Trial Outcomes & Findings for 5-Year Global Study on MAST™ Minimally Invasive Fusion Procedures to Treat Degenerative Lumbar Spine (MASTERS-D2) (NCT NCT02617563)

Last Updated: 2026-01-21

Results Overview

To demonstrate that DDD patients operated for spondylolisthesis fare equally well regardless of the surgical procedure (anterolateral or posterior) performed as measured by the change of ODI at 3 months as compared to baseline. ODI=Oswestry Disability Scale \[0-100\]; higher scores mean a worse outcome Timepoints: Baseline and 3 months

Recruitment status

COMPLETED

Target enrollment

361 participants

Primary outcome timeframe

3 months

Results posted on

2026-01-21

Participant Flow

Of the 361 patient enrolled, twenty-four participants were excluded after pre-op. The reasons for these exclusions were that these 24 participants did not undergo the minimally invasive fusion treatment per CIP

Participant milestones

Participant milestones
Measure	Total Population ANT Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation
4 Weeks STARTED	164	173
4 Weeks COMPLETED	162	173
4 Weeks NOT COMPLETED	2	0
3 Months STARTED	162	173
3 Months COMPLETED	161	172
3 Months NOT COMPLETED	1	1
1 Year STARTED	161	172
1 Year COMPLETED	160	170
1 Year NOT COMPLETED	1	2
2 Year STARTED	160	170
2 Year COMPLETED	157	165
2 Year NOT COMPLETED	3	5
3 Year STARTED	157	165
3 Year COMPLETED	153	160
3 Year NOT COMPLETED	4	5
4 Year STARTED	153	160
4 Year COMPLETED	146	158
4 Year NOT COMPLETED	7	2
5 Year STARTED	146	158
5 Year COMPLETED	136	152
5 Year NOT COMPLETED	10	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Total Population ANT Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation
4 Weeks Withdrawal by Subject	2	0
3 Months Lost to Follow-up	1	0
3 Months Withdrawal by Subject	0	1
1 Year Lost to Follow-up	1	2
2 Year Death	1	0
2 Year Lost to Follow-up	2	1
2 Year Withdrawal by Subject	0	4
3 Year Death	2	1
3 Year Lost to Follow-up	1	3
3 Year Withdrawal by Subject	1	1
4 Year Death	1	0
4 Year Lost to Follow-up	3	1
4 Year Withdrawal by Subject	3	1
5 Year Death	0	1
5 Year Lost to Follow-up	9	5
5 Year Withdrawal by Subject	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Population ANT n=164 Participants Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST n=173 Participants Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation	Total n=337 Participants Total of all reporting groups
Age, Continuous	57.3 years STANDARD_DEVIATION 10.3 • n=164 Participants	59.7 years STANDARD_DEVIATION 11.1 • n=173 Participants	58.5 years STANDARD_DEVIATION 10.8 • n=337 Participants
Sex: Female, Male Female	100 Participants n=164 Participants	103 Participants n=173 Participants	203 Participants n=337 Participants
Sex: Female, Male Male	64 Participants n=164 Participants	70 Participants n=173 Participants	134 Participants n=337 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Argentina	3 participants n=164 Participants	3 participants n=173 Participants	6 participants n=337 Participants
Region of Enrollment Czechia	0 participants n=164 Participants	13 participants n=173 Participants	13 participants n=337 Participants
Region of Enrollment United Kingdom	11 participants n=164 Participants	17 participants n=173 Participants	28 participants n=337 Participants
Region of Enrollment Portugal	17 participants n=164 Participants	22 participants n=173 Participants	39 participants n=337 Participants
Region of Enrollment Spain	39 participants n=164 Participants	2 participants n=173 Participants	41 participants n=337 Participants
Region of Enrollment Russia	22 participants n=164 Participants	12 participants n=173 Participants	34 participants n=337 Participants
Region of Enrollment South Korea	26 participants n=164 Participants	23 participants n=173 Participants	49 participants n=337 Participants
Region of Enrollment Austria	9 participants n=164 Participants	5 participants n=173 Participants	14 participants n=337 Participants
Region of Enrollment Belgium	0 participants n=164 Participants	8 participants n=173 Participants	8 participants n=337 Participants
Region of Enrollment China	0 participants n=164 Participants	48 participants n=173 Participants	48 participants n=337 Participants
Region of Enrollment Denmark	1 participants n=164 Participants	1 participants n=173 Participants	2 participants n=337 Participants
Region of Enrollment Brazil	7 participants n=164 Participants	3 participants n=173 Participants	10 participants n=337 Participants
Region of Enrollment Italy	1 participants n=164 Participants	1 participants n=173 Participants	2 participants n=337 Participants
Region of Enrollment Mexico	0 participants n=164 Participants	1 participants n=173 Participants	1 participants n=337 Participants
Region of Enrollment Slovakia	0 participants n=164 Participants	3 participants n=173 Participants	3 participants n=337 Participants
Region of Enrollment France	28 participants n=164 Participants	7 participants n=173 Participants	35 participants n=337 Participants
Region of Enrollment Germany	0 participants n=164 Participants	4 participants n=173 Participants	4 participants n=337 Participants
BMI (kg/m^2)	27.7 kg/m^2 STANDARD_DEVIATION 4.9 • n=163 Participants • One (1) patient didn't enter data on height, therefore BMI couldn't be calculated for this patient	26.8 kg/m^2 STANDARD_DEVIATION 4.5 • n=173 Participants • One (1) patient didn't enter data on height, therefore BMI couldn't be calculated for this patient	27.2 kg/m^2 STANDARD_DEVIATION 4.7 • n=336 Participants • One (1) patient didn't enter data on height, therefore BMI couldn't be calculated for this patient
Current tobacco use Uses tobacco	38 Participants n=164 Participants	33 Participants n=173 Participants	71 Participants n=337 Participants
Current tobacco use Does not use tobacco	126 Participants n=164 Participants	140 Participants n=173 Participants	266 Participants n=337 Participants
Working status Not employed	91 Participants n=164 Participants	119 Participants n=173 Participants	210 Participants n=337 Participants
Working status Employed or independent worker	73 Participants n=164 Participants	54 Participants n=173 Participants	127 Participants n=337 Participants
History of spine surgery Yes	20 Participants n=164 Participants	15 Participants n=173 Participants	35 Participants n=337 Participants
History of spine surgery No	144 Participants n=164 Participants	158 Participants n=173 Participants	302 Participants n=337 Participants
Medication use at baseline (Nonopioid) Yes	121 Participants n=164 Participants	101 Participants n=173 Participants	222 Participants n=337 Participants
Medication use at baseline (Nonopioid) No	43 Participants n=164 Participants	72 Participants n=173 Participants	115 Participants n=337 Participants
Medication use at baseline (Opioid) Yes	70 Participants n=164 Participants	49 Participants n=173 Participants	119 Participants n=337 Participants
Medication use at baseline (Opioid) No	94 Participants n=164 Participants	124 Participants n=173 Participants	218 Participants n=337 Participants
Medication use at baseline (Other) Yes	83 Participants n=164 Participants	37 Participants n=173 Participants	120 Participants n=337 Participants
Medication use at baseline (Other) No	81 Participants n=164 Participants	136 Participants n=173 Participants	217 Participants n=337 Participants

