Single or double‐level anterior interbody fusion techniques for cervical degenerative disc disease

Wilco Jacobs; Patricia G Anderson; Jacques van Limbeek; Paul C Willems; Paul Pavlov; Ronald Bartels

doi:10.1002/14651858.CD004958

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Figure 1

Summary of risks of bias

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Analysis 1.1

Comparison 1 Discectomy vs Discectomy and fusion with bone graft or substitute, Outcome 1 Hospital stay.

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Analysis 1.2

Comparison 1 Discectomy vs Discectomy and fusion with bone graft or substitute, Outcome 2 Operation time.

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Study	Group	Excellent	Good	Satisfied	poor
Abd‐Alrahman 1999	Discectomy	24	12	2	2
Abd‐Alrahman 1999	Fusion	20	20	7	3

Analysis 1.3

Comparison 1 Discectomy vs Discectomy and fusion with bone graft or substitute, Outcome 3 Odom.

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Analysis 1.4

Comparison 1 Discectomy vs Discectomy and fusion with bone graft or substitute, Outcome 4 No Fusion.

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Analysis 1.5

Comparison 1 Discectomy vs Discectomy and fusion with bone graft or substitute, Outcome 5 Pain not relieved at 5 weeks.

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Analysis 1.6

Comparison 1 Discectomy vs Discectomy and fusion with bone graft or substitute, Outcome 6 Not Returned to work at 5 weeks.

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Analysis 1.7

Comparison 1 Discectomy vs Discectomy and fusion with bone graft or substitute, Outcome 7 Not Returned to work at 10 weeks.

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Study	Group	Excellent	Good	Fair	Poor
Martins 1976	Discectomy	8	15	2	1
Martins 1976	Fusion	21	3	1	0

Analysis 1.8

Comparison 1 Discectomy vs Discectomy and fusion with bone graft or substitute, Outcome 8 Alignment.

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Analysis 2.1

Comparison 2 Fusion with autograft versus human allograft or bone substitute, Outcome 1 Total pain.

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Analysis 2.2

Comparison 2 Fusion with autograft versus human allograft or bone substitute, Outcome 2 Arm pain.

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Analysis 2.3

Comparison 2 Fusion with autograft versus human allograft or bone substitute, Outcome 3 Neck pain.

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Analysis 2.4

Comparison 2 Fusion with autograft versus human allograft or bone substitute, Outcome 4 headache.

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Analysis 2.5

Comparison 2 Fusion with autograft versus human allograft or bone substitute, Outcome 5 Sensory function.

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Analysis 2.6

Comparison 2 Fusion with autograft versus human allograft or bone substitute, Outcome 6 Muscle power.

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Analysis 2.7

Comparison 2 Fusion with autograft versus human allograft or bone substitute, Outcome 7 Odoms criteria.

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Analysis 3.1

Comparison 3 Fusion with human allograft vs animal allograft, Outcome 1 Total pain.

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Analysis 3.2

Comparison 3 Fusion with human allograft vs animal allograft, Outcome 2 Arm pain.

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Analysis 3.3

Comparison 3 Fusion with human allograft vs animal allograft, Outcome 3 Neck pain.

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Analysis 3.4

Comparison 3 Fusion with human allograft vs animal allograft, Outcome 4 Headache.

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Analysis 3.5

Comparison 3 Fusion with human allograft vs animal allograft, Outcome 5 Sensory function.

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Analysis 3.6

Comparison 3 Fusion with human allograft vs animal allograft, Outcome 6 Muscle power.

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Analysis 4.1

Comparison 4 Fusion with autograft vs animal allograft, Outcome 1 Total pain.

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Analysis 4.2

Comparison 4 Fusion with autograft vs animal allograft, Outcome 2 Arm pain.

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Analysis 4.3

Comparison 4 Fusion with autograft vs animal allograft, Outcome 3 Neck pain.

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Analysis 4.4

Comparison 4 Fusion with autograft vs animal allograft, Outcome 4 Headache.

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Analysis 4.5

Comparison 4 Fusion with autograft vs animal allograft, Outcome 5 Sensory function.

