Table 2 SSED summary

Prestige (one-level)

July 2007

276

6 weeks, 3-, 6-, 12-, 24-months and annually thereafter

NR

NR

Assessment criteria: maintenance of height (height change ≤ 2 mm from 6-week post-op height)

Success at 24 mos: 90/92 (97.8%)

Assessment criteria: NR

Displacement/Loosening (reported as AE): 2/276 patients (0.7%), 2 events

Subsidence (reported as AE): 1/276 patients (0.4%), 1 event

Assessment criteria: (I) the existence of flexion/extension angular motion in a range of > 4° to ≤ 20° and 2) no evidence of bridging trabecular bone forming a continuous connection between vertebral bodies

Success at 24 mos: 85/117 (72.6%)

Prodisc (one-level)

December 2007

103

6 weeks, 3-, 6-, 12-, 18-, and 24-months

Assessment criteria: reported as “bridging bone”

Result at 24 mos: 3/98 (3.0%)

Assessment criteria: radiolucencies > 25% around implant

Result at 24 mos: 0/98 (0.0%)

Assessment criteria: height decrease > 3 mm (baseline unclear)

Result at 24 mos: 0/98 (0.0%)

Assessment criteria: device motion > 3 mm

Migration at 24 mos: 0/98 (0.0%)

Subsidence at 24 mos: 0/98 (0.0%)

NR

Bryan (one-level)

May 2009

242

6 weeks, 3-, 6-, 12-, 24-months and biennially thereafter

Assessment criteria: reported as “bridging bone”

Result at 24 mos: 0/154 (0.0%)

Assessment criteria: NR

Result at 24 mos: 0/154 (0.0%)

Assessment criteria: maintenance of height (height change ≤ 2 mm from 3-month post-op height)

Reported as part of radiographic success

Assessment criteria: Subsidence success defined as ≤ 2 mm decrease from the 3-month measurement

Reported as part of Radiographic Success

Assessment criteria: FSU height/subsidence success based on a patient not having a surgical intervention related to a failure finding for either FSU or subsidence

Success at 24 mos: 79.6%

Secure-C (one-level)

September 2012

236 (148 randomized, 88 training)

6 weeks, 3-, 6-, 12-, 24-months and annually thereafter

Assessment criteria: Graded 0–IV per Mehren classification

Result at 24 mos:

Grade 0: 51/198 (25.8%)

Grade I: 40/198 (20.2%)

Grade II: 69/198 (34.8%)

Grade III: 25/198 (12.6%)

Grade IV: 13/198 (6.6%)

Assessment criteria: Radiolucencies > 25% around implant

Result at 24 months: 0 (0.0%)

Assessment criteria: height change > 2 mm from pre-op baseline

Result at 24 mos: 89/189 (47.1%)

Assessment criteria: device motion > 3 mm

Migration/displacement/subsidence at 24 mos: 0 (0.0%)

NR

PCM (one-level)

October 2012

289 (214 randomized, 75 training)

6 weeks, 3-, 6-, 12-, 24-months and annually thereafter

Assessment criteria: Graded 0–IV per Mehren classification

Result at 24 mos:

Grade 0: 141/233 (60.5%)

Grade I: 34/233 (14.6%)

Grade II: 48/233 (20.6%)

Grade III: 7/233 (3.0%)

Grade IV: 3/233 (1.3%)

Assessment criteria: Radiolucencies > 50% length of prosthesis

Result at 24 mos: 14/182 (7.7%; all superior)

AE reports

Occurance at 24 mos: 3/214 patients (1.4%)

Assessment criteria: maintenance of height (≥ 80% of post-op baseline)

Result at 24 mos: 160/177 (90.4%)

Assessment criteria: NR

AE reports

Subsidence at 24 mos: 1/214 patients (0.5%)

Displacement/Loosening at 24 + mos: 10/214 patients (4.7%)

Assessment criteria: lack of evidence of continuous bridging bone between the adjacent endplates of the involved motion segment or > 2° of segmental movement on lateral flexion/extension radiographs

Success at 24 mos: 178/180 (98.9%)

Mobi-C (one-level)

August 2013

179 (164 randomized, 15 training)

6 weeks, 3-, 6-, 12-, 18-, 24-months and annually thereafter

Assessment criteria: Graded 0–IV per Mehren classification

Result at 24 mos:

