Long-Term Range of Motion and Influence on Clinical Outcomes After Lumbar Disc Replacement: A Systematic Review

Abstract

Study Design

Systematic review.

Objective

Lumbar disc replacement (LDR) is a motion-preserving treatment for degenerative disc disease. However, questions remain regarding the durability of segmental range of motion (ROM) over time and its relationship to patient-reported outcome measures (PROMs) and adjacent segment disease (ASD). The purpose of this analysis is to evaluate current clinical evidence regarding the long-term preservation of segmental ROM after LDR, identify predictors of preserved motion, and assess associations with clinical outcomes.

Methods

A systematic review was conducted according to PRISMA guidelines. Studies reporting postoperative ROM following LDR with at least 24 months of follow-up were included. Pooled weighted averages and meta-analyses compared ROM at standardized time points with preoperative baselines. Data on predictors of ROM, PROMs, and ASD was qualitatively synthesized.

Results

Twenty-seven studies comprising 2563 LDRs were included. Compared with preoperative baseline, ROM declined at <6 months (mean difference [MD] = −0.69, P < 0.0001), then returned to baseline at 12 months (MD = 0.02, P = 0.883), increased at 24 months (MD = 0.48, P < 0.0001), and declined below baseline ≥60 months (MD = −1.55, P < 0.0001). Nine studies assessing PROMs reported positive or neutral correlations with ROM. Three studies evaluated the association between ROM and ASD with two finding reduced ASD rates with greater motion. No consistent predictors of preserved ROM were identified.

Conclusion

Segmental ROM decreases gradually in the long term after LDR. While preserved motion may be associated with improved clinical outcomes and reduced ASD, current evidence is inconclusive.

Level of Evidence

IV.

Keywords

lumbar disc replacement ROM range of motion PROMs ASD predictors

Introduction

Lumbar disc replacement (LDR) has emerged as a motion-preserving surgical option for the management of symptomatic degenerative disc disease, particularly in younger patients without significant instability, deformity, or facet arthropathy.^1,2 In contrast to lumbar fusion, which rigidly eliminates motion at the operative segment and has been associated with accelerated adjacent segment degeneration, LDR seeks to preserve segmental mobility while achieving symptom relief.³ By maintaining motion at the index level, theoretically LDR may better preserve spinal kinematics, reduce compensatory biomechanical stress at adjacent levels, and potentially lower the risk of adjacent segment pathology.⁴ Early studies demonstrated encouraging outcomes with LDR, reporting improvements in pain, function, and patient satisfaction that were comparable to those seen with fusion.^1,5

The central theoretical advantage of LDR lies in its ability to preserve segmental range of motion (ROM), thereby relatively maintaining physiologic spinal biomechanics and improving long-term outcomes.⁶ Despite a growing body of literature on LDR, key questions remain regarding the degree and durability of ROM preservation, the variability in motion across different spinal levels, and the clinical significance of preserved mobility. Moreover, the relationship between segmental ROM and patient-reported outcomes, as well as its potential protective effect against adjacent segment degeneration, remains inconsistently reported and poorly understood. This systematic review synthesizes the current evidence on segmental ROM following LDR, aiming to clarify temporal trends, assess durability, identify potential predictors of preserved motion, and evaluate its clinical significance.

Methods

Search Strategy and Study Selection

The present study was exempt from IRB approval. A systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.⁷ A comprehensive search was performed across eight databases: PubMed, Embase, Scopus, Cochrane Library, CINAHL, and Web of Science. Predefined Boolean search strategies were used, incorporating terms related to lumbar disc replacement and range of motion. Full search terms are provided in-Appendix 1. Studies were eligible for inclusion if they (1) reported on a cohort of adult patients undergoing primary 1 or two-level lumbar disc replacement, (2) reported segmental range of motion or clinical outcomes associated with range of motion, and (3) had a minimum of 24-month follow-up. Broad inclusion criteria were kept to comprehensively summarize the current data regarding the range of motion after lumbar disc replacement. Exclusion criteria included case reports, studies not reporting a specific cohort of lumbar disc replacements, studies reporting outcomes of hybrid constructs, non-English publications, abstracts, conference presentations, and review articles. Two reviewers independently screened titles and abstracts, followed by a full-text review. Discrepancies were resolved by consensus and in discussion with the senior author.

