Infections

All Conditions

Symptoms and General Pathology

Wounds and Injuries

Diseases and Abnormalities at or Before Birth

Neoplasms

Communicable Diseases

Congenital Abnormalities

Neoplastic Processes

Single Arm. All participants undergoing posterior thoracolumbar arthrodesis procedures betweenT2-S1 in which preplanning is done using the Mazor X robotic system.

Pedicle screw instrumentation using Mazor X robotic system

The purpose of the study is to assess screw deviation from pre-planned trajectory using the Mazor X robotic system in patients undergoing posterior thoracolumbar arthrodesis procedures between T2-S1.

This trial will prospectively evaluate screw deviation from pre-planned trajectory using the standard of care Mazor X robotic system. Patients undergoing posterior thoracolumbar arthrodesis procedures utilizing pedicle screw instrumentation at previously uninstrumented levels for degenerative conditions, spinal deformity, spinal infection, trauma, or neoplastic processes between T2-S1 will be asked to participate in this prospective cohort study.

This single centered study will enroll up to 50 patients to achieve a total number of 250 screws for assessment. Subjects will be followed till discharge following surgery. All subjects enrolled in the study will be recruited from a pool of subjects eligible for posterior thoracolumbar arthrodesis surgery.

All subjects will undergoing posterior thoracolumbar arthrodesis procedures utilizing pedicle screw instrumentation.

Analysis of Pedicle Screw Accuracy to Plan Using Medtronic Mazor Robotic System

Total deviation (mm) from the pre-planned screw entry point includes: deviation in angle of insertion in the axial plane (degrees), and deviation in angle of insertion in the sagittal plane (degrees) from an O-arm spin after screw placement.

The secondary outcome will include traditional accuracy assessment for degree of pedicle breach utilizing the Gertzbein and Robbins classification system.

Medtronic

Ohio State University

Assistant Clinical Professor Residency Program Director Deformity and Robotic Spinal Fellowship Director

Nervous System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Surgical Wound Infection

Spinal Cord Injuries

Neoplasm Metastasis

Infertility

Spinal Cord Diseases

Central Nervous System Diseases

Trauma, Nervous System

Standard of care treatment - Standard wound care involves the application of an occlusive dressing in the operating room, a dressing change on Post-operative Day 3 and then dressing changes as needed until suture/staple removal on Post-operative Day 14.

The Prevena™ System, a type of vacuum assisted closure, is indicated for use over clean, closed incisions that continue to drain following sutured or stapled closure. It acts by removing exudate, helping hold the edges of the incision together, protecting the surgical site from external contamination in a clean, protected postoperative wound environment.

Patients will be randomized to receive either standard dressing changes or the Prevena™ System on the day of their operation.

Vacuum Assisted Closure

Standard wound care involves the application of an occlusive dressing in the operating room, a dressing change on Post-operative Day 3 and then dressing changes as needed until suture/staple removal on Post-operative Day 14.

Sterile dressing

Allan Aludino

Leilani Reichl

John Street, MD, PhD

John Street, MD,PhD,FRCSI

The purpose of this study is to determine if the use of the Prevena™ System decreases the rate of subcutaneous seroma, superficial wound dehiscence and infection.

Certain risk factors have been identified in patients that may lead to poor wound healing or infection. Many things have been tried to decrease this risk (more antibiotics, different types of stitches, etc) but very few have been shown to be of any significant benefit.

The use of a special vacuum dressing called the Prevena™ System, which has received approval from Health Canada for the management of closed surgical incisions, has been shown to be of some benefit in hip surgery where wounds are identified as being "at risk." Vacuum dressings have been used with great success in patients with open wounds and have resulted in fewer infections and wound related complications. It is thought that if vacuum dressings can be used in the treatment of existing wounds, then maybe they can be used preventatively before there is a problem with the wound.

Standard wound care after spine surgery involves a dressing that seals the wound for 72 hours after surgery and is then changed on a daily basis until the surgical sutures or staples are ready to be removed. This has been routine for many years.

The purpose of this study is to see if using a vacuum dressing (Prevena™ System) will decrease the number of infections and/or clinic and hospital visits for wound related issues compared to using a standard dressing on wounds in patients with risk factors for early wound infection.

Negative Pressure Wound Therapy vs. Sterile Dressing for Patients Undergoing Thoracolumbar Spine Surgery

A Prospective Randomized Clinical Trial Comparing Incisional Negative Pressure Wound Therapy to Conventional Sterile Dressing in Patients Undergoing Thoracolumbar Posterior Spine Surgery

Based on visual inspection of the surgical site, a 'Wound Inspection \& Dressing Utilization' case report form will be completed by a clinician, concluding at Week 6 post-op, to assess for the presence of SSI.

University of British Columbia Orthopaedics Research Excellence Fund

John Street

Assistant Professor

Musculoskeletal Diseases

Blood and Lymph Conditions

Syndrome

Constriction, Pathologic

Intervertebral Disc Displacement

Intervertebral Disc Degeneration

Spondylolisthesis

Spinal Stenosis

Bone Marrow Diseases

Spinal Cord Neoplasms

Failed Back Surgery Syndrome

Spinal Diseases

Bone Diseases

Postoperative Complications

Back Pain

Pain

Neurologic Manifestations

Hernia

Pathological Conditions, Anatomical

Central Nervous System Neoplasms

Nervous System Neoplasms

Patients who undergo a planned spinal fusion procedure requiring approved bone grafting materials (e.g., bone grft substitutes, allograft or autograft).

spine fusion surgery utilizing any commercially available bone graft substitute(s), autograft or allograft

Bone graft substitute, autograft or allograft

Huub Kreuwel, Ph.D

A multi-center, prospective, observational patient registry to collect information on the clinical outcomes and "real world" use of approved and commercially available bone graft substitutes, autograft and allograft.

Bone Graft Materials Observational Registry

A Prospective Patient Registry for Bone Graft Substitutes in Spinal Fusion: Patient Outcomes and Use in Clinical Practice

Apatech, Inc.

Baxter Healthcare Corporation

Fractures, Bone

Spinal Fractures

Spondylosis

Spinal Neoplasms

Spinal Injuries

Back Injuries

Bone Neoplasms

120 subjects with ERISMA® LP/LP EVO implant

120 subjects with ERISMA® Deformity implant

50 subjects with Idys® TLIF PEEK implant

50 subjects with Idys® TLIF TiVAC implant

50 subjects with Idys® TLIF 3DTi implant

50 subjects with Idys® ALIF PEEK implant

50 subjects with Idys® ALIF TiVAC implant

50 subjects with Idys® ALIF 3DTi implant

50 subjects with Idys® ALIF ZP 3DTi implant

50 subjects with Idys® LLIF 3DTi implant

Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.

Spine surgery

Florian Laboulfie

Henri D'ASTORG, MD

International, prospective, single arm, multicenter and observational Post-Market Clinical Follow-up (PMCF).

The overall objective of this study is to collect preoperative, intraoperative and postoperative (at 9 weeks, 6 months, 1 year and 2 years) data on the clinical complications and functional outcomes of the study devices to demonstrate safety and performance in a real-world setting.

The primary objective is to demonstrate that the use of the study devices is safe.

The secondary objective is to demonstrate that the use of the study devices decreases the pain, and improves the quality of life and the daily activities of the subjects.

Clariance ErYs Registry

Clariance Registry of ERISMA® and Idys® Devices

Revision (each time a primary study implant is removed during an additional necessary surgery) rates, as a percentage of the total of cases per primary study device.

Self-report scale consisting in a 10-centimeter horizontal line with each end being an extreme label of the pain or discomfort experienced by the subject. The extreme labels are "no pain" (corresponding to the scale of 0) and "the worst pain imaginable" (corresponding to the scale of 100).

Self-report scale with 10 items each which 6 statements referring to the subject's life in different scenarios. The answers are scored on a 0 - 5 points scale that is then transformed to result in a score that ranges from 0% (indicating least disability) to 100% (indicating most disability).

The SF-12v2® measures eight components of general health: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations due to emotional problems and mental health (psychological distress and psychological wellbeing).

Five questions regarding the surgery outcomes, if the subject would recommend the surgery to family members and if the subject would still undergo the surgery. Each answer indicates a different level of satisfaction.

Evaluation of the interbody fusion from either X-rays or CT-scan images.

Number of untoward medical occurrences, unintended diseases or injuries, or untoward clinical signs (including abnormal laboratory findings) in subjects , users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. May be serious or not.

Number of inadequacies of a medical device with respect to its identity, quality, durability, reliability, usability, safety or performance.

Clariance

Robotics and Navigation, Rods and Screws, Interbodies and Biologics, Spinal Tethers, and Other Spinal Hardware device(s)

Follow-up assessments will be required (therefore interventional) from pre-operative baseline to index surgery for those receiving eligible Medtronic Powered Systems, Instruments, and Imaging device(s)

Follow-up schedule: pre-operative baseline to index surgery

Follow-up assessments will be required (therefore interventional) from pre-operative baseline to index surgery for those receiving eligible Advanced Energy device(s)

Follow-up schedule: pre-operative baseline to discharge

Follow-up assessments will be required (therefore interventional) from pre-operative baseline to index surgery for those receiving eligible Medtronic Robotics and Navigation, Rods and Screws, Interbodies and Biologics, Spinal Tethers, and Other Spinal Hardware device(s)

Follow-up schedule: pre-operative baseline up to 24-months post-procedure

Katelynn Hamer

Nuria Mahmood

Terry Nguyen

Aaron Clark, MD

Carolyn York O'Neil

David Stockwell, MD

Sheetal Vinayek

Joseph Smucker, MD

Melanie Glover

Craig McMains, MD

Leah Carreon

Kathryn McCarthy, MD

Cecile Pestano

Richard Easton, MD

Ifeoluwa Onuoha

David Polly, MD

Allison Garvin

Stephanus Viljoen, MD

Mariah Balmaceno-Criss

Alan Daniels, MD

Erika Frazier

Ryan Snowden, MD

Nazia Begum

Ripul Panchal, DO

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 for up to 24 months. The Ailliance clinical study is intended to collect data congruous with routine clinical care practices.

