Intervertebral Disc DegenerationMASTERS-D2NCT02617563
5-Year Global Study on MAST™ Minimally Invasive Fusion Procedures to Treat Degenerative Lumbar Spine (MASTERS-D2)
An observational study of Intervertebral Disc Degeneration, run by Medtronic Spinal and Biologics at 27 sites in 17 countries.
Trial summary
The purpose of this study is to evaluate the effectiveness of MAST techniques for anterior/lateral and posterior approaches in Degenerative Disc Disease (DDD) patients with spondylolisthesis (≥ grade I). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intervertebral Disc Degeneration
- What is being tested?
- Minimally invasive lumbar fusion
- Type of treatment
- Medical device
- How many people
- 361 participants
- Where
- 27 sitesin 17 countries
- Study dates
- Dec 2015to 14 Nov 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Patient is ≥ 18 years of age (or minimum age as required by local regulations)
- Patient has degenerative disc disease and an indication for a single or double level instrumented lumbar fusion for the treatment
- Patient agrees to participate in the study and is able to sign the Data Release Form/Informed Consent
- The procedure planned for the patient complies with the labeling of the Devices that may be used in the surgical procedure as described in the section Medical Devices of the Clinical Investigation Plan
- 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.
- The patient is willing and is able to perform study procedures and required follow-up visits.
Who cannot join
- Patient that has already undergone a lumbar fusion surgery
- Patient that has already undergone open lumbar surgery other than standard decompression surgery
- Indications for the procedure other than degenerative spine disease like: Osteoporotic vertebral fractures, Spine trauma fractures or Spine tumor
- Illiterate or vulnerable patients (e.g. minors, participants incapable of judgment or participants under tutelage)
- Concurrent participation in another clinical study that may confound study results.
Trial locations and contacts
27 sites in 17 countries.
27 sites in 17 countries
China3 sites
West China Hospital Sichuan University
Chengdu, Sichuan, 610041
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
Shangai Tenth People's Hospital
Shanghai, 200072
France3 sites
Hôpital Civil de Strasbourg (NHC)
Eckbolsheim, 67201
CHRU de Lille, Hôpital Roger Salengro
Lille, 59037
Service de Neurochirurgie la Timone
Marseille
South Korea3 sites
Department of Orthopedics, Korea University Ansan Hospital
Ansan, 425-707
National Health Insurance Corporation Ilsan Hospital
Gyeonggi-do, 10444
Department of Neurological Surgery, Chung-Ang University Hospital
Seoul, 156-755
Portugal2 sites
Hospital Escala Braga
Braga, 4710-243
Centro Hospitalar de Sao Joao
Porto, 4200-319
Russia2 sites
Nizhny Novgorod Research Institute of Traumatology and Orthopedics of Public Health Ministry
Nizhny Novgorod, 603155
Scientific Research Institute of Traumatology and Orthopedics
Novosibirsk, 630091
Spain2 sites
Hospital Universitario Marques de Valdecilla
Santander, 39008
Hospital L'Horta Manises
Valencia, 46026
United Kingdom2 sites
Hull Royal Infirmary
Hull, HU3 2JZ
East Suffolk and North Essex NHS Foundation Trust (was formerly Ipswich Hospital NHS)
Ipswich, IP45PD
About this study
Official title: A Prospective, 5-Year Global Study on MAST™ Minimally Invasive Fusion Procedures for the Treatment of the Degenerative Lumbar Spine
The purpose of this study is
- to evaluate the effectiveness of MAST techniques for anterior/lateral and posterior approaches in Degenerative Disc Disease (DDD) patients with spondylolisthesis (≥ grade I).
- To assess how single or double level MAST(Minimal Access Spinal Technologies) fusion procedures PLIF (Posterior Lumbar Interbody Fusion), TLIF (Transforaminal Lumbar Interbody Fusion), DLIF (Direct Lateral Interbody Fusion), OLIF (Oblique Lumbar Interbody Fusion), ALIF (Anterior Lumbar Interbody Fusion), or MIDLF (Midline Lumbar Interbody Fusion) are used in surgical practice and to describe long-term safety and effectiveness in a broad patient population of patients with degenerative lumbar disc disease .