PRIMARY outcome

Timeframe: 3 months

Population: 227 participants with spondylolisthesis were categorized into either ANT or POST groups, depending on the type of MI lumbar surgery received. n=206 of these patients completed the 3-month follow-up visit.

Outcome measures

Outcome measures
Measure	Total Population ANT n=106 Participants Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST n=100 Participants Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation	OLIF Patients who received OLIF MI lumbar surgery	PLIF Patients who received PLIF MI lumbar surgery	MIDLF Patients who received MIDLF MI lumbar surgery	TLIF Patients who received TLIF MI lumbar surgery
Change (Preop-postop) of Disability, Oswestry Disability Index (ODI) at 3 Months as Compared to Baseline in DDD Patients With Spondylolisthesis	23.19 change of score on a scale (ODI) Standard Deviation 21.32	26.08 change of score on a scale (ODI) Standard Deviation 19.47	—	—	—	—

SECONDARY outcome

Timeframe: 3 months

Population: n=100 patients without spondylolisthesis completed the 3-month follow up, out of a total of n=110 non-spondilolisthesis patients enrolled

To evaluate whether DDD patients without spondylolisthesis fare equally well regardless of the surgical procedure (anterolateral or posterior) performed, as measured by Oswestry Disability Index (ODI) at 3 months. Scored \[0-100\]; higher scores mean a worse outcome Timepoints: Baseline and 3 months

Outcome measures

Outcome measures
Measure	Total Population ANT n=46 Participants Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST n=53 Participants Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation	OLIF Patients who received OLIF MI lumbar surgery	PLIF Patients who received PLIF MI lumbar surgery	MIDLF Patients who received MIDLF MI lumbar surgery	TLIF Patients who received TLIF MI lumbar surgery
Change (Preop-postop) in Disability ODI as Compared to Baseline in DDD Patients Without Spondylolisthesis	13.41 score on a scale (improvement) Standard Deviation 22.09	24.20 score on a scale (improvement) Standard Deviation 20.02	—	—	—	—

SECONDARY outcome

Timeframe: Through 5 years

Population: Participant numbers may deviate per follow-up visit due to data not having been completed for a number of participants (e.g. data not completed by follow-up, drop-out)

To observe the change in ODI scores as compared to baseline through 5 years. The score at baseline gives the baseline score \[0-100\]; the higher the score, the worse the outcome. Additional scores are based on the change from baseline. The higher the score, the greater the improvement. Timepoints: Baseline, 4 weeks, 3 months, 1-,2-,3-,4-, and 5-years

Outcome measures

Outcome measures
Measure	Total Population ANT n=164 Participants Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST n=173 Participants Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation	OLIF Patients who received OLIF MI lumbar surgery	PLIF Patients who received PLIF MI lumbar surgery	MIDLF Patients who received MIDLF MI lumbar surgery	TLIF Patients who received TLIF MI lumbar surgery
Change (Preop-postop) in ODI Scores for the Total Population Baseline (score)	46.46 score on a scale (improvement) Standard Deviation 18.05	47.02 score on a scale (improvement) Standard Deviation 15.89	—	—	—	—
Change (Preop-postop) in ODI Scores for the Total Population 4 Weeks	13.27 score on a scale (improvement) Standard Deviation 22.56	17.57 score on a scale (improvement) Standard Deviation 19.87	—	—	—	—
Change (Preop-postop) in ODI Scores for the Total Population 3 Months	20.23 score on a scale (improvement) Standard Deviation 21.95	25.43 score on a scale (improvement) Standard Deviation 19.62	—	—	—	—
Change (Preop-postop) in ODI Scores for the Total Population 1 Year	24.47 score on a scale (improvement) Standard Deviation 22.30	29.42 score on a scale (improvement) Standard Deviation 19.63	—	—	—	—
Change (Preop-postop) in ODI Scores for the Total Population 2 Year	27.80 score on a scale (improvement) Standard Deviation 23.81	30.31 score on a scale (improvement) Standard Deviation 20.52	—	—	—	—
Change (Preop-postop) in ODI Scores for the Total Population 3 Year	27.15 score on a scale (improvement) Standard Deviation 23.93	29.83 score on a scale (improvement) Standard Deviation 21.08	—	—	—	—
Change (Preop-postop) in ODI Scores for the Total Population 4 Year	26.08 score on a scale (improvement) Standard Deviation 25.48	27.30 score on a scale (improvement) Standard Deviation 21.01	—	—	—	—
Change (Preop-postop) in ODI Scores for the Total Population 5 Year	26.55 score on a scale (improvement) Standard Deviation 25.50	29.26 score on a scale (improvement) Standard Deviation 19.67	—	—	—	—

SECONDARY outcome

Timeframe: Through 5 years

Population: Participant numbers may differ at follow-up time points due to data not being available for some (e.g. participant did not complete the data, or drop-out)

To observe a change in VAS back pain as compared to baseline through 5 years. At baseline scored on a scale from \[0-10\]; 0 = No pain 10= Worst pain possible. Timepoints: Baseline, 4 weeks, 3 months, 1-,2-,3-,4-, and 5-years

