Cervical Spinal StenosisNCT05895968
Researching the Useful of Barb Suture in Obese Patients Undergoing Posterior Cervical Surgery
A study testing posterior cervical surgery in people with Cervical Spinal Stenosis and Posterior Cervical Spine Surgery, run by Xijing Hospital at 1 site in China.
Trial summary
Through a single-center, exploratory clinical study, the safety and effectiveness of using barb wire in the incision and suture of posterior cervical surgery in obese patients were evaluated, providing a basis for its wide clinical application in posterior cervical surgery. Read more about this study
- Who is it for?
- Ages 28 to 85 years
- Conditions the study is for
- Cervical Spinal Stenosis, Posterior Cervical Spine Surgery, Barbed Suture
- What is being tested?
- posterior cervical surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 28 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms and signs of the patients were typical. MRI showed single or multiple central herniation of C3-C7 intervertebral discs or spinal stenosis at corresponding levels, which confirmed cervical myeloid cervical spondylosis or cervical spinal stenosis.
- Preoperative routine tests and examinations showed no contraindications.
- BMI≥28
- Informed consent was obtained from the patient and his family, informed consent was signed, and a complete follow-up was completed after surgery.
Who cannot join
- A history of wasting diseases associated with malignancy and chemoradiotherapy that may interfere with wound healing
- History of dermatosis
- History of immune system diseases
- History of blood diseases
- Skin injury or defect at the back of the neck
- Severe hypersensitivity
Show all 9Show fewer
- Cold, fever, trauma or other infections in the week before surgery
- Infectious disease
- Psychosis could not cooperate with follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jia Yanyan
Xi'an, Shannxi Province, 710034
Yanyan Jia, 15902984776, 14556263@qq.com
About this study
Official title: A Controlled Clinical Study on the Safety and Effectiveness of Barb Suture in Obese Patients Undergoing Posterior Cervical Surgery
Through a single-center, exploratory clinical study, the safety and effectiveness of using barb wire in the incision and suture of posterior cervical surgery in obese patients were evaluated, providing a basis for its wide clinical application in posterior cervical surgery.
- Being tested
- posterior cervical surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior cervical surgeryProcedure or surgery
The patients were operated by the posterior cervical surgery, which were used with the barbed to suture the deep fascia.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative | No intervention | Not described |
| postoperative (2 weeks) | Experimental | Not described Receives: Procedure: posterior cervical surgery |
| postoperative (4 weeks) | Experimental | Not described Receives: Procedure: posterior cervical surgery |
| postoperative (3 months) | Experimental | Not described Receives: Procedure: posterior cervical surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
JOA score change
JOA score is used to assess the function of spinal cord which is in the form of questionnaires. Postoperative improvement rate = ((postoperative score - preoperative score)/ (17- preoperative score)) X100%. Improvement rate can also correspond to the commonly used efficacy criteria: cure when the improvement rate is 100%, effective when the improvement rate is greater than 60%, effective when 25-60%, and ineffective when less than 25%.
Measured: 3 months after surgery
NDI score change
NDI score is used to assess the disorder of spinal cord which is in the form of questionnaires. Postoperative improvement rate = (total score)/ (numbers of programme X5) X100%. Improvement rate can also correspond to the commonly used efficacy criteria: the improvement rate when 60%-80% means extremely severe dysfunction, when 40%-60% means severe dysfunction, when 20-40% means moderate dysfunction, and when less than 20% means mild dysfunction.
Measured: 3 months after surgery
VAS score change
A Visual Analogue Scale (VAS) is used to measure the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Measured: 3 months after surgery
Secondary outcomes (2)
wound infection
The presence of wound infection was confirmed through the assessment of the patient's white blood cell count, erythrocyte sedimentation rate, C-reactive protein levels and other relevant biochemical markers. Additionally, signs such as erythema, edema, warmth, tenderness and other related symptoms should be evaluated to determine the presence of wound infection.
Measured: 2 weeks after surgery, 4 weeks after surgery, 3 months after surgery
wound dehiscence
The assessment of wound dehiscence primarily relied on the identification of suture rupture within the wound site through direct visualization.
Measured: 2 weeks after surgery, 4 weeks after surgery, 3 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 posted9 Jun 2023
- Study start1 Jan 2023
- Primary completion31 Jan 2023
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cervical Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895968
- Sponsor's protocol ID
- KY20232136-F-1
- Status last verified
- May 2026
- First submitted
- 25 May 2023
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Greenberg JA, Einarsson JI. The use of bidirectional barbed suture in laparoscopic myomectomy and total laparoscopic hysterectomy. J Minim Invasive Gynecol. 2008 Sep-Oct;15(5):621-3. doi: 10.1016/j.jmig.2008.06.004. Epub 2008 Jul 10.
PubMed 18619922Sarsam OM, Dunning J, Pochulu B, Baste JM. Robot-assisted bronchoplasty using continuous barbed sutures. J Vis Surg. 2018 Jan 4;4:3. doi: 10.21037/jovs.2017.12.14. eCollection 2018.
PubMed 29445589Yang S, Qi-Heng T, Yi-Xin Z. Comparison of Standard Suture vs Barbed Suture for Closing the Porcine Knee Joint: Evaluation of Biomechanical Integrity and Permeability. J Arthroplasty. 2018 Mar;33(3):903-907. doi: 10.1016/j.arth.2017.10.008. Epub 2017 Oct 10.
PubMed 29103781Chan VWK, Chan PK, Chiu KY, Yan CH, Ng FY. Does Barbed Suture Lower Cost and Improve Outcome in Total Knee Arthroplasty? A Randomized Controlled Trial. J Arthroplasty. 2017 May;32(5):1474-1477. doi: 10.1016/j.arth.2016.12.015. Epub 2016 Dec 21.
