Spinal FusionNCT05190055
Evaluation of Treatment Effect of Minimally Invasive Spinal Fusion Surgery
A study testing bone graft delivery system/wiltrom interbody fusion system/wiltrom spinal fixation system and wiltrom interbody fusion system/wiltrom spinal fixation system in people with Spinal Fusion, run by Chi Mei Medical Hospital.
Trial summary
Participants with lumbar spondylosis, degenerative disc disease, spondylolisthesis, scoliosis, or trauma undergoing elective Transforaminal lumbar interbody fusion (TLIF) were recruited. The follow-up period was 24 months for each participant. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Fusion
- What is being tested?
- bone graft delivery system/wiltrom interbody fusion system/wiltrom spinal fixation system and wiltrom interbody fusion system/wiltrom spinal fixation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- 25 Mar 2015to 26 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- spinal fusion procedures in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. Patients should have had six months of non-operative treatment prior to treatment with an intervertebral body fusion device.
Who cannot join
- Patients unsuitable for anesthesia
- Active systemic infection, infection or suspected latent infection localized to the site of the proposed implantation
- Excessive local inflammation
- Rapid joint disease, bone absorption, osteopenia
- Severe osteoporosis or osteopenia
- Morbid obesity
Show all 13Show fewer
- Pregnancy
- Open wounds
- Patients have demonstrated allergy or foreign body sensitivity to any of the implant materials
- Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, surgery, such as the presence of tumors, congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood cell count (WBC), or marked left shift in the WBC differential count
- Patients whose activity, mental capacity, mental illness, alcoholism, drug abuse, occupation, or lifestyle may interfere with their ability to follow postoperative restrictions and who may place undue stresses on the implant during bony healing and may be at a higher risk of implant failure
- Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance
- Any condition not described in the indications for use
About this study
Official title: Department of Neurosurgery, Chi-Mei Medical Center
Participants with lumbar spondylosis, degenerative disc disease, spondylolisthesis, scoliosis, or trauma undergoing elective Transforaminal lumbar interbody fusion (TLIF) were recruited. The follow-up period was 24 months for each participant. The eligible patients for this study should be above 18 years old with confirmed indication to TLIF through a posterior approach. Patients with an active infection, symptomatic osteoporosis, immature bone, pregnancy, active malignancy, and previous radiotherapy at the planned surgical site were excluded. Informed consent was signed by each participant before recruitment. We strictly followed the protocols of patient confidentiality and human subjects in the clinical trial implementation. The patients were blinded to the allocated surgical technique before the operation and during the follow-up period of two years. On the one hand, the doctor will assess the patient's physiological function recovery and imaging examinations (such as CT, MRI or X-ray) before and after the operation to understand the changes in the patient's pain index and the effect of intervertebral disc fusion after the operation; on the other hand, It also evaluates the quality of life and the degree of improvement of psychological emotions through the questionnaires of patients before and after surgery.
Read the detailed description
After receiving prophylactic antibiotics according to the local hospital protocol, the patients were generally anesthetized in a prone position. Paramedian or midline posterior sections were conducted, exposing the lumber vertebras encompassing the facet joints. The facet joints were removed, and decompression was performed. The diseased disc nucleus was then excised before filling in the bone substitutes. For the control group, the bone substitutes were filled in the disc space manually using a bone grafting funnel. In the case of device group, a novel filler tube with integrated threaded rod, which can be connected to a surgical drill, was used for rapid and continuous graft filling (Figure 1). A polyethyletherketone (PEEK) interbody fusion cage was then placed into the disc space followed by fixation with pedicle screws. The treatment efficacy was assessed by clinical analysis based on the visual analogue scale (VAS) for radicular pain and the Oswestry Disability Index (ODI) questionnaire for low back pain. The VAS back and leg pain scores were measured preoperatively and postoperatively at 1, 3, 6, 12, and 24 months. The ODI questionnaires were taken preoperatively and postoperatively at 3, 6, 12, and 24 months. The bone graft delivery volume and the filling time during the surgery were measured to compare the efficiency of the two approaches.
