Spinal DeformityNCT05856370
The Ailliance Post-Market Clinical Study
A study testing Follow-up schedule: pre-operative baseline up to 24-months post-procedure in people with Spinal Deformity and Spinal Degenerative Disorder, run by Medtronic Spinal and Biologics at 29 sites in 6 countries.
Trial summary
The purpose of this clinical study is to collect performance and safety data for post-market Medtronic devices indicated for cranial and/or spinal indication(s). Subjects are enrolled and followed postoperatively to 24 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Deformity, Spinal Degenerative Disorder, Spinal Fusion Failure
- What is being tested?
- Follow-up schedule: pre-operative baseline up to 24-months post-procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 29 sitesin 6 countries
- Study dates
- 1 May 2023to May 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Subject provides written informed consent per institution and/or geographical requirements.
- Subject is intended to receive or be treated with an eligible Medtronic Cranial and Spinal Technology (CST) device(s) (see product appendices), used alone or in combination, for a cranial and/or spinal indication(s).
- Subject is at least 18 years of age or minimum legal age as required by local regulations.
- Subject agrees to complete all required assessments per the Schedule of Events.
Who cannot join
- Subject is currently enrolled or plans to enroll in concurrent drug/device/biologic trial(s) that may confound this trial's results per investigator assessment (i.e. no required intervention that could affect interpretation of all-around device safety and or performance).
- Subject who is, or is expected to be, inaccessible for all required follow-up visits.
- Subject with exclusion criteria required by local law.
- Subject is considered vulnerable at the time of obtaining consent.
Trial locations and contacts
29 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
29 sites in 6 countries
United States23 sites, 22 recruiting
- Recruiting
University of Maryland Medical Center
Baltimore, Maryland, 21201
Kaitlyn Henry, khenry@som.umaryland.edu
Timothy Chryssikos, MD, PhD
- Recruiting
Indiana University School of Medicine
Bloomington, Indiana, 47401
Carolyn York O'Neil, caoneil@iu.edu
David Stockwell, MD
- Recruiting
University at Buffalo
Buffalo, New York, 14221
Jennifer Gay, jgay@ubns.com
Jeffrey Mullin, MD
- Recruiting
Indiana Spine Group
Carmel, Indiana, 46032
Sheetal Vinayek, svinayek@indianaspinegroup.com
Joseph Smucker, MD
- Recruiting
University of Virginia Health System
Charlottesville, Virginia, 22903
Milos Lesevic, ml4ec@uvahealth.org
Adam Shimer, MD
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
David Haney, david.haney@uhhospitals.org
Gabriel Smith, MD
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Allison Garvin, Allison.Garvin@osumc.edu
Stephanus Viljoen, MD
- Recruiting
American Neurospine Institute, PLLC
Frisco, Texas, 75033
Nazia Begum, nazia.begum@hcahealthcare.com
Ripul Panchal, DO
- Recruiting
The Orthopaedic Research Foundation (OrthoIndy)
Indianapolis, Indiana, 46278
Melanie Glover, mglover@orthoindy.com
Craig McMains, MD
- Recruiting
OrthoArkansas
Little Rock, Arkansas, 72204
Adams Stevens, Adam.Stevens@orthoarkansas.com
Justin Seale, MD
- Recruiting
Norton Leatherman Spine Specialists
Louisville, Kentucky, 40202
Leah Carreon, leah.carreon@nortonhealthcare.org
Kathryn McCarthy, MD
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55454
Ifeoluwa Onuoha, olayi018@umn.edu
David Polly, MD
- Recruiting
Tennessee Orthopaedic Alliance
Nashville, Tennessee, 37209
Erika Frazier, frazieree@toa.com
Ryan Snowden, MD
- Recruiting
Rutgers University Department of Neurosurgery
New Brunswick, New Jersey, 08901-2065
Christine Yohn, cy253@rwjms.rutgers.edu
Jonathan Sherman, MD
- Active, not recruiting
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
- Recruiting
Rhode Island Hospital University Orthopedic
Providence, Rhode Island, 02914
Mariah Balmaceno-Criss, mariah_balmaceno-criss@brown.edu
Alan Daniels, MD
- Recruiting
Virginia Spine Institute
Reston, Virginia, 20191
Nancy Goldbranson, ngold@spinemd.com
Colin Haines, MD
- Recruiting
Michigan Orthopaedic & Spine Surgeons
Rochester Hills, Michigan, 48307
Cecile Pestano, moss.clinicalresearch@gmail.com
Richard Easton, MD
- Recruiting
University of California Davis Medical Center
Sacramento, California, 95816
Janice Wang-Polagruto, jfwang@ucdavis.edu