Grade 0: 14/164 (8.5%)

Grade I: 13/164 (7.9%)

Grade II: 109/164 (66.5%)

Grade III: 16/164 (9.8%)

Grade IV: 10/164 (6.1%)

AE reports

Occurance at 24 mos: 9/179 patients (5.0%), 10 events

Occurance at 60 mos: 13/179 patients (7.3%), 16 events

Assessment criteria: categorized as none, mild (< 25%), moderate (25–50%), or severe (> 50%)

Result 24 mos: mild radiolucency in 2 (1.3%)

Assessment criteria: height change from post-op (at discharge) height

Result at 24 mos (randomized cohort): − 0.41 mm ± 0.427 mm

Result at 24 mos (training cohort): − 0.45 mm ± 0.336 mm

Assessment criteria: device motion ≥ 3 mm (cranial/caudal for subsidence, anterior/posterior for migration)

Subsidence at 24 mos: 0

Migration at 24 mos: 0

Assessment criteria (radiographic failure): evidence of continuous bridging bone and < 2° total angular motion (from flexion to extension)

Reported as a part of overall success/failure

Mobi-C (two-level)

August 2013

234 (225 randomized, 9 training)

6 weeks, 3-, 6-, 12-, 18-, 24-months and annually thereafter

Assessment criteria: Graded 0–IV per Mehren classification

Result at 24 mos:

Grade 0: Sup. 23/225 (10.2%); Inf. 20/225 (8.9%)

Grade I: Sup. 15/225 (6.7%); Inf. 7/225 (3.1%)

Grade II: Sup. 161/225 (71.6%); Inf. 162/225 (72.0%)

Grade III: Sup. 17/225 (7.6%); Inf. 17/225 (7.6%)

Grade IV: Sup. 8/225 (3.6%); Inf. 6/225 (2.7%)

AE reports

Occurance at 24 mos: 6/234 patients (2.6%), 6 events

Occurance at 60 mos: 13/234 patients (5.6%), 13 events

Assessment criteria: categorized as none, mild (< 25%), moderate (25–50%), or severe (> 50%)

Result at 24 mos: mild radiolucency in 2 (1.3%)

Assessment criteria: height change from 6-week post-op height

Result at 24 mos (superior): − 0.43 ± 0.398 mm

Result at 24 mos (inferior): − 0.35 ± 0.385 mm

Assessment criteria: device motion ≥ 3 mm (cranial/caudal for subsidence, anterior/posterior for migration)

Subsidence at 24 mos: 0

Migration at 24 mos: 1

Assessment criteria (radiographic failure): evidence of continuous bridging bone and < 2° total angular motion (from flexion to extension)

Reported as a part of overall success/failure

Prestige LP (one-level)

July 2014

280

6 weeks, 3-, 6-, 12-, 24-months and annually thereafter

Assessment criteria: reported as bone bridging (criteria comparable to Class IV HO assessment per Mehren)

Evidence of bridging at 24 mos: 16/280 (5.9%)

AE reports

Occurance at 24 mos: 27/280 subjects (9.6%), 31 events

Assessment criteria: NR

Reported as part of Radiographic Success

Assessment criteria: maintenance of height (height change ≤ 2 mm from 6-week post-op height)

Result at 24 mos: 205/224 (91.5%)

NR

Assessment criteria: evidence of bone spanning the two vertebral bodies, existence of angular motion stability < 4°, and no radiolucent lines covering more than 50% of the implant surface

Success at 24 mos: 219/316 (69.3%)

Prestige LP (two-level)

July 2016

209

6 weeks, 3-, 6-, 12-, 24-months and annually thereafter until last subject enrollment (36-, 60-, 84-, and 120- months)

Assessment criteria: Graded 0–IV per Mehren classification

Result at 24 mos:

Grade 0: Sup. 143/198 (72.2%); Inf. 126/198 (63.6%)

Grade I: Sup. 10/198 (5.1%); Inf. 11/198 (5.6%)

Grade II: Sup. 13/198 (6.6%); Inf. 22/198 (11.1%)

Grade III: Sup. 28/198 (14.1%); Inf. 33/198 (16.7%)

