A Multi-center Prospective Randomized Controlled Study on Clinical and Radiographic Analysis of ProDisc-C Vivo

Cervical Disc Disease Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03367039
• Other study ID #: Prodisc-C vivo
• Status: Not yet recruiting
• Phase: N/A
• First received: November 29, 2017
• Last updated: December 4, 2017
• Start date: March 1, 2018
• Est. completion date: March 1, 2025

Study information

• Verified date: December 2017
• Source: Peking University People's Hospital
• Contact: Weiwei Xia, Ph.D.
• Phone: 008613260001978
• Email: weiweixia2016[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 648
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Disc Disease
• Disk Degeneration
• Intervertebral Disc Degeneration
• Spinal Diseases

Intervention

Procedure:
• ProDisc-C vivo
Total Disc Replacement using ProDisc-C vivo.
• Anterior cervical discectomy fusion
Anterior Cervical Discectomy and Fusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of overall success rate	A patient's outcome was considered an overall success if all of the following conditions were met: 1) postoperative (Neck Disability Index) NDI score improvement of at least a 15-point increase from preoperative score; 2) maintenance or improvement in neurological status; 3) disc height success; 4) no serious adverse event classified as implant associated or implant/surgical procedure associated; and 5) no additional surgical procedure classified as a "failure".	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	Change of sagittal angular motion	Neutral anteroposterior and lateral radiographs and dynamic flexion-extension lateral radiographs will be measured.	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).
Secondary	Change of neck disability index scores	The neck disability index(NDI) questionnaire measures the level of pain and disability associated with various activities. The NDI is a 10-item, 50-point index that assesses different aspects of daily functioning in patients with neck pain. Each item is scored 0 to 5. The NDI score is a sum of the scores of the10-item. Clinical effects will be evaluated based on scores of the NDI. Higher values represent a better outcome.	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).
Secondary	Change of Arm and Neck pain intensity	Neck and arm pain scores will be measured using a visual analogue scale (VAS) from "0' (no sensation) to '100"(the most intense pain imaginable) where 30 means "pain threshold".	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).