Data Extraction

The following data were extracted from each study: study information (journal, year, study design, level of evidence [LOE]), LDR cohort size, patient demographics (age, gender, body mass index [BMI]), follow-up, operative details (LDR device, operative time, estimated blood loss [EBL], operative levels), range of motion values as measured on lateral flexion/extension radiographs (at preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, ≥60 months, ≥120 months), preoperative/intraoperative factors associated with ROM, and correlation of ROM with clinical outcomes (patient reported outcome measures [PROMs], adjacent segment disease [ASD]). Outcomes in papers that reported cohorts of different disc replacement devices were cumulatively reported for that paper. Studies that compared disc replacement with fusion constructs were still included, and only data for the disc replacement cohort were recorded. When independent studies were published with the same patient cohort and longer-term follow-up, data were extracted as a combined entry.

Pooled Data and Statistical Analysis

A pooled meta-analysis was conducted to compare preoperative ROM with ROM at individual postoperative time points using the methodology published by Zavras et al.⁸ Timepoints defined for the pooled analysis were: Preoperative, ≤6 months (2 weeks, 3 months, or 6 months), 12 months, 24 months, and ≥60 months. Studies that did not have standard deviation available from data extraction were excluded from the pooled meta-analysis. Additionally, studies without preoperative ROM measurements were excluded from the pooled meta-analysis. When a range of ROMs was reported with no SD, imputation was performed to best estimate SD for the meta-analysis, given normal probabilistic distributions. Odds ratios (ORs) and 95% confidence intervals were calculated as pooled metrics using a common effects model in RStudio (RStudio, version 4.3.1; Vienna, Austria). I² statistics and funnel plot analysis were used to assess heterogeneity for each outcome, with I² ≥ 50% used to define significant heterogeneity. Statistical significance was defined as P < 0.05. Clinical outcome data were too heterogeneous for any pooled analysis and were therefore qualitatively summarized.

Results

Study Selection and Patient Demographics

A total of 476 records were identified through database searches. After assessing full texts, 27 studies met the final inclusion criteria and were included in the systematic review (Figure 1). The included studies were published between 2003 and 2021 and spanned a range of international settings. While most studies (n = 16) were Level III or IV evidence, several were Level I or II (n = 11). In sum, a total of 2563 lumbar disc replacements were performed between 1989 and 2010 on patients ranging from 36.4 to 47.8 years old, with follow-up time from 24 to 276 months, and were studied for ROM after LDR (Table 1). Across the 30 included studies, a variety of LDR devices were used, with the most frequently reported being ProDisc (n = 17), followed by Charité (n = 8). Operated levels were most commonly L4–L5 and L5–S1, though some studies also included L2–L3 and L3–L4 disc replacements (Table 2).

Figure 1.

PRISMA diagram for paper screening

Table 1.

