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Clinical Improvement and Motion Preservation After Lumbar Total Disc Replacement with ProDisc-L: A Single-Center Cohort Study
, Pedro Arnulfo Chavira-Ramosb, Ricardo Axel Gomez-Lopezc, Sergio Diaz-Bellod, Diana Chavez-Lizarragad, Gilfredo Jose Gonzalez-Basiled, Apolinar De la luz-Lagunasd, Alfonso Vega-Sosad, Jesus Alberto Perez-Contrerasd,
*Corresponding author: Jesus Alberto Perez-Contreras, Department of Spine Surgery, Hospital Angeles Pedregal, Ciudad de Mexico, Mexico alperezc@gmail.com
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Received: ,
Accepted: ,
How to cite this article: Munuzuri-Camacho MA, Chavira-Ramos A, Gomez-Lopez A, Diaz-Bello S, Chavez-Lizarraga D, Gonzalez-Basile J, et al. Clinical Improvement and Motion Preservation After Lumbar Total Disc Replacement with ProDisc-L: A Single-Center Cohort Study. J Orthoo. 2026;78:23-31. doi: 10.25259/JOO_125_2026
Abstract
Objectives:
Lumbar total disc replacement (LTDR) is a motion-preserving alternative to fusion for selected patients with symptomatic degenerative disc disease. Although favorable outcomes have been reported in clinical trials, data from standardized real-world cohorts remain limited. This study evaluated clinical, radiographic, and perioperative outcomes following LTDR in a consecutive single-center cohort.
Material and Methods:
Adults undergoing LTDR between March 2023 and March 2025 were retrospectively identified. Patients with osteoporosis, lumbar instability, previous retroperitoneal surgery, or disc collapse greater than 50% were excluded. Clinical outcomes were assessed using the Oswestry Disability Index (ODI) and Visual Analog Scale (VAS). Segmental motion was evaluated on standing flexion-extension radiographs using Surgimap®. All patients completed six months of follow-up.
Results:
Sixty patients were included. Mean ODI improved from 43.8 ± 2.5 preoperatively to 12.8 ± 2.2 at six months (mean reduction, 31.0 points; p < 0.001), while VAS improved from 6.7 ± 0.8 to 1.3 ± 0.5 (mean reduction, 5.42 points; p < 0.001). Mean range of motion at the operated and adjacent segments was 5.5 ± 1.1° and 6.0 ± 2.1°, respectively. Clinically meaningful improvement according to predefined ODI and VAS thresholds was observed in all patients. Five intraoperative complications occurred (8.3%), all managed without postoperative sequelae; no postoperative complications or reoperations were observed.
Conclusion:
LTDR was associated with significant improvements in pain and disability while preserving segmental motion and demonstrating a favorable perioperative safety profile. Longer follow-up is required to evaluate implant durability and adjacent segment degeneration.
