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Trial · NCT07894159

Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryUpper Limb Radicular Pain Intensity at 3 Months After Surgery3 months after surgery
Upper limb radicular pain intensity will be assessed using a patient-reported 0-10 pain scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Lower scores indicate less severe pain. The primary analysis will compare pain intensity between the two surgical groups at three months after surgery, adjusting for baseline preoperative pain intensity using analysis of covariance (ANCOVA). The non-inferiority margin is set at 1 point on the 0-10 pain scale. Non-inferiority will be demonstrated if the upper bound of the 95% confidence interval for the adjusted mean difference (endoscopic foraminotomy minus ACDF) is below +1 point.
SecondaryUpper Limb Radicular Pain Intensity at 6 Weeks Measured Using an 11-Point Numerical Rating Scale (0-10)6 weeks after surgery
SecondaryUpper Limb Radicular Pain Intensity at 6 Months Measured Using an 11-Point Numerical Rating Scale (0-10)6 months after surgery
SecondaryUpper Limb Radicular Pain Intensity at 9 Months Measured Using an 11-Point Numerical Rating Scale (0-10)9 months after surgery
SecondaryUpper Limb Radicular Pain Intensity at 12 Months Measured Using an 11-Point Numerical Rating Scale (0-10)12 months after surgery
SecondaryCervical Pain Intensity at 6 Weeks Measured Using an 11-Point Numerical Rating Scale (0-10)6 weeks after surgery
SecondaryCervical Pain Intensity at 3 Months Measured Using an 11-Point Numerical Rating Scale (0-10)3 months after surgery
SecondaryCervical Pain Intensity at 6 Months Measured Using an 11-Point Numerical Rating Scale (0-10)6 months after surgery
SecondaryCervical Pain Intensity at 9 Months Measured Using an 11-Point Numerical Rating Scale (0-10)9 months after surgery
SecondaryCervical Pain Intensity at 12 Months Measured Using an 11-Point Numerical Rating Scale (0-10)12 months after surgery
SecondaryNeck Disability Index at 6 Weeks Measured using the Neck Disability Index questionnaire6 weeks after surgery
SecondaryNeck Disability Index at 3 Months Measured using the Neck Disability Index questionnaire3 months after surgery
SecondaryNeck Disability Index at 6 Months Measured using the Neck Disability Index questionnaire6 months after surgery
SecondaryNeck Disability Index at 9 Months Measured using the Neck Disability Index questionnaire9 months after surgery
SecondaryNeck Disability Index at 12 Months Measured using the Neck Disability Index questionnaire12 months after surgery
SecondaryAdjacent Segment Disc Degeneration12 months after surgeryProportion of Participants With Adjacent Segment Intervertebral Disc Signal Changes on MRI
SecondaryIntervertebral Fusion12 months after surgery
Proportion of Participants With Intervertebral Fusion on Cervical CT Intervertebral fusion will be assessed using cervical computed tomography (CT) performed 12 months after surgery in participants allocated to the anterior cervical discectomy and fusion group.
SecondaryPostoperative ComplicationsFrom surgery through 12 months of postoperative follow-upProportion of Participants Experiencing Surgical Complications
SecondaryOperative Duration measured at the end of the surgery, from skin incision to completion of wound closureImmediately after the surgerySurgical procedure duration will be measured in minutes, from skin incision to completion of wound closure. The duration will be compared between the two treatment groups.
SecondaryLength of Hospital StayFrom surgical admission to hospital dischargeLength of hospital stay associated with the surgical procedure, measured in days, will be compared between the two treatment groups.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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