The X-ray and computed tomography were performed prior to surgery and at 3-, 6-, 12-, and 24-monthspost-surgery for bone fusion assessment. The degree of bone fusion was classified into three grades. Grade I was defined as a complete fusion, union case, and grade II and III was defined as a partial union and a non-union case, respectively. Bone fusion volume was further determined by three-dimensional reconstruction images using ITK-SNAP software
- Conditions
- Spinal Fusion
- Being tested
- bone graft delivery system/wiltrom interbody fusion system/wiltrom spinal fixation system, wiltrom interbody fusion system/wiltrom spinal fixation system
- Keywords
- Spinal Fusion, Minimally invasive surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone graft delivery system/wiltrom interbody fusion system/wiltrom spinal fixation systemDevice
After receiving prophylactic antibiotics according to the local hospital protocol, the patients were generally anesthetized in a prone position. Paramedian or midline posterior sections were conducted, exposing the lumber vertebras encompassing the facet joints. The facet joints were removed, and decompression was performed. The diseased disc nucleus was then excised before filling in the bone substitutes. In the case of the device group, a novel filler tube with an integrated threaded rod, which can be connected to a surgical drill, A PEEK interbody fusion cage was then placed into the disc space followed by fixation with pedicle screws.
wiltrom interbody fusion system/wiltrom spinal fixation systemDevice
After receiving prophylactic antibiotics according to the local hospital protocol, the patients were generally anesthetized in a prone position. Paramedian or midline posterior sections were conducted, exposing the lumber vertebras encompassing the facet joints. The facet joints were removed, and decompression was performed. The diseased disc nucleus was then excised before filling in the bone substitutes. For the control group, the bone substitutes were filled in the disc space manually using a bone grafting funnel. A PEEK interbody fusion cage was then placed into the disc space followed by fixation with pedicle screws.
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive spinal fusion surgery | Experimental | A filler tube with an integrated threaded rod, which can be connected to a surgical drill, was used for rapid and continuous graft filling. Receives: Device: bone graft delivery system/wiltrom interbody fusion system/wiltrom spinal fixation system |
| traditional spinal fusion surgery | Active comparator | Bone substitutes were filled in the disc space manually using a bone grafting funnel. Receives: Device: wiltrom interbody fusion system/wiltrom spinal fixation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of back pain at 24 months from baseline as measured by a 100 mm VAS scale
The back pain intensity on 100-mm VAS will be performed and recorded at Day 1 (within 48 hours before surgery as the Baseline) and 24th month.
Measured: Preoperation and 24month post operation
Change of function at 24 months from baseline as measured by the 100 points Oswestry Disability Index (ODI)
The level of function on 100-point ODI will be performed and recorded at Day 1 (within 48 hours before surgery as the Baseline) and 24th month.
Measured: Preoperation and 24month post operation
Secondary outcomes (1)
Fusion Rates
Fusion rates for each product as evidenced by bridging bone via x-ray radiograph
Measured: 3, 6, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start25 Mar 2015
- Primary completion30 Mar 2022
- Study completion26 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal FusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chi Mei Medical Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sher-Wei Lim, Chi Mei Medical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190055
- Sponsor's protocol ID
- 10508-J01
- Status last verified
- Jul 2022
- First submitted
- 19 Nov 2021
- Last updated
- 19 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang KS, Chen CW, Yau RB, Liang HC, Ko CC, Kuo JR, Chio CC, Lim SW. A novel surgical technique in transforaminal lumbar interbody fusion by the bone graft delivery device: evaluation of therapeutic effect in patients with minimally invasive spine surgery. BMC Surg. 2022 Oct 26;22(1):366. doi: 10.1186/s12893-022-01773-y.
PubMed 36289500
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Neurosurgery, Chi-Mei Medical Center
- ClinicalTrials.gov ID
- NCT05190055
- Acronym / sponsor ID
- 10508-J01
- Conditions
- Spinal Fusion
- Keywords
- Spinal Fusion, Minimally invasive surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Chi Mei Medical HospitalUniversity, hospital or other
- Study start
- 25 Mar 2015 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 26 Feb 2023 (estimated)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants with lumbar spondylosis, degenerative disc disease, spondylolisthesis, scoliosis, or trauma undergoing elective Transforaminal lumbar interbody fusion (TLIF) were recruited. The follow-up period was 24 months for each participant. The eligible patients for this study should be above 18 years old with confirmed indication to TLIF through a posterior approach. Patients with an active infection, symptomatic osteoporosis, immature bone, pregnancy, active malignancy, and previous radiotherapy at the planned surgical site were excluded. Informed consent was signed by each participant before recruitment. We strictly followed the protocols of patient confidentiality and human subjects in the clinical trial implementation. The patients were blinded to the allocated surgical technique before the operation and during the follow-up period of two years. On the one hand, the doctor will assess the patient's physiological function recovery and imaging examinations (such as CT, MRI or X-ray) before and after the operation to understand the changes in the patient's pain index and the effect of intervertebral disc fusion after the operation; on the other hand, It also evaluates the quality of life and the degree of improvement of psychological emotions through the questionnaires of patients before and after surgery.