Keywords
Degenerative disc disease
Lumbar arthroplasty
Lumbar spine
Lumbar total disc replacement
Motion preservation
1. INTRODUCTION
Low back pain is the leading cause of years lived with disability worldwide and represents a substantial socioeconomic burden because of its high prevalence, healthcare costs, and negative impact on quality of life.1-3 Among its multiple etiologies, lumbar degenerative disc disease (DDD) represents one of the most common structural causes of chronic axial low back pain and is frequently encountered in patients who remain symptomatic despite appropriate conservative management.4-6 Although many patients improve with nonoperative treatment, carefully selected individuals with persistent symptoms may ultimately require surgical intervention.1,7
For several decades, lumbar fusion has remained the standard surgical treatment for symptomatic lumbar DDD refractory to conservative management, with numerous studies demonstrating meaningful improvements in pain and functional outcomes.8-10 However, elimination of motion at the treated segment may alter spinal biomechanics and has been associated with concerns regarding pseudarthrosis and adjacent segment degeneration, potentially leading to additional surgical procedures.11,12 These limitations have contributed to the development of motion-preserving strategies aimed at maintaining segmental mobility while achieving comparable clinical improvement.13
Lumbar total disc replacement (LTDR) was introduced as a motion-preserving alternative to fusion with the objective of maintaining physiological segmental movement while providing pain relief and functional recovery.14,15 Prospective studies and randomized controlled trials have demonstrated that LTDR provides clinical outcomes comparable to, and in selected populations potentially superior to, lumbar fusion.15,16 Long-term investigations have further reported sustained improvements in pain and disability, preservation of segmental motion, acceptable implant survivorship, and favorable safety profiles.17-20
Despite this growing evidence, outcomes following LTDR remain highly dependent on appropriate patient selection, accurate identification of discogenic pain, and standardized surgical technique.21,22 Furthermore, much of the current evidence originates from randomized controlled trials, multicenter investigations, and large institutional series performed predominantly in North America and Europe.15,19 Whether these favorable outcomes can be consistently reproduced in routine clinical practice across different healthcare settings remains less well characterized. Data from Latin American centers remains particularly limited despite increasing adoption of lumbar disc arthroplasty. Consecutive single-center cohorts provide complementary evidence by evaluating the reproducibility of established outcomes when standardized indications, surgical techniques, and postoperative protocols are applied in real-world clinical practice.20
Therefore, this study aimed to evaluate clinical, radiographic, and perioperative outcomes following LTDR in a consecutive single-center Latin American cohort of patients with symptomatic lumbar DDD treated using standardized indications and surgical technique.
2. MATERIAL AND METHODS
2.1 Study design and setting
A retrospective consecutive single-center cohort study was conducted at a tertiary private referral center in Mexico City, Mexico. Consecutive adult patients who underwent lumbar total disc replacement (LTDR) between March 2023 and March 2025 were retrospectively identified from the institutional surgical database. All procedures were performed by three experienced spine surgeons using a standardized anterior retroperitoneal approach. Complete clinical and radiographic follow-up at six months was available for all included patients.
Formal Institutional Review Board/Ethics Committee approval was not required for this retrospective study, as patient consent for the use of clinical data for research and publication purposes was obtained as part of the standard surgical informed consent. The study was conducted in accordance with the principles of the Declaration of Helsinki and was reported according to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.
2.2 Patient selection
Adult patients with symptomatic lumbar DDD presenting with chronic discogenic low back pain refractory to conservative treatment were eligible for inclusion.
Patients were excluded if they had osteoporosis, radiographic lumbar instability, previous retroperitoneal surgery, or intervertebral disc collapse greater than 50% of the original disc height. Only patients with complete baseline and six-month clinical and radiographic evaluations were included in the final analysis.
2.3 Surgical technique
All procedures were performed through a standard anterior retroperitoneal approach using the ProDisc-L lumbar total disc replacement system (Centinel Spine, West Chester, PA, USA). All patients received the same implant platform. Implant selection and surgical technique followed the institutional surgical protocol and the manufacturer's recommendations.
Although procedures were performed by three different spine surgeons, patient selection criteria, surgical indications, and operative technique remained consistent throughout the study period.
2.4 Clinical assessment
Clinical outcomes were evaluated using the oswestry disability index (ODI) and the visual analog scale (VAS) for low back pain. ODI was assessed preoperatively and at six months postoperatively. VAS was assessed preoperatively, immediately after surgery, and at the six-month follow-up.
The primary outcome was functional improvement, defined as the change in ODI score between baseline and six months. Secondary outcomes included changes in pain intensity, preservation of segmental motion, perioperative complications, and reoperation rate.
Clinically meaningful improvement was evaluated using predefined thresholds, defined as a reduction of at least 10 points or 30% from baseline for ODI and a reduction of at least 2 points for VAS.
2.5 Radiographic assessment
Standing lateral flexion-extension radiographs were obtained at the six-month follow-up. Segmental range of motion (ROM) at the operated level was defined as the angular difference between maximal flexion and maximal extension and measured in degrees using Surgimap® software (Nemaris Inc., New York, NY, USA).