Study Demographics

Author/year	Journal	Continent	Years of surgical procedure	LOE	Age mean (SD) [range]	BMI	% Female	n LDR	Follow up
Auerbach 2005⁹	Seminars in Spine Surgery	North America	—	I	40 (9)	—	54.5%	32	24
Chung 2006¹⁰	Journal of Spinal Disorders & Techniques	Asia	2002-2003	II	43 [25-89]	—	55.6%	47	37 [25-42]
David 2007¹¹	Spine (Phila Pa 1976)	Europe	1989-1995	IV	36.4 [23-50]	—	58.3%	108	158.4 [120-201.6]
Formica 2020¹²	European Spine Journal	Europe	1998-2008	IV	40.2 (10.3) [17-58]	26 (2.4) [21-31]	83.3%	32	164 (36.5) [120-240]
Guyer 2009¹³	The Spine Journal	North America	2000-2002	I	40.0 (8.58) [19-60]	26.4 (4.13) [17-37]	47.8%	90	60
Guyer 2014, Guyer 2016^a^14,15	Spine (Phila Pa 1976)	North America	—	I	39.7 (8.34) [18-60]	27.0 (4.47)	52.80%	394	24
Huang 2003, Huang 2006^16,17	Journal of Spinal Disorders & Techniques, The Spine Journal	North America	1990-1993	IV	45.2 (8.6) [25-65]	—	45.2%	58	104.4
Huang 2005¹⁸	Spine (Phila Pa 1976)	North America	1990-1993	IV	44.9 (7.7) [25-65]	—	42.1%	51	103.2 (11.6) [82.8-128.4]
Hur 2018¹⁹	Clincial Spine Surgery	Asia	2002-2007	IV	47.8 (7.3)	23.2 (4.4)	62.8%	56	86.67 (11.52) [60-120]
Kim 2007²⁰	Journal of Neurosurgery Spine	Asia	2002-2004	IV	38.9 [24-60]	22.46 (1.9) [18.36-27.73]	—	41	30.4 [24-41]
Kitzen 2021²¹	Global Spine Journal	Europe	1994-2000	IV	42.3 (7.3)	26.9 (4.1)	55.3%	141	200.4 (163.2-276)
Lazennec 2019²²	The Spine Journal	Europe	2007-2010	IV	42.8 (7.7) [27-60]	24.2 (3.4) [18-33]	60.7%	61	60
Lemaire 2005²³	Journal of Spinal Disorders & Techniques	Europe	1989-1993	IV	39.6 [23.9-50.8]	—	59%	147	135.6 [120-160]
Lu 2015, Lu 2018^a^24,25	European Spine Journal	Asia	1999-2002	IV	41.4 [28.6-51.3]	—	56.3%	35	141.6 [135.6-165.6]
McAfee 2005²⁶	Spine (Phila Pa 1976)	North America	2000-2002	I	39.6 (8.16) [19-60]	26 (4.23) [17-39]	44.9%	205	24
Park 2016²⁷	Spine (Phila Pa 1976)	Asia	2002-2007	IV	44.1 (8.5) [23-59]	—	66.70%	69	120 (19.3) [61-144]
Pimenta 2018²⁸	International Journal of Spine Surgery	South America	2007	IV	37.0 [25-54]	23.7 [19.4-28.5]	—	20	84
Radcliff 2021²⁹	International Journal of Spine Surgery	North America	2007-2009	I	40 (9)	27 (4)	49.50%	206	84
Siepe 2009³⁰	Spine (Phila Pa 1976)	Europe	—	IV	44.4 [26.3-62.4]	—	56.50%	62	42.4 [24.2-77.6]
Wuertinger 2018³¹	The Spine Journal	Europe	—	IV	45 [29-66]	—	64.70%	51	93.6 [60-159.6]
Yue 2019³²	Spine (Phila Pa 1976)	North America	2007-2009	I	40 (9)	27 (4)	47.80%	324	60
Zigler 2007, Zigler 2012^a ^33,34	Spine (Phila Pa 1976), Journal of Neurosurgery Spine	North America	2001-2003	I	38.3 (7.7)	26.9 (4.3)	49.60%	161	60
Zigler 2018³⁵	Spine (Phila Pa 1976)	North America	—	III	39.54 (8.92)	26.67 (4.04)	45.10%	175	60

^aData pulled from both preliminary study and follow up study with same patient population.

Table 2.

Surgical Details and Levels Operated of Included Studies

Author/year	LTDR device	EBL	Operative time	n levels operated
Author/year	LTDR device	EBL	Operative time	L2-L3	L3-L4	L4-L5	L5-S1
Auerbach 2005⁹	ProDisc-L	117 (75)	87 (11)	0	0	NR	NR
Chung 2006¹⁰	ProDisc II	—	—	0	2	24	21
David 2007¹¹	Charité	—	90	0	1	25	82
Formica 2020¹²	Maverick, ProDisc II, Charité	—	121 (55.2) [80-240]	1	4	12	15
Guyer 2009¹³	Charité	212.1	108.2	0	0	26	64
Guyer 2014, Guyer 2016^14,15	Charité, ProDisc-L	137 (208.2)	94.3 (36.8)	0	0	94	300
Huang 2003, Huang 2006^16,17	Prodisc	—	—	1	5	32	22
Huang 2005¹⁸	Prodisc	—	—	0	3	29	19
Hur 2018¹⁹	ProDisc-L	221 (83)	198 (102)	0	8	26	22
Kim 2007²⁰	ProDisc II	—	—	0	3	18	20
Kitzen 2021²¹	Charité	—	—	1	3	58	74
Lazennec 2019²²	LP-ESP	—	—	0	0	22	39
Lemaire 2005²³	Charité	—	—	0	6	69	72
Lu 2015, Lu 2018^24,25	Charité	—	—	0	4	24	7
McAfee 2005²⁶	Charité	205 (211.7) [10-1500]	110.8 (47.7) [42-300]	0	0	NR	NR
Park 2016²⁷	ProDisc II	—	—	0	5	35	29
Pimenta 2018²⁸	Physio-L	—	—	0	1	4	15
Radcliff 2021²⁹	ActivL, ProDisc-L	—	—	0	0	NR	NR
Siepe 2009³⁰	ProDisc II	—	—	0	0	24	38
Wuertinger 2018³¹	ProDisc II	—	—	0	0	0	51
Yue 2019³²	ActivL, Charite, ProDisc-L	—	—	0	0	228	96
Zigler 2007, Zigler 2012^33,34	ProDisc-L	207 (246.2)	123.5 (63.1)	0	3	54	104
Zigler 2018³⁵	ActivL, ProDisc-L	137.4 (128.8)	—	0	0	51	124

NR indicates surgical levels were included in the paper, but specific number was not reported.