PubMed 28089469Lee SW, Kawai M, Tashiro K, Nomura E, Tokuhara T, Kawashima S, Tanaka R, Uchiyama K. Laparoscopic gastrointestinal anastomoses using knotless barbed absorbable sutures are safe and reproducible: a single-center experience with 242 patients. Jpn J Clin Oncol. 2016 Apr;46(4):329-35. doi: 10.1093/jjco/hyv212. Epub 2016 Jan 26.
PubMed 26819279
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Clinical Study on the Safety and Effectiveness of Barb Suture in Obese Patients Undergoing Posterior Cervical Surgery
- ClinicalTrials.gov ID
- NCT05895968
- Acronym / sponsor ID
- KY20232136-F-1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Jun 2023 (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.
Through a single-center, exploratory clinical study, the safety and effectiveness of using barb wire in the incision and suture of posterior cervical surgery in obese patients were evaluated, providing a basis for its wide clinical application in posterior cervical surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Preoperative | No intervention | – |
| postoperative (2 weeks) | Experimental | Procedure: posterior cervical surgery |
| postoperative (4 weeks) | Experimental | Procedure: posterior cervical surgery |
| postoperative (3 months) | Experimental | Procedure: posterior cervical surgery |
Who may qualify
- Ages
- 28 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptoms and signs of the patients were typical. MRI showed single or multiple central herniation of C3-C7 intervertebral discs or spinal stenosis at corresponding levels, which confirmed cervical myeloid cervical spondylosis or cervical spinal stenosis.
- Preoperative routine tests and examinations showed no contraindications.
- BMI≥28
- Informed consent was obtained from the patient and his family, informed consent was signed, and a complete follow-up was completed after surgery.
Key exclusion criteria (9 listed)
- A history of wasting diseases associated with malignancy and chemoradiotherapy that may interfere with wound healing
- History of dermatosis
- History of immune system diseases
- History of blood diseases
- Skin injury or defect at the back of the neck
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 |
|---|---|---|
| posterior cervical surgeryThe patients were operated by the posterior cervical surgery, which were used with the barbed to suture the deep fascia. | Procedure or surgery | postoperative (2 weeks), postoperative (3 months), postoperative (4 weeks) |
Primary outcome
JOA score change
Time frame: 3 months after surgery
JOA score is used to assess the function of spinal cord which is in the form of questionnaires. Postoperative improvement rate = ((postoperative score - preoperative score)/ (17- preoperative score)) X100%. Improvement rate can also correspond to the commonly used efficacy criteria: cure when the improvement rate is 100%, effective when the improvement rate is greater than 60%, effective when 25-60%, and ineffective when less than 25%.
NDI score change
Time frame: 3 months after surgery
NDI score is used to assess the disorder of spinal cord which is in the form of questionnaires. Postoperative improvement rate = (total score)/ (numbers of programme X5) X100%. Improvement rate can also correspond to the commonly used efficacy criteria: the improvement rate when 60%-80% means extremely severe dysfunction, when 40%-60% means severe dysfunction, when 20-40% means moderate dysfunction, and when less than 20% means mild dysfunction.
VAS score change
Time frame: 3 months after surgery
A Visual Analogue Scale (VAS) is used to measure the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
2 secondary outcomes
wound infection
Time frame: 2 weeks after surgery, 4 weeks after surgery, 3 months after surgery
wound dehiscence
Time frame: 2 weeks after surgery, 4 weeks after surgery, 3 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Background: PubMed 18619922Greenberg JA, Einarsson JI. The use of bidirectional barbed suture in laparoscopic myomectomy and total laparoscopic hysterectomy. J Minim Invasive Gynecol. 2008 Sep-Oct;15(5):621-3. doi: 10.1016/j.jmig.2008.06.004. Epub 2008 Jul 10.
- Background: PubMed 29445589Sarsam OM, Dunning J, Pochulu B, Baste JM. Robot-assisted bronchoplasty using continuous barbed sutures. J Vis Surg. 2018 Jan 4;4:3. doi: 10.21037/jovs.2017.12.14. eCollection 2018.
- Background: PubMed 29103781Yang S, Qi-Heng T, Yi-Xin Z. Comparison of Standard Suture vs Barbed Suture for Closing the Porcine Knee Joint: Evaluation of Biomechanical Integrity and Permeability. J Arthroplasty. 2018 Mar;33(3):903-907. doi: 10.1016/j.arth.2017.10.008. Epub 2017 Oct 10.
- Results publication: PubMed 28089469Chan VWK, Chan PK, Chiu KY, Yan CH, Ng FY. Does Barbed Suture Lower Cost and Improve Outcome in Total Knee Arthroplasty? A Randomized Controlled Trial. J Arthroplasty. 2017 May;32(5):1474-1477. doi: 10.1016/j.arth.2016.12.015. Epub 2016 Dec 21.
- Results publication: PubMed 26819279Lee SW, Kawai M, Tashiro K, Nomura E, Tokuhara T, Kawashima S, Tanaka R, Uchiyama K. Laparoscopic gastrointestinal anastomoses using knotless barbed absorbable sutures are safe and reproducible: a single-center experience with 242 patients. Jpn J Clin Oncol. 2016 Apr;46(4):329-35. doi: 10.1093/jjco/hyv212. Epub 2016 Jan 26.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing posterior cervical surgery in people with Cervical Spinal Stenosis and Posterior Cervical Spine Surgery, run by Xijing Hospital at 1 site in China.
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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanyan Jia (15902984776, 14556263@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
JOA score change (time frame: 3 months after surgery). The study lists 3 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 NCT05895968, which also lists 5 linked publications.
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 30 Jul 2026.