Outcome measures

Outcome measures
Measure	Total Population ANT n=164 Participants Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST n=173 Participants Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation	OLIF Patients who received OLIF MI lumbar surgery	PLIF Patients who received PLIF MI lumbar surgery	MIDLF Patients who received MIDLF MI lumbar surgery	TLIF Patients who received TLIF MI lumbar surgery
Change (Preop-postop) in Visual Analog Scale (VAS) Back Pain Intensity 5 Year	3.90 score on a scale Standard Deviation 3.25	3.48 score on a scale Standard Deviation 2.93	—	—	—	—
Change (Preop-postop) in Visual Analog Scale (VAS) Back Pain Intensity Baseline (score)	6.48 score on a scale Standard Deviation 2.33	5.76 score on a scale Standard Deviation 2.76	—	—	—	—
Change (Preop-postop) in Visual Analog Scale (VAS) Back Pain Intensity 4 Weeks	3.48 score on a scale Standard Deviation 3.15	3.06 score on a scale Standard Deviation 3.06	—	—	—	—
Change (Preop-postop) in Visual Analog Scale (VAS) Back Pain Intensity 3 Months	3.47 score on a scale Standard Deviation 3.11	3.25 score on a scale Standard Deviation 3.23	—	—	—	—
Change (Preop-postop) in Visual Analog Scale (VAS) Back Pain Intensity 1 Year	3.48 score on a scale Standard Deviation 3.36	3.46 score on a scale Standard Deviation 3.01	—	—	—	—
Change (Preop-postop) in Visual Analog Scale (VAS) Back Pain Intensity 2 Year	3.50 score on a scale Standard Deviation 3.40	3.59 score on a scale Standard Deviation 3.01	—	—	—	—
Change (Preop-postop) in Visual Analog Scale (VAS) Back Pain Intensity 3 Year	3.54 score on a scale Standard Deviation 3.26	3.54 score on a scale Standard Deviation 2.92	—	—	—	—
Change (Preop-postop) in Visual Analog Scale (VAS) Back Pain Intensity 4 Year	3.42 score on a scale Standard Deviation 3.39	3.33 score on a scale Standard Deviation 3.04	—	—	—	—

SECONDARY outcome

Timeframe: Through 5 years

Population: Number of participants may differ as data is not always available for all (e.g. data not completed by participant, drop-out)

To observe the change in VAS leg pain as compared to baseline through 5 years. The score at baseline gives the baseline score \[0-10\]; 0 = No pain 10= Worst pain possible. Timepoints: Baseline, 4 weeks, 3 months, 1-,2-,3-,4-, and 5-years

Outcome measures

Outcome measures
Measure	Total Population ANT n=164 Participants Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST n=173 Participants Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation	OLIF Patients who received OLIF MI lumbar surgery	PLIF Patients who received PLIF MI lumbar surgery	MIDLF Patients who received MIDLF MI lumbar surgery	TLIF Patients who received TLIF MI lumbar surgery
Change (Preop-postop) in VAS Leg Pain Intensity 3 Months	3.99 score on a scale (improvement) Standard Deviation 3.56	4.76 score on a scale (improvement) Standard Deviation 3.44	—	—	—	—
Change (Preop-postop) in VAS Leg Pain Intensity Baseline (score)	6.18 score on a scale (improvement) Standard Deviation 2.70	6.33 score on a scale (improvement) Standard Deviation 2.57	—	—	—	—
Change (Preop-postop) in VAS Leg Pain Intensity 4 Weeks	3.79 score on a scale (improvement) Standard Deviation 3.58	4.64 score on a scale (improvement) Standard Deviation 3.25	—	—	—	—
Change (Preop-postop) in VAS Leg Pain Intensity 1 Year	3.83 score on a scale (improvement) Standard Deviation 3.70	4.50 score on a scale (improvement) Standard Deviation 3.57	—	—	—	—
Change (Preop-postop) in VAS Leg Pain Intensity 2 Year	4.17 score on a scale (improvement) Standard Deviation 3.81	4.84 score on a scale (improvement) Standard Deviation 3.49	—	—	—	—
Change (Preop-postop) in VAS Leg Pain Intensity 3 Year	4.18 score on a scale (improvement) Standard Deviation 3.73	4.62 score on a scale (improvement) Standard Deviation 3.51	—	—	—	—
Change (Preop-postop) in VAS Leg Pain Intensity 4 Year	3.58 score on a scale (improvement) Standard Deviation 4.10	4.52 score on a scale (improvement) Standard Deviation 3.50	—	—	—	—
Change (Preop-postop) in VAS Leg Pain Intensity 5 Year	4.23 score on a scale (improvement) Standard Deviation 3.69	4.65 score on a scale (improvement) Standard Deviation 3.40	—	—	—	—

SECONDARY outcome

Timeframe: Through 5 years

Population: Number of participants may differ as data is not always available for all (e.g. data not completed by participant, drop-out)

To observe the change in EuroQol-5 Dimension (EQ-5D) index score as compared to baseline through 5 years. Scored from \[-0.109 to 1\]. A higher score means a better outcome. Timepoints: Baseline, 4 weeks, 3 months, 1-,2-,3-,4-, and 5-years

Outcome measures

Outcome measures
Measure	Total Population ANT n=164 Participants Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST n=173 Participants Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation	OLIF Patients who received OLIF MI lumbar surgery	PLIF Patients who received PLIF MI lumbar surgery	MIDLF Patients who received MIDLF MI lumbar surgery	TLIF Patients who received TLIF MI lumbar surgery
Change (Postop-preop) in EQ-5D Index Score 3 Months	0.267 score on a scale (improvement) Standard Deviation 0.268	0.285 score on a scale (improvement) Standard Deviation 0.248	—	—	—	—
Change (Postop-preop) in EQ-5D Index Score 1 Year	0.261 score on a scale (improvement) Standard Deviation 0.283	0.287 score on a scale (improvement) Standard Deviation 0.239	—	—	—	—
Change (Postop-preop) in EQ-5D Index Score 2 Year	0.307 score on a scale (improvement) Standard Deviation 0.286	0.314 score on a scale (improvement) Standard Deviation 0.257	—	—	—	—
Change (Postop-preop) in EQ-5D Index Score 3 Year	0.301 score on a scale (improvement) Standard Deviation 0.291	0.315 score on a scale (improvement) Standard Deviation 0.247	—	—	—	—
Change (Postop-preop) in EQ-5D Index Score 4 Year	0.284 score on a scale (improvement) Standard Deviation 0.316	0.286 score on a scale (improvement) Standard Deviation 0.249	—	—	—	—
Change (Postop-preop) in EQ-5D Index Score 5 Year	0.300 score on a scale (improvement) Standard Deviation 0.306	0.291 score on a scale (improvement) Standard Deviation 0.249	—	—	—	—
Change (Postop-preop) in EQ-5D Index Score Baseline (score)	0.492 score on a scale (improvement) Standard Deviation 0.225	0.543 score on a scale (improvement) Standard Deviation 0.226	—	—	—	—
Change (Postop-preop) in EQ-5D Index Score 4 Weeks	0.209 score on a scale (improvement) Standard Deviation 0.271	0.237 score on a scale (improvement) Standard Deviation 0.246	—	—	—	—

SECONDARY outcome

Timeframe: 5 years

Neurological status is based on four types of measurements (sections): motor, sensory, reflexes, and straight leg raising. Overall neurological success is defined as maintenance or improvement in all sections (motor, sensory, reflex, and straight leg raising) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the baseline evaluation to the time period evaluated. Therefore, if any one element in any section does not stay the same or improve, then a patient was not considered a success for neurological status.