Range of Motion

All studies included measured range of motion at a preoperative or postoperative time point (Table 3). Residual mobility at final follow-up ranged from 37.7% to 93.7%, though studies used various ROM cutoffs to define residual mobility (2° to 5° ROM).

Table 3.

ROM at Each Follow up Time Reported as Value (SD) When Available

Author/year	Preop ROM	6-week ROM	3-month ROM	6-month ROM	12-month ROM	24-month ROM	36-month ROM	48-month ROM	60+ month ROM	120+ month ROM	% mobile at final FU
Auerbach 2005⁹	6.1	5.1^a	6^a	6.1^a	6.1^a	5.1	—	—	—	—	—
Chung 2006¹⁰	9.7	—	—	—	13	12.7	—	—	—	—	—
David 2007¹¹	—	—	—	—	—	—	—	—	—	10.1 (overall), 12.2 (L4-L5), 9.4 (L5-S1)	90.6%
Formica 2020¹²	—	—	—	—	—	—	—	—	—	8.9 (overall), 10.2 (L4-L5), 7.9 (L5-S1)	68.75% (≥3 deg ROM)
Guyer 2009¹³	7.79 (5.94, overall), 8.5 (5.8, L4-L5), 7.5 (6, L5-S1)	—	—	—	—	6.20 (4.35, overall), 7.2 (4.7, L4-L5), 5.8 (4.2 L5-S1)^a	—	—	6 (4.98, overall), 6 (5.4, L4-L5), 6 (4.8, L5-S1)^a	—	84.4% (≥3 deg ROM)
Guyer 2014, Guyer 2016^14,15	6.5	—	4.8	6.2	6.3	7.3	7.6^a	7.8^a	7.3^a	—	64.7% (≥4 deg ROM)
Huang 2003, Huang 2006^16,17	—	—	—	—	—	—	—	—	3.8 (2) [0-18]	—	65.5% (≥2 deg ROM)
Huang 2005¹⁸	—	—	—	—	—	—	—	—	4 (3.9, overall), 5 (5.5, L3-L4), 4.5 (4.2, L4-L5), 3 (2.6, L5-S1)^a	—	—
Hur 2018¹⁹	3.5 (2.4, overall), 4.2 (3.1, L3-L4), 3.7 (2.5, L4-L5), 3.1 (1.6, L5-S1)	4.8 (2.3, overall), 7.1 (2.5, L3-L4), 6.5 (3.5, L4-L5), 3.2 (1.9, L5-S1)	—	—	4.9 (2.1, overall), 6.9 (1.6, L3-L4), 6.2 (3.5, L4-L5), 3 (1.4, L5-S1)	5 (2.1, overall), 6.9 (2.1, L3-L4), 6.1 (1.7, L4-L5), 2.9 (0.8, L5-S1)	4.8 (2, overall), 6.7 (2.4, L3-L4), 6.1 (2.2, L4-L5), 2.8 (1.6, L5-S1)^a	—	2.2 (1.5, overall), 4 (2.1, L3-L4), 2.4 (1.4, L4-L5), 1.1 (0.8, L5-S1)	—	42.9% (≥5 deg ROM)
Kim 2007²⁰	3.5 (2.4, overall), 4.2 (3.1, L3–L4), 3.7 (2.5, L4–L5), 3.1 (1.6, L5–S1)^a	—	—	4.7 (2.6, overall), 7.1 (2.5, L3–L4), 6.4 (2.6, L4–L5), 3.1 (1.8, L5–S1)^a	4.8 (2.5, overall), 6.8 (2.7, L3–L4), 6.2 (2.4, L4–L5), 3.0 (1.7, L5–S1)^a	4.8 (2.4, overall), 6.8 (2.6, L3–L4), 6.1 (2.3, L4–L5), 2.9 (1.6, L5–S1)^a	4.7 (2.3, overall), 6.7 (2.5, L3–L4), 6.1 (2.2, L4–L5), 2.8 (1.6, L5–S1)^a	—	—	—	—
Kitzen 2021²¹	—	—	—	—	—	—	—	—	—	4.6 [0-15.6]	38% (≥4.6 deg ROM)
Lazennec 2019²²	—	—	—	—	5.9 (4, overall), 5.8 (3.9, L4-L5), 5.9 (4, L5-S1)	7 (3.8, overall), 5.8 (3.9, L4-L5), 6.4 (3.3, L5-S1)	—	—	7.3 (3.5, overall), 7.3 (4, L4-L5), 7.2 (3.3, L5-S1)	—	—
Lemaire 2005²³	—	—	—	—	—	—	—	—	—	10.3 (overall), 12 (L3-L4), 9.6 (L4-L5), 9.2 (L5-S1)	—
Lu 2015, Lu 2018^24,25	7.4 [6-16]	—	—	—	—	—	—	—	—	5.4 [2-12]	77.1% (≥3 deg ROM)
McAfee 2005²⁶	6.5 (1.3)^a	—	5.0 (1.2)^a	6.1 (1.2)^a	6.8 (1.3)^a	7.5 (1.3)^a	—	—	—	—	—
Park 2016²⁷	10.34 (overall), 12.21 (L4-L5), 8.08 (L5-S1)	—	—	—	11.50 (overall), 14.23 (L4-L5), 8.21 (L5-S1)	11.88 (overall), 14.41 (L4-L5), 8.81 (L5-S1)	—	—	11.21 (overall), 14.07 (L4-L5), 7.75 (L5-S1)	—	—
Pimenta 2018²⁸	12	—	—	—	13.3	—	—	—	9.9 (4.4)	—	89% (≥4 deg ROM)
Radcliff 2021²⁹	5.31	—	—	—	—	—	—	—	5.03 (4.34)	—	—
Siepe 2009³⁰	8.2 (1.7, overall), 9.0 (2.8, L4-L5), 7.3 (1.6, L5-S1)^a	—	5.2 (1.1, overall), 7.5 (1.9, L4-L5), 4.4 (1.3, L5-S1)^a	—	6.0 (1.6, overall), 7.2 (2.1, L4-L5), 5.2 (1.4, L5-S1)^a	5.7 (1.5, overall), 7.1 (2.2, L4-L5), 4.8 (1.6, L5-S1)^a		—	—	—	—
Wuertinger 2018³¹	6.8 (4.4)^a	—	5.8 (1.0)^a	—	5.2 (1.1)^a	—	—	—	4.3 (1)^a	—	37.7% (≥5 deg ROM)
Yue 2019³²	5.6 [−1.4-26.9]	—	—	—	—	—	—	—	7.64 (5.04)	—	—
Zigler 2007, Zigler 2012^33,34	7.3 (4.7)	—	—	—	—	7.7 (4.67)	—	—	6.0 (4.5)	—	93.7% (≥5 deg ROM)
Zigler 2018³⁵	—	—	—	—	—	—	—	—	—	—	—