Kee Kim, MD
- Recruiting
University of California, San Francisco (UCSF)
San Francisco, California, 94143
Terry Nguyen, terry.nguyen@ucsf.edu
Aaron Clark, MD
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110-1010
Kayode Matthew, kayode@wustl.edu
Brian Neuman, MD
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Brigette Bahmani, b.bahmani@wustl.edu
Jacob Greenberg, MD
- Recruiting
University of Arizona
Tucson, Arizona, 85721
Kylie Lew, klew@arizona.edu
Richard Chua, MD
France2 sites, 2 recruiting
- Recruiting
Centre Hospitalier Universitaire Dijon Bourgogne
Dijon, Bourgogne-Franche-Comté, 21079
Jacques Beaurain, jacques.beaurain@chu-dijon.fr
Jacques Beaurain
- Recruiting
Hôpital Roger Salengro
Lille, 59037
Camille Gombert, camille.gombert@chru-lille.fr
Henri-Arthur Leroy, MD
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, 10117
Friederike Schömig, friederike.schoemig@charite.de
Matthias Pumberger
Portugal1 site, 1 recruiting
- Recruiting
Centro Hospitalar Universitário São João
Porto, 4200-319
Antonio Francisco Martingo Serdoura, antonio.serdoura@ulssjoao.min-saude.pt
Antonio Francisco Martingo Serdoura
Spain1 site, 1 recruiting
- Recruiting
Hospital Vall D'Hebron
Barcelona, 08035
Anika Pupak, anika.pupak@vhir.org
Ferran Pelissé, MD
United Kingdom1 site, 1 recruiting
- Recruiting
Kings College Hospital NHS Foundation Trust
London, SE5 9RS
Khan Azarul, azharul.khan@nhs.net
Gordon Grahovac, MD
About this study
Official title: The Ailliance Post-Market Clinical Study: All enablIng technoLogies, bioLogics, IDS, And Core spiNe produCt collEction
The purpose of this clinical study is to collect performance and safety data for post-market Medtronic devices indicated for cranial and/or spinal indication(s).
Subjects are enrolled and followed postoperatively to 24 months. The Ailliance clinical study is intended to collect data congruous with routine clinical care practices.
- Conditions
- Spinal Deformity, Spinal Degenerative Disorder, Spinal Fusion Failure, Spinal Trauma, Spinal Tumor Case
- Being tested
- Follow-up schedule: pre-operative baseline up to 24-months post-procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up schedule: pre-operative baseline up to 24-months post-procedureDevice
Follow-up assessments will be required (therefore interventional) from pre-operative baseline to 24 months post index surgery
| Study group | Role | What they receive |
|---|---|---|
| Receiving eligible Medtronic device(s) from all product groups | Other | Powered Systems, Instruments, and Imaging device(s), Advanced Energy device(s), Robotics and Navigation, Rods and Screws, Interbodies and Biologics, Spinal Tethers, and Other Spinal Hardware device(s) Receives: Device: Follow-up schedule: pre-operative baseline up to 24-months post-procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical success (for any Medtronic eligible market-released Advanced Energy device(s) used)
Defined by amount of: 1) blood loss (mL) during surgery and/or 2) total operation time and/or 3) length of stay in the hospital (measured from surgery completion to discharge), and/or 4) investigator opinion on whether the device(s) directly assisted in the completion of surgery
Measured: Discharge (from Index Surgery completion to 14 days post-operatively)
Fusion Success (for any Medtronic eligible market-released Interbodies and Biologics, Other Spinal Hardware, and/or Rods and Screws device(s) used)
Fusion success at 12-months is determined through evaluation of radiographic evidence (X-ray and/or CT scan) by the investigator by: (1) Confirming the presence of bone bridging, and (2) if using the Brantigan \& Steffee's Classification scale: a score D and/or E are determined.
Measured: 12 months
Surgical performance (for any Medtronic eligible market-released Powered Systems, Instruments, and Imaging device(s) used)
Surgical performance, as defined as the rate at which the device directly assisted in the completion of surgery in the investigator's opinion.
If O-Arm used: whether O-Arm was utilized for validation of implant placement during the surgery.
Measured: Index Surgery
Device performance (for any Medtronic eligible market-released Robotics and Navigation device(s) used)
Robotics: Planned number of screws prior to index surgery compared to number of screws device assisted with placement during surgery. Navigation: Whether or not device was utilized for validation of screw placement during surgery.
