Cervical SpondylosisNCT06027827
Impact of Lateral Bone Grafting With Intraoperative Fusion in ACDF on Clinical Outcomes
An observational study of Cervical Spondylosis, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
The purpose of this trial was to investigate the safety and efficacy of fuser lateral bone grafting in ACDF. By observing the intervertebral bony fusion rate and clinical outcome scores of patients after fusion device lateral bone grafting, it was verified whether the fusion device lateral bone grafting approach could… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cervical Spondylosis
- What is being tested?
- Addition of fusion device lateral bone graft
- Type of treatment
- Surgery or procedure
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to Dec 2024
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Between the ages of 18-60 years; patients with cervical spondylosis about to undergo 1-2 segment ACDF surgery
Who may be able to join
- Age between 18-60 years old; patients with cervical spondylosis who were about to undergo 1-2 segment ACDF surgery; agreement with the surgical plan and willingness to undergo long-term clinical follow-up; and signing of an informed consent form.
Who cannot join
- Drug or alcohol abusers; those with abnormal liver or kidney function unsuitable for surgery; those with cardiac insufficiency unsuitable for surgery; those with severe metabolic and endocrine diseases unsuitable for surgery; those with severe lung disorders such as asthma and abnormal lung function unsuitable for surgery; pregnant and breastfeeding women as well as those who are planning to become pregnant in the near future; those who have participated in other clinical trials within 3 months; and those who are not suitable for participation in the experiment in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality
Fengzeng jian, MD,PhD, 135 5206 7268, fengzengjian@hotmail.com
About this study
The purpose of this trial was to investigate the safety and efficacy of fuser lateral bone grafting in ACDF. By observing the intervertebral bony fusion rate and clinical outcome scores of patients after fusion device lateral bone grafting, it was verified whether the fusion device lateral bone grafting approach could improve the bony fusion rate and clinical outcome of ACDF.
Read the detailed description
The study will include patients who underwent 1-2 segment ACDF surgery, in addition to conventional surgical operations, the appropriate amount of allograft bone was implanted in the joint space of the hook vertebrae lateral to the fusion device, and X-rays and CTs were reviewed in the immediate postoperative period, March, June, and December, to verify intervertebral osseous fusion, as well as to observe the patient's clinical outcomes.
- Conditions
- Cervical Spondylosis
- Being tested
- Addition of fusion device lateral bone graft
- Medical subject headings
- Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Addition of fusion device lateral bone graftProcedure or surgery
In addition to the central bone graft of the fusion cage, the lateral bone graft of the fusion cage was added.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | In addition to the central bone graft of the fusion cage, the lateral bone graft of the fusion cage was added. Receives: Procedure: Addition of fusion device lateral bone graft | |
| control group | Conventional bone grafting in the center of the fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervertebral bone fusion rate
primary Indicator
Measured: 3rd month (±15 days), 6th month (±15 days), 1 year (±30 days) postoperatively
Secondary outcomes (1)
JOA
Japanese Orthopaedic Association Scores
Measured: Preoperative, 7 days postoperative, 3rd month (±15 days), 6th month (±15 days), 1 year (±30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 Dec 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (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 SpondylosisStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fengzeng Jian, MD, PhD, Study chair, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027827
- Sponsor's protocol ID
- XuanwuACDF
- Status last verified
- Aug 2023
- First submitted
- 30 Aug 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Epstein NE. A Review of Complication Rates for Anterior Cervical Diskectomy and Fusion (ACDF). Surg Neurol Int. 2019 Jun 7;10:100. doi: 10.25259/SNI-191-2019. eCollection 2019.
PubMed 31528438Fountas KN, Kapsalaki EZ, Nikolakakos LG, Smisson HF, Johnston KW, Grigorian AA, Lee GP, Robinson JS Jr. Anterior cervical discectomy and fusion associated complications. Spine (Phila Pa 1976). 2007 Oct 1;32(21):2310-7. doi: 10.1097/BRS.0b013e318154c57e.
PubMed 17906571Wewel JT, Kasliwal MK, Adogwa O, Deutsch H, O'Toole JE, Traynelis VC. Fusion rate following three- and four-level ACDF using allograft and segmental instrumentation: A radiographic study. J Clin Neurosci. 2019 Apr;62:142-146. doi: 10.1016/j.jocn.2018.11.040. Epub 2019 Jan 25.
PubMed 30692036Godlewski B, Bebenek A, Dominiak M, Karpinski G, Cieslik P, Pawelczyk T. PEEK versus titanium-coated PEEK cervical cages: fusion rate. Acta Neurochir (Wien). 2022 Jun;164(6):1501-1507. doi: 10.1007/s00701-022-05217-7. Epub 2022 Apr 26.
PubMed 35471708Samartzis D, Shen FH, Lyon C, Phillips M, Goldberg EJ, An HS. Does rigid instrumentation increase the fusion rate in one-level anterior cervical discectomy and fusion? Spine J. 2004 Nov-Dec;4(6):636-43. doi: 10.1016/j.spinee.2004.04.010.
