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A Comparative Study Between Mechanical and a Viscoelastic Disc Prosthesis in the Lumbar Spine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716947
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Svante Berg, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Discogenic Low Back Pain Procedure: Device: ZACK Procedure: Device: ORBIT Procedure: Device: SASCA Not Applicable

Detailed Description:

A total of 250 patients are to be enrolled and treated. Inclusion criteria is unbearable pain and dysfunction from degenerative disc disease (DDD) that at one or two segments in the lover lumbar spine, that has not responded positively from at least one year of conservative treatment (that is combination of intense physical training and drugs).

Patients with DDD below L3 vertebra are divided I three groups:

  1. One segment DDD appropriate for treatment with TDR.
  2. Two segments DDD appropriate for treatment with TDR.
  3. One segment DDD appropriate for treatment with TDR and one segment DDD not appropriate for treatment with TDR, that will be treated with anterior fusion (ALIF) at the same surgical procedure, called "hybrids". Within all three groups there will be an equal randomization between the two prosthesis types.

Clinical outcome will be evaluated from questionnaires sent out to patients after 12- and 24 months and 5- and 10 years after surgery. The questionnaire are the currently used ones from the Swedish Spine Registry (SweSpine) including VAS leg/back, EuroQol ,GA and ODI. Complications will be registered continuously and facet-joint load/health will be examined from flex-ext x-rays at 1 and 2 years. At the 2-year check up a 3D-CT will be performed to further evaluate the facet joints and their load under flex-ext.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study Between Mechanical and a Viscoelastic Disc Prosthesis in the Lumbar Spine. A Comparison on Clinical Outcome and Facet-joint Load Between Two Different TDR Designs.
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ORBIT Mechanical disc prosthesis
Surgical procedure with total disc replacement using mechanical disc prosthesis device, "ORBIT, Globus Medical"
Procedure: Device: ZACK
Surgical procedure with total disc replacement using ZACK disc prostheses

Experimental: ZACK viscoelastic disc prosthesis
Surgical procedure with total disc replacement using viscoelastic disc prosthesis device, "ZACK, FH Orthopaedics"
Procedure: Device: ORBIT
Surgical procedure with total disc replacement using ORBIT disc prostheses

Active Comparator: ORBIT SASCA
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: ZACK
Surgical procedure with total disc replacement using ZACK disc prostheses

Procedure: Device: SASCA
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)

Experimental: ZACK SASCA
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: ORBIT
Surgical procedure with total disc replacement using ORBIT disc prostheses

Procedure: Device: SASCA
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)




Primary Outcome Measures :
  1. Patient reported back pain after two years in Swespine national registry [ Time Frame: 2, 5, 10 years ]
    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


Secondary Outcome Measures :
  1. VAS, Visual Analogue Scale [ Time Frame: 2, 5, 10 years ]
    VAS (Visual Analogue Scale, 0 no pain, 100 worst possible pain) of back and leg,collected from questionnaires

  2. ODI, Oswestry disability index [ Time Frame: 2, 5, 10 years ]
    ODI (Oswestry disability index, self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel, 0-5 zero indicating the least amount of disability and 5 indicating most severe disability)

  3. EQ-5D, Health-related quality of life [ Time Frame: 2, 5, 10 years ]
    EuroQol EQ-5D-5L, Self-completed questionnaire regarding mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.

  4. Re-operation related to facet-joint arthritis [ Time Frame: 2, 5, 10 years ]
    Medical records, questionnaires and further registrations in SweSpine reporting repeat surgery, with a differentiation of the medical reason for that intervention.

  5. Facet-joint pathology prevalence [ Time Frame: 2, 5, 10 years ]
    Prevalence of radiological signs of arthritis or ankylosis from flex-ext X-rays and 3D-CT

  6. Postoperative complications [ Time Frame: Two years after the last patient is treated ]
    Medical records will be evaluated for surgically related complications, death, infection, bleeding, implant loosening, re-operation/revision, neurological complication, thrombosis, implant failure, implant malpositioning/displacement, non-union, incisional hernia, retrograde ejaculation



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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. -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716947


Contacts
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Contact: Svante Berg, MD, PhD +46850902700 svante.berg@spinecenter.se
Contact: Kim Stranger, MD +46850902700 kim.stranger@spinecenter.se

Locations
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Sweden
Stockholm Spine Center Recruiting
Stockholm, Upplands Väsby, Sweden, 194 89
Contact: Svante Berg, MD, PhD         
Principal Investigator: Svante Berg, MD, Phd         
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Svante Berg, MD, PhD Karolinska Institutet, Stockholm, Sweden

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Responsible Party: Svante Berg, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03716947    
Other Study ID Numbers: mojje
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Svante Berg, Karolinska Institutet:
Clinical outcome
Mobility
Facet-joints
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases