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

Spine Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03404232
• Other study ID #: UKKuUKA001
• Status: Completed
• Phase: N/A
• First received: January 5, 2018
• Last updated: January 18, 2018
• Start date: January 1, 2012
• Est. completion date: December 31, 2017

Study information

• Verified date: January 2018
• Source: University Hospital, Aachen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Spine Surgery

Intervention

Device:
• Dynesys DTO device (Zimmer Spine, Inc.)
All patients receive posterior hybrid instrumentation.

Locations

Country	Name	City	State
Germany	University Hospital Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Aachen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the health-related outcome measurement instruments (ODI)		24-48 months
Primary	Changes in the health-related outcome measurement instruments (COMI)		24-48 months
Primary	Changes in the health-related outcome measurement instruments (SF-36)		24-48 months
Primary	Radiological outcomes	Radiological changes within the adjacent segment	24-48 months
Secondary	Device complication (breakage, loosening, etc.)	Complication regarding the device	24 - 48 months
Secondary	Patient-related complication	general and surgical complication	24- 48 months