Read the detailed description
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.
- The study will be monitored with visits conducted at the start, during and at the closure of the clinical study.
- MedDRA coding will be used to classify the Adverse Event.
- The study will be conducted according to Medtronic SOPs
- Sample size calculation: Assuming that the standard deviation for ODI improvement at 3 months is 20 for both groups (anterolateral and posterior) and there is no difference in the mean ODI improvement at 3 months, with 80% power and 5% alpha level, the sample size for the primary endpoint (DDD patients operated for spondylolisthesis) is as follows in order to claim equivalence between two groups with equivalent margin (-10, 10):
- Estimated sample size per group (anterolateral procedures versus posterior procedures): 70
- Estimated total sample size for spondylolisthesis patients: 140
- From the MASTERS-D study it is know that approximately 50% of the patients with degenerative disc disease have spondylolisthesis ≥ grade I. Hence the required total sample size is 140/0.5 = 280. The study is anticipated to enroll 350 patients.
- In addition to a final statistical analysis, 3 months and annual interim analyses are anticipated.
- The study hypothesis for the primary objective is to verify whether patients operated for spondylolisthesis (≥ grade I) have equivalent mean improvement of ODI at 3 months regardless of the minimally invasive surgical procedure (anterolateral or posterior) used.
- The null-hypothesis: Ho: Δ ODI_Anterolateral ≠ Δ ODI_posterior
- will be tested against the alternative hypothesis: HA: Δ ODI_Anterolateral = Δ ODI_posterior Where Δ ODI_Anterolateral is the average improvement in ODI score (baseline - 3 months) in spondylolisthesis subjects treated with the anterolateral approach and Δ ODI_posterior is the average improvement in ODI score (baseline - 3 months) in spondylolisthesis subjects treated with the posterior approach.
- Conditions
- Intervertebral Disc Degeneration
- Being tested
- Minimally invasive lumbar fusion
- Keywords
- spondylolisthesis, CD Horizon® Spinal Systems, minimal invasive, Spinal Fusion, MAST procedure, Lumbar fusion
- Medical subject headings
- Intervertebral Disc Degeneration, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive lumbar fusionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive lumbar fusion | 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. Receives: Device: Minimally invasive lumbar fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (23)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through 5 years
Adverse Events
Document Adverse Events occurrence throughout the study
Measured: 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
Measured: 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.
Measured: 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:
- resources: surgery room, length of hospital stay, additional medical visits (outpatient consultations, visits to primary care services, etc)
- medications
- non-pharmacologic therapies: rehabilitation program
Measured: Baseline to 5-year follow-up
Health Economics Evaluation "Resources"
Healthcare utilization is measured with the following three cost components:
- resources: surgery room, length of hospital stay, additional medical visits (outpatient consultations, visits to primary care services, etc)
- medications
- non-pharmacologic therapies: rehabilitation program
Measured: Through 5 years
Health Economics Evaluation "Rehabilitation Program"
Healthcare utilization is measured with the following three costs components:
- resources: surgery room, length of hospital stay, additional medical visits (outpatient consultations, visits to primary care services, etc)
- medications
- non-pharmacologic therapies: rehabilitation program
Measured: Baseline to 5 years
Health Economics Evaluation "Operative Time"
Healthcare utilization is measured with the following three cost components:
- resources: surgery room, length of hospital stay, additional medical visits (outpatient consultations, visits to primary care services, etc)
- medications
- non-pharmacologic therapies: rehabilitation program
Measured: Peri-operative
Health Economics Evaluation "Estimated Blood Loss"
Healthcare utilization is measured with the following three cost components:
