Disc Disease DegenerativeNCT03674190
A Study Comparing the Outcome of Anterior Lumbar Fusion and Total Lumbar Disc Replacement
A study testing Anterior Lumbar Interbody Fusion and Total Disc Replacement in people with Disc Disease Degenerative and Disk Degeneration, run by Svante Berg at 1 site in Sweden.
Trial summary
Total lumbar disc replacement has previously been compared to posterior fusion of the lumbar spine, showing some favor towards total disc replacement. The study aims to compare total disc replacement to anterior fusion, sparing the muscles of the back and thus comparing the two different methods using the same… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Disc Disease Degenerative, Disk Degeneration, Disc Disease Lumbar
- What is being tested?
- Anterior Lumbar Interbody Fusion and Total Disc Replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- 4 Sep 2018to Oct 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with disabling pain from degenerative disc disease(DDD) both clinical and radiological, in one or two segments of the lumbar spine from L4-S1, were prolonged conservative treatment has failed.
- The patient should be able to understand swedish written and spoken.
- The patient should be between the ages 18-65. The patient has to accept to participate in the study
Who cannot join
- More than two degenerated segments.
- Degeneration above the L4 segment.
- Did not agree to participate in the study
- Previous history of tumor, vertebral fracture, infection, lumbar fusion and dominating leg pain.
- Need for posterior decompression
- Pregnancy
- Psychiatric illness or drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Total lumbar disc replacement has previously been compared to posterior fusion of the lumbar spine, showing some favor towards total disc replacement. The study aims to compare total disc replacement to anterior fusion, sparing the muscles of the back and thus comparing the two different methods using the same surgical approach.
Read the detailed description
A total of 170 patients are planned to be enrolled in the study. If the patients meet the inclusion criteria and accept to participate they will be randomized to either anterior lumbar fusion or total disc replacement. The method of choice will be blinded for the patients until the two year follow up is completed.
Follow-up: after one and two years. Questionnairs: ODI, VAS, EuroQol, and GA Flexion- Extension X-ray after one and two years Complications will be retrieved from the patient journals.
- Being tested
- Anterior Lumbar Interbody Fusion, Total Disc Replacement
- Medical subject headings
- Intervertebral Disc Degeneration, Intervertebral disc disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Lumbar Interbody FusionProcedure or surgery
Anterior Lumbar Fusion(ALIF)
Total Disc ReplacementProcedure or surgery
Total Disc Replacement
| Study group | Role | What they receive |
|---|---|---|
| Anterior Lumbar Interbody Fusion | Experimental | Surgical treatment Anterior Lumbar Interbody Fusion Receives: Procedure: Anterior Lumbar Interbody Fusion |
| Total disc replacement | Active comparator | Surgical treatment total disc replacement in the lumbar spine Receives: Procedure: Total Disc Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
ODI, Oswestry Disability Index
ODI questionnaire. 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: Two years
Secondary outcomes (3)
VAS, Visual Analogue Scale
VAS Scale, VAS (Visual Analogue Scale, 0 no pain, 100 worst possible pain) of back and leg,collected from questionnaires
Measured: Two years
Segment Mobility
Flexion Extension X-ray
Measured: Two years
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: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start4 Sep 2018
- Primary completionOct 2020 (estimated)
- Study completionOct 2022 (estimated)
Why it stopped: Difficult to find patients that accepted the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disc Disease DegenerativeStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Svante Berg
- Sponsor type
- University, hospital or other
- Collaborators
- Yara Asterfjord
- Responsible party
- Sponsor-investigator, Svante Berg, Karolinska Institutet
- Investigators
- Svante Berg, MD, PhD, Study director, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674190
- Sponsor's protocol ID
- MollyMoa
- Status last verified
- Dec 2020
- First submitted
- 2 Sep 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 Study Comparing the Outcome of Anterior Lumbar Fusion and Total Lumbar Disc Replacement
- ClinicalTrials.gov ID
- NCT03674190
- Acronym / sponsor ID
- MollyMoa
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficult to find patients that accepted the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Svante BergUniversity, hospital or other
- Collaborators
- Yara Asterfjord
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 17 Sep 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.
Total lumbar disc replacement has previously been compared to posterior fusion of the lumbar spine, showing some favor towards total disc replacement. The study aims to compare total disc replacement to anterior fusion, sparing the muscles of the back and thus comparing the two different methods using the same surgical approach.
Detailed description
A total of 170 patients are planned to be enrolled in the study. If the patients meet the inclusion criteria and accept to participate they will be randomized to either anterior lumbar fusion or total disc replacement. The method of choice will be blinded for the patients until the two year follow up is completed.
Follow-up: after one and two years. Questionnairs: ODI, VAS, EuroQol, and GA Flexion- Extension X-ray after one and two years Complications will be retrieved from the patient journals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior Lumbar Interbody Fusion | Experimental | Procedure: Anterior Lumbar Interbody FusionSurgical treatment Anterior Lumbar Interbody Fusion |
| Total disc replacement | Active comparator | Procedure: Total Disc ReplacementSurgical treatment total disc replacement in the lumbar spine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with disabling pain from degenerative disc disease(DDD) both clinical and radiological, in one or two segments of the lumbar spine from L4-S1, were prolonged conservative treatment has failed.
- The patient should be able to understand swedish written and spoken.
- The patient should be between the ages 18-65. The patient has to accept to participate in the study
Key exclusion criteria (7 listed)
- More than two degenerated segments.
- Degeneration above the L4 segment.
- Did not agree to participate in the study
- Previous history of tumor, vertebral fracture, infection, lumbar fusion and dominating leg pain.
- Need for posterior decompression
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 |
|---|---|---|
| Anterior Lumbar Interbody FusionAnterior Lumbar Fusion(ALIF) | Procedure or surgery | Anterior Lumbar Interbody Fusion |
| Total Disc ReplacementTotal Disc Replacement | Procedure or surgery | Total disc replacement |
Primary outcome
ODI, Oswestry Disability Index
Time frame: Two years
ODI questionnaire. 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 secondary outcomes
VAS, Visual Analogue Scale
Time frame: Two years
Segment Mobility
Time frame: Two years
Patient reported back pain after two years in Swespine national registry
Time frame: Two years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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 study director
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 Anterior Lumbar Interbody Fusion and Total Disc Replacement in people with Disc Disease Degenerative and Disk Degeneration, run by Svante Berg 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 3 inclusion and 7 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: withdrawn, 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
ODI, Oswestry Disability Index (time frame: Two 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.