Final Long-Term Reporting from a Randomized Controlled IDE Trial for Lumbar Artificial Discs in Single-Level Degenerative Disc Disease: 7-Year Results

Radcliff, Kris; Zigler, Jack E.; Braxton, Ernest; Buttermann, Glen; Coric, Dom; Derman, Peter B.; García, Rolando; Jorgensen, Anton; Ferko, Nicole; Situ, Aaron; Yue, James J.

doi:10.14444/8083

Cited by 10 publications

(10 citation statements)

References 36 publications

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“…The literature reveals that scores above 18.8 are considered a substantial benefit for patients with high levels of disability preoperatively. 31 The specialized literature has suggested the superiority of arthroplasty over intervertebral fusion surgical techniques, 32 data corroborated by our findings. A recent meta-analysis study concluded that after three years of follow-up, the mean percentages for ODI scores were lower among patients who underwent arthroplasty (22.8 points) than patients in the arthrodesis group (27.6 points).…”

Section: Discussionsupporting

confidence: 89%

Quality of Life Analysis on Patients After Arthroplasty or Lumbar Arthrodesis

Silva

Rodrigues²,

Lopes

et al. 2023

Coluna/Columna

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Objective: To perform a retrospective analysis of patients with degenerative disc disease of the lumbar spine undergoing arthrodesis or lumbar arthroplasty in terms of functional capacity and quality of life. Methods: Retrospective observational study analyzing the medical records of patients undergoing arthrodesis or lumbar arthroplasty, followed-up at an outpatient clinic from 2018 to 2020. Patient characteristics were evaluated; the quality of life through the results of the Short Form 36 Health Survey Questionnaire (SF-36) and the functional capacity using the Oswestry Disability Index (ODI) in the pre-surgical and post-surgical periods (6 months, 1 and 2 years). The criterion to establish statistical significance was p≤0.05. Results: Sixty-one patients were evaluated. After the surgical interventions, the individuals migrated from the classification of invalid (61.4%-64.6%) to minimal/moderate disability (17.7%-25.6%). There was a decline in ODI scores over time of follow-up (p≤0.001) as well as in SF-36 values (p≤0.001) for all surgical techniques. In this regard, evaluating the difference in means revealed the better performance of lumbar arthroplasty (p≤0.001). Conclusion: The data suggest that lumbar arthroplasty offers greater benefits to patients regarding functional capacity and quality of life. Level of Evidence III; Retrospective, descriptive, observational study.

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Section: Discussionsupporting

confidence: 89%

Quality of Life Analysis on Patients After Arthroplasty or Lumbar Arthrodesis

Silva

Rodrigues²,

Lopes

et al. 2023

Coluna/Columna

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“…The final long-term follow-up for Activ-L and Prodisc-L lumbar arthroplasty devices was published in 2021 ( 16 ). This represents the two most rigorously studied LTDR devices.…”

Section: Discussionmentioning

confidence: 99%

“…No patient developed ASD that required surgical intervention. Combined analyses of the FDA trial for ActivL and Prodisc-L demonstrated a reoperation rate of 5.0% at 7 years ( 16 ). We report an index level reoperation rate of 1.7% with M6-L in a 60-year-old male with osteopenia who suffered L4/5 M6-L delayed subsidence and required posterior instrumentation without removal of the LTDR.…”