^aEstimated from figure.

Seventeen studies reported preoperative and postoperative ROM on the entire cohort, with 5 and 6 reporting subgroup ROM specifically at the L4-L5 and L5-S1 levels, respectively (Supplemental Table 1). Pooled weighted averages across these studies demonstrated that segmental ROM modestly improved following lumbar total disc replacement through 24 months and subsequently declined through 60 months (Figure 2). Overall ROM increased from 6.55° preoperatively to 7.45° at 24 months, declining to 6.68° at ≥60 months. Stratification by index level revealed similar temporal trends of change in ROM with consistently greater motion at L4–L5 compared to L5–S1.

Figure 2.

Pooled segmental ROM over time following LDR. ROM is plotted at preoperative baseline and at postoperative intervals of ≤6 months, 12 months, 24 months, and ≥60 months. Data represent pooled weighted averages from included studies, stratified by overall, L4–L5, and L5–S1 levels

Pooled meta-analysis of ROM revealed a similar temporal trend in ROM change (Figure 3A–D, Supplemental Figure 1A–D). Pooled analysis of 4 studies comparing preoperative and ≤6-month time points showed an initial decrease in ROM (mean difference [MD] = −0.69 [95% CI: −0.48 to −0.89]; P < 0.0001) (Figure 3A). Pooled analysis of 5 studies comparing preoperative and 12-month time points demonstrated similar ROM (MD = 0.02 [95% CI: −0.20 to 0.23]; P = 0.883) (Figure 3B). Pooled analysis of 6 studies comparing preoperative and 24-month time points demonstrated increased ROM (MD = 0.48 [95% CI: 0.27 to 0.69]; P < 0.0001) (Figure 3C). Pooled analysis of 4 studies comparing preoperative and ≥60-month time points demonstrated decreased ROM (MD = −1.55 [95% CI: −2.06 to −1.04]; P < 0.0001) (Figure 3D).

Figure 3.