The Ailliance Post-Market Clinical Study

The Ailliance Post-Market Clinical Study: All enablIng technoLogies, bioLogics, IDS, And Core spiNe produCt collEction

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 at 12-months, as assessed via radiographic evidence.

Surgical performance, as defined as the rate at which the device directly assisted in the completion of surgery in the investigator's opinion.

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.

Defined by the change of Cobb angle at 12-month

The secondary endpoint is defined as the rate of occurrence for device-related adverse events

* 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)).
* \[For Other Spinal Hardware device(s) used\]: when radiographic fusion is not evident or no fusion is noted, stabilization will be assessed as a secondary endpoint

* 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.

Medtronic Bakken Research Center

Medtronic Spinal and Biologics

Spondylolysis

patents in this arm will be implanted with Johnson\&Johnson Medical Suzhou made Spine Fusion System.

patents in this arm will be implanted with Imported EXPEDIUM screws and OPAL cage .

interventional device is Spine Fusion System that is manufactured by Johnson \& Johnson Medical Suzhou Ltd.

Johnson&Johnson Medical Suzhou made Spine Fusion System

Comparator in this study is active comparator.

Imported EXPEDIUM screws and OPAL cage

Wei Tian

The primary objective of this study is to demonstrate that the efficacy and safety of Spine fusion system manufactured in China is no inferior than imported product.

This study is a prospective, multicenter, randomized, comparative, non-inferiority study comparing the change of Japanese Orthopaedic Association Score from baseline at postoperative 24 weeks for patients implanted with local made Spine Fusion System versus imported products.

A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery

A Prospective, Multicenter, Randomized, Open-label, Controlled Study to Evaluate the Safety and Efficacy of a Spine Fusion System in Vertebral Body Fusion Surgery

Fixation stability should be measured based on translational motion and angular motion which is demonstrated on X-Ray examination (A/P lateral, Flexion and extension).

would healing are classified as 3 classes. (Class I, Class II, Class III)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Analysis of Pedicle Screw Accuracy to Plan Using Medtronic Mazor Robotic System	NCT05884593	Spinal Deformit... Spinal Infectio... Trauma Neoplastic Proc... Degenerative Sp...	Pedicle screw i...	18 Years -	Ohio State University
Negative Pressure Wound Therapy vs. Sterile Dressing for Patients Undergoing Thoracolumbar Spine Surgery	NCT03632005	Metastatic Dise... Spinal Cord Inj... Spinal Degenera... Spinal Deformit...	Vacuum Assisted... Sterile dressin...	17 Years -	University of British Columbia
Bone Graft Materials Observational Registry	NCT00974623	Degenerative Di... Herniated Disc Spinal Stenosis Spondylolithesi... Spinal Deformit... Cervical Myelop... Failed Back Sur... Spinal Cord Neo...	Bone graft subs...	18 Years -	Baxter Healthcare Corporation
Clariance ErYs Registry	NCT05170815	Spine Degenerat... Spine Spondylos... Spinal Deformit... Spinal Tumor Spinal Fracture	Spine surgery	18 Years -	Clariance
Clariance ErYs Registry	NCT05170815	Spine Degenerat... Spine Spondylos... Spinal Deformit... Spinal Tumor Spinal Fracture	Spine surgery	18 Years -	Clariance
The Ailliance Post-Market Clinical Study	NCT05856370	Spinal Deformit... Spinal Degenera... Spinal Fusion F... Spinal Trauma Spinal Tumor Ca...	Follow-up sched... Follow-up sched... Follow-up sched...	18 Years -	Medtronic Spinal and Biologics
The Ailliance Post-Market Clinical Study	NCT05856370	Spinal Deformit... Spinal Degenera... Spinal Fusion F... Spinal Trauma Spinal Tumor Ca...	Follow-up sched... Follow-up sched... Follow-up sched...	18 Years -	Medtronic Spinal and Biologics
Negative Pressure Wound Therapy vs. Sterile Dressing for Patients Undergoing Thoracolumbar Spine Surgery	NCT03632005	Metastatic Dise... Spinal Cord Inj... Spinal Degenera... Spinal Deformit...	Vacuum Assisted... Sterile dressin...	17 Years -	University of British Columbia
The Ailliance Post-Market Clinical Study	NCT05856370	Spinal Deformit... Spinal Degenera... Spinal Fusion F... Spinal Trauma Spinal Tumor Ca...	Follow-up sched... Follow-up sched... Follow-up sched...	18 Years -	Medtronic Spinal and Biologics
A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery	NCT02252185	Disc Degenerati... Spondylolisthes... Spinal Fracture Spinal Deformit... Spinal Stenosis Spinal Tumor	Johnson&Johnson... Imported EXPEDI...	20 Years - 70 Years	Johnson & Johnson Medical (Suzhou) Ltd.

Spots Global Cancer Trial Database for spinal deformity