Outcome measures

Outcome measures
Measure	Total Population ANT n=54 Participants Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST n=59 Participants Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation	OLIF Patients who received OLIF MI lumbar surgery	PLIF Patients who received PLIF MI lumbar surgery	MIDLF Patients who received MIDLF MI lumbar surgery	TLIF Patients who received TLIF MI lumbar surgery
The Neurological Success Rate Motor function · Normal	52 Participants	58 Participants	—	—	—	—
The Neurological Success Rate Motor function · Abnormal	2 Participants	1 Participants	—	—	—	—
The Neurological Success Rate Sensory function · Normal	53 Participants	57 Participants	—	—	—	—
The Neurological Success Rate Sensory function · Abnormal	1 Participants	2 Participants	—	—	—	—
The Neurological Success Rate Reflexes · Normal	54 Participants	58 Participants	—	—	—	—
The Neurological Success Rate Reflexes · Abnormal	0 Participants	1 Participants	—	—	—	—
The Neurological Success Rate Straight leg raise · Normal	53 Participants	59 Participants	—	—	—	—
The Neurological Success Rate Straight leg raise · Abnormal	1 Participants	0 Participants	—	—	—	—
The Neurological Success Rate Overall Neurological Status · Normal	51 Participants	56 Participants	—	—	—	—
The Neurological Success Rate Overall Neurological Status · Abnormal	3 Participants	3 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Through 5 years

Population: Fusion assessments weren't conducted at each time point for each participant, and not all participants had their fusion status assessed, hence the participant numbers are different at each time point.

Fusion success rate was summarized for at 1, 2, 3, 4, 5 year follow-up. If a participant showed fusion success at early time points and non-fusion at a later time point, the fusion status at all earlier points was considered as non-fusion. For 2-level fusion participants, fusion success was defined as achieving fusion at both treated levels.

Outcome measures

Outcome measures
Measure	Total Population ANT n=164 Participants Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST n=173 Participants Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation	OLIF Patients who received OLIF MI lumbar surgery	PLIF Patients who received PLIF MI lumbar surgery	MIDLF Patients who received MIDLF MI lumbar surgery	TLIF Patients who received TLIF MI lumbar surgery
Fusion Success 12 Months · Fused	110 Participants	100 Participants	—	—	—	—
Fusion Success 12 Months · Not Fused	17 Participants	16 Participants	—	—	—	—
Fusion Success 24 Months · Fused	33 Participants	25 Participants	—	—	—	—
Fusion Success 24 Months · Not Fused	2 Participants	3 Participants	—	—	—	—
Fusion Success 36 Months · Fused	19 Participants	18 Participants	—	—	—	—
Fusion Success 36 Months · Not Fused	1 Participants	3 Participants	—	—	—	—
Fusion Success 48 Months · Fused	13 Participants	20 Participants	—	—	—	—
Fusion Success 48 Months · Not Fused	1 Participants	0 Participants	—	—	—	—
Fusion Success 60 Months · Fused	12 Participants	18 Participants	—	—	—	—
Fusion Success 60 Months · Not Fused	1 Participants	0 Participants	—	—	—	—
Fusion Success The Last Evaluation of Fusion Status · Fused	127 Participants	115 Participants	—	—	—	—
Fusion Success The Last Evaluation of Fusion Status · Not Fused	16 Participants	15 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Through 5 years

Population: Not all participants had additional surgery, and some participants had multiple revision surgeries. In the ANT group n=16 participants who had at least 1 revision surgery, in the POST group n=21.

To document Secondary Surgeries at index and/or adjacent level(s)throughout the study. When a participant requires additional surgery at the index level(s), it can be an indicator of insufficient outcomes of the initial surgery. Due to the progressive nature of the degenerative lumbar spine, additional surgeries at the index and/or adjacent levels might be required after the initial surgery. To ensure all safety and economic values are collected, the revision surgeries and their complication types and rates will be assessed during the study by the surgeons. For secondary surgery at index levels and/or secondary surgery at adjacent levels, survival analysis was performed to estimate the cumulative event rate up to 5 years.

Outcome measures

Outcome measures
Measure	Total Population ANT n=164 Participants Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST n=173 Participants Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation	OLIF Patients who received OLIF MI lumbar surgery	PLIF Patients who received PLIF MI lumbar surgery	MIDLF Patients who received MIDLF MI lumbar surgery	TLIF Patients who received TLIF MI lumbar surgery
Proportion of Patients Needing a Secondary Spinal Surgery at the Index and/or Adjacent Level(s) (Reoperation Rates) Throughout the Study Index levels only	6 number of revision surgeries	13 number of revision surgeries	—	—	—	—
Proportion of Patients Needing a Secondary Spinal Surgery at the Index and/or Adjacent Level(s) (Reoperation Rates) Throughout the Study Adjacent levels only	4 number of revision surgeries	8 number of revision surgeries	—	—	—	—
Proportion of Patients Needing a Secondary Spinal Surgery at the Index and/or Adjacent Level(s) (Reoperation Rates) Throughout the Study Both index and adjacent levels	2 number of revision surgeries	2 number of revision surgeries	—	—	—	—
Proportion of Patients Needing a Secondary Spinal Surgery at the Index and/or Adjacent Level(s) (Reoperation Rates) Throughout the Study Others	6 number of revision surgeries	1 number of revision surgeries	—	—	—	—

