Neck Pain Clinical Trial
Official title:
Randomized Controlled Trial: Comparison of Radiological and Axial Pain Outcome Between C3-6 Open Door Laminoplasty and C3 Laminectomy With Cervical Laminoplasty
Verified date | August 2021 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty.
Status | Active, not recruiting |
Enrollment | 126 |
Est. completion date | January 14, 2023 |
Est. primary completion date | January 14, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 100 Years |
Eligibility | Inclusion Criteria: - Cervical stenosis patients with or without cervical myelopathy. Exclusion Criteria: - Metastatic cancer patients. - Any combined fracture. - Previous surgery to cervical spine. - inflammatory joint disease - psychiatric illness |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul | Korea |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Chen C, Li J, Liao Z, Gao Y, Shao Z, Yang C. C3 laminectomy combined with modified unilateral laminoplasty and in situ reconstruction of the midline structures maintained cervical sagittal balance: a retrospective matched-pair case-control study. Spine J. 2020 Sep;20(9):1403-1412. doi: 10.1016/j.spinee.2020.04.023. Epub 2020 May 6. — View Citation
Kudo H, Takeuchi K, Wada K, Kumagai G, Tanaka S, Asari T, Araki R, Yokoyama T, Ishibashi Y. Ten-Year Long-term Results of Modified Cervical Double-door Laminoplasty With C3 Laminectomy Preserving the Semispinalis Cervicis Inserted Into the Axis Compared With Those of Conventional Cervical Laminoplasty. Clin Spine Surg. 2021 Apr 1;34(3):E147-E153. doi: 10.1097/BSD.0000000000001068. — View Citation
Lee GW, Cho CW, Shin JH, Ahn MW. Which Technique Is Better Option for C3 Segment in Multilevel Open-Door Laminoplasty of the Cervical Spine?: Laminectomy Versus Laminoplasty. Spine (Phila Pa 1976). 2017 Jul 15;42(14):E833-E840. doi: 10.1097/BRS.0000000000001974. — View Citation
Nakajima K, Nakamoto H, Kato S, Doi T, Matsubayashi Y, Taniguchi Y, Yoshida Y, Kawamura N, Nakarai H, Higashikawa A, Tozawa K, Takeshita Y, Fukushima M, Iizuka M, Ono T, Shirokoshi T, Azuma S, Tanaka S, Oshima Y. A Multicenter Observational Study on the Postoperative Outcomes of C3 Laminectomy in Cervical Double-door Laminoplasty. Clin Spine Surg. 2021 May 1;34(4):146-152. doi: 10.1097/BSD.0000000000001100. — View Citation
Takeuchi K, Yokoyama T, Aburakawa S, Saito A, Numasawa T, Iwasaki T, Itabashi T, Okada A, Ito J, Ueyama K, Toh S. Axial symptoms after cervical laminoplasty with C3 laminectomy compared with conventional C3-C7 laminoplasty: a modified laminoplasty preserving the semispinalis cervicis inserted into axis. Spine (Phila Pa 1976). 2005 Nov 15;30(22):2544-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the Neck Disability Index (NDI) | scores from 0 to 50 with 50 being the worst performance status related to neck pain. | 1 year | |
Primary | posterior neck with visual analog scale (VAS) | Measuring pain intensity of the posterior neck with visual analog scale (VAS), rated 1 to 10 with 10 being the most severe pain level. | 1 year | |
Primary | C2-C7 lordosis | Measuring C2-C7 lordosis angle by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked. | 1 year | |
Secondary | EuroQol five-dimensional questionnaire (EQ-5D) scores | Responses on a questionnaire with five dimensions, each comprised of five levels. Scores are revised into an index with a range from -0.59-1, with 1.00 indicating full health. The 243 possible health states on the EQ-5D are evaluated against a normal population using the time trade off method (TTO). | 3 month, 6 month, 12 month, 2 year, 3 year | |
Secondary | Radiological outcomes | Measuring C2-C3 lordosis angle, C4-C7 lordosis angle, T1 slope angle, T1 slope - C2-C7 lordosis angle, by using standard lateral cervical x-ray series protocol with the patients standing in a neutral position and instructed to look straight ahead with knees locked. | 1year, 2 year, 3 year | |
Secondary | C2-C7 sagittal vertical axis (C2-C7 SVA) | distance between C2 plumb line and C7) by using standard lateral cervical x-ray series with the patients standing in a neutral position. | 1year, 2 year, 3 year | |
Secondary | C2-C3 interlaminar spontaneous fusion | Measuring the incidence of postoperative C2-C3 interlaminar spontaneous fusion by using standard lateral cervical x-ray series. | through study completion, an average of 2 year | |
Secondary | Estimated intraoperative blood loss | Measuring estimated intraoperative blood loss by using intraoperative records of anesthesiologists. | Intraoperative | |
Secondary | Operative time | Measuring the time between start of the surgery (incision) and the finish of surgery (closure of the skin). | Intraoperative |
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