Adjacent segment ROM was measured using the same methodology. Radiographic measurements were performed by three trained evaluators using standardized measurement criteria, with each evaluator independently analyzing a predefined subset of radiographs.
2.6 Safety assessment
Perioperative complications were identified through review of medical records and classified descriptively. Reoperations occurring during the follow-up period were also recorded.
2.7 Statistical analysis
Continuous variables were assessed for normality using the Shapiro–Wilk test. Because ODI and VAS outcome measures did not demonstrate a normal distribution, nonparametric tests were used for analysis. Paired comparisons of ODI scores were performed using the Wilcoxon signed-rank test, whereas changes in VAS scores across the three assessment time points were analyzed using the Friedman test.
Categorical variables are presented as frequencies and percentages, whereas continuous variables are presented as mean ± standard deviation.
For the primary clinical outcomes, mean change from baseline, percentage improvement, and 95% confidence intervals (CIs) were calculated. Exploratory subgroup analyses were performed to compare clinical improvement, preserved ROM, and perioperative complications between patients undergoing single-level and multilevel LTDR.
Correlations between preserved segmental ROM and clinical improvement were evaluated using Spearman's rank correlation coefficient.
Statistical significance was established at a two-sided p-value < 0.05. All statistical analyses were performed using IBM SPSS Statistics for Windows, version 29.0 (IBM Corp., Armonk, NY, USA).
3. RESULTS
3.1 Patient characteristics
A total of 60 consecutive patients met the inclusion criteria and completed the predefined six-month clinical and radiographic follow-up. The mean age was 40.1 ± 8.9 years, and 32 patients (53.3%) were female.
Single-level LTDR was performed in 40 patients (66.7%), two-level arthroplasty in 19 patients (31.7%), and three-level arthroplasty in one patient (1.6%). The L5–S1 level was treated in all patients, whereas L4–L5 and L3–L4 were additionally treated in 21 (35.0%) and one (1.7%) patient, respectively [Table 1].
| Variable | Overall (n = 60) |
|---|---|
| Age (years), mean ± SD | 40.1 ± 8.9 |
| Sex n (%) | |
| Male | 28 (46.7) |
| Female | 32 (53.3) |
| Number of treated levels, n (%) | |
| • One-level arthroplasty | 40 (66.7) |
| • Two-level arthroplasty | 19 (31.7) |
| • Three-level arthroplasty | 1 (1.6) |
| Operated levels n (%) | |
| • L3–L4 | 1 (1.7) |
| • L4–L5 | 21 (35.0) |
| • L5–S1 | 60 (100) |
SD: Standard deviation
Values are presented as mean ± standard deviation or number (percentage), unless otherwise indicated. Patients undergoing multilevel arthroplasty contributed to more than one operated level.
No patients were lost to follow-up, and complete clinical and radiographic data were available for all included patients.
3.2 Clinical outcomes
Significant improvements in disability and pain were observed at the six-month follow-up. Mean ODI decreased from 43.8 ± 2.5 preoperatively to 12.8 ± 2.2 at six months, corresponding to a mean reduction of 31.0 points (95% CI, −31.67 to −30.33) and a 70.7% improvement from baseline (p < 0.001). Mean VAS progressively improved from 6.7 ± 0.8 preoperatively to 3.4 ± 0.6 immediately after surgery and to 1.3 ± 0.5 at six months, corresponding to a mean reduction of 5.42 points (95% CI, −5.63 to −5.21) and an 80.4% improvement from baseline (p < 0.001) [Table 2, Figure 1].