Meta-analysis reporting ROM for LDR at preoperative versus (A) ≤6 months; (B) 12 months; (C) 24 months; and (D) ≥60 months

Clinical Outcomes

Nine studies consisting of 1162 patients assessed the association between long-term segmental ROM and clinical outcomes, including patient-reported outcome measures (PROMs) such as the Visual Analog Scale (VAS) for back and leg pain, Oswestry Disability Index (ODI), Short Form 36 (SF36), and patient satisfaction (Table 4). Of these, 6 studies (929 patients) reported greater segmental ROM was associated with superior clinical outcomes. Chung et al and Guyer et al demonstrated that patients with segmental ROM ≥4° were more likely to achieve clinically meaningful improvement.^10,14,15 Additional studies by Huang et al, Siepe et al, Wuertinger et al, and Yue et al found that greater ROM was significantly associated with superior individual PROMs (ie, lower VAS and ODI scores, as well as higher Stauffer-Coventry satisfaction scores).^18,30–32 In contrast, 3 studies (233 patients), Hur et al, Kim et al, and Kitzen et al, found no significant correlation between segmental ROM and PROMs, even when stratified by thresholds ranging from 4.6 to 5°.^19–21

Table 4.

Summary of Studies Evaluating the Association Between Segmental ROM and PROMs or ASD

Author/year	Association of ROM with PROMs	Association of ROM with ASD
Chung 2006¹⁰	(+) Higher 2-year segmental ROM associated with ODI improvement >75%	—
Guyer 2014, Guyer 2016^14,15	(+) Patients with segmental ROM ≥4° achieved clinical success at higher rates	—
Huang 2005¹⁸	(+) Patients with segmental ROM >5° had significantly superior PROMs (lower ODI, higher Stauffer-Coventry scores)	—
Huang 2006¹⁷	—	(−) Patients with higher ROM (≥5°) had lower incidence of ASD
Hur 2018¹⁹	(=) No significant correlations between segmental ROM and patient PROMs (VAS, ODI, SF36, modified cincinnati sports activity scale)	—
Kim 2007²⁰	(=) No significant correlations between segmental ROM > or <5° and patient PROMs (ODI, VAS)	—
Kitzen 2021²¹	(=) No significant correlations between segmental ROM > or <4.6° and patient PROMs (ODI, SF 36, EuroQol 5-Dimension)	(=) No significant correlations between segmental ROM > or <4.6° and development of ASD
Siepe 2009³⁰	(+) Higher segmental ROM was correlated with superior PROMs (lower VAS, ODI)	—
Wuertinger 2018³¹	(+) Higher segmental ROM was correlated with superior PROMs (lower VAS)	—
Yue 2019³²	(+) Higher segmental ROM was correlated with superior PROMs (lower VAS, ODI)	—
Zigler 2018³⁵	—	(−) Increase in segmental ROM was associated with decrease in ASD incidence

Studies reporting a positive (+), neutral (=), or negative (−).

Three studies consisting of 371 patients evaluated the relationship between segmental ROM and the development of ASD (Table 4). Two of these studies found that preserved segmental motion conferred a protective effect. Huang et al reported a significantly lower incidence of ASD (0% vs 34%) in patients with >5° of motion at the index level.¹⁷ Similarly, Zigler et al found that increasing segmental ROM was associated with decreased rates of ASD, with no cases observed among patients with >6° of motion at final follow-up.³⁵ In contrast, Kitzen et al found no significant association between segmental ROM and ASD development using a cutoff of 4.6°.²¹

Factors Associated With ROM

Ten studies evaluated factors associated with postoperative segmental ROM (Table 5). Several reported no significant association between ROM and patient or surgical characteristics such as age, BMI, prosthesis position or size, pelvic incidence, implant subsidence, or segmental lordosis.^12,20,21,31 However, a subset identified specific factors associated with reduced ROM, including female gender and adjacent cranial level degeneration,¹⁶ poor implant positioning,²⁶ two-level LDR,²⁷ postoperative heterotopic ossification,²⁴ lower preoperative segmental motion and disc height,³⁰ and specific implant design.³²

Table 5.

Summary of Studies Evaluating Patient, Surgical, and Implant-Related Factors Associated With Postoperative Segmental ROM Following Lumbar Disc Replacement

Author/year	Factors associated/not associated with ROM
Formica 2020¹²	Implant design/type and preoperative disc degeneration were not correlated with residual mobility
Huang 2003¹⁶	Female gender and preoperative adjacent cranial level disc degeneration were associated with decreased ROM at final FU
Kim 2007²⁰	Age, gender, BMI, prosthesis position, and prosthesis size were not correlated with ROM at final FU
Kitzen 2021²¹	Age, BMI, number of levels, pelvic incidence, and implant subsidence were not correlated with residual mobility
Lu 2015²⁴	Postoperative heterotopic ossification was associated with decreased ROM
McAfee 2005²⁶	Poor implant placement (≥5 mm from exact central placement in any axis) was associated with decreased ROM
Park 2016²⁷	Two level LDR (compared with 1 level) was associated with decreased ROM at final FU
Siepe 2009³⁰	Higher preoperative segmental ROM and disc space height were associated with increased ROM at final FU
Wuertinger 2018³¹	Segmental lordosis was not correlated with segmental ROM at any postoperative timepoint
Yue 2019³²	ActiveL device (compared with ProDisc/Charité) was associated with increased segmental ROM

