Expert review with meta-analysis of randomized and nonrandomized controlled studies of Barricaid annular closure in patients at high risk for lumbar disc reherniation

Figures & data

Figure 1. Schematic of the Barricaid Annular Closure Device (left) and lateral radiograph showing the Barricaid Annular Closure Device implanted at L4-L5 (right).

Figure 2. CONSORT patient flow diagram.

Table 1. Compendium of 50 peer-reviewed manuscripts of the Barricaid device for annulus fibrosus closure.

Article Type	Author, Year	Primary Study	Description
Systematic review (3)	Ammerman, 2019^[Citation16]	Review of 15 studies	Systematic review comparing treatments for lumbar disc herniation
	Arts, 2019[5]	Review of 14 studies	Systematic review with network meta-analysis of treatments for lumbar disc herniation
	Choy, 2018[62]	Review of 4 studies	Systematic review with meta-analysis comparing annular closure treatments
Randomized trial (7)	Cho, 2019[23]	60-patient RCT	Clinical outcomes with vs. without Barricaid over 2 years
	Kienzler, 2019[26]	554-patient RCT (NCT01283438)	Clinical outcomes with vs. without Barricaid over 3 years
	Klassen, 2017[27]	554-patient RCT (NCT01283438)	Clinical outcomes with vs. without Barricaid over 90 days
	Kursumovic, 2018[28]	554-patient RCT (NCT01283438)	Endplate changes with vs. without Barricaid over 2 years
	Nanda, 2019[74]	554-patient RCT (NCT01283438)	Clinical outcomes with vs. without Barricaid over 4 years
	Thome, 2018[24]	554-patient RCT (NCT01283438)	Clinical outcomes with vs. without Barricaid over 2 years
	van den Brink, 2019[29]	554-patient RCT (NCT01283438)	Clinical outcomes with vs. without Barricaid over 1 year
Controlled study (3)	Barth, 2016[22]	85-patient retrospective study	Clinical outcomes with vs. without Barricaid over ~2 years
	Trummer, 2013[30]	75-patient retrospective study	Facet degeneration with vs. without Barricaid over 1 year
	Vukas, 2013[25]	102-patient retrospective study	Clinical outcomes with vs. without Barricaid over 2 years
Prospective cohort (9)	Ardeshiri, 2019[31]	50-patient case series	Clinical outcomes with Barricaid over 1 year
	Ardeshiri, 2019[63]	50-patient case series	Clinical outcomes with Barricaid over 2 years
	Bouma, 2013[65]	75-patient case series	Clinical outcomes with Barricaid over 2 years
	Kursumovic, 2018[32]	164-patient registry	Clinical outcomes with trial eligible vs. non-trial eligible Barricaid over 15 months
	Kursumovic, 2017[64]	171-patient registry	Clinical outcomes with Barricaid over 15 months
	Ledic, 2015[33]	75-patient case series	Clinical outcomes with Barricaid over 2 years
	Lequin, 2012[34]	45-patient case series	Clinical outcomes with Barricaid over 1 year
	Parker, 2016[35]	46-patient case series	Clinical outcomes with Barricaid over 2 years
	Sanginov, 2018[66]	120-patient case series	Clinical outcomes with Barricaid over 5 years
Retrospective study (1)	Martens, 2018[36]	60-patient retrospective study	Clinical outcomes with Barricaid over 2 years
Post hoc analysis (6)	Barth, 2018[37]	554-patient RCT (NCT01283438)	Endplate changes with vs. without Barricaid over 1 year
	Bouma, 2019a[72]	554-patient RCT (NCT01283438)	Clinical outcomes with Barricaid in older adults
	Bouma, 2019b[38]	554-patient RCT (NCT01283438)	Analysis of failure-adjusted pain outcomes with vs. without Barricaid
	Bouma, 2019 c[39]	554-patient RCT (NCT01283438)	Influence of patient blinding in an RCT with vs. without Barricaid
	Klassen, 2019[70]	554-patient RCT (NCT01283438)	Reoperation strategies with vs. without Barricaid
	Kursumovic, 2020[40]	554-patient RCT (NCT01283438)	Clinical implications of endplate changes with vs. without Barricaid over 4 years
Health economics (6)	Ament, 2019[41]	554-patient RCT (NCT01283438)	Direct & indirect costs of discectomy with vs. without Barricaid over 5 years
	Ament, 2019[42]	554-patient RCT (NCT01283438)	Direct costs of discectomy with vs. without Barricaid over 5 years
	Bostelmann, 2019[43]	554-patient RCT (NCT01283438)	Direct & indirect costs of discectomy with vs. without Barricaid over 2 years
	Klassen, 2018[44]	554-patient RCT (NCT01283438)	Costs of reoperation with vs. without Barricaid over 2 years
	Parker, 2013[45]	76-patient comparative study	Direct & indirect costs of discectomy with vs. without Barricaid over 1 year
	Thaci, 2019[46]	554-patient RCT (NCT01283438)	Direct costs of discectomy with vs. without Barricaid over 90 days
Letters (7)	Barth, 2018[47]	554-patient RCT (NCT01283438)	Letter re: endplate changes with vs. without Barricaid over 1 year
	Bouma, 2014[48]	75-patient case series	Letter re: clinical outcomes with Barricaid over 2 years
	Grasso, 2019[49]	554-patient RCT (NCT01283438)	Letter re: reoperation strategies with vs. without Barricaid
	Izci, 2014[50]	75-patient case series	Letter re: clinical outcomes with Barricaid over 2 years
	Klassen, 2017[51]	554-patient RCT (NCT01283438)	Erratum re: clinical outcomes with vs. without Barricaid over 90 days
	Lange, 2018[52]	Case report	Letter re: case report of 1 patient who underwent Barricaid revision
	Shiban, 2018[53]	554-patient RCT (NCT01283438)	Letter re: endplate changes with vs. without Barricaid over 1 year
Case reports (4)	Gautschi, 2014[54]	Case report	Case report of 1 patient successfully treated with Barricaid
	Hahn, 2014[55]	Case report	Case report of 3 patients successfully treated with Barricaid
	Krutko, 2016[56]	Case report	Case report of 1 patient who underwent Barricaid revision
	Lange, 2018[57]	Case report	Case report of 1 patient who underwent Barricaid revision
Protocol paper (2)	Klassen, 2016[58]	554-patient RCT (NCT01283438)	Protocol for Barricaid EU RCT
	Strenge, 2019[59]	75-patient case series (NCT03986580)	Protocol for prospective, historically controlled trial in the US
Preclinical paper (2)	Bostelmann, 2017[60]	n/a	Biomechanical in vitro study of human lumbar herniation model
	Wilke, 2013[61]	n/a	Biomechanical in vitro study of human lumbar herniation model