SECONDARY outcome

Timeframe: Through 5 years

Document Adverse Events occurrence throughout the study

Outcome measures

Outcome measures
Measure	Total Population ANT n=164 Participants Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST n=173 Participants Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation	OLIF Patients who received OLIF MI lumbar surgery	PLIF Patients who received PLIF MI lumbar surgery	MIDLF Patients who received MIDLF MI lumbar surgery	TLIF Patients who received TLIF MI lumbar surgery
Adverse Events General Surgery-related	66 Adverse Events (n)	75 Adverse Events (n)	—	—	—	—
Adverse Events Device-related	10 Adverse Events (n)	5 Adverse Events (n)	—	—	—	—
Adverse Events MAST/MI (minimally invasive)-related	18 Adverse Events (n)	17 Adverse Events (n)	—	—	—	—
Adverse Events Disease-related	63 Adverse Events (n)	61 Adverse Events (n)	—	—	—	—

SECONDARY outcome

Timeframe: From surgery up to hospital discharge, up to 11 days

Population: For two participants in the ANT arm, no data was available for "Time needed for first ambulation"

To observe and document the days needed for participants to get out of bed and ambulate with or without assistance. Time range: \[0-11\] days

Outcome measures

Outcome measures
Measure	Total Population ANT n=162 Participants Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST n=173 Participants Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation	OLIF Patients who received OLIF MI lumbar surgery	PLIF Patients who received PLIF MI lumbar surgery	MIDLF Patients who received MIDLF MI lumbar surgery	TLIF Patients who received TLIF MI lumbar surgery
Amount of Days Needed for First Ambulation	1.6 Days Standard Deviation 1.3	1.9 Days Standard Deviation 1.6	—	—	—	—

SECONDARY outcome

Timeframe: Surgery Recovery Day up to hospital discharge, with a maximum of 46 days

Population: Data for 1 participant in the ANT group is unavailable for "Surgery Recovery"

To observe and document the days after the surgery, fulfilling following criteria: * No need for intravenous infusion of analgesic drugs * No ongoing surgery related adverse events impending discharge * No need for nursing care Timeframe: \[0-46\] days The objective of the Surgery Recovery Day assessment is to collect the day when the participant could be discharged based on his actual clinical condition because the effective day of discharge may be prolonged by factors other than the participant's clinical recovery such as social factors or co-morbidity. For the purpose of reporting these parameters the day of the surgery were considered 'D0', the first day after surgery as 'D1', the second day as 'D2' and so on.

Outcome measures

Outcome measures
Measure	Total Population ANT n=163 Participants Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST n=173 Participants Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation	OLIF Patients who received OLIF MI lumbar surgery	PLIF Patients who received PLIF MI lumbar surgery	MIDLF Patients who received MIDLF MI lumbar surgery	TLIF Patients who received TLIF MI lumbar surgery
Amount of Days Needed to Recover From Surgery	4.4 Days Standard Deviation 3.7	5.0 Days Standard Deviation 5.2	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to 5-year follow-up

Population: Not all data completed for each participant at each follow-up visit

Healthcare utilization were measured with the following three costs components: 1. resources: surgery room, length of hospital stay, additional medical visits (outpatient consultations, visits to primary care services, etc) 2. medications 3. non-pharmacologic therapies: rehabilitation program

Outcome measures

Outcome measures
Measure	Total Population ANT n=164 Participants Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST n=173 Participants Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation	OLIF Patients who received OLIF MI lumbar surgery	PLIF Patients who received PLIF MI lumbar surgery	MIDLF Patients who received MIDLF MI lumbar surgery	TLIF Patients who received TLIF MI lumbar surgery
Healthcare Economics Evaluation "Medications" Baseline : Opioid analgesics · Yes	70 Participants	49 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" Baseline : Opioid analgesics · No	94 Participants	124 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 3 Months : Opioid analgesics · Yes	48 Participants	29 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 3 Months : Opioid analgesics · No	111 Participants	131 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 3 Months : Other medications · Yes	67 Participants	23 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 3 Months : Other medications · No	92 Participants	137 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 1 Year : Nonopioid analgesics · Yes	73 Participants	53 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 1 Year : Nonopioid analgesics · No	79 Participants	105 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 1 Year : Opioid analgesics · Yes	29 Participants	16 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 1 Year : Opioid analgesics · No	123 Participants	142 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 1 Year : Other medications · Yes	55 Participants	24 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 1 Year : Other medications · No	97 Participants	134 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 2 Year : Nonopioid analgesics · Yes	56 Participants	48 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 2 Year : Nonopioid analgesics · No	91 Participants	109 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 2 Year : Opioid analgesics · Yes	24 Participants	16 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 2 Year : Opioid analgesics · No	123 Participants	141 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 2 Year : Other medications · Yes	50 Participants	27 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 2 Year : Other medications · No	97 Participants	130 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 3 Year : Nonopioid analgesics · Yes	57 Participants	48 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 3 Year : Nonopioid analgesics · No	87 Participants	106 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 3 Year : Opioid analgesics · Yes	18 Participants	8 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 3 Year : Opioid analgesics · No	126 Participants	146 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 3 Year : Other medications · Yes	46 Participants	23 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 3 Year : Other medications · No	98 Participants	131 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 4 Year : Nonopioid analgesics · Yes	44 Participants	45 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 4 Year : Nonopioid analgesics · No	89 Participants	107 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 4 Year : Opioid analgesics · Yes	21 Participants	10 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 4 Year : Opioid analgesics · No	112 Participants	142 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 4 Year : Other medications · Yes	38 Participants	26 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 4 Year : Other medications · No	95 Participants	126 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 5 Year : Nonopioid analgesics · Yes	38 Participants	41 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 5 Year : Nonopioid analgesics · No	97 Participants	110 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 5 Year : Opioid analgesics · Yes	20 Participants	10 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 5 Year : Opioid analgesics · No	115 Participants	141 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 5 Year : Other medications · Yes	34 Participants	29 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 5 Year : Other medications · No	101 Participants	122 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" Baseline : Nonopioid analgesics · Yes	121 Participants	101 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" Baseline : Nonopioid analgesics · No	43 Participants	72 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" Baseline : Other medications · Yes	83 Participants	37 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" Baseline : Other medications · No	81 Participants	136 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 4 Weeks : Nonopioid analgesics · Yes	99 Participants	89 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 4 Weeks : Nonopioid analgesics · No	55 Participants	68 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 4 Weeks : Opioid analgesics · Yes	53 Participants	42 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 4 Weeks : Opioid analgesics · No	101 Participants	115 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 4 Weeks : Other medications · Yes	75 Participants	32 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 4 Weeks : Other medications · No	79 Participants	125 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 3 Months : Nonopioid analgesics · Yes	97 Participants	68 Participants	—	—	—	—
Healthcare Economics Evaluation "Medications" 3 Months : Nonopioid analgesics · No	62 Participants	92 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Through 5 years

Population: Some questions were left blank by the sites.

