Displacement of Intervertebral Disc Without MyelopathyNCT05927662
Results of Mini-open Discectomy According to Sagittal Profile
An observational study of Displacement of Intervertebral Disc Without Myelopathy, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
In the normal healthy population, the sagittal alignment can be divided into four types based on the size of the sacral slope and lumbar lordosis. The effect of this sagittal profile especially type 2 with almost straight lordosis on the clinical outcomes of patients after mini-open discectomy is unknown. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Displacement of Intervertebral Disc Without Myelopathy
- What is being tested?
- lumbar discectomy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 6 Feb 2023
- Phase
- Observational
- 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
Study population: Adult patients with lumbar disc herniation who are candidates for surgical treatment
Who may be able to join
- Patients with complete skeletal maturation (>18 years)
- Lumbar disc herniation with >50% canal narrowing
- Severe leg and back pain associated with large LDH
- >6 weeks of unsuccessful conservative treatment
- Signed a written consent form
Who cannot join
- Patients with spondyloarthropathy
- Recurrent disc herniation
- Spinal instability
- >10 degrees of coronal deformity
- Incomplete data in the records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Sagittal Profile of the Patient Effect the Results of Mini-open Lumbar Discectomy? A Preliminary Mid-term Results Report
In the normal healthy population, the sagittal alignment can be divided into four types based on the size of the sacral slope and lumbar lordosis. The effect of this sagittal profile especially type 2 with almost straight lordosis on the clinical outcomes of patients after mini-open discectomy is unknown. In this study, the results of patients who underwent mini-open discectomy were evaluated according to sagittal profile types of the patients.
Read the detailed description
Lumbar disc herniation (LDH) is the most common cause of sciatica and when conservative treatment fails or there is progressive neurological deficit, surgical excision of the herniated nucleosus pulposus is standard of care. Although minimally invasive methods such as endoscopic discectomy have been tried to be popular in recent years, open lumbar discectomy is still successfully performed in lumbar disc herniations due to some drawbacks of endoscopic techniques such as having long learning curve, higher radiation exposure to the surgeon, similar long-term results or the deception of commercial enterprises about endoscopic techniques and the pressure placed on surgeons in this direction.
Herniation of the nucleus pulposus as a result of massive LDH will inevitably result in disruption of normal lumbar biomechanics. Moreover, it has been shown that the healing process of the posterolateral herniation, which is biologically the weakest part of the posterior longitudinal ligament, will cause disc degeneration as a result of the repair and inflammation process in the annulus. However, the same authors claimed that, unlike the process in discogenic low back pain, macrophages in herniated discs can act to remove free pulposus fragments. There are few studies in the literature about the long-term consequences of this degeneration, which the investigators can consider as an accelerated aging process. Although clinically very successful results are obtained in the early postoperative period, it has been reported that the long-term success after discectomy may decrease from 90% to 60% over time. Depression or somatization, strenuous job and recurrent disc herniation or degeneration have been shown to cause long-term regression of results. In a prospective cohort study the authors reported a similar or worse leg pain rate in 30% of patients at the end of 10 years. In a study investigating reoperation after open lumbar discectomy, it was reported that the estimated rate of reoperation reached almost 45% at the end of 30 years.
In an extraordinary review evaluating the spinopelvic organization and the pathological adaptation to it, the mechanical stress, especially increased by hypolordosis, would cause the degenerative process in the spine to progress more rapidly. The basic theories explaining this are that the contact force, which is defined as the resultant force of the system created by gravity and abdominal pressure from the front and the dense paraspinal muscle mass from the posterior, mainly targets the discs. However, studies evaluating spinopelvic orientation in patients with LDH are limited. In a case-control study investigating the relationship between sciatica and spinopelvic harmony, more vertical sacrum, anterior C7 plumb line and hypolordosis were found in the LDH group. In a study examining the etiology and mechanism of sagittal imbalance caused by LDH, lumbar lordosis improved almost twice after endoscopic discectomy and LDH is probably one of the causes of compensatory sagittal imbalance.
Although there are studies on the pathogenesis and mechanics of LDH's etiology and post-discectomy results, the effect of the generally accepted normal lordosis types described by Roussouly P. on the degenerative process and patient scores after open standard discectomy is unknown. Therefore, in this study, the investigators aimed to compare the clinical results of patients with hypolordotic Type 2 and other types after open discectomy. Our hypothesis is that the mid-term clinical scores will be worse in Roussouly Type 2 patients with less lordosis.