- resources: surgery room, length of hospital stay, additional medical visits (outpatient consultations, visits to primary care services, etc)
- medications
- non-pharmacologic therapies: rehabilitation program
Measured: Peri-operative
Health Economics Evaluation "Length of Hospital Stay"
Healthcare utilization is measured with the following three cost components:
- resources: surgery room, length of hospital stay, additional medical visits (outpatient consultations, visits to primary care services, etc)
- medications
- non-pharmacologic therapies: rehabilitation program
The minimum-maximum time spent at the hospital was [1-53 days]
Measured: Post-operative, up to 53 days
Health Economics Evaluation "Total Fluoroscopy Time"
Healthcare utilization is measured with the following three cost components:
- resources: surgery room, length of hospital stay, additional medical visits (outpatient consultations, visits to primary care services, etc)
- medications
- non-pharmacologic therapies: rehabilitation program
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startDec 2015
- Primary completion10 Nov 2019
- Study completion14 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intervertebral Disc DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 361 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Medtronic Spinal and Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617563
- Sponsor's protocol ID
- P15-01
- Acronym
- MASTERS-D2
- Status last verified
- Oct 2026
- First submitted
- 17 Nov 2015
- Last updated
- 14 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, 5-Year Global Study on MAST™ Minimally Invasive Fusion Procedures for the Treatment of the Degenerative Lumbar Spine
- ClinicalTrials.gov ID
- NCT02617563
- Acronym / sponsor ID
- MASTERS-D2 / P15-01
- Conditions
- Intervertebral Disc Degeneration
- Keywords
- spondylolisthesis, CD Horizon® Spinal Systems, minimal invasive, Spinal Fusion, MAST procedure, Lumbar fusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- 10 Nov 2019 (actual)
- Study completion
- 14 Nov 2024 (actual)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Posted 21 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is
- to evaluate the effectiveness of MAST techniques for anterior/lateral and posterior approaches in Degenerative Disc Disease (DDD) patients with spondylolisthesis (≥ grade I).
- To assess how single or double level MAST(Minimal Access Spinal Technologies) fusion procedures PLIF (Posterior Lumbar Interbody Fusion), TLIF (Transforaminal Lumbar Interbody Fusion), DLIF (Direct Lateral Interbody Fusion), OLIF (Oblique Lumbar Interbody Fusion), ALIF (Anterior Lumbar Interbody Fusion), or MIDLF (Midline Lumbar Interbody Fusion) are used in surgical practice and to describe long-term safety and effectiveness in a broad patient population of patients with degenerative lumbar disc disease .
Detailed description
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.
- The study will be monitored with visits conducted at the start, during and at the closure of the clinical study.
- MedDRA coding will be used to classify the Adverse Event.
- The study will be conducted according to Medtronic SOPs
- Sample size calculation: Assuming that the standard deviation for ODI improvement at 3 months is 20 for both groups (anterolateral and posterior) and there is no difference in the mean ODI improvement at 3 months, with 80% power and 5% alpha level, the sample size for the primary endpoint (DDD patients operated for spondylolisthesis) is as follows in order to claim equivalence between two groups with equivalent margin (-10, 10):
- Estimated sample size per group (anterolateral procedures versus posterior procedures): 70
- Estimated total sample size for spondylolisthesis patients: 140
- From the MASTERS-D study it is know that approximately 50% of the patients with degenerative disc disease have spondylolisthesis ≥ grade I. Hence the required total sample size is 140/0.5 = 280. The study is anticipated to enroll 350 patients.
- In addition to a final statistical analysis, 3 months and annual interim analyses are anticipated.
- The study hypothesis for the primary objective is to verify whether patients operated for spondylolisthesis (≥ grade I) have equivalent mean improvement of ODI at 3 months regardless of the minimally invasive surgical procedure (anterolateral or posterior) used.
