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

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

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.

Study Overview

• Status: Completed
• Conditions: Spine Surgery
• Intervention / Treatment: Device: Dynesys DTO device (Zimmer Spine, Inc.)

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany, 50937
    • University Hospital Cologne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; 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.); All patients receive posterior hybrid instrumentation.
Active Comparator: Group 2; 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.); All patients receive posterior hybrid instrumentation.
Active Comparator: Group 3; 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.); All patients receive posterior hybrid instrumentation.

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

Collaborators and Investigators

• Sponsor: University Hospital, Aachen

Publications and helpful links

General Publications

• Herren C, Sobottke R, Pishnamaz M, Scheyerer MJ, Bredow J, Westermann L, Berger EM, Oikonomidis S, Eysel P, Siewe J. The use of the DTO hybrid dynamic device: a clinical outcome- and radiological-based prospective clinical trial. BMC Musculoskelet Disord. 2018 Jun 21;19(1):199. doi: 10.1186/s12891-018-2103-x.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: January 5, 2018
• First Submitted That Met QC Criteria: January 18, 2018
• First Posted (Actual): January 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 19, 2018
• Last Update Submitted That Met QC Criteria: January 18, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: UKKuUKA001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No