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Efficacy of using bone wax to fill the pedicular screw hole in reducing peri-operative blood loss in patients who underwent conventional open laminectomy and instrumented fusion due to lumbar spondylotic radiculopathy: A randomized controlled trial study

Efficacy of using bone wax to fill the pedicular screw hole in reducing peri-operative blood loss in patients who underwent conventional open laminectomy and instrumented fusion due to lumbar spondylotic radiculopathy: A randomized controlled trial study

Status
Unknown
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20241101002
Enrollment
44
Registered
2024-11-01
Start date
2024-11-18
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reducing in hemoglobin or hematocrit in the patient who diagnosed with spondylosis with radiculopathy and underwent conventional open laminectomy with posterior instrumented fusion with using bone wax before insertion of pedicular screw Lumbar spondylosis, Conventional open surgery, poster instrumented fusion, bone wax

Interventions

- Bone wax is in the shape of a rectangular prism, measuring 20 millimeters in width, 50 millimeters in length, and 2 millimeters in thickness. The weight of each piece of bone wax in a package is 2.5
Experimental Drug,No Intervention No treatment
bone wax group (Intervention group),conventional group (control group)

Sponsors

Department of Orthopedic, Faculty of medicine, Chiang Mai University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients in the group with degenerative bone and joint diseases who have been diagnosed with degenerative disc disease at the lumbar level, lumbar spinal stenosis, and spondylolisthesis, along with symptoms caused by nerve compression. 2. Patients in category 1 are planned for surgery with conventional open laminectomy and posterior instrument fusion. 3. Age 20 years and older who can provide informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of allergy to bone wax or allergic to materials/substances containing wax. 2. Patients with bleeding disorders (coagulopathy) or those who have difficulty with bleeding control. 3. Patients currently using medications that affect blood coagulation, which may lead to prolonged bleeding, including antiplatelet or anticoagulant medications. 4. Patients with a history of coagulation issues in various systems of the body (venous thromboembolic events). 5. Low hemoglobin levels before surgery (Hb < 8 g/dL). 6. Patients who are currently pregnant or breastfeeding. 7. Female patients currently using estrogen hormone therapy. 8. Patients with impaired kidney function, with creatinine clearance < 30 ml/min. 9. Patients at high risk for spinal surgery (American Society of Anesthesiologists) class 4 and above.

Design outcomes

Primary

MeasureTime frame
Hemoglobin and hematocrit at postoperative since skin incision to 72 hours postoperation Laboratory investigations: esp. serial complete blood count and intraoperative blood loss by Weighing of the gauze

Secondary

MeasureTime frame
blood transfusion since skin incision to 72 hours postoperation unit in PRC, FFP and SDP or Platelet conc.,Intraoperative time since skin incision to skin closure minutes,Acute complications Since skin incision to discharge from hospital Medical records

Countries

Thailand

Contacts

Public ContactRATTHAKORN KHAMSRI

Faculty of Medicine, Chiang Mai University

boomratthakorn@gmail.com0894354388

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026