An observational study in Intervertebral Disc Degeneration, sponsored by Medtronic Spinal and Biologics. Completed at 27 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Medtronic Spinal and Biologics · Observational
The purpose of this study is
In this Prospective, Global (multi center), Post Market Release (PMR) Study, Patients will be submitted to a single or double level instrumented fusion procedure using a PLIF, TLIF, ALIF, OLIF, DLIF or MIDLF technique via a minimally invasive procedure and will receive the same medical treatment as if they would not participate in this study.
361 patients suffering from lumbar degenerative disc disease (DDD) were enrolled over a period of 42 months in 27 sites located in Europe, Latin America, and Asia Pacific.
Patient is planned to be submitted to a minimally invasive fusion procedure using a posterior (PLIF, TLIF, MIDLF) or anterolateral (OLIF, ALIF, DLIF ) technique*
*For a double level instrumented fusion, the same procedure must be used for both levels.
Exclusion Criteria:
A single or double level instrumented fusion using minimally invasive PLIF, TLIF, MIDLF, DLIF, OLIF, ALIF procedures for the treatment of the degenerative lumbar spine.
Device: Minimally invasive lumbar fusion
Patients will receive a single or double level instrumented fusion using a minimally invasive/MAST™ PLIF, TLIF, DLIF, OLIF, ALIF or MIDLF surgical procedure with a posterior fixation. For the use of a posterior fixation system, the CD Horizon™ Spinal System, is mandatory in this study and will be either mini-open and/or percutaneous.
Change (Preop-postop) of Disability, Oswestry Disability Index (ODI) at 3 Months as Compared to Baseline in DDD Patients With Spondylolisthesis
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
Time frame: 3 months
Change (Preop-postop) in Disability ODI as Compared to Baseline in DDD Patients Without Spondylolisthesis
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
Time frame: 3 months
Change (Preop-postop) in ODI Scores for the Total Population
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
Time frame: Through 5 years
Change (Preop-postop) in Visual Analog Scale (VAS) Back Pain Intensity
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
Time frame: Through 5 years
Change (Preop-postop) in VAS Leg Pain Intensity
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
Time frame: Through 5 years
Change (Postop-preop) in EQ-5D Index Score
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
Time frame: Through 5 years
The Neurological Success Rate
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.
Time frame: 5 years
Fusion Success
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.
Time frame: Through 5 years
Proportion of Patients Needing a Secondary Spinal Surgery at the Index and/or Adjacent Level(s) (Reoperation Rates) Throughout the Study
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.
Time frame: Through 5 years
Adverse Events
Document Adverse Events occurrence throughout the study
Time frame: Through 5 years
Amount of Days 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
Time frame: From surgery up to hospital discharge, up to 11 days
Amount of Days Needed to Recover From Surgery
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.
Time frame: Surgery Recovery Day up to hospital discharge, with a maximum of 46 days
Healthcare Economics Evaluation "Medications"
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
Time frame: Baseline to 5-year follow-up
Health Economics Evaluation "Resources"
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
Time frame: Through 5 years
Health Economics Evaluation "Rehabilitation Program"
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
Time frame: Baseline to 5 years
Health Economics Evaluation "Operative Time"
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
Time frame: Peri-operative
Health Economics Evaluation "Estimated Blood Loss"
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
Time frame: Peri-operative
Health Economics Evaluation "Length of Hospital Stay"
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 The minimum-maximum time spent at the hospital was \[1-53 days\]
Time frame: Post-operative, up to 53 days
Health Economics Evaluation "Total Fluoroscopy Time"
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
Time frame: Peri-operative
To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Categorical Variables
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).
Time frame: Baseline
To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Age
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).
Time frame: Baseline
To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Height
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).
Time frame: Baseline
To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Weight
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).
Time frame: Baseline
To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - BMI
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).
