Lumbar Spine DegenerationALAMBUNCT04914728
Mini-invasive Lumbar Arthrodesis in Ambulatory
A study testing mini-invasive lumbar arthrodesis in people with Lumbar Spine Degeneration, run by Elsan at 1 site in France.
Trial summary
Degenerative lumbar pathologies are characterised by functional impairment and the occurrence of severe chronic pain and disability Arthrodesis of the lumbar spine is a common surgery for the treatment of degenerative lumbar pathologies. It is commonly performed during a hospital stay that can vary from 3 to 7 days. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lumbar Spine Degeneration
- What is being tested?
- mini-invasive lumbar arthrodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 28 Sep 2020to 17 Dec 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years
- Patients affiliated to a social security system.
- Informed, dated and signed consent
- ASA 1 or 2
- Patient compliant and adhering to protocol visits
- Indication for a 1-level mini-invasive lumbar arthrodesis performed by anterior or posterior approach
- Failure of conservative treatment for more than 3 months
Who cannot join
- History of lumbar arthrodesis
- Active neoplasia
- History of osteoporotic fractures of the spine
- Arthrodesis superior to 1 level
- Intolerance or contraindication to morphine treatments
- Respiratory insufficiency
Show all 15Show fewer
- Preoperative anticoagulant treatment
- Contraindication to the ambulatory care: patient living alone at home, or at a distance from the establishment, and thus requiring a follow-up care and rehabilitation hospitalization
- Patient with a body mass index of greater than 40 kg/m².
- Patient with a fever (>38°C)
- Suspected or known allergy or intolerance to the materials used and requiring a combination of different metals.
- Patient with a contraindication to the material used or for whom the use of the implant could interfere with their anatomical structures or expected physiological function.
- Pregnant or breastfeeding women
- Patient participating to an ongoing study that may interfere with the present study
- Patient under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mini-invasive Lumbar Arthrodesis in Ambulatory: Pilot Study "ALAMBU"
Degenerative lumbar pathologies are characterised by functional impairment and the occurrence of severe chronic pain and disability Arthrodesis of the lumbar spine is a common surgery for the treatment of degenerative lumbar pathologies. It is commonly performed during a hospital stay that can vary from 3 to 7 days. The development of mini-invasive techniques and the development of the Improved Rehabilitation after Surgery programmes, has considerably reduced the hospital stay of the patients. It is possible that in the future mini-invasive lumbar arthrodesis will be performed on an ambulatory as a standard procedure, but its safety, efficacy and patient satisfaction must be proven and validated.
Read the detailed description
Degenerative lumbar disease (DLD) is a condition of increasing frequency, affecting millions of patients worldwide. They are characterised by functional impairment and the occurrence of severe chronic pain and disability.
Arthrodesis of the lumbar spine is a common surgery for the treatment of DLD. It is commonly performed during a hospital stay that can vary from 3 to 7 days. The advent of mini-invasive techniques and the development of Improved Rehabilitation after Surgery program has made it possible to considerably reduce the duration of hospitalization of patients with a high rate of satisfaction, a reduction in costs and without increasing morbidity. In spinal surgery, decompression procedures such as discectomy and lumbar recalibration are frequently performed on an ambulatory. The first American studies with a low level of evidence on the management of mini-invasive lumbar arthrodesis are beginning to appear. It is quite possible that in the future this type of procedure will be carried out on an ambulatory as a standard procedure, but its safety, efficacy and patient satisfaction must be proven and validated. In the United States, 23-hour hospitalizations are considered as ambulatory procedures, whereas in France, ambulatory is qualified as such when the patient is admitted and discharged in the same day.
The study population was patients who had failed medical treatment (analgesics and rehabilitation) for more than three months and who required a mono-segmental arthrodesis procedure for the management of their lumbar-radiculalgia.
- Conditions
- Lumbar Spine Degeneration
- Being tested
- mini-invasive lumbar arthrodesis
- Keywords
- mini-invasive lumbar arthrodesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mini-invasive lumbar arthrodesisProcedure or surgery
- The mini-invasive posterior approach is performed using a trans-muscular Wiltse approach. Pedicle screws, neurological decompression and intersomatic cage placement are performed.
- The mini-invasive anterior approach is performed via a left retroperitoneal pararectal approach. After complete discectomy, an intersomatic cage stabilised by a screwed plate will be placed.
| Study group | Role | What they receive |
|---|---|---|
| mini-invasive lumbar arthrodesis | Experimental | The patient will be admitted to the hospital on the morning of the surgery, operated on the same morning by either the posterior or anterior mini-invasive approach.
