Influence of preoperative leg pain and radiculopathy on outcomes in mono-segmental lumbar total disc replacement: results from a nationwide registry

Abstract

Purpose Currently, many pre-conditions are regarded as relative or absolute contraindications for lumbar total disc replacement (TDR). Radiculopathy is one among them. In Switzerland it is left to the surgeon's discretion when to operate if he adheres to a list of pre-defined indications. Contraindications, however, are less clearly specified. We hypothesized that, the extent of pre-operative radiculopathy results in different benefits for patients treated with monosegmental lumbar TDR. We used patient perceived leg pain and its correlation with physician recorded radiculopathy for creating the patient groups to be compared. Methods The present study is based on the dataset of SWISSspine, a government mandated health technology assessment registry. Between March 2005 and April 2009, 577 patients underwent either mono-or bi-segmental lumbar TDR, which was documented in a prospective observational multicenter mode. A total of 416 cases with a mono-segmental procedure were included in the study. The data collection consisted of pre-operative and follow-up data (physician based) and clinical outcomes (NASS form, EQ-5D). A receiver operating characteristic (ROC) analysis was conducted with patients' self-indicated leg pain and the surgeon-based diagnosis ''radiculopathy'', as marked on the case report forms. As a result, patients were divided into two groups according to the severity of leg pain. The two groups were compared with regard to the pre-operative patient characteristics and pre-and post-operative pain on Visual Analogue Scale (VAS) and quality of life using general linear modeling. ResultsThe optimal ROC model revealed a leg pain threshold of 40 B VAS [ 40 for the absence or the presence of ''radiculopathy''. Demographics in the resulting two groups were well comparable. Applying this threshold, the mean preoperative leg pain level was 16.5 points in group 1 and 68.1 points in group 2 (p \ 0.001). Back pain levels differed less with 63.6 points in group 1 and 72.6 in group 2 (p \ 0.001).Pre-operative quality of life showed considerable differences with an 0.44 EQ-5D score in group 1 and 0.29 in group 2 (p \ 0.001, possible score range -0.6 to 1). At a mean followup time of 8 months, group 1 showed a mean leg pain improvement of 3.6 points and group 2 of 41.1 points (p \ 0.001). Back pain relief was 35.6 and 39.1 points, respectively (p = 0.27). EQ-5D score improvement was 0.27 in group 1 and 0.41 in group 2 (p = 0.11). ConclusionsPatients labeled as having radiculopathy (group 2) do mostly have pre-operative leg pain levels C 40. Applying this threshold, the patients with preoperative leg pain do also have more severe back pain and a considerably lower quality of life. Their net benefit from the lumbar TDR is higher and they do have similar postoperative back and leg pain levels as well as the quality of life as patients without pre-operative leg pain. Although randomized controlled trials are required to confirm these findings, they put leg pain and radiculopathy into perspective as absolute contr...

Reduction of Leg Pain by Oxiplex Gel After Lumbar Discectomy in Patients With Predominant Leg Pain and Elevated Levels of Lower Back Pain

“…5,6,[16][17][18][19][20] Decompression surgery typically improves sciatica more than LBP. 5,6,20 Patients with a herniated lumbar disk often have a greater density of sensory nerves in the annulus fibrosus and epidural space than patients with less severe back pain.…”

Maverick total disc replacement in a real-world patient population: a prospective, multicentre, observational study

“…AEs occurring within 6 months post-surgery are described in Table 5. Between 6 and 24 months, the following additional AEs occurred (in parentheses the number of events not resolved at study end): 13 late radiculopathies (10), 6 occurrences of late nonspecific low back pain (3), and 18 other events (10). One foreign body (allergic) reaction was observed during the 2-year follow-up period.…”

“…The optimal patient population for total disc replacement (TDR) is not fully defined [9][10][11]. Available information outside a controlled clinical study setting comes from a single national registry [10,12].…”

“…The optimal patient population for total disc replacement (TDR) is not fully defined [9][10][11]. Available information outside a controlled clinical study setting comes from a single national registry [10,12]. The objective of this first international observational study was to investigate changes in disability and back pain in a broad patient population treated with Maverick TDR in varied surgical practices reflecting different national standards of care.…”

The Michel Benoist and Robert Mulholland yearly European Spine Journal Review

“…I found the paper by Zweig rather curious [63]. The authors state that radiculopathy is regarded as a contraindication to the use of an intervertebral disc replacement, and they present figures to show that examining a registry of 577 patients with SWISS spine, patients with severe leg pain and a radiculopathy had done as well as those without these features, indicating that these features should not be regarded as a contraindication to disc replacement.…”