| Outcome | Time point | Mean ± SD | Mean change | 95% CI | % Improvement | p-value |
|---|---|---|---|---|---|---|
| ODI (%) | Preoperative | 43.8 ± 2.5 | — | — | — | — |
| 6-month follow-up | 12.8 ± 2.2 | −31.0 | −31.67 to −30.33 | 70.7% | <0.001 | |
| VAS (0–10) | Preoperative | 6.7 ± 0.8 | — | — | — | — |
| Immediate postoperative | 3.4 ± 0.6 | — | — | — | — | |
| 6-month follow-up | 1.3 ± 0.5 | −5.42 | −5.63 to −5.21 | 80.4% | <0.001 |
Values are presented as mean ± standard deviation. Mean change was calculated from baseline to the six-month follow-up. Percentage improvement was calculated relative to the preoperative value. p-values were obtained using the Wilcoxon signed-rank test for ODI and the Friedman test for VAS. Statistical significance was set at p < 0.05. ODI: Oswestry disability index, VAS: Visual analog scale, CI: Confidence interval, SD: Standard deviation.
Values are presented as mean ± standard deviation. Mean change was calculated from baseline to the six-month follow-up. Percentage improvement was calculated relative to the preoperative value. p-values were obtained using the Wilcoxon signed-rank test for ODI and the Friedman test for VAS.
Clinically meaningful improvement according to predefined ODI and VAS thresholds was observed in all patients at six months. A reduction of at least 10 points and 30% from baseline in ODI was observed in all patients (100%), and all patients achieved a reduction of at least 2 points in VAS score.
Exploratory subgroup analysis demonstrated no significant differences in ODI improvement (30.8 ± 2.6 vs. 31.4 ± 2.6 points, p = 0.392), VAS improvement (5.40 ± 0.74 vs. 5.45 ± 0.94 points, p = 0.527), or operated segment ROM (5.48 ± 1.09° vs. 5.56 ± 1.10°, p = 0.936) between patients undergoing single-level and multilevel LTDR. Multilevel procedures demonstrated lower six-month VAS scores (1.05 ± 0.22 vs. 1.45 ± 0.50, p = 0.002); however, the magnitude of improvement from baseline was comparable between groups [Table 3].
| Variable | Single-level LTDR (n = 40) | Multilevel LTDR (n = 20) | p-value |
|---|---|---|---|
| ODI at 6 months (%) | 12.9 ± 2.2 | 12.7 ± 2.2 | 0.714 |
| VAS at 6 months (0–10) | 1.45 ± 0.50 | 1.05 ± 0.22 | 0.002 |
| ODI change (%) | 30.8 ± 2.6 | 31.4 ± 2.6 | 0.392 |
| VAS change (0–10) | 5.40 ± 0.74 | 5.45 ± 0.94 | 0.527 |
| Operated segment ROM (°) | 5.48 ± 1.09 | 5.56 ± 1.10 | 0.936 |
| Intraoperative complications, n (%) | 2 (5.0) | 3 (15.0) | 0.322 |
LTDR: Lumbar total disc replacement; ODI: Oswestry disability index; VAS: Visual analog scale; ROM: Range of motion. Statistical significance was set at p < 0.05.
Values are presented as mean ± standard deviation or number (percentage). Multilevel LTDR includes patients undergoing two- or three-level arthroplasty. Continuous variables were compared using the Mann–Whitney U test, whereas categorical variables were compared using Fisher's exact test.
3.3 Radiographic outcomes
A representative case illustrating preserved motion at the operated segment on standing flexion-extension radiographs is shown in Figure 2.
Standing flexion-extension radiographs obtained at six months demonstrated preserved segmental mobility. Mean ROM at the operated level was 5.5 ± 1.1°, whereas adjacent segment ROM measured 6.0 ± 2.1° [Table 4, Figure 3].
| Variable | Mean ± SD |
|---|---|
| Operated segment ROM (°) | 5.5 ± 1.1 |
| Adjacent segment ROM (°) | 6.0 ± 2.1 |
ROM: Range of motion, SD: Standard deviation
Values are presented as mean ± standard deviation. ROM was measured on standing flexion-extension radiographs using Surgimap® software at the six-month follow-up.