- Being tested
- lumbar discectomy
- Keywords
- intervertebral disc displacement, spinal curvatures, Outcome
- Medical subject headings
- Intervertebral Disc Displacement, Spinal Curvatures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar discectomyProcedure or surgery
mini-open discectomy
| Study group | Role | What they receive |
|---|---|---|
| Type 2 | Patients with Roussouly type 2 sagittal profile Receives: Procedure: lumbar discectomy | |
| Type 1,3,4 | Patients with other Roussouly type sagittal profiles (1,3,4) Receives: Procedure: lumbar discectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
quantify disability for low back pain
Measured: change between preoperative and postoperative last (12th month) control
Japanese Orthopedic Association scores
a simple scoring measure for radiculopathy with 29 points: Excellent neurological function 25-28 points: Good neurological function 17-24 points: Fair neurological function 11-16 points: Poor neurological function 10 points and below: Bad neurological function
Measured: at 12th month control
Secondary outcomes (8)
Body mass index (kg/cm2)
demographic characteristic
Measured: preoperative
abdominal diameter
radiological assessment of coronal abdominal diameter, cm
Measured: preoperative
classification of disc degeneration
Pfirrmann grading scale for intervertebral disc degeneration where Grade I: Normal disc appearance with high signal intensity, a smooth contour, and high water content.
Grade II: Mild signs of degeneration with slightly decreased high signal intensity compared to normal discs.
Grade III: Moderate degeneration with an irregular contour, further decreased high signal intensity, and possible small fissures within the disc.
Grade IV: Severe degeneration with a more pronounced irregularity, significant decrease in high signal intensity, and presence of larger fissures and herniations within the disc.
Grade V: Advanced degeneration with a substantially decreased signal intensity, loss of contour, and structural integrity of the disc. Large herniations may be present within the disc.
Measured: change between preoperative and at 12th month control
visual analogue scale
pain rating scale from 0 (no pain) to 10 (maximum pain)
Measured: change between preoperative and postoperative 1st, 6th and 12th month controls
Tanita-SC 240 body analysis
Body fat percentages of the patients
Measured: preoperative and 12th month control
sagittal abdominal diameter
radiological assessment of sagittal abdominal diameter, cm
Measured: preoperatively
ventral subcutaneous thickness
radiological assessment of ventral fat thickness, cm
Measured: preoperatively
Adjacent muscle cross-sectional areas (cm2)
Musculus Multifidus, Erector spina and Psoas muscle cross-sectional areas
Measured: preoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Feb 2019
- Primary completion31 Jan 2022
- Study completion6 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Displacement of Intervertebral Disc Without MyelopathyStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İsmail Demirkale, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Investigators
- süheyla atay, Study chair, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927662
- Sponsor's protocol ID
- 2012KAEK15-2603
- Status last verified
- Jun 2023
- First submitted
- 8 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gadjradj PS, Harhangi BS, Amelink J, van Susante J, Kamper S, van Tulder M, Peul WC, Vleggeert-Lankamp C, Rubinstein SM. Percutaneous Transforaminal Endoscopic Discectomy Versus Open Microdiscectomy for Lumbar Disc Herniation: A Systematic Review and Meta-analysis. Spine (Phila Pa 1976). 2021 Apr 15;46(8):538-549. doi: 10.1097/BRS.0000000000003843.
PubMed 33290374Ropper AH, Zafonte RD. Sciatica. N Engl J Med. 2015 Mar 26;372(13):1240-8. doi: 10.1056/NEJMra1410151. No abstract available.
PubMed 25806916Hsu HT, Chang SJ, Yang SS, Chai CL. Learning curve of full-endoscopic lumbar discectomy. Eur Spine J. 2013 Apr;22(4):727-33. doi: 10.1007/s00586-012-2540-4. Epub 2012 Oct 17.
PubMed 23076645Ahn Y, Kim CH, Lee JH, Lee SH, Kim JS. Radiation exposure to the surgeon during percutaneous endoscopic lumbar discectomy: a prospective study. Spine (Phila Pa 1976). 2013 Apr 1;38(7):617-25. doi: 10.1097/BRS.0b013e318275ca58.
PubMed 23026867Gadjradj PS, Rubinstein SM, Peul WC, Depauw PR, Vleggeert-Lankamp CL, Seiger A, van Susante JL, de Boer MR, van Tulder MW, Harhangi BS. Full endoscopic versus open discectomy for sciatica: randomised controlled non-inferiority trial. BMJ. 2022 Feb 21;376:e065846. doi: 10.1136/bmj-2021-065846.
PubMed 35190388Peng B, Hao J, Hou S, Wu W, Jiang D, Fu X, Yang Y. Possible pathogenesis of painful intervertebral disc degeneration. Spine (Phila Pa 1976). 2006 Mar 1;31(5):560-6. doi: 10.1097/01.brs.0000201324.45537.46.
PubMed 16508552Benzakour A, Benzakour T. Lumbar disc herniation: long-term outcomes after mini-open discectomy. Int Orthop. 2019 Apr;43(4):869-874. doi: 10.1007/s00264-019-04312-2. Epub 2019 Mar 8.
PubMed 30848331Prolo DJ, Oklund SA, Butcher M. Toward uniformity in evaluating results of lumbar spine operations. A paradigm applied to posterior lumbar interbody fusions. Spine (Phila Pa 1976). 1986 Jul-Aug;11(6):601-6. doi: 10.1097/00007632-198607000-00012.
PubMed 3787326Guo JJ, Yang H, Tang T. Long-term outcomes of the revision open lumbar discectomy by fenestration: A follow-up study of more than 10 years. Int Orthop. 2009 Oct;33(5):1341-5. doi: 10.1007/s00264-008-0648-2. Epub 2008 Oct 14.
PubMed 18853159Loupasis GA, Stamos K, Katonis PG, Sapkas G, Korres DS, Hartofilakidis G. Seven- to 20-year outcome of lumbar discectomy. Spine (Phila Pa 1976). 1999 Nov 15;24(22):2313-7. doi: 10.1097/00007632-199911150-00005.
PubMed 10586454Atlas SJ, Keller RB, Wu YA, Deyo RA, Singer DE. Long-term outcomes of surgical and nonsurgical management of sciatica secondary to a lumbar disc herniation: 10 year results from the maine lumbar spine study. Spine (Phila Pa 1976). 2005 Apr 15;30(8):927-35. doi: 10.1097/01.brs.0000158954.68522.2a.
PubMed 15834338Son IN, Kim YH, Ha KY. Long-term clinical outcomes and radiological findings and their correlation with each other after standard open discectomy for lumbar disc herniation. J Neurosurg Spine. 2015 Feb;22(2):179-84. doi: 10.3171/2014.10.SPINE131126. Epub 2014 Nov 28.
PubMed 25431963Roussouly P, Pinheiro-Franco JL. Biomechanical analysis of the spino-pelvic organization and adaptation in pathology. Eur Spine J. 2011 Sep;20 Suppl 5(Suppl 5):609-18. doi: 10.1007/s00586-011-1928-x. Epub 2011 Aug 2.
PubMed 21809016Endo K, Suzuki H, Tanaka H, Kang Y, Yamamoto K. Sagittal spinal alignment in patients with lumbar disc herniation. Eur Spine J. 2010 Mar;19(3):435-8. doi: 10.1007/s00586-009-1240-1. Epub 2009 Dec 20.
PubMed 20091188Liang C, Sun J, Cui X, Jiang Z, Zhang W, Li T. Spinal sagittal imbalance in patients with lumbar disc herniation: its spinopelvic characteristics, strength changes of the spinal musculature and natural history after lumbar discectomy. BMC Musculoskelet Disord. 2016 Jul 22;17:305. doi: 10.1186/s12891-016-1164-y.
PubMed 27444272
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Sagittal Profile of the Patient Effect the Results of Mini-open Lumbar Discectomy? A Preliminary Mid-term Results Report
- ClinicalTrials.gov ID
- NCT05927662
- Acronym / sponsor ID
- 2012KAEK15-2603
- Keywords
- intervertebral disc displacement, spinal curvatures, Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 6 Feb 2023 (actual)
- First posted
- 3 Jul 2023 (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.
In the normal healthy population, the sagittal alignment can be divided into four types based on the size of the sacral slope and lumbar lordosis. The effect of this sagittal profile especially type 2 with almost straight lordosis on the clinical outcomes of patients after mini-open discectomy is unknown. In this study, the results of patients who underwent mini-open discectomy were evaluated according to sagittal profile types of the patients.
Detailed description
Lumbar disc herniation (LDH) is the most common cause of sciatica and when conservative treatment fails or there is progressive neurological deficit, surgical excision of the herniated nucleosus pulposus is standard of care. Although minimally invasive methods such as endoscopic discectomy have been tried to be popular in recent years, open lumbar discectomy is still successfully performed in lumbar disc herniations due to some drawbacks of endoscopic techniques such as having long learning curve, higher radiation exposure to the surgeon, similar long-term results or the deception of commercial enterprises about endoscopic techniques and the pressure placed on surgeons in this direction.
