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Compare Different Cervical Anterior Discectomy Procedures by After Procedure Sagittal Alignment on Radiograph

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ClinicalTrials.gov Identifier: NCT03360409
Recruitment Status : Not yet recruiting
First Posted : December 4, 2017
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):
Zhu Zhenqi, Peking University People's Hospital

Brief Summary:
Patients with single-level cervical degenerative disc disease commonly undertook anterior discectomy. To compare the effect of anterior cervical discectomy without fusion (ACD), anterior cervical discectomy with fusion by stand-alone cage (ACDF) or anterior cervical discectomy with arthroplasty (ACDA), a multiple center randomised controlled trial will be performed in patients with single-level cervical disease. The primary outcome will be cervical alignment by upright cervical spine radiographs estimated by Harrison posterior tangent method.

Condition or disease Intervention/treatment Phase
Cervical Disc Degeneration Procedure: ACD Procedure: ACDF Procedure: ACDA Not Applicable

Detailed Description:
This study will use a multiple center open-label randomised controlled trial to estimate the effect of ACD, ACDF, ACDA for single-level cervical degenerative disc. Patients with arm pain not responding to conservative treatment take part in this trial. They will be randomised assigned into 3 parallel arms. The participants in the each arm will undertake ACD ACDF or ACDA. The baseline is the day of surgery. The Harrison posterior tangent method was used as an estimate for measuring cervical alignment. The primary outcome will be the cervical sagittal alignment estimated by Harrison posterior tangent method.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Compare Different Cervical Anterior Discectomy Procedures for Cervical Degenerative Disc Disease by After Procedure Sagittal Alignment on Radiograph :a Multiple Center Randomized Controlled Trial
Estimated Study Start Date : February 1, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: X-Rays

Arm Intervention/treatment
Experimental: grade 1
ACD
Procedure: ACD
Undertake anterior cervical discectomy without fusion

Active Comparator: grade 2
ACDF
Procedure: ACDF
anterior cervical discectomy with fusion

Active Comparator: grade 3
ACDA
Procedure: ACDA
anterior cervical discectomy with arthroplasty




Primary Outcome Measures :
  1. change of cervical alignment [ Time Frame: 1 day postoperatively, 6 weeks, 3 months, 1 year and 2 years ]
    The Harrison posterior tangent method was used as an estimate for curvature


Secondary Outcome Measures :
  1. quality of life [ Time Frame: 1 day postoperatively, 6 weeks, 3 months, 1 year and 2 years ]
    Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO)



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with arm pain not responding to conservative treatment
  • lasted longer than 10 weeks
  • single level disc degeneration
  • mobile spine on dynamic lateral cervical X-rays

Exclusion Criteria:

  • severe cardiopulmonary comorbidity
  • suspected underlying malignant disease
  • radicular syndrome
  • spinal-cord compression syndrome
  • contraindication for radiography

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360409


Contacts
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Contact: chen guo 8618055644700 fantasy_g@163.com

Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Study Director: zhenqi zhu PekingUPH department of spinal surgery

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Responsible Party: Zhu Zhenqi, department of spinal surgery, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03360409     History of Changes
Other Study ID Numbers: CACD3
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhu Zhenqi, Peking University People's Hospital:
Cervical Disc Degeneration
cervical anterior discectomy
Spinal alignment

Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases