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Lumbar Disc DiseasePhase 4NCT06034041

The Effect of Mediclore as an Anti-adhesion Agent and Safety in Full-endoscopic Spine Surgery: a Preliminary Study

A Phase 4 study testing Mediclore and Normal Saline in people with Lumbar Disc Disease and Epidural Fibrosis, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical trial is to compare efficacy and safety of Mediclore as anti-adhesion agent in patient who undergo endoscopic lumbar discectomy. The main question[s] it aims to answer are: efficacy (patient-reported outcomes, epidural fibrosis) safety (complications) Participants will received Mediclore at… Read more about this study

Who is it for?
Ages 20 to 80 years
What is being tested?
Mediclore and Normal Saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
78 participants
Where
1 siteThailand
Study dates
Oct 2023to Jun 2024
Phase
Phase 4
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Lumbar disc herniated patients
  • Failed proper conservative treatment more than 6 months

Who cannot join

  • Previous history of lumbar spine surgery OR lumbar epidural steroid injection
  • Infection OR malignancy
  • Allergic to any given components
  • Lactation and pregnency

Trial locations and contacts

1 site in 1 country.

Nattapat Tangchitcharoen, MD contact

6622565351

t-nattapat@hotmail.com

Thailand1 site

  • King Chulalongkorn Memorial Hospital

    Pathum Wan, Bangkok, 10330

    Nattapat Tangchitcharoen, MD, t-nattapat@hotmail.com

Other trials in Thailand

About this study

The goal of this clinical trial is to compare efficacy and safety of Mediclore as anti-adhesion agent in patient who undergo endoscopic lumbar discectomy. The main question[s] it aims to answer are:

  • efficacy (patient-reported outcomes, epidural fibrosis)
  • safety (complications) Participants will received Mediclore at surgical site after finish the operation in experimental group and normal saline in control group.

Researchers will compare to see if experimental group have better patient-reported outcomes (PROs) after surgery with no different in complications rate.

Read the detailed description

This study is a randomized clinical trial arrange in King Chulalongkorn Memorial Hospital. Participant will be randomly assigned into 2 groups by computer-generated sequence. Patients based-line characteristic data, patient-reported outcomes (VAS back/leg, ODI and EQ-5D) and a results of straight leg raising test will be collected. Participant will undergo a endoscopic lumbar discectomy by a singer spine surgeon. In experimental group, 1.5 CC. of Mediclore (poloxamer-based thermosensitive anti-adhesive agent) will be applied in after finish the operation. In control group normal saline 1.5 CC. will be applied instead.

Participants will proceed to regular follow-up protocol which include 1, 3 and 6 months visit at out-patient department. All of the PROs and a result of a straight leg raising test will be collected at each visit. MRI will be performed at 3 month after the surgery. The amount of epidural fibrosis will be evaluated according to Ross's method.

Being tested
Mediclore, Normal Saline
Medical subject headings
Intervertebral disc disease, Failed Back Surgery Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MedicloreDrug

    After finish the operation, Mediclore group will be applied 1.5 CC of Mediclore at the surgical site. Mediclore is a Poloxamer-based thermosensitive anti-adhesive agent which is in a liquid solution and transform to a gel-state after being in a body temperature.

  • Normal SalineDrug

    Also called Control

    After finish the operation, Control group will be applied 1.5 CC of normal saline at the surgical site.

Study groups in NCT06034041
Study groupRoleWhat they receive
MedicloreExperimentalAfter finish the operation, Mediclore group will be applied 1.5 CC of Mediclore at the surgical site. Mediclore is a Poloxamer-based thermosensitive anti-adhesive agent which is in a liquid solution and transform to a gel-state after being in a body temperature.
Receives: Drug: Mediclore
ControlPlacebo comparatorAfter finish the operation, Control group will be applied 1.5 CC of normal saline at the surgical site.
Receives: Drug: Normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analogue Score for Leg pain (VAS Leg)

    The VAS Leg consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('the worst pain in a lifetime'). The patient was asked to rate their current pain level by pointing the mark on the line.