The choice of the approach depends on the specificity of the pathology leading to the arthrodesis procedure and the surgeon's experience. It is the surgeon who decides this in agreement with the patient. The patient will be discharged in the evening after agreement of the anaesthetist and the surgeon. Receives: Procedure: mini-invasive lumbar arthrodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the feasibility of mini-invasive lumbar arthrodesis on an ambulatory in patients with degenerative lumbar disease who have failed with conventional treatment.
Percentage of patients with same-day discharge
Measured: within 24 hours after surgery
Secondary outcomes (41)
Evaluate the safety of ambulatory lumbar arthrodesis
Record of adverse event
Measured: through study completion, an average of 1 year
Evaluate early morbidity
Occurrence of re-hospitalization and/or emergency readmission and/or need for re-operation of the patient
Measured: within 1st week
Evaluate the short-term morbidity
Presence of a cicatrization disorder, the occurrence of an infection, neurological damage, adverse event related to the implants, vascular and/or medical problem.
Measured: within 1st month
Evaluate the mid-term morbidity
occurrence of pseudoarthrosis
Measured: within 1st year
Evaluate the patients' quality of life
Short Form-36 Health Survey questionnaire
Measured: at 1-month visit
Evaluate the patients' quality of life
Evaluated by Oswestry
Measured: at 1-month visit
Evaluate the patients' quality of life
Evaluated by Short Form-36 Health Survey questionnaire
Measured: at 6-month visit
Evaluate the patients' quality of life
Evaluated by Oswestry
Measured: at 6-month visit
Evaluate the patients' quality of life
Evaluated by Short Form-36 Health Survey questionnaire
Measured: at 1-year visit
Evaluate the patients' quality of life
Evaluated by Oswestry
Measured: at 1-year visit
Evaluate the patients' quality of life
Return to professional activity
Measured: at 1-month visit
Evaluate the patients' quality of life
Return to professional activity
Measured: at 6-month visit
Evaluate the patients' quality of life
Return to professional activity
Measured: at 1-year visit
Evaluate radiological parameters
The radiological parameter: L1S1 lumbar lordosis
Measured: at 1-month visit
Evaluate radiological parameters
The radiological parameter: Segmental lordosis of the arthrodesis level
Measured: at 1-month visit
Evaluate radiological parameters
The radiological parameter: Pelvic Incidence
Measured: at 1-month visit
Evaluate radiological parameters
The radiological parameter: Pelvic version
Measured: at 1-month visit
Evaluate radiological parameters
The radiological parameter: Sacral slope
Measured: at 1-month visit
Evaluate radiological parameters
The radiological parameter: Disc height
Measured: at 1-month visit
Evaluate radiological parameters
The radiological parameter: L1S1 lumbar lordosis
Measured: at 6-month visit
Evaluate radiological parameters
The radiological parameter: Segmental lordosis of the arthrodesis level
Measured: at 6-month visit
Evaluate radiological parameters
The radiological parameter: Pelvic Incidence
Measured: at 6-month visit
Evaluate radiological parameters
The radiological parameter: Pelvic version
Measured: at 6-month visit
Evaluate radiological parameters
The radiological parameter: Sacral slope
Measured: at 6-month visit
Evaluate radiological parameters
The radiological parameter: Disc height
Measured: at 6-month visit
Evaluate radiological parameters
The radiological parameter: L1S1 lumbar lordosis
Measured: at 1-year visit
Evaluate radiological parameters
The radiological parameter: Segmental lordosis of the arthrodesis level
Measured: at 1-year visit
Evaluate radiological parameters
The radiological parameter: Pelvic Incidence
Measured: at 1-year visit
Evaluate radiological parameters
The radiological parameter: Pelvic version
Measured: at 1-year visit
Evaluate radiological parameters
The radiological parameter: Sacral slope
Measured: at 1-year visit
Evaluate radiological parameters
The radiological parameter: Disc height
Measured: at 1-year visit
Evaluate patient satisfaction with the procedure
Satisfaction score
Measured: at 1-month visit
Evaluate patient satisfaction with the procedure
Satisfaction score
Measured: at 6-month visit
Evaluate patient satisfaction with the procedure
Satisfaction score
Measured: at 1-year visit
Evaluate lumbar pain
Lumbar Visual Analogue Scales pain
Measured: at 1-month visit
Evaluate lumbar pain
Lumbar Visual Analogue Scales pain
Measured: at 6-month visit
Evaluate lumbar pain
Lumbar Visual Analogue Scales pain
Measured: at 1-year visit
Evaluate radicular pain
Radicular Visual Analogue Scales pain
Measured: at 1-month visit
Evaluate radicular pain
Radicular Visual Analogue Scales pain
Measured: at 6-month visit
Evaluate radicular pain
Radicular Visual Analogue Scales pain
Measured: at 1-year visit
Evaluate lumbar and radicular pain
record of analgesic treatments taken before and after surgery
Measured: before the 1-month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start28 Sep 2020
- Primary completion17 Dec 2021
- Study completion17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spine DegenerationStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-centre, pilot study evaluating the feasibility, difficulties and morbidity of ambulatory lumbar arthrodesis
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis BOISSIERE, MD, Principal investigator, Unité de Chirurgie de la Colonne Vertébrale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914728
- Sponsor's protocol ID
- ALAMBU
- Other IDs
- 2020-A01211-38
- Acronym
- ALAMBU
- Status last verified
- Nov 2022
- First submitted
- 17 May 2021
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hoy D, Brooks P, Blyth F, Buchbinder R. The Epidemiology of low back pain. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):769-81. doi: 10.1016/j.berh.2010.10.002.