Herniation of the nucleus pulposus as a result of massive LDH will inevitably result in disruption of normal lumbar biomechanics. Moreover, it has been shown that the healing process of the posterolateral herniation, which is biologically the weakest part of the posterior longitudinal ligament, will cause disc degeneration as a result of the repair and inflammation process in the annulus. However, the same authors claimed that, unlike the process in discogenic low back pain, macrophages in herniated discs can act to remove free pulposus fragments. There are few studies in the literature about the long-term consequences of this degeneration, which the investigators can consider as an accelerated aging process. Although clinically very successful results are obtained in the early postoperative period, it has been reported that the long-term success after discectomy may decrease from 90% to 60% over time. Depression or somatization, strenuous job and recurrent disc herniation or degeneration have been shown to cause long-term regression of results. In a prospective cohort study the authors reported a similar or worse leg pain rate in 30% of patients at the end of 10 years. In a study investigating reoperation after open lumbar discectomy, it was reported that the estimated rate of reoperation reached almost 45% at the end of 30 years.
In an extraordinary review evaluating the spinopelvic organization and the pathological adaptation to it, the mechanical stress, especially increased by hypolordosis, would cause the degenerative process in the spine to progress more rapidly. The basic theories explaining this are that the contact force, which is defined as the resultant force of the system created by gravity and abdominal pressure from the front and the dense paraspinal muscle mass from the posterior, mainly targets the discs. However, studies evaluating spinopelvic orientation in patients with LDH are limited. In a case-control study investigating the relationship between sciatica and spinopelvic harmony, more vertical sacrum, anterior C7 plumb line and hypolordosis were found in the LDH group. In a study examining the etiology and mechanism of sagittal imbalance caused by LDH, lumbar lordosis improved almost twice after endoscopic discectomy and LDH is probably one of the causes of compensatory sagittal imbalance.
Although there are studies on the pathogenesis and mechanics of LDH's etiology and post-discectomy results, the effect of the generally accepted normal lordosis types described by Roussouly P. on the degenerative process and patient scores after open standard discectomy is unknown. Therefore, in this study, the investigators aimed to compare the clinical results of patients with hypolordotic Type 2 and other types after open discectomy. Our hypothesis is that the mid-term clinical scores will be worse in Roussouly Type 2 patients with less lordosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 | – | Procedure: lumbar discectomyPatients with Roussouly type 2 sagittal profile |
| Type 1,3,4 | – | Procedure: lumbar discectomyPatients with other Roussouly type sagittal profiles (1,3,4) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with lumbar disc herniation who are candidates for surgical treatment
Key inclusion criteria (5 listed)
- Patients with complete skeletal maturation (>18 years)
- Lumbar disc herniation with >50% canal narrowing
- Severe leg and back pain associated with large LDH
- >6 weeks of unsuccessful conservative treatment
- Signed a written consent form
Key exclusion criteria (5 listed)
- Patients with spondyloarthropathy
- Recurrent disc herniation
- Spinal instability
- >10 degrees of coronal deformity
- Incomplete data in the records
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 |
|---|---|---|
| lumbar discectomymini-open discectomy | Procedure or surgery | Type 1,3,4, Type 2 |
Primary outcome
Oswestry Disability Index (ODI)
Time frame: change between preoperative and postoperative last (12th month) control
quantify disability for low back pain
Japanese Orthopedic Association scores
Time frame: at 12th month control
a simple scoring measure for radiculopathy with 29 points: Excellent neurological function 25-28 points: Good neurological function 17-24 points: Fair neurological function 11-16 points: Poor neurological function 10 points and below: Bad neurological function
8 secondary outcomes
Body mass index (kg/cm2)
Time frame: preoperative
abdominal diameter
Time frame: preoperative
classification of disc degeneration
Time frame: change between preoperative and at 12th month control
visual analogue scale
Time frame: change between preoperative and postoperative 1st, 6th and 12th month controls
Tanita-SC 240 body analysis
Time frame: preoperative and 12th month control
sagittal abdominal diameter
Time frame: preoperatively
ventral subcutaneous thickness
Time frame: preoperatively
Adjacent muscle cross-sectional areas (cm2)
Time frame: preoperatively
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 3 Jul 2023.
