. 2017 Nov 16;8(4):413–423. doi: 10.1177/2192568217737317

Table 1.

Study and Baseline Participant Characteristics for Included Trials Reporting 5-Year Follow-up Data.

Study; ClinicalTrials.gov Identifier	Treatment	Blinding	Analysis Set	N	5-Year LTFU (%)	Mean Age (Years)	Prior Spinal Surgery	Mean BMI (kg/m²)	Single-Level Surgery (%)	L4/5 Level Treated (%)	L5/S1 Level Treated (%)	Mean Baseline ODI Score^a	Mean Baseline Back Pain Score^b	Preoperative Work Status (% Working)
Gornet 2010; NCT00635843	Maverick	Open	ITT	577	27%	40	28%	—	100%	24%	75%	54%	72	60%
Gornet 2010; NCT00635843	ALIF	Open	ITT	577	27%	40	28%	—	100%	24%	75%	54%	72	60%
Guyer 2009; NCT00215332	Charité	Single^c	ITT	304	43%	39.6	34%	26	100%	30%	69%	51%	72	53%
Guyer 2009; NCT00215332	ALIF	Single^c	ITT	304	43%	39.6	34%	26	100%	30%	69%	51%	72	53%
Skold 2013	Charité, ProDisc, Maverick	single^a	ITT	152	1%	39.4	12%	—	51%	—	—	41%	60	31%
Skold 2013	PLIF/PLF	single^a	ITT	152	1%	39.4	12%	—	51%	—	—	41%	60	31%
Zigler 2012; NCT00295009	ProDisc-L	Single^c	ITT	292	18%	39	34%	27	100%	32%	65%	63%	76	—
Zigler 2012; NCT00295009	CF	Single^c	ITT	292	18%	39	34%	27	100%	32%	65%	63%	76	—

Abbreviations: —, not reported; LTFU, loss to follow-up; BMI, body mass index; ODI, Oswestry Disability Index; ITT, intention to treat; ALIF, anterior lumbar interbody fusion; PLIF, posterior lumbar interbody fusion; PLF, posterior lumbar fusion; VAS, Visual Analogue Scale; NRS, Numerical Rating Scale.

^aODI questionnaire v2.0 was used in Gornet 2010, Guyer 2009, and Skold 2013, and a modified ODI questionnaire was used in Zigler 2012.

^bVAS pain scale (in mm) was used in Guyer 2009, Skold 2013, and Zigler 2012, and the NRS pain scale was used in Gornet 2010.

^cParticipants were preoperatively blinded.