No significant association was identified between preserved segmental ROM and clinical improvement. Operated segment ROM was not significantly correlated with ODI improvement (Spearman's ρ = −0.244, p = 0.060) or VAS improvement (ρ = −0.080, p = 0.545). Similarly, adjacent segment ROM was not associated with ODI improvement (ρ = −0.134, p = 0.308). A weak correlation was observed between adjacent segment ROM and VAS improvement (ρ = −0.255, p = 0.049); however, this finding should be interpreted cautiously given the exploratory nature of the analysis [Table 5].
| Variable | Spearman’s ρ | p-value |
|---|---|---|
| Operated segment ROM (°) vs. ODI improvement | −0.244 | 0.060 |
| Operated segment ROM (°) vs. VAS improvement | −0.080 | 0.545 |
| Adjacent segment ROM (°) vs. ODI improvement | −0.134 | 0.308 |
| Adjacent segment ROM (°) vs. VAS improvement | −0.255 | 0.049 |
Spearman’s rank correlation coefficient was used to evaluate the association between segmental ROM and clinical improvement at six months. Positive ODI and VAS improvement values represent greater reductions from baseline. Statistical significance was set at p < 0.05. ODI: Oswestry disability index, VAS: Visual analog scale, ROM: Range of motion.
Spearman's rank correlation coefficient was used to evaluate the association between segmental ROM and clinical improvement at six months. Positive ODI and VAS improvement values represent greater reductions from baseline.
3.4 Perioperative safety
Five intraoperative complications (8.3%) occurred during the study period, including two vascular injuries (3.3%) and three peritoneal tears (5.0%). All complications were recognized intraoperatively and successfully managed during the index procedure without postoperative sequelae.
No postoperative complications or reoperations occurred during the six-month follow-up period [Table 6].
| Variable | n (%) |
|---|---|
| Patients with intraoperative complications | 5 (8.3) |
| • Vascular injury | 2 (3.3) |
| • Peritoneal tear | 3 (5.0) |
| Postoperative complications | 0 (0) |
| Reoperations | 0 (0) |
Values are presented as number (percentage). All intraoperative complications were recognized and managed during the index procedure without postoperative sequelae. No postoperative complications or reoperations occurred during the six-month follow-up.
The frequency of intraoperative complications did not differ significantly between single-level and multilevel procedures (p = 0.322).
4. DISCUSSION
The principal finding of the present study is that LTDR was associated with substantial improvements in pain and disability while preserving segmental mobility and maintaining a favorable perioperative safety profile in carefully selected patients. These outcomes were observed in a consecutive cohort managed using standardized patient selection criteria, a uniform surgical technique, and complete clinical and radiographic follow-up. Collectively, these findings support the reproducibility of previously reported LTDR outcomes in a standardized real-world clinical setting.14,15,20,21,23,24
The magnitude of improvement observed in ODI and VAS scores was comparable to that reported in prospective studies and randomized controlled trials evaluating LTDR.14,25-28 Although direct comparisons should be interpreted cautiously because of differences in patient selection, implant design, outcome measures, and follow-up duration,15,19 our findings reinforce that clinically meaningful improvements following LTDR can be achieved outside controlled trial environments when strict indications and standardized surgical protocols are applied. These results further emphasize the importance of appropriate patient selection as a determinant of successful outcomes after lumbar disc arthroplasty.21,22
Clinically meaningful improvement according to established ODI and VAS thresholds was observed in all patients, indicating that the observed statistical improvements translated into clinically relevant functional recovery. Exploratory subgroup analyses demonstrated comparable improvements in disability, pain reduction, and preserved segmental motion between single-level and multilevel LTDR. Furthermore, preserved postoperative ROM was not significantly associated with clinical improvement, suggesting that pain relief after LTDR is likely influenced by multiple factors beyond mechanical preservation of motion. Although exploratory, these findings provide additional insight into the relationship between radiographic motion and clinical outcomes after lumbar disc arthroplasty.