Measured: 24 months
Pain Resolution (for select Medtronic eligible market-released Other Spinal Hardware device(s) used)
Resolution of pain at 12-months when compared to baseline Pain reported by the subject using the Neck Disability Index (NDI) questionnaire
Measured: 12 months
Stabilization (for any Medtronic eligible market-released device(s) used from the following product groups: Other Spinal Hardware)
- Stabilization is the radiographic verification of no noticeable hardware and/or implant loosening, the presence of the hardware in the appropriate position without cage subsidence and/or implant loosening, and noticeable stable alignment of the spine post-surgery.
- Since all products are market-released, assessment for stabilization will be completed by the investigator.
- Stabilization will be assessed by the collection of radiographic evidence (X-Ray(s) and CT-scan(s)).
Measured: Up to 12 months
Deformity Correction (for specified Medtronic eligible market-released device(s) used from the following product groups: Spinal Tethers)
Defined by the change of Cobb angle at 12-month
Measured: 12 months
Secondary outcomes (3)
Rate of Device-related Adverse Events any Medtronic eligible market-released Cranial & Spinal Technologies (CST) device(s) as aligned with ISO 14155 standards
The secondary endpoint is defined as the rate of occurrence for device-related adverse events
Measured: 24 months
Stabilization [for any Medtronic eligible market-released device(s) used from the following product groups: Interbodies and Biologics, Rods and Screws]
- Stabilization is the radiographic verification of no noticeable hardware and/or implant loosening, the presence of the hardware in the appropriate position without cage subsidence and/or implant loosening, and noticeable stable alignment of the spine post-surgery.
- Since all products are market-released, assessment for stabilization will be completed by the investigator.
- Stabilization will be assessed by the collection of radiographic evidence (X-Ray(s) and CT-scan(s)).
Measured: Up to 12 months
Deformity Correction [for specified Medtronic eligible market-released device(s) used from the following product groups: Rods and Screws]
- Deformity correction is defined by the change of Cobb angle at the 12-month postoperative visit compared to baseline.
- Assessment(s) for deformity correction will be completed by the investigator. The investigator will determine whether the subject meets requirements of deformity correction based on the comparison of the Cobb angle measurements at all postoperative visits, when compared to the subject's baseline assessments.
- Cobb angle measurements will be provided through collection of radiographic evidence (X-Ray(s) and CT-scan(s)) and assessed by the investigator.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start1 May 2023
- Primary completionMay 2031 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DeformityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Spinal and Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic Cardiac Rhythm and Heart Failure
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856370
- Sponsor's protocol ID
- MDT22045CSTAIL
- Status last verified
- Aug 2026
- First submitted
- 16 Mar 2023
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ailliance Post-Market Clinical Study: All enablIng technoLogies, bioLogics, IDS, And Core spiNe produCt collEction
- ClinicalTrials.gov ID
- NCT05856370
- Acronym / sponsor ID
- MDT22045CSTAIL
- Conditions
- Spinal Deformity, Spinal Degenerative Disorder, Spinal Fusion Failure, Spinal Trauma, Spinal Tumor Case
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic Cardiac Rhythm and Heart Failure
- Study start
- 1 May 2023 (actual)
- Primary completion
- May 2031 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
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 clinical study is to collect performance and safety data for post-market Medtronic devices indicated for cranial and/or spinal indication(s).
Subjects are enrolled and followed postoperatively to 24 months. The Ailliance clinical study is intended to collect data congruous with routine clinical care practices.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Receiving eligible Medtronic device(s) from all product groups | Other | Device: Follow-up schedule: pre-operative baseline up to 24-months post-procedurePowered Systems, Instruments, and Imaging device(s), Advanced Energy device(s), Robotics and Navigation, Rods and Screws, Interbodies and Biologics, Spinal Tethers, and Other Spinal Hardware device(s) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject provides written informed consent per institution and/or geographical requirements.
- Subject is intended to receive or be treated with an eligible Medtronic Cranial and Spinal Technology (CST) device(s) (see product appendices), used alone or in combination, for a cranial and/or spinal indication(s).
- Subject is at least 18 years of age or minimum legal age as required by local regulations.
- Subject agrees to complete all required assessments per the Schedule of Events.
Key exclusion criteria (4 listed)
- Subject is currently enrolled or plans to enroll in concurrent drug/device/biologic trial(s) that may confound this trial's results per investigator assessment (i.e. no required intervention that could affect interpretation of all-around device safety and or performance).