Discussion

Lumbar disc replacement was developed to preserve segmental motion while achieving symptom relief, potentially mitigating complications associated with fusion, such as ASD and pseudarthrosis. While certain clinical outcomes of LDR have been well described, the extent to which segmental ROM is preserved over time and which factors influence this preservation remains less clearly summarized. This systematic review identified all studies reporting ROM data following LDR with a minimum follow-up of 24 months. With pooled analysis of ROM and qualitative reporting of clinical outcomes, this review clarifies the temporal trends and potential determinants of motion as they currently exist in the literature.

Our pooled analysis demonstrated that segmental ROM after LDR follows a dynamic trajectory over time. ROM decreased in the early postoperative period (≤6 months) compared to preoperative values (MD = −0.69), returned to baseline by 12 months (MD = 0.02), and increased at 24 months (MD = 0.48), suggesting a transient period of enhanced motion. However, this improvement was not sustained long-term, with ROM decreasing below preoperative levels by >60 months (MD = −1.55). Subgroup analysis showed that ROM remained consistently higher at the L4-L5 level than at L5-S1, although both levels demonstrated similar temporal patterns. This pattern mirrors findings from cervical disc replacement (CDR). Zavras et al reported a similar trajectory in their meta-analysis, with segmental ROM increasing at 1-year post-CDR before decreasing in the long term.⁸ The exact mechanism of this is still unclear, it is possible patients do eventually develop facet degeneration which inhibits ROM in the long term even if they did not have it preoperatively. Despite these general trends, there was substantial heterogeneity across studies. Reported rates of preserved segmental motion at final follow-up, often variably defined, ranged from 37% to 93%, highlighting that a significant proportion of patients may not experience the theoretical benefits of motion preservation.

Although clinical outcomes could not be pooled quantitatively due to heterogeneity in study design and reporting, ten studies in this review, comprising 1162 patients, investigated the relationship between segmental ROM and PROMs. Of these, 7 studies with 929 patients demonstrated a positive relationship, finding increased segmental ROM to be associated with improved PROMs. However, 3 studies with 233 patients demonstrated no association between increased ROM and PROMs. The contrast in these reported findings may be attributed to several methodological limitations, including the lack of uniform PROM instruments, variations in implant type, and different surgical techniques/indications. Despite these limitations, the available evidence suggests a weak trend towards improved PROMs with increased segmental mobility after LDR. However, the current literature, regarding ROM and PROMs remains limited, and future high-quality studies that standardize the surgical implant and technique as well as pre- and postoperative PROM instruments may assist with understanding the true relationship.

Only 3 studies correlated ROM with ASD development. Huang et al and Zigler et al plotted the incidence of ASD across various postoperative ROM values, finding no incidence of ASD at postoperative ROM greater than 5 to 6°.^17,35 While these findings suggest a possible threshold effect, the methodology is limited in several respects. First, these analyses were observational and post hoc, lacking any stratification or adjustment for confounding variables such as age, baseline degeneration at adjacent levels, or implant positioning. Second, the definition of ASD varied across studies, ranging from radiographic changes to symptomatic reoperations, which introduces heterogeneity in outcome interpretation. Radiographic and symptomatic ASD represent distinct clinical entities. Radiographic changes are frequently observed and often remain asymptomatic, while only a small subset of patients develop clinically significant symptoms that may require re-intervention.^36,37 As such, while the absence of ASD above certain ROM thresholds is intriguing, current evidence remains insufficient to establish a causal or clinically actionable relationship between postoperative motion and ASD prevention. The final study, Kitzen et al, compared rates of ASD for patients above and below their mobility threshold of 4.6°, finding no significant difference.²¹ Taken together, the current evidence is not sufficient to make the claim that improved segmental ROM is associated with reduced clinically significant ASD. While broadly supported by biomechanical studies,³⁸ recent systematic reviews have suggested, at best, moderate evidence that LDR decreases the incidence of ASD when compared to fusions.^3,39 Higher quality, better-controlled research is necessary to elucidate fully if the theoretical advantages of ROM preservation manifest clinically.

