Degenerative Cervical Kyphosis With StenosisNCT04806360
Anterior Spinal Canal Reconstruction and Fusion Surgery for Treating Degenerative Cervical Kyphosis With Stenosis
A study testing ACRF surgery, conventional anterior surgery and conventional posterior surgery in people with Degenerative Cervical Kyphosis With Stenosis, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
Degenerative cervical kyphosis with stenosis (DCKS) is a common cervical spine degenerative disease, causing pain, numbness, and weakness of limbs, which seriously affect the quality of life of the patient. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Degenerative Cervical Kyphosis With Stenosis
- What is being tested?
- ACRF surgery, conventional anterior surgery and conventional posterior surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 30 Dec 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are diagnosed with degenerative cervical kyphosis with stenosis
- Patients aged between 30 and 70 years
- Patients meet the indications for surgery
- Patients submitted written informed consent
Who cannot join
- Tumor, infection, or trauma of the cervical spine
- Severe cervical kyphosis that greater than 50°
- Severe ossification of the posterior longitudinal ligament of the cervical spine
- Patients with ankylosing spondylitis
- Previous surgery of the cervical spine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Anterior Spinal Canal Reconstruction and Fusion Surgery for Treating Degenerative Cervical Kyphosis With Stenosis：a Multicenter Randomized Controlled Trial
Degenerative cervical kyphosis with stenosis (DCKS) is a common cervical spine degenerative disease, causing pain, numbness, and weakness of limbs, which seriously affect the quality of life of the patient. Surgery is an effective way to treat this condition, however, the best surgical procedure is still controversial. Anterior spinal canal reconstruction and fusion surgery (ACRF) is a new surgical procedure that previously proposed by our team, it combines the advantages of both the conventional anterior and posterior approach. The purpose of this study is to evaluate the safety and effectiveness of ACRF surgery for treating DCKS. A multicenter prospective randomized controlled trial was designed. Eligible patients will be randomly divided into three groups, including the ACRF group, the conventional anterior surgery group, and the conventional posterior surgery group. Demographic data, surgery Information, and follow-up results will be collected and compared between groups.
- Being tested
- ACRF surgery, conventional anterior surgery, conventional posterior surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACRF surgeryProcedure or surgery
A new surgical procedure that previously proposed by our team.
conventional anterior surgeryProcedure or surgery
Anterior cervical discectomy and fusion surgery or anterior cervical corpectomy and fusion surgery.
conventional posterior surgeryProcedure or surgery
Laminectomy and fusion surgery or laminoplasty surgery.
| Study group | Role | What they receive |
|---|---|---|
| ACRF group | Experimental | ACRF is a new surgical procedure that previously proposed by our team, it combines the advantages of both the conventional anterior and posterior approach. Eligible patients in this group will receive ACRF surgery. Receives: Procedure: ACRF surgery |
| conventional anterior surgery group | Active comparator | Eligible patients in this group will receive conventional anterior surgery, including anterior cervical discectomy and fusion surgery or anterior cervical corpectomy and fusion surgery. Receives: Procedure: conventional anterior surgery |
| conventional posterior surgery group | Active comparator | Eligible patients in this group will receive conventional posterior surgery, including laminectomy and fusion surgery or laminoplasty surgery. Receives: Procedure: conventional posterior surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Japanese Orthopaedic Association Score (JOA)
Total score 0-17. The lower the score the more severe the deficits.
Measured: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Change of Neck Disability Index (NDI)
Ranging from 0%-100%. A higher score indicates more patient-rated disability.
Measured: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Change of Sagittal Lordosis Angle
Measured by lateral X-Ray image. The change of lordosis was calculated and compared.
Measured: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Change of Cross-sectional area of the spinal canal
Measured by MRI image. The change of cross-sectional area of the spinal canal was calculated and compared.
Measured: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Secondary outcomes (4)
Reoperation rate
Any reoperation involving the same segments or adjacent segments will be calculated.
Measured: 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Change of Pain Scores on the Visual Analog Scale (VAS)
Ranging from 0-10. A higher score indicates more severe pain.
Measured: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Change of Range of Motion
Measured by dynamic X-Ray image.
Measured: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Complication rate
Any complications related to surgery will be recorded.
