Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2018-11-26
2019-09-15
Brief Summary
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The purpose of the present study is to compare cosmetic outcomes in vertical versus transverse platysmal incisions for anterior cervical spine exposures. Researchers intend to analyze this effect with a prospective comparative study model. A targeted number of 100 patients who undergo anterior cervical surgery, as part of their standard of care, will be randomized to receive either a transverse or vertical platysmal incision during the exposure part of their procedure. Informed consent for inclusion in the study, as approved by the Institutional Review Board, will be obtained from all patients in addition to consent for the surgical procedure. Regardless of the platysmal incision, all patients will receive a standard transverse skin incision, as is done routinely in anterior cervical exposures. After the surgery, all closures will be done in a standard manner.
These patients will be followed up in the clinic at two weeks, three months, six months, and one year. They will be evaluated for wound healing and incision cosmesis using a modification of The Hollander Wound Evaluation Scale. Clinical photographs of the patients' necks will be captured during these visits in a manner that does not reveal any patient identifiers in any way. The incisions and overall cosmesis will be graded using the scale mentioned above. The data will be analyzed to determine if a transverse platysmal incision offers better cosmetic results than a vertical platysmal incision, or vice versa, and will also be used to validate the modified wound evaluation scale.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Vertical Platysma Incision
Patients in this arm who have anterior cervical decompression and fusion will receive the vertical platysma incision.
Anterior Cervical Decompression and Fusion
Patients will receive the anterior cervical decompression and fusion as part of their standard of care. They will be randomized to either receive the vertical or transverse platysma incision.
Vertical Platysma Incision
A vertical platysma Incision will be used for the anterior cervical decompression and fusion surgical procedure
Transverse Platysma Incision
Patients in this arm who have anterior cervical decompression and fusion will receive the transverse platysma incision.
Anterior Cervical Decompression and Fusion
Patients will receive the anterior cervical decompression and fusion as part of their standard of care. They will be randomized to either receive the vertical or transverse platysma incision.
Transverse Platysma Incision
A transverse platysma incision will be used for the anterior cervical decompression and fusion surgical procedure
Interventions
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Anterior Cervical Decompression and Fusion
Patients will receive the anterior cervical decompression and fusion as part of their standard of care. They will be randomized to either receive the vertical or transverse platysma incision.
Vertical Platysma Incision
A vertical platysma Incision will be used for the anterior cervical decompression and fusion surgical procedure
Transverse Platysma Incision
A transverse platysma incision will be used for the anterior cervical decompression and fusion surgical procedure
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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Boston Medical Center
OTHER
Responsible Party
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Principal Investigators
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Chadi Tannoury, MD
Role: STUDY_CHAIR
Boston Medical Center
Locations
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Boston Medical Center
Boston, Massachusetts, United States
Countries
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References
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Denaro V, Di Martino A. Cervical spine surgery: an historical perspective. Clin Orthop Relat Res. 2011 Mar;469(3):639-48. doi: 10.1007/s11999-010-1752-3.
Fransen P. A simplified technique for anterior cervical discectomy and fusion using a screw-plate implanted over the Caspar distractor pins. Acta Orthop Belg. 2010 Aug;76(4):546-8.
Fehlings MG, Arvin B. Surgical management of cervical degenerative disease: the evidence related to indications, impact, and outcome. J Neurosurg Spine. 2009 Aug;11(2):97-100. doi: 10.3171/2009.5.SPINE09210.
Other Identifiers
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H-36610
Identifier Type: -
Identifier Source: org_study_id
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