Time frame: Baseline
| Milestone | Total Population ANT | Total Population POST |
|---|---|---|
| Started | 164 | 173 |
| Completed | 162 | 173 |
| Not completed | 2 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 |
| Milestone | Total Population ANT | Total Population POST |
|---|---|---|
| Started | 162 | 173 |
| Completed | 161 | 172 |
| Not completed | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Milestone | Total Population ANT | Total Population POST |
|---|---|---|
| Started | 161 | 172 |
| Completed | 160 | 170 |
| Not completed | 1 | 2 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Milestone | Total Population ANT | Total Population POST |
|---|---|---|
| Started | 160 | 170 |
| Completed | 157 | 165 |
| Not completed | 3 | 5 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Lost to follow-up | 2 | 1 |
| Withdrew: Withdrawal by subject | 0 | 4 |
| Milestone | Total Population ANT | Total Population POST |
|---|---|---|
| Started | 157 | 165 |
| Completed | 153 | 160 |
| Not completed | 4 | 5 |
| Withdrew: Death | 2 | 1 |
| Withdrew: Lost to follow-up | 1 | 3 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Milestone | Total Population ANT | Total Population POST |
|---|---|---|
| Started | 153 | 160 |
| Completed | 146 | 158 |
| Not completed | 7 | 2 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Lost to follow-up | 3 | 1 |
| Withdrew: Withdrawal by subject | 3 | 1 |
| Milestone | Total Population ANT | Total Population POST |
|---|---|---|
| Started | 146 | 158 |
| Completed | 136 | 152 |
| Not completed | 10 | 6 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Lost to follow-up | 9 | 5 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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
| change of score on a scale (ODI) | Spondylolisthesis ANT | Spondylolisthesis POST |
|---|---|---|
| Change (Preop-postop) of Disability, Oswestry Disability Index (ODI) at 3 Months as Compared to Baseline in DDD Patients With Spondylolisthesis | 23.19 ± 21.32 | 26.08 ± 19.47 |
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
| score on a scale (improvement) | Non-spondylolisthesis ANT | Non-spondylolisthesis POST |
|---|---|---|
| Change (Preop-postop) in Disability ODI as Compared to Baseline in DDD Patients Without Spondylolisthesis | 13.41 ± 22.09 | 24.20 ± 20.02 |
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
| score on a scale (improvement) | Total Population ANT | Total Population POST |
|---|---|---|
| Baseline (score) | 46.46 ± 18.05 | 47.02 ± 15.89 |
| 4 Weeks | 13.27 ± 22.56 | 17.57 ± 19.87 |
| 3 Months | 20.23 ± 21.95 | 25.43 ± 19.62 |
| 1 Year | 24.47 ± 22.30 | 29.42 ± 19.63 |
| 2 Year | 27.80 ± 23.81 | 30.31 ± 20.52 |
| 3 Year | 27.15 ± 23.93 | 29.83 ± 21.08 |
| 4 Year | 26.08 ± 25.48 | 27.30 ± 21.01 |
| 5 Year | 26.55 ± 25.50 | 29.26 ± 19.67 |
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
| score on a scale | Total Population ANT | Total Population POST |
|---|---|---|
| Baseline (score) | 6.48 ± 2.33 | 5.76 ± 2.76 |
| 4 Weeks | 3.48 ± 3.15 | 3.06 ± 3.06 |
| 3 Months | 3.47 ± 3.11 | 3.25 ± 3.23 |
| 1 Year | 3.48 ± 3.36 | 3.46 ± 3.01 |
| 2 Year | 3.50 ± 3.40 | 3.59 ± 3.01 |
| 3 Year | 3.54 ± 3.26 | 3.54 ± 2.92 |
| 4 Year | 3.42 ± 3.39 | 3.33 ± 3.04 |
| 5 Year | 3.90 ± 3.25 | 3.48 ± 2.93 |
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
| score on a scale (improvement) | Total Population ANT | Total Population POST |
|---|---|---|
| Baseline (score) | 6.18 ± 2.70 | 6.33 ± 2.57 |
| 4 Weeks | 3.79 ± 3.58 | 4.64 ± 3.25 |
| 3 Months | 3.99 ± 3.56 | 4.76 ± 3.44 |
| 1 Year | 3.83 ± 3.70 | 4.50 ± 3.57 |
| 2 Year | 4.17 ± 3.81 | 4.84 ± 3.49 |
| 3 Year | 4.18 ± 3.73 | 4.62 ± 3.51 |
| 4 Year | 3.58 ± 4.10 | 4.52 ± 3.50 |
| 5 Year | 4.23 ± 3.69 | 4.65 ± 3.40 |
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
| score on a scale (improvement) | Total Population ANT | Total Population POST |
|---|---|---|
| Baseline (score) | 0.492 ± 0.225 | 0.543 ± 0.226 |
| 4 Weeks | 0.209 ± 0.271 | 0.237 ± 0.246 |
| 3 Months | 0.267 ± 0.268 | 0.285 ± 0.248 |
| 1 Year | 0.261 ± 0.283 | 0.287 ± 0.239 |
| 2 Year | 0.307 ± 0.286 | 0.314 ± 0.257 |
| 3 Year | 0.301 ± 0.291 | 0.315 ± 0.247 |
| 4 Year | 0.284 ± 0.316 | 0.286 ± 0.249 |
| 5 Year | 0.300 ± 0.306 | 0.291 ± 0.249 |
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.
| Participants | Total Population ANT | Total Population POST |
|---|---|---|
| Motor function — Normal | 52 | 58 |
| Motor function — Abnormal | 2 | 1 |
| Sensory function — Normal | 53 | 57 |
| Sensory function — Abnormal | 1 | 2 |
| Reflexes — Normal | 54 | 58 |
| Reflexes — Abnormal | 0 | 1 |
| Straight leg raise — Normal | 53 | 59 |
| Straight leg raise — Abnormal | 1 | 0 |
| Overall Neurological Status — Normal | 51 | 56 |
| Overall Neurological Status — Abnormal | 3 | 3 |
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.
| Participants | Total Population ANT | Total Population POST |
|---|---|---|
| 12 Months — Fused | 110 | 100 |
| 12 Months — Not Fused | 17 | 16 |
| 24 Months — Fused | 33 | 25 |
| 24 Months — Not Fused | 2 | 3 |
| 36 Months — Fused | 19 | 18 |
| 36 Months — Not Fused | 1 | 3 |
| 48 Months — Fused | 13 | 20 |
| 48 Months — Not Fused | 1 | 0 |
| 60 Months — Fused | 12 | 18 |
| 60 Months — Not Fused | 1 | 0 |
| The Last Evaluation of Fusion Status — Fused | 127 | 115 |
| The Last Evaluation of Fusion Status — Not Fused | 16 | 15 |
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.
| number of revision surgeries | Total Population ANT | Total Population POST |
|---|---|---|
| Index levels only | 6 | 13 |
| Adjacent levels only | 4 | 8 |
| Both index and adjacent levels | 2 | 2 |
| Others | 6 | 1 |
Document Adverse Events occurrence throughout the study
| Adverse Events (n) | Total Population ANT | Total Population POST |
|---|---|---|
| Device-related | 10 | 5 |
| MAST/MI (minimally invasive)-related | 18 | 17 |
| General Surgery-related | 66 | 75 |
| Disease-related | 63 | 61 |
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
| Days | Total Population ANT | Total Population POST |
|---|---|---|
| Amount of Days Needed for First Ambulation | 1.6 ± 1.3 | 1.9 ± 1.6 |
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.
| Days | Total Population ANT | Total Population POST |
|---|---|---|
| Amount of Days Needed to Recover From Surgery | 4.4 ± 3.7 | 5.0 ± 5.2 |
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
| Participants | Total Population ANT | Total Population POST |
|---|---|---|
| Baseline : Nonopioid analgesics — Yes | 121 | 101 |
| Baseline : Nonopioid analgesics — No | 43 | 72 |
| Baseline : Opioid analgesics — Yes | 70 | 49 |
| Baseline : Opioid analgesics — No | 94 | 124 |
| Baseline : Other medications — Yes | 83 | 37 |
| Baseline : Other medications — No | 81 | 136 |
| 4 Weeks : Nonopioid analgesics — Yes | 99 | 89 |
| 4 Weeks : Nonopioid analgesics — No | 55 | 68 |
| 4 Weeks : Opioid analgesics — Yes | 53 | 42 |
| 4 Weeks : Opioid analgesics — No | 101 | 115 |
| 4 Weeks : Other medications — Yes | 75 | 32 |
| 4 Weeks : Other medications — No | 79 | 125 |
| 3 Months : Nonopioid analgesics — Yes | 97 | 68 |
| 3 Months : Nonopioid analgesics — No | 62 | 92 |
| 3 Months : Opioid analgesics — Yes | 48 | 29 |
| 3 Months : Opioid analgesics — No | 111 | 131 |
| 3 Months : Other medications — Yes | 67 | 23 |
| 3 Months : Other medications — No | 92 | 137 |
| 1 Year : Nonopioid analgesics — Yes | 73 | 53 |
| 1 Year : Nonopioid analgesics — No | 79 | 105 |
| 1 Year : Opioid analgesics — Yes | 29 | 16 |
| 1 Year : Opioid analgesics — No | 123 | 142 |
| 1 Year : Other medications — Yes | 55 | 24 |
| 1 Year : Other medications — No | 97 | 134 |
| 2 Year : Nonopioid analgesics — Yes | 56 | 48 |
| 2 Year : Nonopioid analgesics — No | 91 | 109 |
| 2 Year : Opioid analgesics — Yes | 24 | 16 |
| 2 Year : Opioid analgesics — No | 123 | 141 |
| 2 Year : Other medications — Yes | 50 | 27 |
| 2 Year : Other medications — No | 97 | 130 |
| 3 Year : Nonopioid analgesics — Yes | 57 | 48 |
| 3 Year : Nonopioid analgesics — No | 87 | 106 |
| 3 Year : Opioid analgesics — Yes | 18 | 8 |
| 3 Year : Opioid analgesics — No | 126 | 146 |
| 3 Year : Other medications — Yes | 46 | 23 |
| 3 Year : Other medications — No | 98 | 131 |
| 4 Year : Nonopioid analgesics — Yes | 44 | 45 |
| 4 Year : Nonopioid analgesics — No | 89 | 107 |
| 4 Year : Opioid analgesics — Yes | 21 | 10 |
| 4 Year : Opioid analgesics — No | 112 | 142 |
| 4 Year : Other medications — Yes | 38 | 26 |
| 4 Year : Other medications — No | 95 | 126 |
| 5 Year : Nonopioid analgesics — Yes | 38 | 41 |
| 5 Year : Nonopioid analgesics — No | 97 | 110 |
| 5 Year : Opioid analgesics — Yes | 20 | 10 |
| 5 Year : Opioid analgesics — No | 115 | 141 |
| 5 Year : Other medications — Yes | 34 | 29 |
| 5 Year : Other medications — No | 101 | 122 |
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
| Number of occurrences | Total Study Population ANT | Total Study Population POST |
|---|---|---|
| Nr of times patient received care in outpatient centre due to back pain at 5 years | 2.2 ± 1.6 | 3.6 ± 3.6 |
| Nr of times patient received care in primary care service due to back pain at 5 years | 1.8 ± 0.5 | 2.2 ± 1.1 |
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
| Participants | Total Population ANT | Total Population POST |
|---|---|---|
| Discharge :Will the patient be transferred to a Rehabilitation center? — Yes | 9 | 6 |
| Discharge :Will the patient be transferred to a Rehabilitation center? — No | 154 | 167 |
| Discharge : Rehabilitation care at home — Yes | 22 | 21 |
| Discharge : Rehabilitation care at home — No | 141 | 152 |
| Discharge : Care at an outpatient rehabilitation center — Yes | 15 | 42 |
| Discharge : Care at an outpatient rehabilitation center — No | 148 | 131 |
| 4 Weeks: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit — Yes | 20 | 8 |
| 4 Weeks: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit — No | 134 | 149 |
| 4 Weeks : Rehab center — Yes | 4 | 3 |
| 4 Weeks : Rehab center — No | 15 | 5 |
| 4 Weeks : Rehabilitation care at home — Yes | 11 | 1 |
| 4 Weeks : Rehabilitation care at home — No | 8 | 7 |
| 4 Weeks : Care at an outpatient rehabilitation center — Yes | 5 | 5 |
| 4 Weeks : Care at an outpatient rehabilitation center — No | 14 | 3 |
| 3 Months: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit — Yes | 34 | 36 |
| 3 Months: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit — No | 125 | 124 |
| 3 Months : Rehab center — Yes | 6 | 9 |
| 3 Months : Rehab center — No | 28 | 27 |
| 3 Months : Rehabilitation care at home — Yes | 3 | 6 |
| 3 Months : Rehabilitation care at home — No | 31 | 30 |
| 3 Months : Care at an outpatient rehabilitation center — Yes | 27 | 22 |
| 3 Months : Care at an outpatient rehabilitation center — No | 7 | 14 |
| 1 Year: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit — Yes | 27 | 27 |
| 1 Year: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit — No | 125 | 131 |
| 1 Year : Rehab center — Yes | 12 | 8 |
| 1 Year : Rehab center — No | 15 | 18 |
| 1 Year : Rehabilitation care at home — Yes | 2 | 1 |
| 1 Year : Rehabilitation care at home — No | 25 | 25 |
| 1 Year : Care at an outpatient rehabilitation center — Yes | 22 | 18 |
| 1 Year : Care at an outpatient rehabilitation center — No | 5 | 8 |
| 2 Year: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit — Yes | 9 | 9 |
| 2 Year: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit — No | 138 | 148 |
| 2 Year : Rehab center — Yes | 1 | 2 |
| 2 Year : Rehab center — No | 8 | 7 |
| 2 Year : Rehabilitation care at home — Yes | 1 | 0 |
| 2 Year : Rehabilitation care at home — No | 8 | 9 |
| 2 Year : Care at an outpatient rehabilitation center — Yes | 7 | 7 |
| 2 Year : Care at an outpatient rehabilitation center — No | 2 | 2 |
| 3 Year: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit — Yes | 6 | 9 |
| 3 Year: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit — No | 139 | 145 |
| 3 Year : Rehab center — Yes | 2 | 3 |
| 3 Year : Rehab center — No | 4 | 5 |
| 3 Year : Rehabilitation care at home — Yes | 2 | 0 |
| 3 Year : Rehabilitation care at home — No | 4 | 8 |
| 3 Year : Care at an outpatient rehabilitation center — Yes | 2 | 5 |
| 3 Year : Care at an outpatient rehabilitation center — No | 4 | 3 |
| 4 Year: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit — Yes | 3 | 10 |
| 4 Year: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit — No | 130 | 142 |
| 4 Year : Rehab center — Yes | 0 | 3 |
| 4 Year : Rehab center — No | 3 | 7 |
| 4 Year : Rehabilitation care at home — Yes | 0 | 1 |
| 4 Year : Rehabilitation care at home — No | 3 | 9 |
| 4 Year : Care at an outpatient rehabilitation center — Yes | 3 | 6 |
| 4 Year : Care at an outpatient rehabilitation center — No | 0 | 4 |
| 5 Year: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit — Yes | 4 | 3 |
| 5 Year: Any Rehabilitation Program Between This Scheduled Visit and the Previous Scheduled Visit — No | 131 | 148 |
| 5 Year : Rehab center — Yes | 1 | 1 |
| 5 Year : Rehab center — No | 3 | 2 |
| 5 Year : Rehabilitation care at home — Yes | 0 | 1 |
| 5 Year : Rehabilitation care at home — No | 4 | 2 |
| 5 Year : Care at an outpatient rehabilitation center — Yes | 3 | 1 |
| 5 Year : Care at an outpatient rehabilitation center — No | 1 | 2 |
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
| hours | Total Population ANT | Total Population POST |
|---|---|---|
| Health Economics Evaluation "Operative Time" | 3.371 ± 1.279 | 2.860 ± 1.028 |
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
| ml | Total Population ANT | Total Population POST |
|---|---|---|
| Health Economics Evaluation "Estimated Blood Loss" | 148.2 ± 201.5 | 296.3 ± 238.7 |
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 The minimum-maximum time spent at the hospital was \[1-53 days\]
| Days | Total Population ANT | Total Population POST |
|---|---|---|
| Health Economics Evaluation "Length of Hospital Stay" | 6.6 ± 5.4 | 7.5 ± 5.9 |
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
| seconds | Total Population ANT | Total Population POST |
|---|---|---|
| Health Economics Evaluation "Total Fluoroscopy Time" | 144.8 ± 151.0 | 143.5 ± 202.9 |
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).
| Participants | ALIF | DLIF | OLIF | PLIF | MIDLF | TLIF |
|---|---|---|---|---|---|---|
| Gender: Female? — Yes | 20 | 27 | 53 | 11 | 43 | 49 |
| Gender: Female? — No | 23 | 23 | 18 | 11 | 22 | 37 |
| Does the patient currently use tobacco? — Yes | 18 | 10 | 10 | 6 | 6 | 21 |
| Does the patient currently use tobacco? — No | 25 | 40 | 61 | 16 | 59 | 65 |
| Preoperative work status: Employed/independent worker? — Yes | 27 | 22 | 24 | 9 | 23 | 22 |
| Preoperative work status: Employed/independent worker? — No | 16 | 28 | 47 | 13 | 42 | 64 |
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).
| years | ALIF | DLIF | OLIF | PLIF | MIDLF | TLIF |
|---|---|---|---|---|---|---|
| To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Age | 49.4 ± 9.5 | 59.5 ± 9.0 | 60.5 ± 9.2 | 54.5 ± 10.8 | 61.3 ± 10.6 | 59.8 ± 11.3 |
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).
| centimeter (cm) | ALIF | DLIF | OLIF | PLIF | MIDLF | TLIF |
|---|---|---|---|---|---|---|
| To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Height | 169.4 ± 9.0 | 167.5 ± 9.6 | 162.3 ± 8.7 | 167.3 ± 8.1 | 164.0 ± 10.4 | 164.2 ± 8.2 |
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).
| kilogram (kg) | ALIF | DLIF | OLIF | PLIF | MIDLF | TLIF |
|---|---|---|---|---|---|---|
| To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Weight | 77.2 ± 15.2 | 82.3 ± 15.5 | 71.4 ± 13.8 | 80.9 ± 15.3 | 75.2 ± 18.6 | 69.4 ± 13.1 |
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).
| kg/m2 | ALIF | DLIF | OLIF | PLIF | MIDLF | TLIF |
|---|---|---|---|---|---|---|
| To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - BMI | 26.8 ± 4.2 | 29.4 ± 5.6 | 27.0 ± 4.3 | 28.9 ± 5.0 | 27.7 ± 5.1 | 25.6 ± 3.5 |
Collected over The data was collected from Baseline until the 5-year follow-up visit.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Total Population ANT | 4/164 (2.4%) | 58/164 (35.4%) | 56/164 (34.1%) |
| Total Population POST | 2/173 (1.2%) | 55/173 (31.8%) | 43/173 (24.9%) |
| Event | Total Population ANT | Total Population POST |
|---|---|---|
| OsteoarthritisMusculoskeletal and connective tissue disorders | 11/164 | 5/173 |
| Adjacent segment degenerationInjury, poisoning and procedural complications | 2/164 | 5/173 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 4/164 | 3/173 |
| CataractEye disorders | 0/164 | 4/173 |
| Wrong technique in device usage processInjury, poisoning and procedural complications | 2/164 | 4/173 |
| Humerus fractureInjury, poisoning and procedural complications | 3/164 | 0/173 |
| Vertebral foraminal stenosisMusculoskeletal and connective tissue disorders | 2/164 | 3/173 |
| AnaemiaBlood and lymphatic system disorders | 2/164 | 0/173 |
| Muscular weaknessMusculoskeletal and connective tissue disorders | 2/164 | 0/173 |
| OsteonecrosisMusculoskeletal and connective tissue disorders | 2/164 | 0/173 |
| Event | Total Population ANT | Total Population POST |
|---|---|---|
| Back painMusculoskeletal and connective tissue disorders | 31/164 | 16/173 |
| Procedural painInjury, poisoning and procedural complications | 18/164 | 4/173 |
| PyrexiaGeneral disorders | 3/164 | 18/173 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 12/164 | 2/173 |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 2/164 | 10/173 |
| Age, Continuous(years) | Total Population ANT | Total Population POST | Total |
|---|---|---|---|
| Mean | 57.3 ± 10.3 | 59.7 ± 11.1 | 58.5 ± 10.8 |
| Sex: Female, Male(Participants) | Total Population ANT | Total Population POST | Total |
|---|---|---|---|
| Female | 100 | 103 | 203 |
| Male | 64 | 70 | 134 |
| Race and Ethnicity Not Collected(Participants) | Total Population ANT | Total Population POST | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Total Population ANT | Total Population POST | Total |
|---|---|---|---|
| Argentina | 3 | 3 | 6 |
| Czechia | 0 | 13 | 13 |
| United Kingdom | 11 | 17 | 28 |
| Portugal | 17 | 22 | 39 |
| Spain | 39 | 2 | 41 |
| Russia | 22 | 12 | 34 |
| South Korea | 26 | 23 | 49 |
| Austria | 9 | 5 | 14 |
| Belgium | 0 | 8 | 8 |
| China | 0 | 48 | 48 |
| Denmark | 1 | 1 | 2 |
| Brazil | 7 | 3 | 10 |
| Italy | 1 | 1 | 2 |
| Mexico | 0 | 1 | 1 |
| Slovakia | 0 | 3 | 3 |
| France | 28 | 7 | 35 |
| Germany | 0 | 4 | 4 |
| BMI (kg/m^2)(kg/m^2) | Total Population ANT | Total Population POST | Total |
|---|---|---|---|
| Mean | 27.7 ± 4.9 | 26.8 ± 4.5 | 27.2 ± 4.7 |
| Current tobacco use(Participants) | Total Population ANT | Total Population POST | Total |
|---|---|---|---|
| Uses tobacco | 38 | 33 | 71 |
| Does not use tobacco | 126 | 140 | 266 |
| Working status(Participants) | Total Population ANT | Total Population POST | Total |
|---|---|---|---|
| Not employed | 91 | 119 | 210 |
| Employed or independent worker | 73 | 54 | 127 |
| History of spine surgery(Participants) | Total Population ANT | Total Population POST | Total |
|---|---|---|---|
| Yes | 20 | 15 | 35 |
| No | 144 | 158 | 302 |
3 further baseline measures are reported on the registry.
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Intervertebral Disc Degeneration→
Medtronic Spinal and Biologics