NCT03716947

Brief Summary

TDR implants for the lumbar spine are currently most 2- or 3-piece devices with a purely mechanical function that provide/restore mobility. Lately interest is growing on non-mechanical implants that could possibly provide/restore mobility, but also produce counterforces on mobility as in healthy discs. No previous comparison between these two concepts has been performed, neither on clinical outcome, neither on specific differences on facet-joint load and wear.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
246

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 23, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

4.5 years

First QC Date

July 12, 2018

Last Update Submit

December 12, 2020

Conditions

Degenerative Disc DiseaseDiscogenic Low Back Pain

Keywords

Clinical outcomeMobilityFacet-joints

Outcome Measures

Primary Outcomes (1)

  • Patient reported back pain after two years in Swespine national registry

    GA (Global Assessment of back pain, patient-based evaluation of leg and back pain as compared to preoperatively,1-5, 1 disappeared and 5 worsened) ,collected from questionnaires

    2, 5, 10 years

Secondary Outcomes (6)

  • VAS, Visual Analogue Scale

    2, 5, 10 years

  • ODI, Oswestry disability index

    2, 5, 10 years

  • EQ-5D, Health-related quality of life

    2, 5, 10 years

  • Re-operation related to facet-joint arthritis

    2, 5, 10 years

  • Facet-joint pathology prevalence

    2, 5, 10 years

  • +1 more secondary outcomes

Study Arms (4)

ORBIT Mechanical disc prosthesis

ACTIVE COMPARATOR

Surgical procedure with total disc replacement using mechanical disc prosthesis device, "ORBIT, Globus Medical"

Procedure: Device: ZACK

ZACK viscoelastic disc prosthesis

EXPERIMENTAL

Surgical procedure with total disc replacement using viscoelastic disc prosthesis device, "ZACK, FH Orthopaedics"

Procedure: Device: ORBIT

ORBIT SASCA

ACTIVE COMPARATOR

Surgical procedure with total disc replacement (TDR) using ORBIT disc prostheses device combined with adjacent level anterior intracorporal fusion (ALIF) with intracorporal device SASCA.

Procedure: Device: ZACKProcedure: Device: SASCA

ZACK SASCA

EXPERIMENTAL

Surgical procedure with total disc replacement (TDR) using ZACK disc prostheses device combined with adjacent level anterior intracorporal fusion (ALIF) with intracorporal device SASCA.

Procedure: Device: ORBITProcedure: Device: SASCA

Interventions

Device: ZACKPROCEDURE

Surgical procedure with total disc replacement using ZACK disc prostheses

ORBIT Mechanical disc prosthesisORBIT SASCA
Device: ORBITPROCEDURE

Surgical procedure with total disc replacement using ORBIT disc prostheses

ZACK SASCAZACK viscoelastic disc prosthesis
Device: SASCAPROCEDURE

Surgical procedure with anterior intracorporal fusion (ALIF) combined with adjacent level total disc replacement (TDR) (using either ORBIT mechanical disc prosthesis or ZACK viscoelastic disc prosthesis)

ORBIT SASCAZACK SASCA

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Incapacitating pain from DDD (both clinical and radiological) in one or two segments below the L3 vertebra, were at least one segment is suitable for TDR treatment.
  • Patient with more than one year of pain, that has during this period made a prolonged and adequate conservative program.
  • Patient between 20 and 55 years of age. -
  • Patient able to understand written and spoken Swedish.

You may not qualify if:

  • Patient does not accept to be part of the study.
  • Three or more segments suspected to be symptomatic.
  • Earlier vertebral fracture, tumour, infection or fusion in the lumbar spine. -Substantial scoliosis/deformity.
  • Need for posterior decompression.
  • Pregnancy, psychiatric illness or drug abuse. -Patient does not understand written and spoken Swedish and can thus not take part in information and answer questionnaires.
  • Patient residing outside Sweden and thus is not covered with SweSpine. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stockholm Spine Center

Stockholm, Upplands Väsby, 194 89, Sweden

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Svante Berg, MD,PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Associate Professor, Senior Consultant

Study Record Dates

First Submitted

July 12, 2018

First Posted

October 23, 2018

Study Start

February 1, 2018

Primary Completion

August 1, 2022

Study Completion

December 1, 2022

Last Updated

December 16, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)