Intervertebral Disc DisorderNCT06386666
A Clinical Trial to Evaluate the Safety and Efficacy of Single-use Fibrous Ring Sutures for the Suture of Fibrous Ring Incision After Nucleus Pulposus Removal
A study testing Disposable fibrous ring sutures in people with Intervertebral Disc Disorder, run by Suzhou Care-Real Medical Technology Co., Ltd..
Trial summary
The objective of this clinical trial was to evaluate the safety and effectiveness of single-use annular sutures for the closure of annular incisions after nucleus pulposus removal. Participants used single-use annular sutures to close the annular fibers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intervertebral Disc Disorder
- What is being tested?
- Disposable fibrous ring sutures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2024to 15 Nov 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old, gender unlimited;
- Meet the diagnosis of lumbar disc herniation (refer to the Guidelines for Diagnosis and Treatment of Lumbar disc herniation), and expect to undergo single-level disc nucleus pulposus extraction;
- The history of lumbar disc herniation is more than 6 weeks, and systematic conservative treatment is ineffective；
- ODI index ≥20 points;
- In the VAS score of bilateral lower limbs, at least one side was ≥4 points;
- The score of the three evaluation indicators according to the modified Pfirrmann grade, age and disc height is no more than 7 points (see Annex 1 for the criteria);
- Voluntarily participate and sign informed consent;
- Be able to communicate well with research doctors, have good compliance, and can follow the requirements of clinical research.
Who cannot join
- Laboratory examination (blood routine examination, blood biochemistry, coagulation function and blood pregnancy, etc.), imaging examination (MRI) and vital signs examination have abnormal results with clinical significance, and the researchers believe that they are not suitable for inclusion;
- Active local or systemic infection;
- Patients with lumbar tumors and/or spinal malformations;
- Imaging showed calcification of the posterior longitudinal ligament;
- A history of serious diseases of important organs (such as cardiovascular system, liver, lung, kidney and nervous system);
- There are autoimmune diseases or abnormal coagulation function;
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- Previous or planned surgical procedures to fuse or stabilize the lumbar spine during the trial;
- Intraoperative exploration of the location of the annulus fibriatus could not satisfy the requirement that the needle entry point was more than 2mm away from the margin of the annulus fibriatus;
- Pregnant or lactating women, or those who have a pregnancy plan during the trial period;
- Those who are participating in other clinical trials at the same time;
- Other situations that the researcher considers inappropriate to participate in this study.
About this study
Official title: A Prospective, Multicenter, Single-group, Target-value Clinical Trial to Evaluate the Safety and Efficacy of Single-use Annular Sutures for Annular Incisions Following Nucleus Pulposus Removal
The objective of this clinical trial was to evaluate the safety and effectiveness of single-use annular sutures for the closure of annular incisions after nucleus pulposus removal. Participants used single-use annular sutures to close the annular fibers. The success rate of suture, reduction value of annulus, proportion of annulus reduction, intraoperative blood loss, suture time, VAS pain score (low back, bilateral lower extremities), Oswestry index (ODI index), and Short were evaluated The effectiveness evaluation results of Form-12 health survey (SF-12 score), treatment success rate, device defects, product operation satisfaction, and safety evaluation results of recurrence rate, adverse events, and serious adverse events were used to verify the safety and effectiveness of disposable fibrillar suture for annular incision suture after nucleus pulposus removal.
- Conditions
- Intervertebral Disc Disorder
- Being tested
- Disposable fibrous ring sutures
- Medical subject headings
- Intervertebral disc disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disposable fibrous ring suturesDevice
A new disposable fibrous ring suture device developed and produced by 2020 (Beijing) Medical Technology Co., Ltd
| Study group | Role | What they receive |
|---|---|---|
| The fibrous ring was sutured using a disposable fibrous ring suturing device | Experimental | Not described Receives: Device: Disposable fibrous ring sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of suture
After the intraoperative suture was completed, the quality of the suture was evaluated by the investigator. After all subjects completed the operation, the success rate of suture was calculated.
Evaluation criteria: 1) No sutures fell off during the suture process; 2) No suture fracture during the suture process; 3) A sterile scale was used to measure annulus fibrosus cleft before and after suture, and medical image data were retained. Finally, the size changes of cleft before and after suture were compared. The size of the wound after suture should be reduced by more than 60% compared with that before suture (the size of the annulus fibrous tear should be determined by its maximum diameter).
If all the above three conditions are met, the suture is successful. If any one of the conditions is not met, the suture is failed.
Successful rate of suture = Number of successful sutures/total number of sutures *100%
Measured: Immediately after surgery
Secondary outcomes (8)
Annulus fibril cleft decreased in value
The change of annulus cleft was evaluated according to annulus suture.Annular cleft reduction = annular cleft size before suture - annular cleft size after suture.
Measured: During the surgery.
Reduced proportion of annular fibril cleft
The change of annular tear reduction was assessed according to annular suture.Annulus cut reduction ratio = (size of annulus cut before unsutured - size of annulus cut after sutured)/size of annulus cut without suture *100%
Measured: During the surgery.
Intraoperative blood loss
Information on intraoperative blood loss was obtained from surgical records.
Measured: The day after the surgery
Suture time
The time between assembly and completion of the suture from the single use of the ring suture.
Measured: The day after the surgery
Treatment success rate
After the subjects completed the 6-month post-operation interview, the researchers made the judgment. If the subjects met all the following evaluation criteria, they were recorded as "treatment success"; otherwise, they were "treatment failure".Evaluation criteria: 1) ODI index decreased by ≥10 points compared with pre-operation; 2) Compared with the preoperative results, the VAS score of lower extremities decreased by ≥2 points (if only one side was ≥4 points, that side was dominant; If both sides are ≥4 points, the average score of both sides is used to calculate the VAS score decline value); 3) No nerve root symptoms; 4) No second operation and/or other therapeutic intervention at the treated site after surgery; 5) MRI images showed no swelling or other abnormalities of clinical significance in the operative segment.