PubMed 21665125Peng CW, Yue WM, Poh SY, Yeo W, Tan SB. Clinical and radiological outcomes of minimally invasive versus open transforaminal lumbar interbody fusion. Spine (Phila Pa 1976). 2009 Jun 1;34(13):1385-9. doi: 10.1097/BRS.0b013e3181a4e3be.
PubMed 19478658Dietz N, Sharma M, Adams S, Alhourani A, Ugiliweneza B, Wang D, Nuno M, Drazin D, Boakye M. Enhanced Recovery After Surgery (ERAS) for Spine Surgery: A Systematic Review. World Neurosurg. 2019 Oct;130:415-426. doi: 10.1016/j.wneu.2019.06.181. Epub 2019 Jul 2.
PubMed 31276851Sivaganesan A, Hirsch B, Phillips FM, McGirt MJ. Spine Surgery in the Ambulatory Surgery Center Setting: Value-Based Advancement or Safety Liability? Neurosurgery. 2018 Aug 1;83(2):159-165. doi: 10.1093/neuros/nyy057.
PubMed 29538716Wiltse LL, Bateman JG, Hutchinson RH, Nelson WE. The paraspinal sacrospinalis-splitting approach to the lumbar spine. J Bone Joint Surg Am. 1968 Jul;50(5):919-26. No abstract available.
PubMed 5676831Harmon PH. A simplified surgical technic for anterior lumbar diskectomy and fusion; avoidance of complications; anatomy of the retroperitoneal veins. Clin Orthop Relat Res. 1964 Nov-Dec;37:130-44. No abstract available.
PubMed 5889125Perneger TV, Leplege A, Etter JF, Rougemont A. Validation of a French-language version of the MOS 36-Item Short Form Health Survey (SF-36) in young healthy adults. J Clin Epidemiol. 1995 Aug;48(8):1051-60. doi: 10.1016/0895-4356(94)00227-h.
PubMed 7775992Hayashi K, Boissiere L, Guevara-Villazon F, Larrieu D, Nunez-Pereira S, Bourghli A, Gille O, Vital JM, Pellise F, Sanchez Perez-Grueso FJ, Kleinstuck F, Acaroglu E, Alanay A, Obeid I. Factors influencing patient satisfaction after adult scoliosis and spinal deformity surgery. J Neurosurg Spine. 2019 May 10;31(3):408-417. doi: 10.3171/2019.2.SPINE181486. Print 2019 Sep 1.
PubMed 31075761Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
PubMed 26092476
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mini-invasive Lumbar Arthrodesis in Ambulatory: Pilot Study "ALAMBU"
- ClinicalTrials.gov ID
- NCT04914728
- Acronym / sponsor ID
- ALAMBU / ALAMBU
- Conditions
- Lumbar Spine Degeneration
- Keywords
- mini-invasive lumbar arthrodesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 7 Jun 2021 (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.
Degenerative lumbar pathologies are characterised by functional impairment and the occurrence of severe chronic pain and disability Arthrodesis of the lumbar spine is a common surgery for the treatment of degenerative lumbar pathologies. It is commonly performed during a hospital stay that can vary from 3 to 7 days. The development of mini-invasive techniques and the development of the Improved Rehabilitation after Surgery programmes, has considerably reduced the hospital stay of the patients. It is possible that in the future mini-invasive lumbar arthrodesis will be performed on an ambulatory as a standard procedure, but its safety, efficacy and patient satisfaction must be proven and validated.
Detailed description
Degenerative lumbar disease (DLD) is a condition of increasing frequency, affecting millions of patients worldwide. They are characterised by functional impairment and the occurrence of severe chronic pain and disability.
Arthrodesis of the lumbar spine is a common surgery for the treatment of DLD. It is commonly performed during a hospital stay that can vary from 3 to 7 days. The advent of mini-invasive techniques and the development of Improved Rehabilitation after Surgery program has made it possible to considerably reduce the duration of hospitalization of patients with a high rate of satisfaction, a reduction in costs and without increasing morbidity. In spinal surgery, decompression procedures such as discectomy and lumbar recalibration are frequently performed on an ambulatory. The first American studies with a low level of evidence on the management of mini-invasive lumbar arthrodesis are beginning to appear. It is quite possible that in the future this type of procedure will be carried out on an ambulatory as a standard procedure, but its safety, efficacy and patient satisfaction must be proven and validated. In the United States, 23-hour hospitalizations are considered as ambulatory procedures, whereas in France, ambulatory is qualified as such when the patient is admitted and discharged in the same day.
The study population was patients who had failed medical treatment (analgesics and rehabilitation) for more than three months and who required a mono-segmental arthrodesis procedure for the management of their lumbar-radiculalgia.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-centre, pilot study evaluating the feasibility, difficulties and morbidity of ambulatory lumbar arthrodesis
| Arm | Type | Receives |
|---|---|---|
| mini-invasive lumbar arthrodesis | Experimental | Procedure: mini-invasive lumbar arthrodesisThe patient will be admitted to the hospital on the morning of the surgery, operated on the same morning by either the posterior or anterior mini-invasive approach. The choice of the approach depends on the specificity of the pathology leading to the arthrodesis procedure and the surgeon's experience. It is the surgeon who decides this in agreement with the patient. The patient will be discharged in the evening after agreement of the anaesthetist and the surgeon. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 75 years
- Patients affiliated to a social security system.
- Informed, dated and signed consent
- ASA 1 or 2
- Patient compliant and adhering to protocol visits
Key exclusion criteria (15 listed)
- History of lumbar arthrodesis
- Active neoplasia
- History of osteoporotic fractures of the spine
- Arthrodesis superior to 1 level
- Intolerance or contraindication to morphine treatments
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 |
|---|---|---|
| mini-invasive lumbar arthrodesis* The mini-invasive posterior approach is performed using a trans-muscular Wiltse approach. Pedicle screws, neurological decompression and intersomatic cage placement are performed. * The mini-invasive anterior approach is performed via a left retroperitoneal pararectal approach. After complete discectomy, an intersomatic cage stabilised by a screwed plate will be placed. | Procedure or surgery | mini-invasive lumbar arthrodesis |
Primary outcome
To evaluate the feasibility of mini-invasive lumbar arthrodesis on an ambulatory in patients with degenerative lumbar disease who have failed with conventional treatment.
Time frame: within 24 hours after surgery
Percentage of patients with same-day discharge
41 secondary outcomes
Evaluate the safety of ambulatory lumbar arthrodesis
Time frame: through study completion, an average of 1 year
Evaluate early morbidity
Time frame: within 1st week
Evaluate the short-term morbidity
Time frame: within 1st month
Evaluate the mid-term morbidity
Time frame: within 1st year
Evaluate the patients' quality of life
Time frame: at 1-month visit
Evaluate the patients' quality of life
Time frame: at 1-month visit
Evaluate the patients' quality of life
Time frame: at 6-month visit
Evaluate the patients' quality of life
Time frame: at 6-month visit
Evaluate the patients' quality of life
Time frame: at 1-year visit
Evaluate the patients' quality of life
Time frame: at 1-year visit
Evaluate the patients' quality of life
Time frame: at 1-month visit
Evaluate the patients' quality of life
Time frame: at 6-month visit
Evaluate the patients' quality of life
Time frame: at 1-year visit
Evaluate radiological parameters
Time frame: at 1-month visit
Evaluate radiological parameters
Time frame: at 1-month visit
Evaluate radiological parameters
