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

University Hospital, Aachen

Status: Completed

Conditions: Spine Surgery

Treatments: Device: Dynesys DTO device (Zimmer Spine, Inc.)

Study type: Interventional

Funder types: Other

Identifiers

NCT03404232

UKKuUKA001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Group 1

Active Comparator group

Description:

patients with their first surgical intervention at the lumbar spine receive the Dynesys DTO device (Zimmer Spine, Inc.).

Treatment:

Device: Dynesys DTO device (Zimmer Spine, Inc.)

Group 2

Active Comparator group

Description:

patients with a previous surgical decompression but non-fusion procedure after lumbar spinal stenosis surgery receive the Dynesys DTO device (Zimmer Spine, Inc.).

Treatment:

Device: Dynesys DTO device (Zimmer Spine, Inc.)

Group 3

Active Comparator group

Description:

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.).

Treatment:

Device: Dynesys DTO device (Zimmer Spine, Inc.)