Healthcare utilization is measured with the following three cost components: 1. resources: surgery room, length of hospital stay, additional medical visits (outpatient consultations, visits to primary care services, etc) 2. medications 3. non-pharmacologic therapies: rehabilitation program

Outcome measures

Outcome measures
Measure	Total Population ANT n=164 Participants Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST n=173 Participants Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation	OLIF Patients who received OLIF MI lumbar surgery	PLIF Patients who received PLIF MI lumbar surgery	MIDLF Patients who received MIDLF MI lumbar surgery	TLIF Patients who received TLIF MI lumbar surgery
Health Economics Evaluation "Resources" Nr of times patient received care in outpatient centre due to back pain at 5 years	2.2 Number of occurrences Standard Deviation 1.6	3.6 Number of occurrences Standard Deviation 3.6	—	—	—	—
Health Economics Evaluation "Resources" Nr of times patient received care in primary care service due to back pain at 5 years	1.8 Number of occurrences Standard Deviation 0.5	2.2 Number of occurrences Standard Deviation 1.1	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to 5 years

Population: Data was not always completed for each participant by the site

Healthcare utilization is measured with the following three costs components: 1. resources: surgery room, length of hospital stay, additional medical visits (outpatient consultations, visits to primary care services, etc) 2. medications 3. non-pharmacologic therapies: rehabilitation program

Outcome measures

Outcome measures
Measure	Total Population ANT n=164 Participants Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST n=173 Participants Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation	OLIF Patients who received OLIF MI lumbar surgery	PLIF Patients who received PLIF MI lumbar surgery	MIDLF Patients who received MIDLF MI lumbar surgery	TLIF Patients who received TLIF MI lumbar surgery
Health Economics Evaluation "Rehabilitation Program" 5 Year : Rehab center · Yes	1 Participants	1 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" Discharge :Will the patient be transferred to a Rehabilitation center? · Yes	9 Participants	6 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" Discharge :Will the patient be transferred to a Rehabilitation center? · No	154 Participants	167 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" Discharge : Rehabilitation care at home · Yes	22 Participants	21 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" Discharge : Rehabilitation care at home · No	141 Participants	152 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" Discharge : Care at an outpatient rehabilitation center · Yes	15 Participants	42 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" Discharge : Care at an outpatient rehabilitation center · No	148 Participants	131 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 4 Weeks: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit · Yes	20 Participants	8 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 4 Weeks: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit · No	134 Participants	149 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 4 Weeks : Rehab center · Yes	4 Participants	3 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 4 Weeks : Rehab center · No	15 Participants	5 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 4 Weeks : Rehabilitation care at home · Yes	11 Participants	1 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 4 Weeks : Rehabilitation care at home · No	8 Participants	7 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 4 Weeks : Care at an outpatient rehabilitation center · Yes	5 Participants	5 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 4 Weeks : Care at an outpatient rehabilitation center · No	14 Participants	3 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 3 Months: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit · Yes	34 Participants	36 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 3 Months: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit · No	125 Participants	124 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 3 Months : Rehab center · Yes	6 Participants	9 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 3 Months : Rehab center · No	28 Participants	27 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 3 Months : Rehabilitation care at home · Yes	3 Participants	6 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 3 Months : Rehabilitation care at home · No	31 Participants	30 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 3 Months : Care at an outpatient rehabilitation center · Yes	27 Participants	22 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 3 Months : Care at an outpatient rehabilitation center · No	7 Participants	14 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 1 Year: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit · Yes	27 Participants	27 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 1 Year: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit · No	125 Participants	131 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 1 Year : Rehab center · Yes	12 Participants	8 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 1 Year : Rehab center · No	15 Participants	18 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 1 Year : Rehabilitation care at home · Yes	2 Participants	1 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 1 Year : Rehabilitation care at home · No	25 Participants	25 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 1 Year : Care at an outpatient rehabilitation center · Yes	22 Participants	18 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 1 Year : Care at an outpatient rehabilitation center · No	5 Participants	8 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 2 Year: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit · Yes	9 Participants	9 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 2 Year: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit · No	138 Participants	148 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 2 Year : Rehab center · Yes	1 Participants	2 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 2 Year : Rehab center · No	8 Participants	7 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 2 Year : Rehabilitation care at home · Yes	1 Participants	0 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 2 Year : Rehabilitation care at home · No	8 Participants	9 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 2 Year : Care at an outpatient rehabilitation center · Yes	7 Participants	7 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 2 Year : Care at an outpatient rehabilitation center · No	2 Participants	2 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 3 Year: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit · Yes	6 Participants	9 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 3 Year: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit · No	139 Participants	145 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 3 Year : Rehab center · Yes	2 Participants	3 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 3 Year : Rehab center · No	4 Participants	5 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 3 Year : Rehabilitation care at home · Yes	2 Participants	0 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 3 Year : Rehabilitation care at home · No	4 Participants	8 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 3 Year : Care at an outpatient rehabilitation center · Yes	2 Participants	5 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 3 Year : Care at an outpatient rehabilitation center · No	4 Participants	3 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 4 Year: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit · Yes	3 Participants	10 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 4 Year: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit · No	130 Participants	142 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 4 Year : Rehab center · Yes	0 Participants	3 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 4 Year : Rehab center · No	3 Participants	7 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 4 Year : Rehabilitation care at home · Yes	0 Participants	1 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 4 Year : Rehabilitation care at home · No	3 Participants	9 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 4 Year : Care at an outpatient rehabilitation center · Yes	3 Participants	6 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 4 Year : Care at an outpatient rehabilitation center · No	0 Participants	4 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 5 Year: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit · Yes	4 Participants	3 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 5 Year: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit · No	131 Participants	148 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 5 Year : Rehab center · No	3 Participants	2 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 5 Year : Rehabilitation care at home · Yes	0 Participants	1 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 5 Year : Rehabilitation care at home · No	4 Participants	2 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 5 Year : Care at an outpatient rehabilitation center · Yes	3 Participants	1 Participants	—	—	—	—
Health Economics Evaluation "Rehabilitation Program" 5 Year : Care at an outpatient rehabilitation center · No	1 Participants	2 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Peri-operative