Time frame: at 1-month visit
Evaluate radiological parameters
Time frame: at 1-month visit
Evaluate radiological parameters
Time frame: at 1-month visit
Evaluate radiological parameters
Time frame: at 1-month visit
Evaluate radiological parameters
Time frame: at 6-month visit
Evaluate radiological parameters
Time frame: at 6-month visit
Evaluate radiological parameters
Time frame: at 6-month visit
Evaluate radiological parameters
Time frame: at 6-month visit
Evaluate radiological parameters
Time frame: at 6-month visit
Evaluate radiological parameters
Time frame: at 6-month visit
Evaluate radiological parameters
Time frame: at 1-year visit
Evaluate radiological parameters
Time frame: at 1-year visit
Evaluate radiological parameters
Time frame: at 1-year visit
Evaluate radiological parameters
Time frame: at 1-year visit
Evaluate radiological parameters
Time frame: at 1-year visit
Evaluate radiological parameters
Time frame: at 1-year visit
Evaluate patient satisfaction with the procedure
Time frame: at 1-month visit
Evaluate patient satisfaction with the procedure
Time frame: at 6-month visit
Evaluate patient satisfaction with the procedure
Time frame: at 1-year visit
Evaluate lumbar pain
Time frame: at 1-month visit
Evaluate lumbar pain
Time frame: at 6-month visit
Evaluate lumbar pain
Time frame: at 1-year visit
Evaluate radicular pain
Time frame: at 1-month visit
Evaluate radicular pain
Time frame: at 6-month visit
Evaluate radicular pain
Time frame: at 1-year visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Background: PubMed 21665125Hoy D, Brooks P, Blyth F, Buchbinder R. The Epidemiology of low back pain. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):769-81. doi: 10.1016/j.berh.2010.10.002.
- Background: PubMed 19478658Peng CW, Yue WM, Poh SY, Yeo W, Tan SB. Clinical and radiological outcomes of minimally invasive versus open transforaminal lumbar interbody fusion. Spine (Phila Pa 1976). 2009 Jun 1;34(13):1385-9. doi: 10.1097/BRS.0b013e3181a4e3be.
- Background: PubMed 31276851Dietz N, Sharma M, Adams S, Alhourani A, Ugiliweneza B, Wang D, Nuno M, Drazin D, Boakye M. Enhanced Recovery After Surgery (ERAS) for Spine Surgery: A Systematic Review. World Neurosurg. 2019 Oct;130:415-426. doi: 10.1016/j.wneu.2019.06.181. Epub 2019 Jul 2.
- Background: PubMed 29538716Sivaganesan A, Hirsch B, Phillips FM, McGirt MJ. Spine Surgery in the Ambulatory Surgery Center Setting: Value-Based Advancement or Safety Liability? Neurosurgery. 2018 Aug 1;83(2):159-165. doi: 10.1093/neuros/nyy057.
- Background: PubMed 5676831Wiltse LL, Bateman JG, Hutchinson RH, Nelson WE. The paraspinal sacrospinalis-splitting approach to the lumbar spine. J Bone Joint Surg Am. 1968 Jul;50(5):919-26. No abstract available.
- Background: PubMed 5889125Harmon PH. A simplified surgical technic for anterior lumbar diskectomy and fusion; avoidance of complications; anatomy of the retroperitoneal veins. Clin Orthop Relat Res. 1964 Nov-Dec;37:130-44. No abstract available.
- Background: PubMed 7775992Perneger TV, Leplege A, Etter JF, Rougemont A. Validation of a French-language version of the MOS 36-Item Short Form Health Survey (SF-36) in young healthy adults. J Clin Epidemiol. 1995 Aug;48(8):1051-60. doi: 10.1016/0895-4356(94)00227-h.
- Background: PubMed 31075761Hayashi K, Boissiere L, Guevara-Villazon F, Larrieu D, Nunez-Pereira S, Bourghli A, Gille O, Vital JM, Pellise F, Sanchez Perez-Grueso FJ, Kleinstuck F, Acaroglu E, Alanay A, Obeid I. Factors influencing patient satisfaction after adult scoliosis and spinal deformity surgery. J Neurosurg Spine. 2019 May 10;31(3):408-417. doi: 10.3171/2019.2.SPINE181486. Print 2019 Sep 1.
- Background: PubMed 26092476Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
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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.
Louis BOISSIERE, MD principal investigator
Unité de Chirurgie de la Colonne Vertébrale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mini-invasive lumbar arthrodesis in people with Lumbar Spine Degeneration, run by Elsan at 1 site in France.
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 7 inclusion and 15 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: finished, as of the sponsor's last update on 21 Nov 2022. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the feasibility of mini-invasive lumbar arthrodesis on an ambulatory in patients with degenerative lumbar disease who have failed with conventional treatment. (time frame: within 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04914728, which also lists 9 linked publications.
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 21 Nov 2022.