Minimally invasive versus conventional pedicle screw fixation in thoracolumbar spinal metastases for palliative surgery, A randomized control trial

Phase 2

Recruiting

• Conditions: Symptomatic thoracic and lumbar spinal metastasisTokuhashi score 9-11; Minimally invasive spinal surgery; MIS; MISS; Percutaneous pedicle screw; Open spinal surgery; Palliative spinal surgery; Spinal metastasis; Post-operative pain

• Registration Number: TCTR20220115001
• Lead Sponsor: Faculty of Medicine, Prince of Songkla university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-15
• Study Completion: 2022-05-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Patients with symptomatic thoraco- and lumbar spinal metastasis with Tokuhashi score 9-11
- Patients who had Localized pain, Mechanical back pain or Radicular pain, which VAS score at least 5 (Moderate to severe pain according to WHO guideline, that did not response to pain killer medication
- Age 20-80 years old

Exclusion Criteria

- Patients who had previous surgery or radiation therapy of thoracic- and lumbar spine
- Patients with skipped spinal metastasis
- Patients who unable to evaluate VAS score
- Patients who allergy to Titanium that is the main component of pedicle screw.
- Patients who allergy to Fentanyl, Paracetamol, Naproxen, Tramadol that are medication in protocol.
- Pregnancy
- Patients with inflammatory spinal disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative pain score 3 days, 7 days, 14 days, 6 weeks, 12 weeks and 6 months post operation Visual analog scale score

Secondary Outcome Measures

Name	Time	Method
Blood loss Intraoperative and postoperative blood loss (drained blood) Millimeters/ from Intraoperative and drained postoperative blood loss