Despite the emphasis on motion preservation as a core advantage of LDR, factors that influence postoperative ROM remain poorly defined. Among the studies that evaluated predictors of ROM, most found no significant associations with commonly considered variables such as age, BMI, pelvic parameters, implant size, or prosthesis position. A minority of studies identified possible contributors to reduced ROM, including female gender, suboptimal implant placement, multilevel surgery, and heterotopic ossification (HO). However, these findings were inconsistent and often limited by small sample sizes or a lack of controlled multivariate analysis. Heterotopic ossification and its prevention are a topic of significant CDR research.⁴⁰ Few included studies reported rates of high-grade HO in LDRs ranging from 3.5%-25.7%.^15,24,29 However, only Lu et al correlated HO with ROM, finding a “dose response” relationship between HO and ROM (ie, as HO grade increased per McAfee classification, average ROM decreased).²⁴ Nonetheless, no single factor has been reliably shown to predict postoperative ROM, underscoring the need for more rigorous, standardized studies to clarify the determinants of motion preservation following LDR. Within the CDR literature, lower age, higher mobility of preoperative discs, and proper device positioning/insertion angle have been associated with long-term ROM maintenance.^41,42 Further research within the LDR literature is necessary to elucidate how these factors may play a similar role.

This study has several limitations inherent to the available literature. First, heterogeneity in study design, implant type, surgical technique, and outcome reporting limited our ability to perform formal meta-analyses for outcomes such as PROMs, ASD, and factors associated with increased/decreased ROM. Second, ROM measurements were inconsistently reported across studies, with variation in radiographic techniques, definitions of motion, and follow-up intervals. Third, most included studies were retrospective and subject to selection and reporting bias. Specifically, surgical indications may be different in the many studies and were usually not well reported. Outcomes of ROM, ASD, and PROMs do rely on the assumption of properly indicated patients, which is not verifiable. Additionally, the influence of implant-specific design features on ROM could not be isolated due to a lack of direct comparison within individual studies. Despite these limitations, the present review represents the most comprehensive attempt at summarizing current ROM data available in the current literature.

Conclusion

While patients experience initial improvement in segmental ROM following lumbar disc replacement, over time, ROM gradually decreases. Substantial heterogeneity in residual ROM highlights that motion preservation is not uniformly achieved. Evidence regarding the association between preserved ROM and clinical outcomes remains limited and mixed, with most studies showing either positive or neutral relationships with PROMs and ASD. Factors influencing postoperative ROM remain poorly defined, with no consistently reproducible predictors identified. Future research should focus on prospective, standardized evaluation of ROM and its clinical implications to better guide surgical decision-making, implant selection, as well as patient counseling.

Supplemental Material

Supplemental Material - Long-Term Range of Motion and Influence on Clinical Outcomes After Lumbar Disc Replacement: A Systematic Review

Supplemental Material for Long-Term Range of Motion and Influence on Clinical Outcomes After Lumbar Disc Replacement: A Systematic Review by Tejas Subramanian, Stephane Owusu-Sarpong, Adrian T. H. Lu, Michael Mazzucco, Sereen Halayqeh, Tony Da Lomba, Miriyam Ghali, Jordan Swindle, Douglas Weaver, Mihir Dekhne, Gregory S. Kazarian, Pratyush Shahi, Takashi Hirase, Karim A. Shafi, Russell C. Huang, Sravisht Iyer, Michael J. Lee, and Sheeraz A. Qureshi in Global Spine Journal.

Supplemental Material

Supplemental Material - Long-Term Range of Motion and Influence on Clinical Outcomes After Lumbar Disc Replacement: A Systematic Review

Footnotes

ORCID iDs

Tejas Subramanian

Adrian T. H. Lu

Sereen Halayqeh

Mihir Dekhne

Gregory S. Kazarian

Pratyush Shahi

Karim A. Shafi

Sravisht Iyer

Sheeraz A. Qureshi

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

Declaration of Conflicting Interests

The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: State: - Tissue Differentiation Intelligence Spinal Simplicity Sustain Surgical Inc HS2, LLC Stryker K2M LifeLink.com Inc. SeeALL AI Globus Medical, Inc. AMOpportunities Viseon, Inc. Contemporary Spine Surgery North American Spine Society (NASS) - North American Spine Society (NASS) - Annals of Translational Medicine (ATM) - Editorial Board Hospital Special Surgery Journal Society of Minimally Invasive Spine Surgery (SMISS) - Lumbar Spine Research Society (LSRS) - Cervical Spine Research Society (CSRS) Minimally Invasive Spine Study Group Association of Bone and Joint Surgeons (ABJS) International Society for the Advancement of Spine Surgery (ISASS).

Supplemental Material

Supplemental material for this article is available online.

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