Radiological and Clinical Efficacy of a Hybrid Spinal Implant (Topping Off): a Mono-center, Prospective Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The study aim is to show the effectiveness of a hybrid system (DTO) regarding clinical outcome and radiological alteration in a single-center prospective setting.

Detailed Description
-----------------
Posterior spondylodesis and monosegmental intervertebral cage plus flexible instrumentation of the superiorly adjacent segment (Dynesys DTO). Planned follow-up visits up to 48 months with documentation of health-related outcome measurement instruments and radiological control of possible segment alteration and device-related complication.

Official Title
-----------------
The Use of the DTO Hybrid Dynamic Device: a Clinical Outcome- and Radiological-based Prospective Clinical Trial

Conditions
-----------------
Spine Surgery

Intervention / Treatment
-----------------
* Device: Dynesys DTO device (Zimmer Spine, Inc.)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent Legal capacity Age ≥ 18 years Indication for monosegmental lumbar spine fusion (PLIF or topping-off ) L2-S1 with osteochondrosis Modic grades I-III or spondylolisthesis Meyerding grades I-III. Radiologic signs of degeneration in the adjacent segment of the intended fusion without signs of instability Exclusion Criteria: Motor deficit Cauda equina syndrome Previous surgical intervention of the lumbar spine Relevant peripheral neuropathy Acute denervation subsequent to a radiculopathy Scoliosis with Cobb angle greater than 25° Spondylolisthesis > Meyerding grade III Radiologic signs of degeneration in the adjacent segment of the intended fusion with signs of instability (for definition, see inclusion criteria) No radiologic signs of degeneration in the adjacent segment of the intended fusion (for definition, see inclusion criteria) Radiologic signs of degeneration in the adjacent segment of the intended fusion with >Fujiwara grade II or >Pfirrmann grade IV Signs of instability in any lumbar spine segment other than that undergoing fusion General contraindication for elective lumbar spine surgery Pathologic fracture Osteoporosis with pathologic fracture Active systemic infection Rheumatic disease Disease of bone metabolism (e.g. Paget's Disease) Bone metastasis Local infection focus lumbar spine Seizure disorder Chronic ischemia Fontaine classification IIb-IV Severe heart insufficiency (NYHA III-IV) Blood coagulation disorder or blood thinning therapy Cortisone intake more than one month in the last 12 months before randomization Simultaneous participation in another clinical trial in the 30 days before randomization Known allergy or intolerance to the implants Dependency on investigator Lack of familiarity with the German language Placement in an institution by governmental or juridical advice Absent legal capacity Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All patients requiring lumbar spinal surgery by the use of a hybrid spinal implant (DTO): (1) patients with their first surgical intervention at the lumbar spine, (2) patients with a previous surgical decompression but non-fusion procedure after LSS and (3) patients with medical history of PLIF-/TLIF-technique and later onset of symptomatic ASD within the superior adjacent segment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>patients with their first surgical intervention at the lumbar spine receive the Dynesys DTO device (Zimmer Spine, Inc.). | Device: Dynesys DTO device (Zimmer Spine, Inc.)<br>* All patients receive posterior hybrid instrumentation.<br>|
| Active Comparator: Group 2<br>patients with a previous surgical decompression but non-fusion procedure after lumbar spinal stenosis surgery receive the Dynesys DTO device (Zimmer Spine, Inc.). | Device: Dynesys DTO device (Zimmer Spine, Inc.)<br>* All patients receive posterior hybrid instrumentation.<br>|
| Active Comparator: Group 3<br>patients with the medical history of PLIF-/TLIF-technique and later onset of symptomatic ASD within the superior adjacent segment receive the Dynesys DTO device (Zimmer Spine, Inc.). | Device: Dynesys DTO device (Zimmer Spine, Inc.)<br>* All patients receive posterior hybrid instrumentation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the health-related outcome measurement instruments (ODI) |  | 24-48 months | 
| Changes in the health-related outcome measurement instruments (COMI) |  | 24-48 months | 
| Changes in the health-related outcome measurement instruments (SF-36) |  | 24-48 months | 
| Radiological outcomes | Radiological changes within the adjacent segment | 24-48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device complication (breakage, loosening, etc.) | Complication regarding the device | 24 - 48 months | 
| Patient-related complication | general and surgical complication | 24- 48 months |