Clinical trial NCT03367039: A Multi-center Prospective Randomized Controlled Study on Clinical and Radiographic Analysis of ProDisc-C Vivo
Official title: Clinical and Radiographic Analysis of ProDisc-C Vivo to Treat Degenerative Disc Disease: A 7-year Follow-up, Multi-center, Prospective, Randomized, Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Disk Degeneration
Cervical Disc Disease
Keywords: ProDisc-C vivo
ACDF
Cervical degenerative disc disease
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 648
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 648 DDD patients (age from 20 to 70) from several hospitals matching the inclusion criteria will be randomly assigned to two groups (324 patients in each group). One group will be treated with ProDisc-C vivo disc replacement. The other groups will be treated with ACDF.
Primary purpose: TREATMENT

Brief summary: The object of this study is to assess the long-term safety and efficacy of cervical disc replacement with the ProDisc-C vivo Cervical Disc in a prospective, randomized, multi-center trial with 7 years of follow-up.

Detailed description: This is a prospective, randomized, multicenter trial at 7 years of follow-up comparing ProDisc-C vivo artificial cervical disc replacement and ACDF (Anterior cervical discectomy fusion) to treat degenerative disc disease (DDD). 648 DDD patients (age from 20 to 70) from several hospitals matching the inclusion criteria will be randomly assigned to two groups (324 patients in each group). One group will be treated with ProDisc-C vivo disc replacement. The other group will be treated with ACDF. The clinical outcomes and radiographic measurements will be compared between two groups at 1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments.

Eligibility criteria: Inclusion Criteria:

* Single-level cervical disc disease.
* At least one additional confirmatory neuroradiographic study, such as MRI or CT- enhanced myelography that showed findings consistent with clinical findings and complaints.

Exclusion Criteria:

* Patients have cervical spinal conditions other than single-level symptomatic degenerative disc disease or evidence of instability.
* Symptomatic disc disease at level C2 -3 or C7-T1.
* A history of discitis.
* A medical condition that required medication,such as steroids or nonsteroidal antiinflammatory medications that could interfere with fusion.

Primary outcomes:
measure: Change of overall success rate
timeFrame: The overall success will be assessed at each time point (1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments).
Secondary outcomes:
measure: Change of sagittal angular motion
timeFrame: The radiographic outcomes will be obtained at each study point (before surgery,1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments).
measure: Change of neck disability index scores
timeFrame: The NDI scores will be obtained at each study point (before surgery,1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments).
measure: Change of Arm and Neck pain intensity
timeFrame: Neck and arm pain scores will be measured at each study point (before surgery,1.5, 3, 6, 12, 24, 36, 60, and 84 months after the surgical treatments).
Other outcomes:
Locations:
Study officials:
affiliation: Peking University People's Hospital
name: Zhenqi Zhu, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sasso RC, Anderson PA, Riew KD, Heller JG. Results of cervical arthroplasty compared with anterior discectomy and fusion: four-year clinical outcomes in a prospective, randomized controlled trial. J Bone Joint Surg Am. 2011 Sep 21;93(18):1684-92. doi: 10.2106/JBJS.J.00476.
citation: Steinmetz MP, Patel R, Traynelis V, Resnick DK, Anderson PA. Cervical disc arthroplasty compared with fusion in a workers' compensation population. Neurosurgery. 2008 Oct;63(4):741-7; discussion 747. doi: 10.1227/01.NEU.0000325495.79104.DB.
citation: Mummaneni PV, Burkus JK, Haid RW, Traynelis VC, Zdeblick TA. Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial. J Neurosurg Spine. 2007 Mar;6(3):198-209. doi: 10.3171/spi.2007.6.3.198.