Section: Discussionmentioning

confidence: 99%

Long-term outcomes following lumbar total disc replacement with M6-L

Faulks¹,

Biddau²,

Rossi³

et al. 2022

J Spine Surg

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Background The motion preserving benefits of lumbar total disc replacement (LTDR) are well established. There is a paucity of long-term follow-up data on the M6-L prosthesis. The aim was to evaluate the clinical and radiographic outcomes of patients undergoing LTDR with M6-L and make comment about its effectiveness and durability. Methods A retrospective single center chart review was performed of all patients who underwent LTDR with M6-L between January 1, 2011, and January 1, 2021, either as standalone device or combined with a caudal anterior lumbar interbody fusion (ALIF) (hybrid procedure). Preoperative, postoperative, and final follow-up patient reported outcome measures (PROMs) (VAS back, VAS leg, ODI, and SF-12) and patient satisfaction were recorded prospectively. Device range of motion (ROM), adjacent segment degeneration/disease and heterotopic ossification (HO) were obtained from flexion and extension lumbar radiographs at most recent follow-up. Results Sixty patients underwent LTDR with the M6-L device. Mean age was 41 [16–71] years and 38 (63%) were male. Sixteen (26.7%) underwent standalone LTDR, 42 (70.0%) a hybrid procedure, and 2 (3.3%) a 3-level procedure. Twenty-three (38.3%) patients were lost to follow-up. Thirty-seven (61.7%) were followed for a mean of 4.3 [1–10] years with 36/37 reviewed at a minimum of 2-years and 13/37 followed for over 5-years. Only one patient with osteopenia needed index level revision LTDR surgery for subsidence requiring supplemental posterior instrumentation. There were no osteolysis induced device related failures. Thirty patients obtained long-term follow-up radiographic data. Six patients had adjacent segment degeneration; none required surgery for adjacent segment disease (ASD). Three patients presented with clinically significant HO (2 with McAfee class III, 1 with class IV). The average M6-L ROM was 8.6 degrees. Mean preoperative baseline PROMs demonstrated statistically significant improvements postoperatively and were sustained at last follow-up (P<0.05). Conclusions Total disc replacement (TDR) with M6-L showed clinically significant improvement in PROMs that were sustained at long-term follow-up. There were no osteolysis induced device related failures. The device ROM was maintained and showed a downward trend over the 10-year study follow-up period. This paper demonstrated that the M6-L was an effective and durable arthroplasty device in this series.

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“…The 7-year results of the activL IDE trial were published in 2021. 33 Of note, these results only included activL and ProDisc-L patients. Data were available for 72.7% of patients at 7 years.…”

Section: Activlmentioning

confidence: 99%

Preservation of Motion in Spine Surgery

Preston

Hoffmann²,

Satin³

et al. 2023

J Am Acad Orthop Surg

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The number of spinal procedures and spinal fusions continues to grow. Although fusion procedures have a high success rate, they have inherent risks such as pseudarthrosis and adjacent segment disease. New innovations in spine techniques have sought to eliminate these complications by preserving motion in the spinal column. Several techniques and devices have been developed in the cervical and lumbar spine including cervical laminoplasty, cervical disk ADA, posterior lumbar motion preservation devices, and lumbar disk ADA. In this review, advantages and disadvantages of each technique will be discussed.T he number of spinal fusions being conducted continues to grow. 1 Although technical success is high, fusion procedures have several downsides, including loss of motion at the index levels and accelerated degeneration at adjacent levels. 2 The concept of motion preservation in spine surgery aims at minimizing the change in kinematics compared with normal motion at the surgical level, thereby decreasing the incidence of adjacent segment disease. Classic techniques to decompress the spinal canal and nerve roots, while still preserving motion, include laminectomy and foraminotomies. Several techniques and devices have been developed in the cervical and lumbar spine including cervical laminoplasty, cervical disk ADA, posterior lumbar motion preservation devices, and lumbar disk ADA. Each method offers distinctive advantages and limitations. Preservation of Motion in the Cervical Spine LaminoplastyLaminoplasty is a posterior cervical surgery that decompresses the spinal cord by expansion of the spinal canal while preserving the posterior tension band and facet joints. This technique is often used as an alternative to laminectomy and fusion. Preservation of the posterior elements while avoiding fusion allows for maintenance of motion.Indications for cervical laminoplasty include cervical myelopathy or myeloradiculopathy due to ossification of the posterior longitudinal ligament, cervical spondylosis, congenital stenosis, multilevel disk herniations, and central cord syndrome without instability, and it is typically used when the disease includes three or more levels. In a neutral to lordotic cervical spine, laminoplasty allows for posterior drift of the spinal cord. Laminoplasty may be done in patients with up to

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Final Long-Term Reporting from a Randomized Controlled IDE Trial for Lumbar Artificial Discs in Single-Level Degenerative Disc Disease: 7-Year Results

Cited by 10 publications

References 36 publications

Quality of Life Analysis on Patients After Arthroplasty or Lumbar Arthrodesis

Quality of Life Analysis on Patients After Arthroplasty or Lumbar Arthrodesis

Long-term outcomes following lumbar total disc replacement with M6-L

Preservation of Motion in Spine Surgery

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