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Analysis 4.6

Comparison 4 Fusion with autograft vs animal allograft, Outcome 6 Muscle power.

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Analysis 5.1

Comparison 5 Fusion with autograft versus fusion with autograft and additional instrumentation, Outcome 1 No Fusion.

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Analysis 6.1

Comparison 6 Fusion with autograft versus fusion with autograft and additional instrumentation, Outcome 1 No Fusion.

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Table 1. Definitions

Term	Definition
Spondylosis	Degenerative disease of the spine associated with degeneration of the intervertebral discs and osteophytes
Radiculopathy	Symptoms arising from compression of the nerve roots
Myelopathy	Symptoms arising from compression of the spinal cord
Herniated disc	Bulging of the intervertebral disc, often causing pressure on the nerve roots
Spondylotic myelopathy	Dysfunction of the spinal cord due to direct compression by for example stenosis, herniation or osteophytes.
Autograft	Implant material derived from the same individual
Allograft	Implant material from any other source than the same individual

Table 1. Definitions

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Table 2. Search strategy

Dimension	Search strings
Diagnosis	Cervical(TW) Cervical vertebrae(SH) Degenerative(TW)
Treatment	Fusion(TW) Spinal Fusion(SH) Interbody(TW) Spondylodesis(TW)
Study design	Randomised Controlled Trial(PT) Controlled Clinical Trial(PT) Clinical trial(PT) Multicentre studies(PT) Multicase review(PT) Trial(TW) Random(TW) Controlled(TW) Prospective(TW)

Table 2. Search strategy

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Table 3. Criteria for the Risk of Bias Assessment

	Criteria for a judgment of yes for the sources of risk of bias
Randomisation	Was the method of randomization adequate?
Allocation concealment	Wat the treatment allocation concealed?
Patient blinding	Is the patient blinded for the treatment allocation?
Surgeon blinding	Is the surgeon blinded for the treatment allocation?
Outcome assessor blinding	Is the outcome assessor blinded for the treatment allocation?
Drop‐out	Is the drop‐out rate given and acceptable?
Intention to treat	Is an intention to treat analysis given?
Prognostic factors	Are the patient groups comparable on prognostic factors?
Co‐interventions	Are the co‐interventions described in sufficient detail?
Compliance	Is the compliance acceptable?
Timing	Is the timing of the outcome assessments comparable between groups and consistent within groups?

Table 3. Criteria for the Risk of Bias Assessment

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Table 4. Methodological criteria

	Criteria	Description
External validity	Parameter choice	Is the outcome parameter relevant? At least 'pain' should be scored to receive a '+'. If no pain, but another functional or clinical measure was used, a +/‐ was given.
	Selection criteria	Are the selection criteria given?
	Treatment	Is the treatment described in sufficient detail?
	Adverse effect	Are the adverse effects described?
	Short‐term follow‐up	Is a short‐term follow‐up assessment used?
	Long‐term follow‐up	Is a long‐term follow‐up assessment used?
Statistical analyses	Group sizes	Are the group sizes and subgroup sizes given?
	Point estimates	Are point estimates given for all relevant outcome parameters?
	Variabilty or individual data	Is a usable indicator of variability given for all point estimates?
	Statistical analyses	Are the statistical analyses used described?
	Statistical analyses valid	Are the statistical analyses used valid?

Table 4. Methodological criteria

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Table 5. Methodological quality (external validity)

Study	Selection criteria	Description methods	Adverse effects	Short‐term follow‐up	Long‐term follow‐up
Abd‐alrahman	+	+	+	+	‐
Dowd	+/‐	+/‐	+	+	+/‐
Martins	+/‐	+/‐	+	+	‐
Rosenorn	+	+	+	+	‐
van den Bent	+	+	+	+	‐
Lofgren	+/‐	+	+	+	‐
Madawi	+	+	+	+	‐
Baskin	+	+	‐	+	‐
McConnel	‐	+	+	+	‐
Hacker	+	+	+	+	‐
Savolainen	+	+	+	+	‐
Vavruch/ Peolsson	+	+	+	+	‐
Zoega	‐	‐	+	+	‐
McGuire	+	+	‐	+	‐

