Introduction: Cervical hybrid surgery (HS) combines anterior cervical discectomy and fusion (ACDF) and cervical disc arthroplasty (CDA) to establish an individualized surgical plan for patients with multiple cervical disc degenerative diseases. In order to maintain the stability of the spine after HS, an external cervical collar is often used. However, there is still controversy regarding the importance of a cervical collar following surgery. This study aims to determine whether the cervical collar is effective and how long it should be worn after surgery.
Methods: This is a randomized, single-center, prospective, parallel-controlled trial. Eligible participants will be selected according to the inclusion and exclusion criteria. The primary outcome is the neck disability index, which will be evaluated before surgery and at one week, 3 weeks, 6 weeks, 3 months, 6 months, and 12 months following surgery. The secondary outcomes consist of the Japanese Orthopedic Association Scores, MOS 36-item short-form health survey (SF-36), visual analog scale, Pittsburgh Sleep Quality Index (PSQI), Bazaz dysphagia scoring system, Falls Efficacy Scale, cervical collar satisfaction score, neck soft tissue assessment, and Braden Scale, as well as radiologic assessments for cervical lordosis, disc height of the operative levels, fusion rate, range of motion (ROM), and complications including anterior bone loss, prosthesis migration, and heterotopic ossification. The clinical and radiologic examinations were performed by investigators with no therapeutic relationship with the individual patient. All radiographs were examined by one independent radiologist.
Ethics and dissemination: The results of this study will be published in peer-reviewed journals and presented at conferences. Upon completion of this trial, our findings could provide an appropriate cervical collar-wearing guideline for patients receiving HS.
Trial registration: ChiCTR.org.cn ChiCTR2000033002. Registered on 2020-05-17.
© 2023. The Author(s).