An 11-year minimum follow-up of the Charite III lumbar disc replacement for the treatment of symptomatic degenerative disc disease

OBJECT The purpose of this study was to evaluate the safety and effectiveness of 2-level total disc replacement (TDR) using a Mobi-C cervical artificial disc at 48 months' follow-up. METHODS A prospective randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc was conducted at 24 centers in the US. Three hundred thirty patients with degenerative disc disease were randomized and treated with cervical total disc replacement (225 patients) or the control treatment, anterior cervical discectomy and fusion (ACDF) (105 patients). Patients were followed up at regular intervals for 4 years after surgery. RESULTS At 48 months, both groups demonstrated improvement in clinical outcome measures and a comparable safety profile. Data were available for 202 TDR patients and 89 ACDF patients in calculation of the primary endpoint. TDR patients had statistically significantly greater improvement than ACDF patients for the following outcome measures compared with baseline: Neck Disability Index scores, 12-Item Short Form Health Survey Physical Component Summary scores, patient satisfaction, and overall success. ACDF patients experienced higher subsequent surgery rates and displayed a higher rate of adjacent-segment degeneration as seen on radiographs. Overall, TDR patients maintained segmental range of motion through 48 months with no device failure. CONCLUSIONS Four-year results from this study continue to support TDR as a safe, effective, and statistically superior alternative to ACDF for the treatment of degenerative disc disease at 2 contiguous cervical levels. Clinical trial registration no.: NCT00389597 (clinicaltrials.gov)

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DEGENERATIVE DISC DISEASE TREATED BY DECOMPRESSION AND ARTHRODESIS USING A PEEK-TITANIUM POLYAXIAL INTERSPINOUS POSTERIOR FUSION DEVICE: ROMEO®2 PAD. 2 YEARS PROSPECTIVE FOLLOW-UP

Case Medical Research ◽

10.31525/ct1-nct04174534 ◽

2019 ◽

Author(s):

Keyword(s):

Degenerative Disc Disease ◽

Posterior Fusion ◽

Disc Disease ◽

Degenerative Disc ◽

Fusion Device

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Titanium-interlayer mediated hydroxyapatite coating on polyetheretherketone: a prospective study in patients with single-level cervical degenerative disc disease

Journal of Translational Medicine ◽

10.1186/s12967-020-02688-z ◽

2021 ◽

Vol 19 (1) ◽

Author(s):

Ce Zhu ◽

Miaomiao He ◽

Lili Mao ◽

Tao Li ◽

Li Zhang ◽

...

Keyword(s):

Degenerative Disc Disease ◽

Fusion Rate ◽

Peek Cage ◽

Disc Disease ◽

Degenerative Disc ◽

Single Level ◽

Cervical Degenerative Disc Disease ◽

Post Operation

Abstract Background Currently, there are limited reports regarding investigation of the biological properties of polyetheretherketone (PEEK) coated with titanium (Ti) and hydroxyapatite (HA) in human. The objective of this study is to evaluate the in vivo response of the PEEK cages coated with Ti and HA versus uncoated PEEK cages after anterior cervical discectomy and fusion (ACDF) in patients with single-level cervical degenerative disc disease (CDDD). Methods Twenty-four patients with PEEK cages coated with Ti and HA (PEEK/Ti/HA group) were matched one-to-one with patients with uncoated PEEK cages (PEEK group) based on age, gender, and operative segment. All patients had been followed up for more than 2 years. Radiological assessments included intervertebral height (IH), C2-7 angle (C2-7a), segmental alignment (SA), and fusion rate. Clinical parameters included Visual Analogue Scale (VAS) and Japanese Orthopedic Association (JOA) scores. Results There was no statistical difference in SA, IH, and C2-7a between the two groups before and after surgery and all these parameters were restored postoperatively. The fusion rate of PEEK/Ti/HA group was significantly higher than PEEK group at 3-month post-operation (87.5% vs. 62.5%). At the last follow-up, the fusion rate of the both groups achieved 100%. The VAS and JOA scores were comparable between two groups and improved postoperatively. Conclusions In patients with single-level ACDF, PEEK cage coated with Ti and HA provided a higher fusion rate than uncoated PEEK cage at 3-month post-operation, while both two cages could achieve solid osseous fusion at the last follow up. Compared with the uncoated PEEK cage, PEEK/Ti/HA cage yielded similar favorable segmental and overall cervical lordosis, IH, and clinical outcomes after the surgery.

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Effect of Core Stabilizing Training on Young Individuals Presenting Different Stages of Degenerative Disc Disease—Preliminary Report

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18073499 ◽

2021 ◽

Vol 18 (7) ◽

pp. 3499

Author(s):

Tomasz Kuligowski ◽

Błażej Cieślik ◽

Natalia Kuciel ◽

Agnieszka Dębiec-Bąk ◽

Anna Skrzek

Keyword(s):

Lumbar Spine ◽

Outcome Measures ◽

Degenerative Disc Disease ◽

Preliminary Report ◽

Primary Outcome ◽

Core Stability ◽

Post Intervention ◽

Disc Disease ◽

Degenerative Disc

The aim of this study was to assess the efficacy of stabilizing training for the deep core muscles of the lumbar spine in subjects with degenerative disc disease. This study was conducted on 38 participants. The participants were divided into two groups: the extrusion group (EXT, n = 17) and the protrusion group (PRO, n = 21). All the subjects underwent a four-week-long core stability exercise-based treatment (five sessions/week). Clinical outcome measures were assessed pre-intervention (pre), post-intervention (post) and four weeks after the intervention (follow-up). The primary outcome measures were the spinal range of motion (ROM; Spinal Mouse® device) and the Oswestry Disability Index (ODI). In the PRO group, the ROM decreased from 88.52° pre-intervention to 83.33° post-intervention and to 82.82° at follow-up (p = 0.01), while the ODI decreased from 16.14 points pre-intervention to 6.57 points post-intervention, with 9.42 points at follow-up (p < 0.01). In the EXT group, the ROM decreased from 81.00° pre-intervention to 77.05° post-intervention, then increased to 77.94° at follow-up (p = 0.03), while the ODI decreased from 22.58 points pre-intervention to 15.41 points post-intervention and to 14.70 points at follow-up (p < 0.001). Although the stabilizing exercise sessions improved the clinical outcomes in each group, we cannot make conclusions as to whether the type of intervertebral disc damage significantly affects the results of stabilizing exercise-based treatment.

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