Table 5. Methodological quality (external validity)

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Table 6. Methdological quality (data presentation and general remarks)

Study	Group sizes	Point estimates	Descr of variability	Statistics described	Statistics valid	General remarks
Abd‐alrahman	+	‐	‐	+	+/‐	The randomisation technique is not described. The description of in‐ and exclusion criteria is sufficient. The results are not split for one or two level procedures. Results for arm and neck pain with VAS scores are not presented.
Dowd	‐	‐	‐	‐	?	The randomisation technique is valid and the allocation is concealed. The results were not split for one or two level procedures and exclusion criteria are not mentioned. The percentage lost to follow‐up at 4.5 years is larger than 20%. The study found a shorter hospital stay, but a lower fusion rate and no difference in patient satisfaction for the discectomy group.
Martins	+/‐	‐	‐	+	‐	The randomisation technique is not described (lottery style) and it is not clear whether patients form a homogeneous group. Data presentation is lacking detail.
Rosenorn	+	+	na	+	+	The randomisation technique is not described. It is unclear whether groups are comparable on diagnosis and, consequently, it is unclear whether the groups are homogeneous. Data presentation is sufficient.
van den Bent	+/‐	‐	‐	+	‐	Randomisation method is valid and allocation is concealed. One and two‐level procedures were mixed. Results are presented in bars with no information of values.
Lofgren	+	‐	‐	+	+	A good description of the randomisation with allocation concealment, but did not discriminate between clinical indication of radiculopathy and myelopathy, had high lost to follow‐up for the RSA measurements and did not describe their in and exclusion criteria sufficiently.
Madawi	+	‐	‐	+	+	The randomisation technique is not described. Madawi et al. did not discriminate between one or two level surgeries and the timing of the follow‐up is questionable.
Baskin	+	+	‐	‐	?	The randomisation technique is not described, results of One and two‐level surgeries were combined, and there is considerable lost to follow‐up at 12 and 24 months.
McConnel	+	‐	‐	‐	+	The randomization technique used sealed envelopes. In‐ and exclusion criteria are not mentioned, drop out percentage is moderate and point estimates and variability are not given. There is a range of indications and one and two‐level procedures were included.
Hacker	+	‐	‐	+	+	Randomisation procedure is not clear, results are not split for one and two level procedures and point estimates of pain with SD are not given. Authors did not find a difference, except for reduced donor site pain for the cage group.
Savolainen	+	+/‐	na	+	‐	The randomisation technique is not clear.
Vavruch/ Peolsson	+	+	‐	+	+	The randomisation technique is adequate with allocation concealment. This study included two and three level surgeries, but separate results are not given. Also, no measures of variability are given.
Zoega	+	+	+/‐	+	+	The randomisation technique is valid with allocation concealment. In‐ and exclusion criteria are not explicitly specified, the acquired group characteristics are described. Ranges are given instead of standard deviations.
McGuire	‐	‐	‐	+	‐	The randomisation technique is not described which makes the study suspicious because of the unequal group sizes. Pain is mentioned as being significantly different between the groups, but data is not given.

Table 6. Methdological quality (data presentation and general remarks)

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Comparison 1. Discectomy vs Discectomy and fusion with bone graft or substitute

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Hospital stay Show forest plot	2	174	Std. Mean Difference (IV, Random, 95% CI)	‐0.86 [‐1.57, ‐0.15]