Motion preservation represents the primary biomechanical rationale for lumbar disc arthroplasty and distinguishes LTDR from fusion-based procedures.23,29,30 In the present study, flexion-extension radiographs demonstrated preserved mobility at the operated segment and maintained adjacent segment motion at six months, consistent with previous radiographic investigations.31,32 However, whether preserved motion ultimately reduces the incidence of adjacent segment degeneration remains uncertain and requires long-term follow-up.17,18 Therefore, the present study should not be interpreted as demonstrating a protective effect against adjacent segment pathology.
The present cohort demonstrated a favorable perioperative safety profile despite the technical demands associated with the anterior retroperitoneal approach. Five intraoperative complications occurred, including two vascular injuries and three peritoneal tears; all were recognized intraoperatively and successfully managed without postoperative sequelae. No postoperative complications or reoperations were observed during follow-up. These findings reinforce the importance of meticulous surgical technique, appropriate access management, and prompt recognition of approach-related complications.33,34
The strengths of this study include the consecutive inclusion of patients, complete clinical and radiographic follow-up, standardized selection criteria, use of a single implant platform, and a uniform surgical technique performed by three experienced spine surgeons. Unlike heterogeneous series involving multiple implant designs and variable surgical indications, this cohort reflects a standardized clinical experience and provides complementary evidence regarding the reproducibility of LTDR outcomes in routine practice.
5. LIMITATIONS
This study has several limitations that should be considered when interpreting its findings. First, the retrospective design is inherently subject to selection and information bias. Second, the study was conducted at a single tertiary referral center, which may limit the generalizability of the findings to other institutions and patient populations. Third, the sample size may have limited the ability to detect uncommon adverse events and reduced the statistical power of exploratory subgroup and correlation analyses; therefore, these findings should be interpreted cautiously and validated in larger prospective cohorts.
Fourth, clinical and radiographic outcomes were evaluated at six months postoperatively; consequently, conclusions regarding long-term implant survivorship, durability of clinical improvement, and the potential effect of LTDR on adjacent segment degeneration cannot be established. Finally, the absence of a comparison group prevents direct comparison with lumbar fusion or other motion-preserving technologies.
Future prospective multicenter studies with longer follow-up and comparative designs are warranted to further define the long-term role of LTDR. Despite these limitations, the consecutive inclusion of patients, complete clinical and radiographic follow-up, standardized patient selection criteria, and uniform surgical technique strengthen the internal validity of the present findings.
6. CONCLUSION
LTDR was associated with significant improvements in pain and disability while preserving segmental mobility and demonstrating a favorable perioperative safety profile in this consecutive single-center Latin American cohort. These findings are consistent with previously reported outcomes of LTDR and provide additional evidence regarding its performance in a standardized real-world clinical setting with carefully selected patients. Longer-term follow-up is required to evaluate implant durability, sustained clinical outcomes, and the potential impact of LTDR on adjacent segment degeneration.
Authors’ contributions:
MAM-C: Conceptualization, methodology, investigation, data curation, formal analysis, writing – original draft, writing – review & editing. PAC-R - Investigation and Data Curation. RAG-L, SD-B, DC-L, GJG-B, ADL-L and AV-S - Investigation. JAP-C: Conceptualization, methodology, writing – review & editing, supervision, investigation, project administration. All authors read and approved of the final manuscript.
Ethical approval:
Institutional Review Board approval is not required as it is a retrospective study.
Declaration of patient consent:
Patient's consent not required as patients identity is not disclosed or compromised.
Conflicts of interest:
There are no conflicts of interest.
Use of artificial intelligence (AI)-assisted technology for manuscript preparation:
The authors confirm that there was no use of artificial intelligence (AI)-assisted technology for assisting in the writing or editing of the manuscript and no images were manipulated using AI.
Financial support and sponsorship: Nil.
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