M-JOA ScorePPECDNCT04175535
The Comparative Study of Full-Endoscopic Cervical Posterior Discectomy and Anterior Cervical Decompression and Fusion
A study testing Percutaneous Posterior Endoscopic Cervical Discectomy and Anterior cervical decompression and fusion in people with M-JOA Score, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Anterior cervical decompression and fusion is the standard procedure for operation of cervical disc herniations. Mobility-preserving Full-Endoscopic Cervical Posterior discectomy is the most common alternative in the case of soft localization of the pathology. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- M-JOA Score
- What is being tested?
- Percutaneous Posterior Endoscopic Cervical Discectomy and Anterior cervical decompression and fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 1 Dec 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Single cervical intervertebral dis herniation wih symptoms of radicular pain or spinal cord compression ; 2) the herniated lesions had no obvious calcification; 3) conservative treatment fails ; 4) mild myelopathy (Nurick grade 3 or blow. (6) patients agree to participate in this study.
Who cannot join
- cervical segmental instability or deformity (cervical spondylolisthesis or Cobb Angle greater than 25°); 2) multisegmental lesions (≥2); 3) tumor, infection or other unknown space occupying in cervical vertebra; 4) surgical history of the target segment; 5) severe myelopathy (Nurick grade 4 or above); 6) the patients were not suitable for surgery, had poor medical management or did not agree to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Yongjian Zhu, PhD, 13588881949, Neurosurgery@zju.edu.cn
About this study
Official title: The Comparative Study of Full-Endoscopic Cervical Posterior Discectomy and Anterior Cervical Decompression and Fusion for the Operation of Soft Cervical Disc Herniation.
Anterior cervical decompression and fusion is the standard procedure for operation of cervical disc herniations. Mobility-preserving Full-Endoscopic Cervical Posterior discectomy is the most common alternative in the case of soft localization of the pathology. Endoscopic techniques are considered standard in many areas, since they may offer advantages in surgical technique and rehabilitation. These days, all disc herniations can be operated in full-endoscopic technique. With the full-endoscopic posterior cervical discectomy a procedures is available for cervical disc operations.
Read the detailed description
Investigators conducted a differential, randomized, 1:1, double-blind clinical control trial to compare the clinical effect, safety and feasibility of Full-Endoscopic Cervical Posterior discectomy and Anterior cervical decompression and fusion. The study was conducted in three centers at the same time, including the Second Affiliated Hospital of Zhejiang University Medical College, Zhejiang Provincial People's Hospital and Ningbo University Medical College Affiliated Hospital. This study is expected to include 308 patients with single level soft cervical disc herniation.Participants were randomly assigned to different groups for corresponding surgical intervention after complete preoperative evaluation.Participants received a standard 5-year follow-up procedure
- Conditions
- M-JOA Score
- Being tested
- Percutaneous Posterior Endoscopic Cervical Discectomy, Anterior cervical decompression and fusion
- Keywords
- cervical disc herniation, endoscope, posterior, minimally invasive spine surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Posterior Endoscopic Cervical DiscectomyProcedure or surgery
The most common alternative in the case of soft cervical disc herniations.
Anterior cervical decompression and fusionProcedure or surgery
The standard procedure for operation of cervical disc herniations.
| Study group | Role | What they receive |
|---|---|---|
| The experimental group | Other | PPECD was performed in the experimental group Receives: Procedure: Percutaneous Posterior Endoscopic Cervical Discectomy |
| control group | Other | ACDF was performed in the control group Receives: Procedure: Anterior cervical decompression and fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement rate
M-JOA Scoring
Measured: Follow up for 5 years
Secondary outcomes (6)
Basic information of participants
Age in year, gender in male or female, occupation
Measured: Follow up for 5 years
Basic information of participants
weight and height will be combined to report BMI in kg/m^2
Measured: Follow up for 5 years
Imaging examination
Cervical cobb angle change i
Measured: Follow up for 5 years
Pain Assessment
VAS Score
Measured: Follow up for 5 years
Operation duration
Operation duration in minute
Measured: intraoperative
Amount of bleeding during operation
Amount of bleeding during operation in milliliter
Measured: Follow up for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start1 Mar 2021 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for M-JOA ScoreStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175535
- Sponsor's protocol ID
- zeyy1985811
- Acronym
- PPECD
- Status last verified
- Dec 2020
- First submitted
- 17 Oct 2019
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Study of Full-Endoscopic Cervical Posterior Discectomy and Anterior Cervical Decompression and Fusion for the Operation of Soft Cervical Disc Herniation.
