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

NCT03404232 | Completed

• 1 other identifier: UKKuUKA001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Spine Surgery

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Device complication (breakage, loosening, etc.)

  24 - 48 months

• Patient-related complication

  24- 48 months

Study Arms (3)

Group 1

ACTIVE COMPARATOR

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.)

Group 2

ACTIVE COMPARATOR

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.)

Group 3

ACTIVE COMPARATOR

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.)

Interventions

Dynesys DTO device (Zimmer Spine, Inc.) DEVICE

All patients receive posterior hybrid instrumentation.

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 \>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)

Sponsors & Collaborators

• University Hospital, Aachen: lead

Study Sites (1)

University Hospital Cologne

Cologne, 50937, Germany

Location

Related Publications (1)

• 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.

  PMID: 30016956 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 19, 2018
• Study Start: January 1, 2012
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2017
• Last Updated: January 19, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)