Population: Some questions were left blank by the sites

Outcome measures

Outcome measures
Measure	Total Population ANT n=162 Participants Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST n=171 Participants Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation	OLIF Patients who received OLIF MI lumbar surgery	PLIF Patients who received PLIF MI lumbar surgery	MIDLF Patients who received MIDLF MI lumbar surgery	TLIF Patients who received TLIF MI lumbar surgery
Health Economics Evaluation "Operative Time"	3.371 hours Standard Deviation 1.279	2.860 hours Standard Deviation 1.028	—	—	—	—

SECONDARY outcome

Timeframe: Peri-operative

Population: Some questions were left blank by the sites

Outcome measures

Outcome measures
Measure	Total Population ANT n=155 Participants Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST n=166 Participants Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation	OLIF Patients who received OLIF MI lumbar surgery	PLIF Patients who received PLIF MI lumbar surgery	MIDLF Patients who received MIDLF MI lumbar surgery	TLIF Patients who received TLIF MI lumbar surgery
Health Economics Evaluation "Estimated Blood Loss"	148.2 ml Standard Deviation 201.5	296.3 ml Standard Deviation 238.7	—	—	—	—

SECONDARY outcome

Timeframe: Post-operative, up to 53 days

Population: Some questions were left blank by the sites

Outcome measures

Outcome measures
Measure	Total Population ANT n=163 Participants Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST n=173 Participants Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation	OLIF Patients who received OLIF MI lumbar surgery	PLIF Patients who received PLIF MI lumbar surgery	MIDLF Patients who received MIDLF MI lumbar surgery	TLIF Patients who received TLIF MI lumbar surgery
Health Economics Evaluation "Length of Hospital Stay"	6.6 Days Standard Deviation 5.4	7.5 Days Standard Deviation 5.9	—	—	—	—

SECONDARY outcome

Timeframe: Peri-operative

Population: Some questions were left blank by the sites

Outcome measures

Outcome measures
Measure	Total Population ANT n=150 Participants Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST n=166 Participants Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation	OLIF Patients who received OLIF MI lumbar surgery	PLIF Patients who received PLIF MI lumbar surgery	MIDLF Patients who received MIDLF MI lumbar surgery	TLIF Patients who received TLIF MI lumbar surgery
Health Economics Evaluation "Total Fluoroscopy Time"	144.8 seconds Standard Deviation 151.0	143.5 seconds Standard Deviation 202.9	—	—	—	—

SECONDARY outcome

Timeframe: Baseline

To observe and document the patient profile when choosing a particular minimally invasive fusion procedure: Baseline information is summarized for all DDD patients per surgical procedure (ALIF, OLIF, DLIF, PLIF, TLIF, MIDLF).

Outcome measures

Outcome measures
Measure	Total Population ANT n=43 Participants Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST n=50 Participants Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation	OLIF n=71 Participants Patients who received OLIF MI lumbar surgery	PLIF n=22 Participants Patients who received PLIF MI lumbar surgery	MIDLF n=65 Participants Patients who received MIDLF MI lumbar surgery	TLIF n=86 Participants Patients who received TLIF MI lumbar surgery
To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Categorical Variables Gender: Female? · Yes	20 Participants	27 Participants	53 Participants	11 Participants	43 Participants	49 Participants
To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Categorical Variables Gender: Female? · No	23 Participants	23 Participants	18 Participants	11 Participants	22 Participants	37 Participants
To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Categorical Variables Does the patient currently use tobacco? · Yes	18 Participants	10 Participants	10 Participants	6 Participants	6 Participants	21 Participants
To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Categorical Variables Does the patient currently use tobacco? · No	25 Participants	40 Participants	61 Participants	16 Participants	59 Participants	65 Participants
To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Categorical Variables Preoperative work status: Employed/independent worker? · Yes	27 Participants	22 Participants	24 Participants	9 Participants	23 Participants	22 Participants
To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Categorical Variables Preoperative work status: Employed/independent worker? · No	16 Participants	28 Participants	47 Participants	13 Participants	42 Participants	64 Participants

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Total Population ANT n=43 Participants Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST n=50 Participants Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation	OLIF n=71 Participants Patients who received OLIF MI lumbar surgery	PLIF n=22 Participants Patients who received PLIF MI lumbar surgery	MIDLF n=65 Participants Patients who received MIDLF MI lumbar surgery	TLIF n=86 Participants Patients who received TLIF MI lumbar surgery
To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Age	49.4 years Standard Deviation 9.5	59.5 years Standard Deviation 9.0	60.5 years Standard Deviation 9.2	54.5 years Standard Deviation 10.8	61.3 years Standard Deviation 10.6	59.8 years Standard Deviation 11.3

SECONDARY outcome

Timeframe: Baseline

Population: For one participant in the OLIF Arm/Group height wasn't provided on the eCRF

Outcome measures

Outcome measures
Measure	Total Population ANT n=43 Participants Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST n=50 Participants Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation	OLIF n=70 Participants Patients who received OLIF MI lumbar surgery	PLIF n=22 Participants Patients who received PLIF MI lumbar surgery	MIDLF n=65 Participants Patients who received MIDLF MI lumbar surgery	TLIF n=86 Participants Patients who received TLIF MI lumbar surgery
To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Height	169.4 centimeter (cm) Standard Deviation 9.0	167.5 centimeter (cm) Standard Deviation 9.6	162.3 centimeter (cm) Standard Deviation 8.7	167.3 centimeter (cm) Standard Deviation 8.1	164.0 centimeter (cm) Standard Deviation 10.4	164.2 centimeter (cm) Standard Deviation 8.2

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Total Population ANT n=43 Participants Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST n=50 Participants Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation	OLIF n=71 Participants Patients who received OLIF MI lumbar surgery	PLIF n=22 Participants Patients who received PLIF MI lumbar surgery	MIDLF n=65 Participants Patients who received MIDLF MI lumbar surgery	TLIF n=86 Participants Patients who received TLIF MI lumbar surgery
To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Weight	77.2 kilogram (kg) Standard Deviation 15.2	82.3 kilogram (kg) Standard Deviation 15.5	71.4 kilogram (kg) Standard Deviation 13.8	80.9 kilogram (kg) Standard Deviation 15.3	75.2 kilogram (kg) Standard Deviation 18.6	69.4 kilogram (kg) Standard Deviation 13.1

SECONDARY outcome

Timeframe: Baseline

Population: For one participant height wasn't provided on the eCRF, hence this data and the BMI calculation are not available for this participant.