Grade IV: Sup. 4/198 (2.0%); Inf. 6/198 (3.0%)

Bone bridging comparable to Class IV HO also reported

AE reports

Occurance ≤ 24 months: 22/209 subjects (10.5%), 27 events

Occurance ≤ 84 months: 33/209 subjects (15.8%), 40 events

Assessment criteria: NR

Reported as part of Radiographic Success

Assessment criteria: maintenance of height (height change ≤ 2 mm from 6-week post-op height at both treated levels)

Result at 24 mos: 159/170 (93.5%)

AE reports

Displacement:

 ≤ 24 Months: 6/209 subjects (2.9%), 6 events

 ≤ 84 Months: 7/209 subjects (3.3%), 7 events

Subsidence:

 ≤ 24 Months: 2/209 subjects (1.0%), 3 events

 ≤ 84 Months: 3/209 subjects (1.4%), 4 events

Loosening:

 ≤ 24 Months: 0/209 subjects (0.0%)

 ≤ 84 Months: 0/209 subjects (0.0%)

Assessment criteria: angular motion on lateral flexion/extension radiographs > 4° but ≤ 20° and no radiographic evidence of bridging trabecular bone that forms a continuous bony connection with the vertebral bodies (i.e., no bridging bone) at both treated levels

Success at 24 mos (superior): 137/197 (69.5%)

Success at 24 mos (inferior): 126/195 (64.6%)

Success at 24 mos (both levels): 100/196 (51.0%)

M6-C (one-level)

February 2019

160

6 weeks, 3-, 6-, 12-, 24-months and annually thereafter

Assessment criteria: Graded 0-IV per Mehren classification

Result at 24 mos:

Grade 0: 61/150 (40.7%)

Grade I: 22/150 (14.7%)

Grade II: 50/150 (33.3%)

Grade III: 16/150 (10.7%)

Grade IV: 1/150 (0.7%)

Assessment criteria: categorized as none, mild (< 25%), moderate (25–50%), or severe (> 50%)

Result at 24 mos:

None: 144 (96.0%)

Mild (< 25%): 6 (4.0%)

Moderate (25–50%): 0 (0.0%)

Severe (> 50%): 0 (0.0%)

Assessment criteria: disc height comparison from pre-op height

Height preoperatively: 3.22 ± 0.73 mm

Height at 24 months: 5.31 ± 1.02 mm

Assessment criteria: NR

Loosening at 24 mos: 4/150 (2.6%)

Subsidence at 24 mos: 1/150 (0.7%)

Migration at 24 mos: 0/150 (0.0%)

NR

Simplify (one-level)

September 2020

166 (150 randomized, 16 training)

6 weeks, 3-, 6-, 12-, 24-months and annually thereafter

Assessment criteria: Graded 0–IV per Mehren classification

Results at 24 mos:

Grade 0: 20/139 (14%)

Grade I: 16/139 (12%)

Grade II: 80/139 (58%)

Grade III: 11/139 (8%)

Grade IV: 10/139 (7%)

NR

Assessment criteria: disc height comparison from pre-op height

Height preoperatively: 3.31 ± 0.74

Height at 24 months: 4.24 ± 0.94 mm

Superior and inferior adjacent level height also reported

Assessment criteria: device motion > 3 mm compared to position at implantation

Migration at 24 months: 0

AE reports

Implant collapse or Subsidence through Day 790: 0

NR

Simplify (two-level)

April 2021

200 (182 randomized, 18 training)

6 weeks, 3-, 6-, 12-, 24-, 36-months and annually thereafter

Assessment criteria: Graded 0–IV per Mehren classification

Results at 24 mos:

Grade 0: 21/166 (13%)

Grade I: 21/166 (13%)

Grade II: 106/166 (64%)

Grade III: 8/166 (5%)

Grade IV: 8/166 (5%)

NR

Assessment criteria: height change from post-op height

Result at 24 months:

Superior component: 1.19 ± 0.81 mm

Inferior component: 0.84 ± 0.96 mm

Superior and inferior adjacent level height also reported

Assessment criteria for disc height success also reported but with no corresponding results

Assessment criteria: device motion > 3 mm compared to position at implantation

Migration at 24 months: 0

AE reports

Implant collapse or Subsidence through Day 790: 0

NR