- Results publication: PubMed 33290374Gadjradj PS, Harhangi BS, Amelink J, van Susante J, Kamper S, van Tulder M, Peul WC, Vleggeert-Lankamp C, Rubinstein SM. Percutaneous Transforaminal Endoscopic Discectomy Versus Open Microdiscectomy for Lumbar Disc Herniation: A Systematic Review and Meta-analysis. Spine (Phila Pa 1976). 2021 Apr 15;46(8):538-549. doi: 10.1097/BRS.0000000000003843.
- Results publication: PubMed 25806916Ropper AH, Zafonte RD. Sciatica. N Engl J Med. 2015 Mar 26;372(13):1240-8. doi: 10.1056/NEJMra1410151. No abstract available.
- Results publication: PubMed 23076645Hsu HT, Chang SJ, Yang SS, Chai CL. Learning curve of full-endoscopic lumbar discectomy. Eur Spine J. 2013 Apr;22(4):727-33. doi: 10.1007/s00586-012-2540-4. Epub 2012 Oct 17.
- Results publication: PubMed 23026867Ahn Y, Kim CH, Lee JH, Lee SH, Kim JS. Radiation exposure to the surgeon during percutaneous endoscopic lumbar discectomy: a prospective study. Spine (Phila Pa 1976). 2013 Apr 1;38(7):617-25. doi: 10.1097/BRS.0b013e318275ca58.
- Results publication: PubMed 35190388Gadjradj PS, Rubinstein SM, Peul WC, Depauw PR, Vleggeert-Lankamp CL, Seiger A, van Susante JL, de Boer MR, van Tulder MW, Harhangi BS. Full endoscopic versus open discectomy for sciatica: randomised controlled non-inferiority trial. BMJ. 2022 Feb 21;376:e065846. doi: 10.1136/bmj-2021-065846.
- Results publication: PubMed 16508552Peng B, Hao J, Hou S, Wu W, Jiang D, Fu X, Yang Y. Possible pathogenesis of painful intervertebral disc degeneration. Spine (Phila Pa 1976). 2006 Mar 1;31(5):560-6. doi: 10.1097/01.brs.0000201324.45537.46.
- Results publication: PubMed 30848331Benzakour A, Benzakour T. Lumbar disc herniation: long-term outcomes after mini-open discectomy. Int Orthop. 2019 Apr;43(4):869-874. doi: 10.1007/s00264-019-04312-2. Epub 2019 Mar 8.
- Results publication: PubMed 3787326Prolo DJ, Oklund SA, Butcher M. Toward uniformity in evaluating results of lumbar spine operations. A paradigm applied to posterior lumbar interbody fusions. Spine (Phila Pa 1976). 1986 Jul-Aug;11(6):601-6. doi: 10.1097/00007632-198607000-00012.
- Results publication: PubMed 18853159Guo JJ, Yang H, Tang T. Long-term outcomes of the revision open lumbar discectomy by fenestration: A follow-up study of more than 10 years. Int Orthop. 2009 Oct;33(5):1341-5. doi: 10.1007/s00264-008-0648-2. Epub 2008 Oct 14.
- Results publication: PubMed 10586454Loupasis GA, Stamos K, Katonis PG, Sapkas G, Korres DS, Hartofilakidis G. Seven- to 20-year outcome of lumbar discectomy. Spine (Phila Pa 1976). 1999 Nov 15;24(22):2313-7. doi: 10.1097/00007632-199911150-00005.
- Results publication: PubMed 15834338Atlas SJ, Keller RB, Wu YA, Deyo RA, Singer DE. Long-term outcomes of surgical and nonsurgical management of sciatica secondary to a lumbar disc herniation: 10 year results from the maine lumbar spine study. Spine (Phila Pa 1976). 2005 Apr 15;30(8):927-35. doi: 10.1097/01.brs.0000158954.68522.2a.
- Results publication: PubMed 25431963Son IN, Kim YH, Ha KY. Long-term clinical outcomes and radiological findings and their correlation with each other after standard open discectomy for lumbar disc herniation. J Neurosurg Spine. 2015 Feb;22(2):179-84. doi: 10.3171/2014.10.SPINE131126. Epub 2014 Nov 28.
- Individual participant dataSharing planned: No
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.
süheyla atay study chair
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Displacement of Intervertebral Disc Without Myelopathy, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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 3 Jul 2023. 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 Turkey (Türkiye). 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?
Oswestry Disability Index (ODI) (time frame: change between preoperative and postoperative last (12th month) control). The study lists 2 primary outcomes in all. 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 NCT05927662, which also lists 27 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 3 Jul 2023.