Degenerative Disc DiseaseNCT03716947
A Comparative Study Between Mechanical and a Viscoelastic Disc Prosthesis in the Lumbar Spine
A study testing Device: ZACK, Device: ORBIT and Device: SASCA in people with Degenerative Disc Disease and Discogenic Low Back Pain, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Degenerative Disc Disease, Discogenic Low Back Pain
- What is being tested?
- Device: ZACK, Device: ORBIT and Device: SASCA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2018to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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. -
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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:
- One segment DDD appropriate for treatment with TDR.
- Two segments DDD appropriate for treatment with TDR.
- 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.
- Being tested
- Device: ZACK, Device: ORBIT, Device: SASCA
- Keywords
- Clinical outcome, Mobility, Facet-joints
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: ZACKProcedure or surgery
Surgical procedure with total disc replacement using ZACK disc prostheses
Device: ORBITProcedure or surgery
Surgical procedure with total disc replacement using ORBIT disc prostheses
Device: SASCAProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| ORBIT Mechanical disc prosthesis | Active comparator | Surgical procedure with total disc replacement using mechanical disc prosthesis device, "ORBIT, Globus Medical" Receives: Procedure: Device: ZACK |
| ZACK viscoelastic disc prosthesis | Experimental | Surgical procedure with total disc replacement using viscoelastic disc prosthesis device, "ZACK, FH Orthopaedics" Receives: 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. Receives: Procedure: Device: ZACK; Procedure: 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. Receives: Procedure: Device: ORBIT; Procedure: Device: SASCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2, 5, 10 years
Secondary outcomes (6)
VAS, Visual Analogue Scale
VAS (Visual Analogue Scale, 0 no pain, 100 worst possible pain) of back and leg,collected from questionnaires
Measured: 2, 5, 10 years
ODI, Oswestry disability index
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)
Measured: 2, 5, 10 years
EQ-5D, Health-related quality of life
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.
Measured: 2, 5, 10 years
Re-operation related to facet-joint arthritis
Medical records, questionnaires and further registrations in SweSpine reporting repeat surgery, with a differentiation of the medical reason for that intervention.
Measured: 2, 5, 10 years
Facet-joint pathology prevalence
Prevalence of radiological signs of arthritis or ankylosis from flex-ext X-rays and 3D-CT
Measured: 2, 5, 10 years
Postoperative complications
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
Measured: Two years after the last patient is treated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start1 Feb 2018
- Primary completion1 Aug 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Svante Berg, Karolinska Institutet
- Investigators
- Svante Berg, MD,PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716947
- Sponsor's protocol ID
- mojje
- Status last verified
- Dec 2020
- First submitted
- 12 Jul 2018
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03716947
- Acronym / sponsor ID
- mojje
- Keywords
- Clinical outcome, Mobility, Facet-joints
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- One segment DDD appropriate for treatment with TDR.
- Two segments DDD appropriate for treatment with TDR.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ORBIT Mechanical disc prosthesis | Active comparator | Procedure: Device: ZACKSurgical procedure with total disc replacement using mechanical disc prosthesis device, "ORBIT, Globus Medical" |
| ZACK viscoelastic disc prosthesis | Experimental | Procedure: Device: ORBITSurgical procedure with total disc replacement using viscoelastic disc prosthesis device, "ZACK, FH Orthopaedics" |
| ORBIT SASCA | Active comparator | Procedure: Device: ZACK, Procedure: Device: SASCASurgical procedure with total disc replacement (TDR) using ORBIT disc prostheses device combined with adjacent level anterior intracorporal fusion (ALIF) with intracorporal device SASCA. |
| ZACK SASCA | Experimental | Procedure: Device: ORBIT, Procedure: Device: SASCASurgical procedure with total disc replacement (TDR) using ZACK disc prostheses device combined with adjacent level anterior intracorporal fusion (ALIF) with intracorporal device SASCA. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: ZACKSurgical procedure with total disc replacement using ZACK disc prostheses | Procedure or surgery | ORBIT Mechanical disc prosthesis, ORBIT SASCA |
| Device: ORBITSurgical procedure with total disc replacement using ORBIT disc prostheses | Procedure or surgery | ZACK SASCA, ZACK viscoelastic disc prosthesis |
| Device: SASCASurgical 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) | Procedure or surgery | ORBIT SASCA, ZACK SASCA |
Primary outcome
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
6 secondary outcomes
VAS, Visual Analogue Scale
Time frame: 2, 5, 10 years
ODI, Oswestry disability index
Time frame: 2, 5, 10 years
EQ-5D, Health-related quality of life
Time frame: 2, 5, 10 years
Re-operation related to facet-joint arthritis
Time frame: 2, 5, 10 years
Facet-joint pathology prevalence
Time frame: 2, 5, 10 years
Postoperative complications
Time frame: Two years after the last patient is treated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Svante Berg, MD,PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: ZACK, Device: ORBIT and Device: SASCA in people with Degenerative Disc Disease and Discogenic Low Back Pain, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported back pain after two years in Swespine national registry (time frame: 2, 5, 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020.