Detailed description
After receiving prophylactic antibiotics according to the local hospital protocol, the patients were generally anesthetized in a prone position. Paramedian or midline posterior sections were conducted, exposing the lumber vertebras encompassing the facet joints. The facet joints were removed, and decompression was performed. The diseased disc nucleus was then excised before filling in the bone substitutes. For the control group, the bone substitutes were filled in the disc space manually using a bone grafting funnel. In the case of device group, a novel filler tube with integrated threaded rod, which can be connected to a surgical drill, was used for rapid and continuous graft filling (Figure 1). A polyethyletherketone (PEEK) interbody fusion cage was then placed into the disc space followed by fixation with pedicle screws. The treatment efficacy was assessed by clinical analysis based on the visual analogue scale (VAS) for radicular pain and the Oswestry Disability Index (ODI) questionnaire for low back pain. The VAS back and leg pain scores were measured preoperatively and postoperatively at 1, 3, 6, 12, and 24 months. The ODI questionnaires were taken preoperatively and postoperatively at 3, 6, 12, and 24 months. The bone graft delivery volume and the filling time during the surgery were measured to compare the efficiency of the two approaches.
The X-ray and computed tomography were performed prior to surgery and at 3-, 6-, 12-, and 24-monthspost-surgery for bone fusion assessment. The degree of bone fusion was classified into three grades. Grade I was defined as a complete fusion, union case, and grade II and III was defined as a partial union and a non-union case, respectively. Bone fusion volume was further determined by three-dimensional reconstruction images using ITK-SNAP software
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive spinal fusion surgery | Experimental | Device: bone graft delivery system/wiltrom interbody fusion system/wiltrom spinal fixation systemA filler tube with an integrated threaded rod, which can be connected to a surgical drill, was used for rapid and continuous graft filling. |
| traditional spinal fusion surgery | Active comparator | Device: wiltrom interbody fusion system/wiltrom spinal fixation systemBone substitutes were filled in the disc space manually using a bone grafting funnel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- spinal fusion procedures in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. Patients should have had six months of non-operative treatment prior to treatment with an intervertebral body fusion device.
Key exclusion criteria (13 listed)
- Patients unsuitable for anesthesia
- Active systemic infection, infection or suspected latent infection localized to the site of the proposed implantation
- Excessive local inflammation
- Rapid joint disease, bone absorption, osteopenia
- Severe osteoporosis or osteopenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bone graft delivery system/wiltrom interbody fusion system/wiltrom spinal fixation systemAfter receiving prophylactic antibiotics according to the local hospital protocol, the patients were generally anesthetized in a prone position. Paramedian or midline posterior sections were conducted, exposing the lumber vertebras encompassing the facet joints. The facet joints were removed, and decompression was performed. The diseased disc nucleus was then excised before filling in the bone substitutes. In the case of the device group, a novel filler tube with an integrated threaded rod, which can be connected to a surgical drill, A PEEK interbody fusion cage was then placed into the disc space followed by fixation with pedicle screws. | Device | Minimally invasive spinal fusion surgery |
| wiltrom interbody fusion system/wiltrom spinal fixation systemAfter receiving prophylactic antibiotics according to the local hospital protocol, the patients were generally anesthetized in a prone position. Paramedian or midline posterior sections were conducted, exposing the lumber vertebras encompassing the facet joints. The facet joints were removed, and decompression was performed. The diseased disc nucleus was then excised before filling in the bone substitutes. For the control group, the bone substitutes were filled in the disc space manually using a bone grafting funnel. A PEEK interbody fusion cage was then placed into the disc space followed by fixation with pedicle screws. | Device | traditional spinal fusion surgery |
Primary outcome
Change of back pain at 24 months from baseline as measured by a 100 mm VAS scale
Time frame: Preoperation and 24month post operation
The back pain intensity on 100-mm VAS will be performed and recorded at Day 1 (within 48 hours before surgery as the Baseline) and 24th month.
Change of function at 24 months from baseline as measured by the 100 points Oswestry Disability Index (ODI)
Time frame: Preoperation and 24month post operation
The level of function on 100-point ODI will be performed and recorded at Day 1 (within 48 hours before surgery as the Baseline) and 24th month.
1 secondary outcome
Fusion Rates
Time frame: 3, 6, 12, and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Derived from this study: PubMed 36289500Yang KS, Chen CW, Yau RB, Liang HC, Ko CC, Kuo JR, Chio CC, Lim SW. A novel surgical technique in transforaminal lumbar interbody fusion by the bone graft delivery device: evaluation of therapeutic effect in patients with minimally invasive spine surgery. BMC Surg. 2022 Oct 26;22(1):366. doi: 10.1186/s12893-022-01773-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing bone graft delivery system/wiltrom interbody fusion system/wiltrom spinal fixation system and wiltrom interbody fusion system/wiltrom spinal fixation system in people with Spinal Fusion, run by Chi Mei Medical Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of back pain at 24 months from baseline as measured by a 100 mm VAS scale (time frame: Preoperation and 24month post operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05190055, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.