- ClinicalTrials.gov ID
- NCT04175535
- Acronym / sponsor ID
- PPECD / zeyy1985811
- Conditions
- M-JOA Score
- Keywords
- cervical disc herniation, endoscope, posterior, minimally invasive spine surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 25 Nov 2019 (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.
Anterior cervical decompression and fusion is the standard procedure for operation of cervical disc herniations. Mobility-preserving Full-Endoscopic Cervical Posterior discectomy is the most common alternative in the case of soft localization of the pathology. Endoscopic techniques are considered standard in many areas, since they may offer advantages in surgical technique and rehabilitation. These days, all disc herniations can be operated in full-endoscopic technique. With the full-endoscopic posterior cervical discectomy a procedures is available for cervical disc operations.
Detailed description
Investigators conducted a differential, randomized, 1:1, double-blind clinical control trial to compare the clinical effect, safety and feasibility of Full-Endoscopic Cervical Posterior discectomy and Anterior cervical decompression and fusion. The study was conducted in three centers at the same time, including the Second Affiliated Hospital of Zhejiang University Medical College, Zhejiang Provincial People's Hospital and Ningbo University Medical College Affiliated Hospital. This study is expected to include 308 patients with single level soft cervical disc herniation.Participants were randomly assigned to different groups for corresponding surgical intervention after complete preoperative evaluation.Participants received a standard 5-year follow-up procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group | Other | Procedure: Percutaneous Posterior Endoscopic Cervical DiscectomyPPECD was performed in the experimental group |
| control group | Other | Procedure: Anterior cervical decompression and fusionACDF was performed in the control group |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Single cervical intervertebral dis herniation wih symptoms of radicular pain or spinal cord compression ; 2) the herniated lesions had no obvious calcification; 3) conservative treatment fails ; 4) mild myelopathy (Nurick grade 3 or blow. (6) patients agree to participate in this study.
Key exclusion criteria (1 listed)
- cervical segmental instability or deformity (cervical spondylolisthesis or Cobb Angle greater than 25°); 2) multisegmental lesions (≥2); 3) tumor, infection or other unknown space occupying in cervical vertebra; 4) surgical history of the target segment; 5) severe myelopathy (Nurick grade 4 or above); 6) the patients were not suitable for surgery, had poor medical management or did not agree to participate in this study.
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 |
|---|---|---|
| Percutaneous Posterior Endoscopic Cervical DiscectomyThe most common alternative in the case of soft cervical disc herniations. | Procedure or surgery | The experimental group |
| Anterior cervical decompression and fusionThe standard procedure for operation of cervical disc herniations. | Procedure or surgery | control group |
Primary outcome
Improvement rate
Time frame: Follow up for 5 years
M-JOA Scoring
6 secondary outcomes
Basic information of participants
Time frame: Follow up for 5 years
Basic information of participants
Time frame: Follow up for 5 years
Imaging examination
Time frame: Follow up for 5 years
Pain Assessment
Time frame: Follow up for 5 years
Operation duration
Time frame: intraoperative
Amount of bleeding during operation
Time frame: Follow up for 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Individual participant dataSharing planned: No
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.
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Posterior Endoscopic Cervical Discectomy and Anterior cervical decompression and fusion in people with M-JOA Score, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 1 inclusion and 1 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 29 Dec 2020. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement rate (time frame: Follow up for 5 years). 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 29 Dec 2020.