Surgical Spinal Decompression of Metastatic Spinal Cord Compression, Minimal Access Versus Open Surgery. A Randomized Clinical Trial.
Surgical Spinal Decompression of Metastatic Spinal Cord Compression, Minimal Access Versus
Open Surgery. A Randomized Clinical Trial
Purpose To investigate the effect of minimal access spine surgery (MASS) compared with
conventional open surgery in the treatment of patients with metastatic spinalcord
Hypotheses The group of patient's receiving MASS will have better improvement in quality
after surgery compared to the group that will receive traditional open surgery. The MASS
patient group will have reduction in per-operative bleeding and less wound complications
needing surgical revision compered to the group of patients receiving open or traditional
Primary outcome Perioperative bleeding.
Secondary outcomes Quality of life and incidence of revision surgery.
Material and method A randomised controlled trial with a 1-year follow up will be conducted.
Sample size From previous studies and based patient files it is calculated that the mean
blood loss during open surgery is 1500 ml (standard deviation 750 ml). A clinical relevant
reduction in blood loss will be 400 ml corresponding to one unit of packed red blood cells.
With a significance level of 5% and a power of 80% a total of 62 patients have to be
included in the study.
Most studies using QLQ-C30 as a measurement for health related quality of life (HRQL) in
randomized comparison of treatment modalities in cancer patients have included between 100
and 200 patients. This includes studies where both QLQ-C30 and EQ-5D have been used. EQ-5D
is widely used as a generic measurement of HRQL.
62 patients will be randomly allocated to receive either minimal invasive or open surgery.
Inclusion criteria are patients with spinal metastases at level Th5-L3 who are candidates
for surgery. Exclusion criteria are: Tokuhashi score ≤ 4, preoperative presumptions that
something else than pedicle screws would be needed, potentially the need for sacral or
iliosacral instrumentation, and patients who need more radical treatment. The QLQ-C30
(Quality of Life Cancer) will be assessed since this instrument is especially developed for
use in cancer patients and will be used as a clinical measure.
Outcome measure on bleeding will be recorded during the operation. Outcome measures on
quality of life will be estimated with QLQ-C30, EQ-5D and VAS-pain score. This will be
recorded before operation, by time of discharge, 6 weeks and 3, 6 and 12 months after the
operation. Records on wound complications leading to an intervention of revision-surgery,
antibiotics or other procedures are registered at the same follow up times.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The investigators compare the bleeding for each treatment modality during the operation.
Søren Schmidt Morgen, MD
Spine Section, Department of Orthopedic Surgery, Copenhagen University Hospital, Rigshospitalet
Denmark: Danish Dataprotection Agency