The Treatment of Disabling Single-Level Lumbar Discogenic Low Back Pain With Total Disc Arthroplasty Utilizing the Prodisc Prosthesis

Bertagnoli, Rudolf; Yue, James J.; Shah, Rahul V.; Nanieva, Regina; Pfeiffer, Frank; Fenk-Mayer, Andrea; Kershaw, Trace; Husted, Daniel S.

doi:10.1097/01.brs.0000182217.87660.40

Cited by 120 publications

(53 citation statements)

References 46 publications

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“…Two-level replacement patients scored better on clinical outcome parameters than the single-level replacement patients. Similar results were shown by Bertagnoli et al 19,20 but contradicted by others. 21 We only replaced the clinically or discographically conÀ rmed disc level in 2-level and multilevel degeneration.…”

Section: Discussionsupporting

confidence: 69%

Kineflex (Centurion) Lumbar Disc Prosthesis: Insertion Technique and 2-Year Clinical Results in 100 Patients

Hähnle¹,

Weinberg²,

Sliwa³

et al. 2007

SAS Journal

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Adjacent-level degeneration is a major concern in lumbar fusion operations. [1][2][3][4] Lumbar artiÀ cial discs are an alternative to arthrodesis (fusion). The purpose of total disc replacement is to restore the intervertebral segment and protect the adjacent levels against abnormal loading conditions. A description of the surgical insertions of a lumbar prosthetic nucleus replacement, ABSTRACT BackgroundThe KineÁ ex lumbar disc is a mechanical, unconstrained, re-centering disc prosthesis developed in South Africa. The À rst implantation took place in October 2002. We present a single-center, prospective, longitudinal study of the À rst 100 patients treated with the KineÁ ex lumbar disc. Our objective was to evaluate the insertion technique, clinical outcomes, and patient satisfaction at 2 years postimplantation in 100 consecutive patients with 132 (68 single-and 32 2-level) KineÁ ex lumbar disc replacements. MethodsWe determined the exact central placement of all disc implants in the coronal and midsagittal planes. We measured clinical outcome with the Oswestry disability index (ODI), our own questionnaire, and the time needed to return to work. All patients received radiological and clinical follow-up assessments for 2 years after the index procedure. ResultsForty-three patients were female. The mean age of the patients at operation was 44.9 years (range, 23-63 years). Postoperative hospitalization averaged 2.8 days (range, 2 to 8 days). All patients who were employed before surgery returned to work 31 ± 16.8 days after the operation. Fifty-six percent of operated disc levels had intervertebral disc heights of less than 5 mm. A 2-year clinical outcome was available for 98 of the 100 patients (58 excellent, 30 good, 7 fair, 3 poor). The ODI score improved from 47.8 ± 16.0 preoperatively to 14.2 ± 14.0 (P < .01) at 2 years. At 2 years, 95% of disc implants were radiologically in the ideal position. The insertion technique, with a released prosthetic mechanism for À nal placement, allowed ideal placement in the sagittal plane in 98% of discs. The radiographic placement accuracy achieved was equal in patients with preoperative intervertebral disc height below and above 5 mm. ConclusionsGood short-term clinical results were achieved with the KineÁ ex disc in a heterogeneous patient group with a high number of patients with advanced disc degeneration, severe disc space narrowing, and lumbar Á at-back deformity. In this cohort, accurate implant placement could be achieved in our À rst 100 patients. Clinical RelevenceThis is the À rst report on the KineÁ ex mechanical lumbar disc prosthesis.Key Words KineÁ ex disc, degenerative disc disease, lumbar disc prosthesis, insertion technique, unconstrained disc prosthesis, Oswestry disability index.

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Section: Discussionsupporting

confidence: 69%

Kineflex (Centurion) Lumbar Disc Prosthesis: Insertion Technique and 2-Year Clinical Results in 100 Patients

Hähnle¹,

Weinberg²,

Sliwa³

et al. 2007

SAS Journal

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“…In addition, ACDA appears to lessen adverse loading and changes in range of motion at adjacent segments by preserving motion and improving function in the treated level [6]. Clinical success rates of approximately 90 % have been reported following implantation of cervical disc prostheses [9]. Despite these excellent success rates, artificial cervical disc implants may fail from device-related complications such as dislocation, subsidence, vertebral body fracture, heterotopic ossification, spontaneous fusion and device wear [2].…”

Section: Discussionmentioning

confidence: 99%

“…Inadequate endplate design can equally contribute to subsidence as a result of extremely concentrated stress [2]. Subsidence is most frequently reported within the first 3 months after surgery, while reports on late subsidence are rare [9]. Clinically, inadequate determination of preoperative bone quality, such as in patients with osteopenia or osteoporosis, is considered a risk factor for subsidence of the prosthesis [9].…”