Outcome measures

Outcome measures
Measure	Total Population ANT n=43 Participants Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST n=50 Participants Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation	OLIF n=70 Participants Patients who received OLIF MI lumbar surgery	PLIF n=22 Participants Patients who received PLIF MI lumbar surgery	MIDLF n=65 Participants Patients who received MIDLF MI lumbar surgery	TLIF n=86 Participants Patients who received TLIF MI lumbar surgery
To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - BMI	26.8 kg/m2 Standard Deviation 4.2	29.4 kg/m2 Standard Deviation 5.6	27.0 kg/m2 Standard Deviation 4.3	28.9 kg/m2 Standard Deviation 5.0	27.7 kg/m2 Standard Deviation 5.1	25.6 kg/m2 Standard Deviation 3.5

Adverse Events

Total Population ANT

Serious events: 58 serious events

Other events: 56 other events

Deaths: 4 deaths

Total Population POST

Serious events: 55 serious events

Other events: 43 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Total Population ANT n=164 participants at risk Participants who received anterolateral MI lumbar surgery (ALIF, DLIF or OLIF) with posterior fixation	Total Population POST n=173 participants at risk Participants who received posterior MI lumbar surgery (MIDLF, PLIF or TLIF) with posterior fixation
General disorders Pyrexia	1.8% 3/164 • Number of events 3 • The data was collected from Baseline until the 5-year follow-up visit. AE reporting through systematic assessment: at each follow-up visit site personnel was asked to review if new AEs had occurred since the previous visit. For the non-serious AE we have only reported those cases that occurred in 5% or more of the patients (at least in one arm), as is detailed below. The total number of patients who experienced any (i.e. including those that occurred in \<5% and \>=5% of the patients ) non-serious AE in the Anterolateral group is 114, and the Posterior group is 104.	10.4% 18/173 • Number of events 19 • The data was collected from Baseline until the 5-year follow-up visit. AE reporting through systematic assessment: at each follow-up visit site personnel was asked to review if new AEs had occurred since the previous visit. For the non-serious AE we have only reported those cases that occurred in 5% or more of the patients (at least in one arm), as is detailed below. The total number of patients who experienced any (i.e. including those that occurred in \<5% and \>=5% of the patients ) non-serious AE in the Anterolateral group is 114, and the Posterior group is 104.
Injury, poisoning and procedural complications Procedural pain	11.0% 18/164 • Number of events 18 • The data was collected from Baseline until the 5-year follow-up visit. AE reporting through systematic assessment: at each follow-up visit site personnel was asked to review if new AEs had occurred since the previous visit. For the non-serious AE we have only reported those cases that occurred in 5% or more of the patients (at least in one arm), as is detailed below. The total number of patients who experienced any (i.e. including those that occurred in \<5% and \>=5% of the patients ) non-serious AE in the Anterolateral group is 114, and the Posterior group is 104.	2.3% 4/173 • Number of events 4 • The data was collected from Baseline until the 5-year follow-up visit. AE reporting through systematic assessment: at each follow-up visit site personnel was asked to review if new AEs had occurred since the previous visit. For the non-serious AE we have only reported those cases that occurred in 5% or more of the patients (at least in one arm), as is detailed below. The total number of patients who experienced any (i.e. including those that occurred in \<5% and \>=5% of the patients ) non-serious AE in the Anterolateral group is 114, and the Posterior group is 104.
Musculoskeletal and connective tissue disorders Back pain	18.9% 31/164 • Number of events 35 • The data was collected from Baseline until the 5-year follow-up visit. AE reporting through systematic assessment: at each follow-up visit site personnel was asked to review if new AEs had occurred since the previous visit. For the non-serious AE we have only reported those cases that occurred in 5% or more of the patients (at least in one arm), as is detailed below. The total number of patients who experienced any (i.e. including those that occurred in \<5% and \>=5% of the patients ) non-serious AE in the Anterolateral group is 114, and the Posterior group is 104.	9.2% 16/173 • Number of events 16 • The data was collected from Baseline until the 5-year follow-up visit. AE reporting through systematic assessment: at each follow-up visit site personnel was asked to review if new AEs had occurred since the previous visit. For the non-serious AE we have only reported those cases that occurred in 5% or more of the patients (at least in one arm), as is detailed below. The total number of patients who experienced any (i.e. including those that occurred in \<5% and \>=5% of the patients ) non-serious AE in the Anterolateral group is 114, and the Posterior group is 104.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	1.2% 2/164 • Number of events 2 • The data was collected from Baseline until the 5-year follow-up visit. AE reporting through systematic assessment: at each follow-up visit site personnel was asked to review if new AEs had occurred since the previous visit. For the non-serious AE we have only reported those cases that occurred in 5% or more of the patients (at least in one arm), as is detailed below. The total number of patients who experienced any (i.e. including those that occurred in \<5% and \>=5% of the patients ) non-serious AE in the Anterolateral group is 114, and the Posterior group is 104.	5.8% 10/173 • Number of events 10 • The data was collected from Baseline until the 5-year follow-up visit. AE reporting through systematic assessment: at each follow-up visit site personnel was asked to review if new AEs had occurred since the previous visit. For the non-serious AE we have only reported those cases that occurred in 5% or more of the patients (at least in one arm), as is detailed below. The total number of patients who experienced any (i.e. including those that occurred in \<5% and \>=5% of the patients ) non-serious AE in the Anterolateral group is 114, and the Posterior group is 104.
Musculoskeletal and connective tissue disorders Pain in extremity	7.3% 12/164 • Number of events 15 • The data was collected from Baseline until the 5-year follow-up visit. AE reporting through systematic assessment: at each follow-up visit site personnel was asked to review if new AEs had occurred since the previous visit. For the non-serious AE we have only reported those cases that occurred in 5% or more of the patients (at least in one arm), as is detailed below. The total number of patients who experienced any (i.e. including those that occurred in \<5% and \>=5% of the patients ) non-serious AE in the Anterolateral group is 114, and the Posterior group is 104.	1.2% 2/173 • Number of events 3 • The data was collected from Baseline until the 5-year follow-up visit. AE reporting through systematic assessment: at each follow-up visit site personnel was asked to review if new AEs had occurred since the previous visit. For the non-serious AE we have only reported those cases that occurred in 5% or more of the patients (at least in one arm), as is detailed below. The total number of patients who experienced any (i.e. including those that occurred in \<5% and \>=5% of the patients ) non-serious AE in the Anterolateral group is 114, and the Posterior group is 104.

Additional Information

Clinical Study Manager

Medtronic Cranial and Spinal Technologies

Phone: +31433566584

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place