Spinal CurvaturePECDNCT02486107
Prospective Cohort Study of Outcome After Minimally Invasive Posterior Cervical Spine Surgery
An observational study of Spinal Curvature, run by Seoul National University Hospital at 3 sites in South Korea.
Trial summary
In case of cervical foraminal stenosis without central stenosis, there are several options; anterior discectomy and fusion (ACDF), tubular retractor assisted micro-foraminotomy (MTPF) and posterior percutaneous cervical foraminotomy and discectomy (P-PECD). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Spinal Curvature
- What is being tested?
- surgical procedure
- Type of treatment
- Surgery or procedure
- How many people
- 156 participants
- Where
- 3 sitesSouth Korea
- Study dates
- May 2015to Dec 2020
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Alpha = 0.05, Beta = 0.2, q1 = 0.5, effect size = 0.6 drop rate 12% 52 patients in each group
Who may be able to join
- cervical radicular pain
- no cervical myelopathy
Who cannot join
- motor weakness less than MMT Gr III
- cervical myelopathy
- OPLL and myelopathy
- previous cervical spine surgery
- combined fracture or spinal tumor
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Kyoung-Pook National University Hospital
Seoul, Province, 03080
Seoul National University Bundang Hospital
Seoul, 03080
Seoul National University Hospital
Seoul, 110-744
About this study
Official title: Prospective Cohort Study of Outcome After Minimally Invasive Posterior Surgery (Posterior Percutaneous Endoscopic Foraminotomy or Tubular Retractor Assisted Micro-foraminotomy) for Single Level Cervical Foraminal Stenosis
In case of cervical foraminal stenosis without central stenosis, there are several options; anterior discectomy and fusion (ACDF), tubular retractor assisted micro-foraminotomy (MTPF) and posterior percutaneous cervical foraminotomy and discectomy (P-PECD). P-PECD is a modern technique and there was no RCT with MTPF, although P-PECD showed not inferior result to ACDF. Nowadays MTPF and P-PECD are minimally invasive surgical techniques, but there was no comparative study.
The primary object of the study is to compare radiological outcome (segment angle) after MTPF or P-PECD.
Read the detailed description
P-PECDs are performed in Seoul National University Hospital MTPFs are performed in Kyoung-Pook National University Hospital and ACDF are performed in Seoul National University Bundang Hospital.
- Conditions
- Spinal Curvature
- Being tested
- surgical procedure
- Keywords
- cervical vertebra, surgery, tubular retractor, endoscope
- Medical subject headings
- Spinal Curvatures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical procedureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| PECD | percutaneous endoscopic cervical foraminotomy Receives: Procedure: surgical procedure | |
| MTPF | microscopic tubular retractor assisted foraminotomy Receives: Procedure: surgical procedure | |
| ACDF | anterior cervical discectomy and fusion Receives: Procedure: surgical procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of segmental angle
Measured: postoperative 1 year
Secondary outcomes (4)
operation time
Measured: postoperative 1 year
neck/arm pain
Measured: postop 1 year
neck disability, index
Measured: postop 1 year
cervical curvature
Measured: postop 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2019
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal CurvatureStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Kyungpook National University Hospital
- Responsible party
- Principal investigator, Chun Kee Chung, Seoul National University Hospital
- Investigators
- Chun Kee Chung, Professor, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486107
- Sponsor's protocol ID
- PECD
- Acronym
- PECD
- Status last verified
- Apr 2024
- First submitted
- 20 May 2015
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Outcome After Minimally Invasive Posterior Surgery (Posterior Percutaneous Endoscopic Foraminotomy or Tubular Retractor Assisted Micro-foraminotomy) for Single Level Cervical Foraminal Stenosis
- ClinicalTrials.gov ID
- NCT02486107
- Acronym / sponsor ID
- PECD / PECD
- Conditions
- Spinal Curvature
- Keywords
- cervical vertebra, surgery, tubular retractor, endoscope
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital, Kyungpook National University Hospital
- Study start
- May 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 1 Jul 2015 (estimated)
- 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.
In case of cervical foraminal stenosis without central stenosis, there are several options; anterior discectomy and fusion (ACDF), tubular retractor assisted micro-foraminotomy (MTPF) and posterior percutaneous cervical foraminotomy and discectomy (P-PECD). P-PECD is a modern technique and there was no RCT with MTPF, although P-PECD showed not inferior result to ACDF. Nowadays MTPF and P-PECD are minimally invasive surgical techniques, but there was no comparative study.
The primary object of the study is to compare radiological outcome (segment angle) after MTPF or P-PECD.
Detailed description
P-PECDs are performed in Seoul National University Hospital MTPFs are performed in Kyoung-Pook National University Hospital and ACDF are performed in Seoul National University Bundang Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PECD | – | Procedure: surgical procedurepercutaneous endoscopic cervical foraminotomy |
| MTPF | – | Procedure: surgical proceduremicroscopic tubular retractor assisted foraminotomy |
| ACDF | – | Procedure: surgical procedureanterior cervical discectomy and fusion |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Alpha = 0.05, Beta = 0.2, q1 = 0.5, effect size = 0.6 drop rate 12% 52 patients in each group
Key inclusion criteria (2 listed)
- cervical radicular pain
- no cervical myelopathy
Key exclusion criteria (5 listed)
- motor weakness less than MMT Gr III
- cervical myelopathy
- OPLL and myelopathy
- previous cervical spine surgery
- combined fracture or spinal tumor
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 |
|---|---|---|
| surgical procedure | Procedure or surgery | ACDF, MTPF, PECD |
Primary outcome
change of segmental angle
Time frame: postoperative 1 year
4 secondary outcomes
operation time
Time frame: postoperative 1 year
neck/arm pain
Time frame: postop 1 year
neck disability, index
Time frame: postop 1 year
cervical curvature
Time frame: postop 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 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.
Chun Kee Chung, Professor principal investigator
Seoul National University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Curvature, run by Seoul National University Hospital at 3 sites in South Korea.
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 2 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: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 segmental angle (time frame: postoperative 1 year). 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 18 Apr 2024.