Treatment success rate = Number of successful cases/total cases *100%
Measured: Six months after surgery
VAS pain score (lower back, bilateral lower limbs)
According to their subjective feelings, the subjects were evaluated by Visual Analogue Scales (VAS). On a 10cm scale, "0" means painless and "10" means the most intense pain.
Measured: Before surgery, 4 days after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery
SF-12 rating
The SF-12 Health Questionnaire consists of 12 questions divided into 2 dimensions: physical health and mental health. Each question is set with different options, subjects according to their own feelings and actual situation, choose the most suitable option, each option corresponds to a different score. The score ranges from 0 to 100, with higher scores indicating better physical and mental health, and lower scores indicating worse physical and mental health.
Measured: Before surgery, 4 days after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery
ODI index
ODI index includes 3 areas of single function, pain and individual comprehensive function, with a total of 10 items, the score range is 0 ~ 5 points, the total score is 50 points, the higher the score, the more serious the dysfunction of the subject.
Measured: Before surgery, 4 days after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start15 Aug 2024 (estimated)
- Primary completion29 Aug 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disc DisorderStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Care-Real Medical Technology Co., Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- 2020 (Beijing) Medical Technology Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386666
- Sponsor's protocol ID
- RLRL-CTP
- Status last verified
- Jul 2024
- First submitted
- 15 Apr 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-group, Target-value Clinical Trial to Evaluate the Safety and Efficacy of Single-use Annular Sutures for Annular Incisions Following Nucleus Pulposus Removal
- ClinicalTrials.gov ID
- NCT06386666
- Acronym / sponsor ID
- RLRL-CTP
- Conditions
- Intervertebral Disc Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Suzhou Care-Real Medical Technology Co., Ltd.University, hospital or other
- Collaborators
- 2020 (Beijing) Medical Technology Co., Ltd
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 29 Aug 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 26 Apr 2024 (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.
The objective of this clinical trial was to evaluate the safety and effectiveness of single-use annular sutures for the closure of annular incisions after nucleus pulposus removal. Participants used single-use annular sutures to close the annular fibers. The success rate of suture, reduction value of annulus, proportion of annulus reduction, intraoperative blood loss, suture time, VAS pain score (low back, bilateral lower extremities), Oswestry index (ODI index), and Short were evaluated The effectiveness evaluation results of Form-12 health survey (SF-12 score), treatment success rate, device defects, product operation satisfaction, and safety evaluation results of recurrence rate, adverse events, and serious adverse events were used to verify the safety and effectiveness of disposable fibrillar suture for annular incision suture after nucleus pulposus removal.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The fibrous ring was sutured using a disposable fibrous ring suturing device | Experimental | Device: Disposable fibrous ring sutures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years old, gender unlimited;
- Meet the diagnosis of lumbar disc herniation (refer to the Guidelines for Diagnosis and Treatment of Lumbar disc herniation), and expect to undergo single-level disc nucleus pulposus extraction;
- The history of lumbar disc herniation is more than 6 weeks, and systematic conservative treatment is ineffective；
- ODI index ≥20 points;
- In the VAS score of bilateral lower limbs, at least one side was ≥4 points;
Key exclusion criteria (11 listed)
- Laboratory examination (blood routine examination, blood biochemistry, coagulation function and blood pregnancy, etc.), imaging examination (MRI) and vital signs examination have abnormal results with clinical significance, and the researchers believe that they are not suitable for inclusion;
- Active local or systemic infection;
- Patients with lumbar tumors and/or spinal malformations;
- Imaging showed calcification of the posterior longitudinal ligament;
- A history of serious diseases of important organs (such as cardiovascular system, liver, lung, kidney and nervous system);
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 |
|---|---|---|
| Disposable fibrous ring suturesA new disposable fibrous ring suture device developed and produced by 2020 (Beijing) Medical Technology Co., Ltd | Device | The fibrous ring was sutured using a disposable fibrous ring suturing device |
Primary outcome
Success rate of suture
Time frame: Immediately after surgery
After the intraoperative suture was completed, the quality of the suture was evaluated by the investigator. After all subjects completed the operation, the success rate of suture was calculated. Evaluation criteria: 1) No sutures fell off during the suture process; 2) No suture fracture during the suture process; 3) A sterile scale was used to measure annulus fibrosus cleft before and after suture, and medical image data were retained. Finally, the size changes of cleft before and after suture were compared. The size of the wound after suture should be reduced by more than 60% compared with that before suture (the size of the annulus fibrous tear should be determined by its maximum diameter). If all the above three conditions are met, the suture is successful. If any one of the conditions is not met, the suture is failed. Successful rate of suture = Number of successful sutures/total number of sutures *100%
8 secondary outcomes
Annulus fibril cleft decreased in value
Time frame: During the surgery.
Reduced proportion of annular fibril cleft
Time frame: During the surgery.
Intraoperative blood loss
Time frame: The day after the surgery
Suture time
Time frame: The day after the surgery
Treatment success rate
Time frame: Six months after surgery
VAS pain score (lower back, bilateral lower limbs)
Time frame: Before surgery, 4 days after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery
SF-12 rating
Time frame: Before surgery, 4 days after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery
ODI index
Time frame: Before surgery, 4 days after surgery, 1 month after surgery, 3 months after surgery, 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
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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 Disposable fibrous ring sutures in people with Intervertebral Disc Disorder, run by Suzhou Care-Real Medical Technology Co., Ltd..
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 8 inclusion and 11 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 2024. 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?
Success rate of suture (time frame: Immediately after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2024.