- The null-hypothesis: Ho: Δ ODI_Anterolateral ≠ Δ ODI_posterior
- will be tested against the alternative hypothesis: HA: Δ ODI_Anterolateral = Δ ODI_posterior Where Δ ODI_Anterolateral is the average improvement in ODI score (baseline - 3 months) in spondylolisthesis subjects treated with the anterolateral approach and Δ ODI_posterior is the average improvement in ODI score (baseline - 3 months) in spondylolisthesis subjects treated with the posterior approach.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive lumbar fusion | – | Device: Minimally invasive lumbar fusionA single or double level instrumented fusion using minimally invasive PLIF, TLIF, MIDLF, DLIF, OLIF, ALIF procedures for the treatment of the degenerative lumbar spine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- Patient is ≥ 18 years of age (or minimum age as required by local regulations)
- Patient has degenerative disc disease and an indication for a single or double level instrumented lumbar fusion for the treatment
- Patient agrees to participate in the study and is able to sign the Data Release Form/Informed Consent
- The procedure planned for the patient complies with the labeling of the Devices that may be used in the surgical procedure as described in the section Medical Devices of the Clinical Investigation Plan
- Patient is planned to be submitted to a minimally invasive fusion procedure using a posterior (PLIF, TLIF, MIDLF) or anterolateral (OLIF, ALIF, DLIF ) technique*
Key exclusion criteria (5 listed)
- Patient that has already undergone a lumbar fusion surgery
- Patient that has already undergone open lumbar surgery other than standard decompression surgery
- Indications for the procedure other than degenerative spine disease like: Osteoporotic vertebral fractures, Spine trauma fractures or Spine tumor
- Illiterate or vulnerable patients (e.g. minors, participants incapable of judgment or participants under tutelage)
- Concurrent participation in another clinical study that may confound study results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive lumbar fusionPatients 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. | Device | Minimally invasive lumbar fusion |
Primary outcome
Change (Preop-postop) of Disability, Oswestry Disability Index (ODI) at 3 Months as Compared to Baseline in DDD Patients With Spondylolisthesis
Time frame: 3 months
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
23 secondary outcomes
Change (Preop-postop) in Disability ODI as Compared to Baseline in DDD Patients Without Spondylolisthesis
Time frame: 3 months
Change (Preop-postop) in ODI Scores for the Total Population
Time frame: Through 5 years
Change (Preop-postop) in Visual Analog Scale (VAS) Back Pain Intensity
Time frame: Through 5 years
Change (Preop-postop) in VAS Leg Pain Intensity
Time frame: Through 5 years
Change (Postop-preop) in EQ-5D Index Score
Time frame: Through 5 years
The Neurological Success Rate
Time frame: 5 years
Fusion Success
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
Time frame: Through 5 years
Adverse Events
Time frame: Through 5 years
Amount of Days Needed for First Ambulation
Time frame: From surgery up to hospital discharge, up to 11 days
Amount of Days Needed to Recover From Surgery
Time frame: Surgery Recovery Day up to hospital discharge, with a maximum of 46 days
Healthcare Economics Evaluation "Medications"
Time frame: Baseline to 5-year follow-up
Health Economics Evaluation "Resources"
Time frame: Through 5 years
Health Economics Evaluation "Rehabilitation Program"
Time frame: Baseline to 5 years
Health Economics Evaluation "Operative Time"
Time frame: Peri-operative
Health Economics Evaluation "Estimated Blood Loss"
Time frame: Peri-operative
Health Economics Evaluation "Length of Hospital Stay"
Time frame: Post-operative, up to 53 days
Health Economics Evaluation "Total Fluoroscopy Time"
Time frame: Peri-operative
To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Categorical Variables
Time frame: Baseline
To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Age
Time frame: Baseline
To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Height
Time frame: Baseline
To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - Weight
Time frame: Baseline
To Observe and Document the Patient Profile When Choosing a Particular Minimally Invasive Fusion Procedure - BMI
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Intervertebral Disc Degeneration
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
Cervical Degenerative Disc Disease
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
RecruitingObservational study
OssDsign® Spine Registry Study ("Propel")
Degenerative Disc Disease, Spinal Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intervertebral Disc Degeneration, run by Medtronic Spinal and Biologics at 27 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in China, France, South Korea, Portugal, Russia and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change (Preop-postop) of Disability, Oswestry Disability Index (ODI) at 3 Months as Compared to Baseline in DDD Patients With Spondylolisthesis (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.