Results from a randomized controlled study between total disc replacement and fusion compared with results from a spine register

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Fig. 1
Total number of patients included in spine register at clinic for DDD surgery (fusion or TDR) from September 2003 until the end of 2008. The figure illustrates how the entire material was divided into gradually smaller subgroups. Non-r, nonresponders.

Table 1

Inclusion and exclusion criteria for RCT

Inclusion criteria

Exclusion criteria

Low-back pain with or without leg pain for >1 year; if leg pain occurred, then low-back pain should dominate
Failure of conservative treatment scheduled for >3 months
Radiographic confirmation of disc degeneration on magnetic resonance imaging
Age 20–55 years
ODI ≥30 or back pain (VAS) >50/100 the week before inclusion
Signed informed consent
Patient having an open mind regarding the treatment options

Spinal stenosis requiring decompression
Moderate or worse facet joint arthritis
Three or more painful levels at clinical examination
No obvious painful level(s) at diagnostic injection evaluation (if done)
Isthmic spondylolysis/spondylolisthesis
Degenerative spondylolisthesis >3mm
Major deformity
Manifest osteoporosis—if osteoporosis was suspected because of gender and age (women aged >50 years)illness, or medication, osteoporosis should be evaluated and excluded before inclusion
Previous lumbar fusion or decompression with potential instability (eg, facet joint damage or wide laminectomy)
Compromised vertebral body
Previous spinal infection or tumor
Inability to understand information because of abuse or for psychological or medical reasons
Language difficulties with inability to understand follow-up instruments
Pregnancy or other medical condition that would be contraindication to surgery

Table 2

Key variables

	TDR/RCT	TDR/non-RCT	FUSION/RCT	FUSION/non RCT
Baseline variables in the RCT and the non-RCT group (±SD)
Demographic
N	80	163	72	178
Age	40	40	39	43
Gender	61% fem	49% fem	58% fem	54% fem
Smokers	10%	11%	11%	19%, P < 0.05
Surgical
Prior surgery	11%	26%, P = 0.007	12%	31%, P < 0.002
Levels	1 = 55%	1 = 60%	1 = 45%	1 = 60%
	2 = 45%	2 = 40%	2 = 55%	2 = 40%
Outcome variables at baseline
Back Pain VAS (0–100)	62 (±21)	60 (±20)	58 (±22)	63 (±20)
ODI (0–100)	42 (±12)	41 (±12)	41 (±14)	45 (±14)
EQ5D	0.41 (±0.31)	0.39 (±0.31)	0.38 (±0.33)	0.34 (±0.32)
EQVAS	46 (±22)	51 (±20)	47 (±23)	47 (±21)

	TDR/RCT	TDR/non-RCT	FUSION/RCT	FUSION/no

One year outcomes of key variables
Back pain (VAS)	25 (±27)	27 (±26)	34 (±27)	35 (±30)
Back Pain Improvement(VAS)	37 (±30)	33 (±30)	24 (±34)	30 (±30)
ODI (0–100)	19 (±19)	20 (±17)	25 (±16)	30 (±23)
ODI improvement	23 (±18)	19 (±17)	16 (±18)	15 (±19)
EDQ5	0.71 (±0.28)	0.69 (±0.29)	0.63 (±0.27)	0.55 (±0.36)
EDQ5 improvement	0.29 (±0.35)	0.28 (±0.37)	0.25 (±0.37)	0.20 (±0.37)
Two year outcomes of key variables
Back pain (VAS)	25 (±30)	22 (±25)	30 (±24)	38 (±32)
Back Pain Improvement (VAS)	37 (±31)	34 (±28)	28 (±32)	24 (±31)
ODI (0–100)	20 (±20)	18 (±16)	23 (±17)	30 (±21)
ODI improvement	22 (±19)	20 (±18)	17 (±19)	14 (±19)
EQ5D	0.67 (±0.33)	0.70 (±0.29)	0.69 (±0.25)	0.58 (±0.36)
EQ5D improvement	0.26 (±0.37)	0.31 (±0.38)	0.31 (±0.37)	0.23 (±0.33)

Abbreviations: ODI, Oswestry disability index (Original version); EQ5D, EuroQol; TDR, total disc replacement; RCT, randomized controlled trial.

Table 3

Clinical outcome at one year in RCT group and non-RCT group (± SD). Percentage indicates the responding patients that have passed one year

	TDR/RCT n = 80 100% answer	TDR/non-RCT n = 163 80% answer	FUSION/RCT n = 72 100% answer	FUSION/non-RCT, n = 178 83% answer
Global assessment of back pain	Totally pain-free 29%	Totally pain-free 20%	Totally pain-free 10%	Totally pain-free 11%
	Unchanged o worse 13%	Unchanged o worse 11%	Unchanged o worse 17%	Unchanged o worse 21%
Totally pain-free or better	88%	89%	83%	79%
On full sick-leave	32%	24%	40%	37%
Satisfied with result	76%	75%	65%	65%
Reop	1%	8%	7%	10%
EQVAS	69 (25)	71 (22)	67 (22)	62 (26)
EQVAS improvement	24 (26)	20 (23)	20 (26)	16 (23)

Table 4

Clinical outcome at two years in RCT group and non-RCT group (± SD). Percentage indicates the responding patients that have passed two years

	TDR/RCT n = 80 100% answer	TDR/non-RCT n = 91 64% answer	FUSION/RCT n = 72 100% answer	FUSION/non-RCT, n = 136 62% answer
Global assessment of back pain	Totally pain-free 30%	Totally pain-free 32%	Totally pain-free 15%	Totally pain-free 14%
	Unchanged o worse 13%	Unchanged o worse 15%	Unchanged o worse 14%	Unchanged o worse 21%
Totally pain-free or better	88%	85%	86%	76%
Satisfied with result	71%	79%	67%	58%
Reop	5%	0%	12%	10%
EQVAS	67 (26)	74 (21)	69 (22)	62 (27)
EQVAS improvement	22 (27)	20 (24)	22 (28)	14 (29)