Table 2. Patient and study characteristics in controlled studies with the Barricaid device for annulus fibrosus closure.

Study	Random Allocation	No. of Sites	Follow-up Duration (yr)	No. of Patients	Age (yr)	Male Sex	Body Mass Index (kg/m^2)
Barth, 2016[22]	No	4	2	45/40	42/40	52%/48%	26/26
Cho, 2019[23]	Yes	2	2	30/30	41/43	67%/83%	24/24
Thomé, 2018[24]	Yes	21	2*	276/278	43/44	57%/62%	26/26
Vukas, 2013[25]	No	2	2	30/72	38/41	53%/68%	–

*Four-year data from the pivotal trial of the Barricaid device have been published [74]. However, 2-year data were included in the meta-analysis in order to ensure the comparability of results among studies[24].

Table 3. Risk of bias in controlled studies with the Barricaid device for annulus fibrosus closure.

Primary Study	Random Sequence Generation	Allocation Concealment	Blinding of Participants	Blinding of Personnel	Blinding of Outcome Assessment	Incomplete Outcome Data	Selective Outcome Reporting	Other Sources of Bias	Other Sources of Bias Description
Barth, 2016[22]	H	H	U	U	U	L	L	U	Non-concurrent control group enrollment
Cho, 2019[23]	L	L	U	U	U	L	U	L	None
Thomé, 2018[24]	L	L	U	U	U	L	L	U	Industry funding
Vukas, 2013[25]	H	H	U	U	U	L	L	U	Non-concurrent control group enrollment

H, high risk of bias; L, low risk of bias; U, uncertain risk of bias.

Figure 3. Symptomatic reherniation within 2 years in controlled studies of lumbar discectomy with or without the Barricaid Annular Closure Device. The risk ratio = 0.45 (p < 0.001), which indicates a 55% risk reduction with the Barricaid device.

Figure 4. Reoperations within 2 years in controlled studies of lumbar discectomy with or without the Barricaid Annular Closure Device. The risk ratio = 0.52 (p = 0.003), which indicates a 48% risk reduction with the Barricaid device.

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