2 Operation time Show forest plot	2	174	Std. Mean Difference (IV, Random, 95% CI)	‐0.92 [‐1.24, ‐0.61]

3 Odom Show forest plot			Other data	No numeric data

4 No Fusion Show forest plot	2	136	Risk Ratio (M‐H, Random, 95% CI)	0.53 [0.02, 11.93]

5 Pain not relieved at 5 weeks Show forest plot	2	165	Risk Ratio (M‐H, Random, 95% CI)	0.45 [0.25, 0.81]

6 Not Returned to work at 5 weeks Show forest plot	2	144	Risk Ratio (M‐H, Random, 95% CI)	1.26 [1.02, 1.54]

7 Not Returned to work at 10 weeks Show forest plot	2	128	Risk Ratio (M‐H, Random, 95% CI)	1.44 [0.77, 2.69]

8 Alignment Show forest plot			Other data	No numeric data

Comparison 1. Discectomy vs Discectomy and fusion with bone graft or substitute

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Comparison 2. Fusion with autograft versus human allograft or bone substitute

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Total pain Show forest plot	1	27	Mean Difference (IV, Random, 95% CI)	16.0 [2.31, 29.69]

2 Arm pain Show forest plot	1	27	Mean Difference (IV, Random, 95% CI)	32.0 [17.30, 46.70]

3 Neck pain Show forest plot	1	27	Std. Mean Difference (IV, Random, 95% CI)	0.95 [0.15, 1.75]

4 headache Show forest plot	1	27	Mean Difference (IV, Random, 95% CI)	18.0 [4.77, 31.23]

5 Sensory function Show forest plot	1	27	Mean Difference (IV, Random, 95% CI)	15.0 [2.07, 27.93]

6 Muscle power Show forest plot	1	27	Mean Difference (IV, Random, 95% CI)	27.0 [11.48, 42.52]

7 Odoms criteria Show forest plot	1	115	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.77, 1.15]

Comparison 2. Fusion with autograft versus human allograft or bone substitute

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Comparison 3. Fusion with human allograft vs animal allograft

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Total pain Show forest plot	1	28	Mean Difference (IV, Random, 95% CI)	12.0 [‐3.74, 27.74]

2 Arm pain Show forest plot	1	28	Mean Difference (IV, Random, 95% CI)	4.0 [‐13.05, 21.05]

3 Neck pain Show forest plot	1	28	Mean Difference (IV, Random, 95% CI)	10.0 [‐6.70, 26.70]

4 Headache Show forest plot	1	28	Mean Difference (IV, Random, 95% CI)	6.0 [‐9.93, 21.93]

5 Sensory function Show forest plot	1	28	Mean Difference (IV, Random, 95% CI)	22.0 [6.07, 37.93]

6 Muscle power Show forest plot	1	28	Mean Difference (IV, Random, 95% CI)	6.0 [‐11.22, 23.22]

Comparison 3. Fusion with human allograft vs animal allograft

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Comparison 4. Fusion with autograft vs animal allograft

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Total pain Show forest plot	1	27	Mean Difference (IV, Random, 95% CI)	28.0 [14.10, 41.90]

2 Arm pain Show forest plot	1	27	Mean Difference (IV, Random, 95% CI)	36.0 [22.19, 49.81]

3 Neck pain Show forest plot	1	27	Mean Difference (IV, Random, 95% CI)	28.0 [13.02, 42.98]

4 Headache Show forest plot	1	27	Mean Difference (IV, Random, 95% CI)	24.0 [7.35, 40.65]

5 Sensory function Show forest plot	1	27	Mean Difference (IV, Random, 95% CI)	37.0 [23.62, 50.38]

6 Muscle power Show forest plot	1	27	Mean Difference (IV, Random, 95% CI)	33.0 [17.28, 48.72]

Comparison 4. Fusion with autograft vs animal allograft

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Comparison 5. Fusion with autograft versus fusion with autograft and additional instrumentation

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 No Fusion Show forest plot	2	143	Risk Ratio (M‐H, Random, 95% CI)	2.37 [1.10, 5.13]

1.1 One and two‐levels	2	143	Risk Ratio (M‐H, Random, 95% CI)	2.37 [1.10, 5.13]

Comparison 5. Fusion with autograft versus fusion with autograft and additional instrumentation

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Comparison 6. Fusion with autograft versus fusion with autograft and additional instrumentation

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 No Fusion Show forest plot	1	46	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

1.1 One level	1	46	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 6. Fusion with autograft versus fusion with autograft and additional instrumentation

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