Measured: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start1 Sep 2022 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Cervical Kyphosis With StenosisStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Naval Specialty Medical Center, China, The NO.72 Army Hospital of Huzhou, China, 903 Hospital of Chinese People's Liberation Army
- Responsible party
- Principal investigator, Xuhua Lu, Shanghai Changzheng Hospital
- Investigators
- Xuhua Lu, M.D., Principal investigator, Shanghai Changzheng Hospotal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806360
- Sponsor's protocol ID
- 2020YLCYJ-Y09
- Status last verified
- May 2022
- First submitted
- 16 Feb 2021
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Anterior Spinal Canal Reconstruction and Fusion Surgery for Treating Degenerative Cervical Kyphosis With Stenosis：a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04806360
- Acronym / sponsor ID
- 2020YLCYJ-Y09
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Collaborators
- Naval Specialty Medical Center, China, The NO.72 Army Hospital of Huzhou, China, 903 Hospital of Chinese People's Liberation Army
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 19 Mar 2021 (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.
Degenerative cervical kyphosis with stenosis (DCKS) is a common cervical spine degenerative disease, causing pain, numbness, and weakness of limbs, which seriously affect the quality of life of the patient. Surgery is an effective way to treat this condition, however, the best surgical procedure is still controversial. Anterior spinal canal reconstruction and fusion surgery (ACRF) is a new surgical procedure that previously proposed by our team, it combines the advantages of both the conventional anterior and posterior approach. The purpose of this study is to evaluate the safety and effectiveness of ACRF surgery for treating DCKS. A multicenter prospective randomized controlled trial was designed. Eligible patients will be randomly divided into three groups, including the ACRF group, the conventional anterior surgery group, and the conventional posterior surgery group. Demographic data, surgery Information, and follow-up results will be collected and compared between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ACRF group | Experimental | Procedure: ACRF surgeryACRF is a new surgical procedure that previously proposed by our team, it combines the advantages of both the conventional anterior and posterior approach. Eligible patients in this group will receive ACRF surgery. |
| conventional anterior surgery group | Active comparator | Procedure: conventional anterior surgeryEligible patients in this group will receive conventional anterior surgery, including anterior cervical discectomy and fusion surgery or anterior cervical corpectomy and fusion surgery. |
| conventional posterior surgery group | Active comparator | Procedure: conventional posterior surgeryEligible patients in this group will receive conventional posterior surgery, including laminectomy and fusion surgery or laminoplasty surgery. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients are diagnosed with degenerative cervical kyphosis with stenosis
- Patients aged between 30 and 70 years
- Patients meet the indications for surgery
- Patients submitted written informed consent
Key exclusion criteria (5 listed)
- Tumor, infection, or trauma of the cervical spine
- Severe cervical kyphosis that greater than 50°
- Severe ossification of the posterior longitudinal ligament of the cervical spine
- Patients with ankylosing spondylitis
- Previous surgery of the cervical spine
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 |
|---|---|---|
| ACRF surgeryA new surgical procedure that previously proposed by our team. | Procedure or surgery | ACRF group |
| conventional anterior surgeryAnterior cervical discectomy and fusion surgery or anterior cervical corpectomy and fusion surgery. | Procedure or surgery | conventional anterior surgery group |
| conventional posterior surgeryLaminectomy and fusion surgery or laminoplasty surgery. | Procedure or surgery | conventional posterior surgery group |
Primary outcome
Change of Japanese Orthopaedic Association Score (JOA)
Time frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Total score 0-17. The lower the score the more severe the deficits.
Change of Neck Disability Index (NDI)
Time frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Ranging from 0%-100%. A higher score indicates more patient-rated disability.
Change of Sagittal Lordosis Angle
Time frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Measured by lateral X-Ray image. The change of lordosis was calculated and compared.
Change of Cross-sectional area of the spinal canal
Time frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Measured by MRI image. The change of cross-sectional area of the spinal canal was calculated and compared.
4 secondary outcomes
Reoperation rate
Time frame: 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Change of Pain Scores on the Visual Analog Scale (VAS)
Time frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Change of Range of Motion
Time frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Complication rate
Time frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Individual participant dataSharing planned: Undecided
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.
Xuhua Lu, M.D. principal investigator
Shanghai Changzheng Hospotal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACRF surgery, conventional anterior surgery and conventional posterior surgery in people with Degenerative Cervical Kyphosis With Stenosis, run by Shanghai Changzheng 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 5 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 9 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuhua Lu, M.D. (+862181885793, xuhualu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Japanese Orthopaedic Association Score (JOA) (time frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months post-treatment). The study lists 4 primary outcomes in all. 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 9 May 2022.