Section: Discussionmentioning

confidence: 99%

“…Subsidence is most frequently reported within the first 3 months after surgery, while reports on late subsidence are rare [9]. Clinically, inadequate determination of preoperative bone quality, such as in patients with osteopenia or osteoporosis, is considered a risk factor for subsidence of the prosthesis [9]. Extensive work has been aimed at studying the graft endplate interface and the risk of subsidence.…”

Section: Discussionmentioning

confidence: 99%

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Footprint mismatch in total cervical disc arthroplasty

et al. 2012

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Purpose Cervical disc arthroplasty has become a commonplace surgery for the treatment of cervical radiculopathy and myelopathy. Most manufacturers derive their implant dimensions from early published cadaver studies. Ideal footprint match of the prosthesis is essential for good surgical outcome. Methods We measured the dimensions of cervical vertebrae from computed tomography (CT) scans and to assess the accuracy of match achieved with the most common cervical disc prostheses [Bryan (Medtronic), Prestige LP (Medtronic), Discover (DePuy) Prodisc-C (Synthes)]. A total of 192 endplates in 24 patients (56.3 years) were assessed. The anterior-posterior and mediolateral diameters of the superior and inferior endplates were measured with a digital measuring system. Results Overall, 53.5 % of the largest device footprints were smaller in the anterior-posterior diameter and 51.1 % in the mediolateral diameter were smaller than cervical endplate diameters. For levels C5/C6 and C6/C7 an inappropriate size match was noted in 61.9 % as calculated from the anteroposterior diameter. Mismatch at the center mediolateral diameter was noted in 56.8 %. Of the endplates in the current study up to 58.1 % of C5/C6 and C6/ C7, and up to 45.3 % of C3/C4 and C4/C5 were larger than the most frequently implanted cervical disc devices. Conclusion Surgeons and manufacturers should be aware of the size mismatch in currently available cervical disc prostheses, which may endanger the safety and efficacy of the procedure. Undersizing the prosthetic device may lead to subsidence, loosening, heterotopic ossification and biomechanical failure caused by an incorrect center of rotation and load distribution, affecting the facet joints.

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“…[12,13,19,20,34,35] The reduction in mean ODI for single-level TDA has ranged from 24.0 (Prodisc) to 26.0 at 24-month follow-up and reduction of mean VAS back ranges from 4.1 (Charite) to 4.8 at 24-month follow-up. [13][14][15][16][17][18][19][20][34][35][36] Although onelevel TDA has demonstrated good clinical outcome, two or more level TDA constructs have been less impressive. Siepe showed deterioration in postoperative results in both ODI and VAS for two-level TDA [20].…”

Section: Discussionmentioning

confidence: 99%

Hybrid construct for two levels disc disease in lumbar spine

et al. 2009

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Prospective study. To study the validity of Hybrid construction (Anterior Lumbar Interbody Fusion) ALIF at one level and total disc arthroplasty (TDA) at adjacent, for two levels disc disease in lumbar spine as surgical strategy. With growing evidence that fusion constructs in the treatment of degenerative disc disease (DDD) may alter sagittal balance and contribute to undesirable complications in the long-term, total disc arthroplasty (TDA) slowly becomes an accepted treatment option for a selected group of patients. Despite encouraging early and intermediate term results of single-level total disc arthroplasty reported in the literature, there is growing evidence that two-level arthroplasty does not fare as well. Hybrid fusion is an attempt to address two-level DDD by combining the advantages of a single-level ALIF with those of a single-level arthroplasty. 42 patients (25 females and 17 males) underwent Hybrid fusion and had a median followup of 26.3 months. The primary functional outcomes were assessed before and after surgery with Oswestry Disability Index and the visual analogue score of the back and legs. Patients were divided into four groups according to the percentage improvement between preop and postop ODI scores. A total of 42 patients underwent a hybrid fusion as follows: 35 L5-S1 ALIF/L4-5 prosthesis, 3 L4-5 ALIF/L3-4 prosthesis, 2 L5-S1 ALIF/L4-5 prosthesis/L3-4 prosthesis, 1 L5-S1 prosthesis/L4-5 ALIF, and 1 L5-S1 ALIF/L4-5 ALIF/L3-4 prosthesis. At 2-years clinical outcomes, mean reduction in ODI is 24.9 points (53.0% improvement compared to preop ODI). The visual analogue score for the back is 64.6% improvement. At 2-year clinical outcomes, Hybrid fusion is a viable surgical alternative for the treatment of two-level DDD in comparison with two-level TDA and with two-level fusion.

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The Treatment of Disabling Single-Level Lumbar Discogenic Low Back Pain With Total Disc Arthroplasty Utilizing the Prodisc Prosthesis

Cited by 120 publications

References 46 publications

Kineflex (Centurion) Lumbar Disc Prosthesis: Insertion Technique and 2-Year Clinical Results in 100 Patients

Kineflex (Centurion) Lumbar Disc Prosthesis: Insertion Technique and 2-Year Clinical Results in 100 Patients

Footprint mismatch in total cervical disc arthroplasty

Hybrid construct for two levels disc disease in lumbar spine

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