department of Orthopedics, Affiliated Dongfeng Hospital, Hubei University of Medicine, Shiyan 442008, Hubei, China
Shiyan, Hubei
442008
China
Study information
| Study design | Observational case series |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No available in web format, please use contact details to request a participant information sheet |
| Scientific title | A modified triangular osteosynthesis protocol for the rod and pedicle screw of vertical unstable sacral fracture: an observational case series. |
| Study acronym | N/A |
| Study objectives | The aim of the present study was to analyze the clinical effect of a modified technique (vertical and transverse bringing-fixation with the rod and pedicle screw system) for sacral fracture. |
| Ethics approval(s) | Medical Ethics Committee of Sinopharm Dongfeng General Hospital, 10/08/2010, ref. 201008002. |
| Health condition(s) or problem(s) studied | Sacral fracture |
| Intervention | Following initial treatment, when the patient’s condition was sufficiently improved to allow surgical intervention, the current surgery was performed. This is a single step procedure, which took an average lag time of 6 - 8 days that spans the initial trauma and definite operation. The anterior external fixation was then removed. The posterior pelvis injury was addressed first with reduction and stabilization. The patient was placed in the prone position; an image boost was used during the course of operation (conventional C-arm fluoroscopy). Two initial skin incisions were made for all cases. A longitudinal and curved approach to the lumbosacral spine was made on a posterior median line，between the L4, L5 and iliac bone through the posterior-superior-iliac-spine; another one was made on a line along the contralateral iliac bone through PSIS. To allow a deeper seating of the screw head and prevent prominence of the metal work under the soft tissues, we made a bone window with a reamer in the bilateral iliac bone. A third paravertebral incision was made to perform sacral laminectomy when the patient was accompanied with pre-operative perineal neurological impairment. We used an USS rod and pedicle screw system (USS Fixateur Interne) during the procedure. First, pedicle screw insertion points were identified. After tapping, two pedicle screws were inserted into the pedicle of L4 and L5. The other three pedicle screws were inserted into the ilium between the inner and outer cortices. Then a straight rod was pre-curved to a L-shape with the angle according to screws position in L4、L5 pedicle and iliac bone through the PSIS, that consisted of a vertical fixation. A straight rod was connected in situ between bilateral parallel iliac screws through the PSIS that consisted of a transverse fixation. To reduce the fracture, screws were used as “joysticks” and a manipulator between the two screws was used. We loosened and tightened one screw that followed with a compressor to perform the reduction as well as manual forces to distract the ilium both posteriorly and caudally. The correct reduction of sacral fractures was confirmed posteriorly by palpation of the symmetrical positions of the bilateral PSIS and the image boost. The pedicle screw and the iliac screw were finally connected with the rod system. After copious irrigation, the surgical wound was closed on two suction drains. Next, the disrupted symphysis pubis or fractures of the pelvic rami was performed in the supine position using a dynamic compression plate, fixation depending on displacement level of anterior pelvic ring injury. Total duration of observation: from October 7th in 2010 to December 30th in 2017. Total duration of follow-up: from November 1st in 2010 to December 30th in 2017. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1.The following were measured post-operatively by reviewing patient and operation notes: 1.1. Time from admittance to surgery (delay days) 1.2. Duration of surgery 1.3. Blood loss volume and blood vessel 1.4. Nerve injury |
| Secondary outcome measures | 1. The following were measured post-operatively by reviewing patient and operation notes: 1.1. Follow-up duration 1.2. Neurological deficit 1.3. Skin lesion 1.4. Deep infection when reviewing patient and operation notes. 2. The following were measured using X-ray and CT imaging: 2.1. Tenderness 2.2. Loss of reduction 2.3. Fracture heal |
| Overall study start date | 10/06/2010 |
| Completion date | 30/07/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 28 |
| Total final enrolment | 28 |
| Key inclusion criteria | 1. Vertical unstable sacral fractures 2. Neural injury with associated intraforaminal debris |
| Key exclusion criteria | 1. Soft tissue defects that prevent operation zone coverage (the lumbosacral spine zone) 2. L4, L5 and iliac bone fractures through the insertion points of rod and pedicle screw system 3. Pathological fracture caused by osteoporosis or tumor 4. Follow-up less than 10 months. |
| Date of first enrolment | 10/08/2010 |
| Date of final enrolment | 30/07/2016 |
Locations
Countries of recruitment
- China
Study participating centre
Shiyan, Hubei Province
442008
China
Sponsor information
Hospital/treatment centre
Affiliated Dongfeng Hospital, Hubei University of Medicine
Shiyan, Hubei Province
442008
China
"ROR" |
https://ror.org/04fb6qy86 |
|---|
Funders
Funder type
Government
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 30/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We will publicate our observation as soon as possible. |
| IPD sharing plan | The data for the current study has been stored in medical records room of Affiliated Dongfeng Hospital of Hubei University of Medicine. The hospital is located in Shiyan 442008, Hubei, China. The data will be shared for scientific research upon request, but patient’s information should kept anonymous. We obtained consent from participants and are aware of ethical restrictions. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 07/01/2019 | 24/01/2019 | No | No | |
| Results article | 01/06/2021 | 27/02/2023 | Yes | No |
Additional files
- ISRCTN81077281_BasicResults_7Jan19.pdf
- Uploaded 24/01/2019
Editorial Notes
27/02/2023: Publication reference and total final enrolment added.