PubMed 15541695
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Lateral Bone Grafting With Intraoperative Fusion in ACDF on Clinical Outcomes
- ClinicalTrials.gov ID
- NCT06027827
- Acronym / sponsor ID
- XuanwuACDF
- Conditions
- Cervical Spondylosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 7 Sep 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.
The purpose of this trial was to investigate the safety and efficacy of fuser lateral bone grafting in ACDF. By observing the intervertebral bony fusion rate and clinical outcome scores of patients after fusion device lateral bone grafting, it was verified whether the fusion device lateral bone grafting approach could improve the bony fusion rate and clinical outcome of ACDF.
Detailed description
The study will include patients who underwent 1-2 segment ACDF surgery, in addition to conventional surgical operations, the appropriate amount of allograft bone was implanted in the joint space of the hook vertebrae lateral to the fusion device, and X-rays and CTs were reviewed in the immediate postoperative period, March, June, and December, to verify intervertebral osseous fusion, as well as to observe the patient's clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Procedure: Addition of fusion device lateral bone graftIn addition to the central bone graft of the fusion cage, the lateral bone graft of the fusion cage was added. |
| control group | – | –Conventional bone grafting in the center of the fusion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Between the ages of 18-60 years; patients with cervical spondylosis about to undergo 1-2 segment ACDF surgery
Key inclusion criteria (1 listed)
- Age between 18-60 years old; patients with cervical spondylosis who were about to undergo 1-2 segment ACDF surgery; agreement with the surgical plan and willingness to undergo long-term clinical follow-up; and signing of an informed consent form.
Key exclusion criteria (1 listed)
- Drug or alcohol abusers; those with abnormal liver or kidney function unsuitable for surgery; those with cardiac insufficiency unsuitable for surgery; those with severe metabolic and endocrine diseases unsuitable for surgery; those with severe lung disorders such as asthma and abnormal lung function unsuitable for surgery; pregnant and breastfeeding women as well as those who are planning to become pregnant in the near future; those who have participated in other clinical trials within 3 months; and those who are not suitable for participation in the experiment in the opinion of the investigator.
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 |
|---|---|---|
| Addition of fusion device lateral bone graftIn addition to the central bone graft of the fusion cage, the lateral bone graft of the fusion cage was added. | Procedure or surgery | experimental group |
Primary outcome
Intervertebral bone fusion rate
Time frame: 3rd month (±15 days), 6th month (±15 days), 1 year (±30 days) postoperatively
primary Indicator
1 secondary outcome
JOA
Time frame: Preoperative, 7 days postoperative, 3rd month (±15 days), 6th month (±15 days), 1 year (±30 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Results publication: PubMed 31528438Epstein NE. A Review of Complication Rates for Anterior Cervical Diskectomy and Fusion (ACDF). Surg Neurol Int. 2019 Jun 7;10:100. doi: 10.25259/SNI-191-2019. eCollection 2019.
- Results publication: PubMed 17906571Fountas KN, Kapsalaki EZ, Nikolakakos LG, Smisson HF, Johnston KW, Grigorian AA, Lee GP, Robinson JS Jr. Anterior cervical discectomy and fusion associated complications. Spine (Phila Pa 1976). 2007 Oct 1;32(21):2310-7. doi: 10.1097/BRS.0b013e318154c57e.
- Results publication: PubMed 30692036Wewel JT, Kasliwal MK, Adogwa O, Deutsch H, O'Toole JE, Traynelis VC. Fusion rate following three- and four-level ACDF using allograft and segmental instrumentation: A radiographic study. J Clin Neurosci. 2019 Apr;62:142-146. doi: 10.1016/j.jocn.2018.11.040. Epub 2019 Jan 25.
- Results publication: PubMed 35471708Godlewski B, Bebenek A, Dominiak M, Karpinski G, Cieslik P, Pawelczyk T. PEEK versus titanium-coated PEEK cervical cages: fusion rate. Acta Neurochir (Wien). 2022 Jun;164(6):1501-1507. doi: 10.1007/s00701-022-05217-7. Epub 2022 Apr 26.
- Results publication: PubMed 15541695Samartzis D, Shen FH, Lyon C, Phillips M, Goldberg EJ, An HS. Does rigid instrumentation increase the fusion rate in one-level anterior cervical discectomy and fusion? Spine J. 2004 Nov-Dec;4(6):636-43. doi: 10.1016/j.spinee.2004.04.010.
- 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. This study is not recruiting at the moment.
Fengzeng Jian, MD, PhD study chair
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Spondylosis, run by Xuanwu Hospital, Beijing 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 7 Sep 2023. 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 Fengzeng Jian, MD, PhD (135 5206 7268, fengzengjian@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervertebral bone fusion rate (time frame: 3rd month (±15 days), 6th month (±15 days), 1 year (±30 days) postoperatively). 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 NCT06027827, 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 7 Sep 2023.