- Subject who is, or is expected to be, inaccessible for all required follow-up visits.
- Subject with exclusion criteria required by local law.
- Subject is considered vulnerable at the time of obtaining consent.
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 |
|---|---|---|
| Follow-up schedule: pre-operative baseline up to 24-months post-procedureFollow-up assessments will be required (therefore interventional) from pre-operative baseline to 24 months post index surgery | Device | Receiving eligible Medtronic device(s) from all product groups |
Primary outcome
Surgical success (for any Medtronic eligible market-released Advanced Energy device(s) used)
Time frame: Discharge (from Index Surgery completion to 14 days post-operatively)
Defined by amount of: 1) blood loss (mL) during surgery and/or 2) total operation time and/or 3) length of stay in the hospital (measured from surgery completion to discharge), and/or 4) investigator opinion on whether the device(s) directly assisted in the completion of surgery
Fusion Success (for any Medtronic eligible market-released Interbodies and Biologics, Other Spinal Hardware, and/or Rods and Screws device(s) used)
Time frame: 12 months
Fusion success at 12-months is determined through evaluation of radiographic evidence (X-ray and/or CT scan) by the investigator by: (1) Confirming the presence of bone bridging, and (2) if using the Brantigan \& Steffee's Classification scale: a score D and/or E are determined.
Surgical performance (for any Medtronic eligible market-released Powered Systems, Instruments, and Imaging device(s) used)
Time frame: Index Surgery
Surgical performance, as defined as the rate at which the device directly assisted in the completion of surgery in the investigator's opinion. If O-Arm used: whether O-Arm was utilized for validation of implant placement during the surgery.
Device performance (for any Medtronic eligible market-released Robotics and Navigation device(s) used)
Time frame: 24 months
Robotics: Planned number of screws prior to index surgery compared to number of screws device assisted with placement during surgery. Navigation: Whether or not device was utilized for validation of screw placement during surgery.
Pain Resolution (for select Medtronic eligible market-released Other Spinal Hardware device(s) used)
Time frame: 12 months
Resolution of pain at 12-months when compared to baseline Pain reported by the subject using the Neck Disability Index (NDI) questionnaire
Stabilization (for any Medtronic eligible market-released device(s) used from the following product groups: Other Spinal Hardware)
Time frame: Up to 12 months
* Stabilization is the radiographic verification of no noticeable hardware and/or implant loosening, the presence of the hardware in the appropriate position without cage subsidence and/or implant loosening, and noticeable stable alignment of the spine post-surgery. * Since all products are market-released, assessment for stabilization will be completed by the investigator. * Stabilization will be assessed by the collection of radiographic evidence (X-Ray(s) and CT-scan(s)).
Deformity Correction (for specified Medtronic eligible market-released device(s) used from the following product groups: Spinal Tethers)
Time frame: 12 months
Defined by the change of Cobb angle at 12-month
3 secondary outcomes
Rate of Device-related Adverse Events any Medtronic eligible market-released Cranial & Spinal Technologies (CST) device(s) as aligned with ISO 14155 standards
Time frame: 24 months
Stabilization [for any Medtronic eligible market-released device(s) used from the following product groups: Interbodies and Biologics, Rods and Screws]
Time frame: Up to 12 months
Deformity Correction [for specified Medtronic eligible market-released device(s) used from the following product groups: Rods and Screws]
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
Related trials for Spinal Deformity
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
RecruitingObservational study
Rare Disease Registry Database for Movement Disorders in Southern Anhui Province
Motor Neuron Diseases, Spinocerebellar Ataxias
RecruitingObservational study
Phenotype/Genotype Correlations in Movement Disorders
Movement Disorder
Active, not recruitingObservational study
Clinical Study of Bone Graft Substitutes in Orthopaedic and Spinal Applications.
Bone Deformity
RecruitingPhase 2
Neoadjuvant Pembrolizumab and Porustobart in Resectable pMMR/MSS Colon Cancer
Colon Cancer
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.
29 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow-up schedule: pre-operative baseline up to 24-months post-procedure in people with Spinal Deformity and Spinal Degenerative Disorder, run by Medtronic Spinal and Biologics at 29 sites in 6 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, France, Germany, Portugal, Spain and 1 more country. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Oien (+17635268124, lauren.k.oien@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical success (for any Medtronic eligible market-released Advanced Energy device(s) used) (time frame: Discharge (from Index Surgery completion to 14 days post-operatively)). The study lists 7 primary outcomes in all. 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 17 Aug 2026.