    Measured: 3 month after surgery

Secondary outcomes (6)

  1. Visual Analogue Score for Leg and Back pain (VAS Leg, Back)

    The VAS Leg and Back consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('the worst pain in a lifetime'). The patient was asked to rate their current pain level by pointing the mark on the line.

    Measured: 1, 3 and 6 month after surgery (for VAS Back) and 1 and 6 month after surgery (for VAS Leg)

  2. Oswestry Disability Index (ODI)

    The ODI consists of 10 questions to assess the function in daily activities living, in which the responses are presented as 6-point Likert scales. Scores range from 0% (no disability) to 100% (most severe disability).

    Measured: 1, 3 and 6 month after surgery

  3. EQ-5D-5L

    The EQ-5D-5L has 2 parts. In the first part, consist of 5 questions to assess the function in daily activities living, in which the responses are presented as 5 level (1 means no problems to 5 means extreme problems). The digits for the five questions can be combined into a 5-digit number that describes the patient's health state. The results will interpreted with the country specific utility score (Thailand) and reported as three decimal digit range from 0 (the worst health you can imagine) to 1 (the best health you can imagine).

    Measured: 1, 3 and 6 month after surgery

  4. Epidural Fibrosis

    Evaluation of epidural fibrosis by method proposed by Ross et al (1999) by MRI. From MRI axial cut, A surgical intervertebral level will be marked as level 3, 2 adjacent cephalic image will be marked as level 1 and 2. 2 adjacent caudad level will be marked as level 4 and 5. Then each image will be separated into 4 quadrant. Fibrosis will be graded on a scale of 0-4 for each quadrant at each imaging slice encompassing the operative level: 0 = no/trace scar; 1 = > 0-25% of quadrant filled with scar; 2 = 25-50% of quadrant filled with scar; 3 = 50-75% of quadrant filled with scar; 4 = > 75% of quadrant filled with scar. The highest grade of epidural fibrosis from any image will represent the degree of epidural ficrosis.

    Measured: 3 month after surgery

  5. Complication rate

    Measured: peri-operation, 1, 3 and 6 month after surgery

  6. Straight leg raising test

    Straight leg raising test will be performed at each visit. Results will be recorded as negative or positive. If positive, the degree that make a test positive will be also recorded.

    Measured: 1, 3 and 6 month after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2023
  2. Study startOct 2023 (estimated)
  3. Primary completionMar 2024 (estimated)
  4. Study completionJun 2024 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06034041
Sponsor's protocol ID
66
Status last verified
Sep 2023
First submitted
2 Sep 2023
Last updated
14 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Atlas SJ, Keller RB, Chang Y, Deyo RA, Singer DE. Surgical and nonsurgical management of sciatica secondary to a lumbar disc herniation: five-year outcomes from the Maine Lumbar Spine Study. Spine (Phila Pa 1976). 2001 May 15;26(10):1179-87. doi: 10.1097/00007632-200105150-00017.

    PubMed 11413434

  • Hansson E, Hansson T. The cost-utility of lumbar disc herniation surgery. Eur Spine J. 2007 Mar;16(3):329-37. doi: 10.1007/s00586-006-0131-y. Epub 2006 May 9.

    PubMed 16683121

  • Tosteson AN, Skinner JS, Tosteson TD, Lurie JD, Andersson GB, Berven S, Grove MR, Hanscom B, Blood EA, Weinstein JN. The cost effectiveness of surgical versus nonoperative treatment for lumbar disc herniation over two years: evidence from the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2008 Sep 1;33(19):2108-15. doi: 10.1097/brs.0b013e318182e390.

    PubMed 18777603

  • Loupasis 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 10586454

  • Asch HL, Lewis PJ, Moreland DB, Egnatchik JG, Yu YJ, Clabeaux DE, Hyland AH. Prospective multiple outcomes study of outpatient lumbar microdiscectomy: should 75 to 80% success rates be the norm? J Neurosurg. 2002 Jan;96(1 Suppl):34-44. doi: 10.3171/spi.2002.96.1.0034.

    PubMed 11795712

  • Ivanic GM, Pink TP, Homann NC, Scheitza W, Goyal S. The post-discectomy syndrome. Aetiology, diagnosis, treatment, prevention. Arch Orthop Trauma Surg. 2001 Oct;121(9):494-500. doi: 10.1007/s004020100289.

    PubMed 11599749

  • Hosseini S, Niakan A, Dehghankhalili M, Dehdab R, Shahjouei S, Rekabdar Y, Shaghaghian E, Shaghaghian A, Ghaffarpasand F. Effects of adhesion barrier gel on functional outcomes of patients with lumbar disc herniation surgery; A systematic review and meta-analysis of clinical trials. Heliyon. 2021 Jun 11;7(6):e07286. doi: 10.1016/j.heliyon.2021.e07286. eCollection 2021 Jun.

    PubMed 34189319

  • BenDebba M, Augustus van Alphen H, Long DM. Association between peridural scar and activity-related pain after lumbar discectomy. Neurol Res. 1999;21 Suppl 1:S37-42. doi: 10.1080/01616412.1999.11741025.

    PubMed 10214570

  • Ross JS, Robertson JT, Frederickson RC, Petrie JL, Obuchowski N, Modic MT, deTribolet N. Association between peridural scar and recurrent radicular pain after lumbar discectomy: magnetic resonance evaluation. ADCON-L European Study Group. Neurosurgery. 1996 Apr;38(4):855-61; discussion 861-3.

    PubMed 8692415

  • Ivanic GM, Pink PT, Schneider F, Stuecker M, Homann NC, Preidler KW. Prevention of epidural scarring after microdiscectomy: a randomized clinical trial comparing gel and expanded polytetrafluoroethylene membrane. Eur Spine J. 2006 Sep;15(9):1360-6. doi: 10.1007/s00586-006-0120-1. Epub 2006 Jun 9.

    PubMed 16763848

  • Guner D, Asik I, Ozgencil GE, Peker E, Erden MI. The Correlation of Epidural Fibrosis with Epiduroscopic and Radiologic Imaging for Chronic Pain after Back Surgery. Pain Physician. 2021 Dec;24(8):E1219-E1226.

    PubMed 34793648

  • Wang H, Sun W, Fu D, Shen Y, Chen YY, Wang LL. Update on biomaterials for prevention of epidural adhesion after lumbar laminectomy. J Orthop Translat. 2018 Mar 7;13:41-49. doi: 10.1016/j.jot.2018.02.001. eCollection 2018 Apr.

    PubMed 29662790

  • Gerszten PC, Moossy JJ, Flickinger JC, Welch WC. Low-dose radiotherapy for the inhibition of peridural fibrosis after reexploratory nerve root decompression for postlaminectomy syndrome. J Neurosurg. 2003 Oct;99(3 Suppl):271-7. doi: 10.3171/spi.2003.99.3.0271.

    PubMed 14563144

  • Du X, Wu L, Yan H, Jiang Z, Li S, Li W, Bai Y, Wang H, Cheng Z, Kong D, Wang L, Zhu M. Microchannelled alkylated chitosan sponge to treat noncompressible hemorrhages and facilitate wound healing. Nat Commun. 2021 Aug 5;12(1):4733. doi: 10.1038/s41467-021-24972-2.

    PubMed 34354068

  • Hajosch R, Suckfuell M, Oesser S, Ahlers M, Flechsenhar K, Schlosshauer B. A novel gelatin sponge for accelerated hemostasis. J Biomed Mater Res B Appl Biomater. 2010 Aug;94(2):372-379. doi: 10.1002/jbm.b.31663.

    PubMed 20578223

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mediclore and Normal Saline in people with Lumbar Disc Disease and Epidural Fibrosis, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.

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 2 inclusion and 4 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 14 Sep 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 Thailand. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Contact Nattapat Tangchitcharoen, MD (6622565351, t-nattapat@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Score for Leg pain (VAS Leg) (time frame: 3 month 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 NCT06034041, which also lists 23 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 14 Sep 2023.

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