Neoplasms

Symptoms and General Pathology

All Conditions

Nervous System Diseases

Wounds and Injuries

Neoplasm Metastasis

Spinal Cord Compression

Neoplastic Processes

Spinal Cord Diseases

Central Nervous System Diseases

Spinal Cord Injuries

One arm receives open surgery. In our department open surgery is considered as the standard procedure since all spine surgeons are preforming this operation.

We compare to well-known types of surgery for metastatic spinal cord compression. The other arm receive open surgery. In our department minimal access surgery is considered as a standard procedure but it is not preformed by all spine surgeons.

The to surgical procedures are individually well know, but the outcome of the procedures in respect to perioperative bleeding and change in quality of life has to our knowledge not been compared.

open surgery

Minimal access surgery

Søren Schmidt Morgen, MD

The investigators wish to evaluate the effect of minimal access spinal surgery compared to traditional open surgery spinal surgery in patients with metastatic spinal cord compression.

Minimal access surgery has been shown to bee less damaging for the tissue compared to traditional open surgery and also cause fewer wound complications, the investigators expect the above could have impact in a vulnerable patient group like patients with metastatic spinal cord compression.

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 compression (MSCC).

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 surgery.

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.

Surgical Spinal Decompression of Metastatic Spinal Cord Compression, Minimal Access Versus Open Surgery

Surgical Spinal Decompression of Metastatic Spinal Cord Compression, Minimal Access Versus Open Surgery. A Randomized Clinical Trial.

The investigators compare the bleeding for each treatment modality during the operation.

The EORTC EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status.

The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients.

Rigshospitalet, Denmark

Medical doctor

Musculoskeletal Diseases

Spinal Diseases

Anti-Infective Agents

All Drugs and Chemicals

Carbon Fiber

Anti-Infective Agents, Local

Transpedicular spinal stabilization using a radiolucent composite system made of carbon fibers and PEEK followed by stereotactic radiotherapy of the spine at a dose of 5x5 Gy (25 Gy in the total dose)

Transpedicular spinal stabilization using a titanium system followed by stereotactic radiotherapy of the spine at a dose of 5x5 Gy (25 Gy in the total dose)

Transpedicular spinal stabilization using a titanium system preceded with stereotactic spine radiotherapy at a dose of 5x5 Gy (25 Gy in the total dose) as the first stage of treatment

Transpedicular stabilization with carbon fiber and PEEK-based implants in one of the two possible variants - first involves a large skin incision and separation of the back extensor muscles; second is associated with minimally invasive, which is percutaneous procedure that allows the stabilization with implants without the need to detach the muscles, using only a small skin incision.

Transpedicular spinal stabilization - carbon fibers-based implants

Transpedicular stabilization with titanium implants in one of the two possible variants - first involves a large skin incision and separation of the back extensor muscles; second is associated with minimally invasive, which is percutaneous procedure that allows the stabilization with implants without the need to detach the muscles, using only a small skin incision.

Transpedicular spinal stabilization - titanium implants

Spinal tumors will be treated with stereotactic body radiotherapy at a dose of 5x5 Gy (25 Gy in a total dose); either prior to or post-surgical treatment, accordingly the allocation to one of the study arms.

Stereotactic body radiotherapy

Kamil Krystkiewicz, PhD

Marcin Tosik, PhD

Krystkiewicz

Background: Spinal metastatic disease constitute a serious clinical problem in oncology. Bones are the third most common organ where metastases are located, and the spine is the place where they are most often located. Due to the complexity of the clinical problem, metastatic spine disease remains of interest to many medical specialties: neurosurgery, orthopedics, clinical oncology, radiotherapy and rehabilitation. With the development of modern diagnostic methods and wider access to them, the demand for neurosurgical treatment in this group of patients is growing. Surgical treatment is undertaken in cases of spinal cord compression, instability, spinal deformation or pain that is resistant to radiotherapy. The standard treatment in most cases is posterior instrumentation of the spine using titanium pedicle screws. Unfortunately, these systems cause numerous artifacts in diagnostic imaging, both in CT and MRI. These distortions make it difficult to plan radiotherapy and determine the optimal dose that would avoid healthy tissues. Moreover, artifacts could make difficult postoperative follow-ups aimed at assessing local recurrence. The solution to these problems is the use of radiolucent implants. There are systems based on carbon fibers embedded in PEEK which do not cause typical artifacts for titanium implants.

Study plan: The open, three-arm, prospective randomized study is planned to involve 226 patients with metastatic disease of the spine, with a known or undiagnosed primary site. Patients will be qualified for 2 types of interventions. The first one includes treatment with stereotactic radiotherapy (SBRT) in the first stage of treatment and early instrumentation of the spine with titanium implants. The second type of intervention includes patients qualified for surgical treatment using spine stabilization and postoperative SBRT. Patients within this arm will be randomized into two groups differing in the type of material the instrumentation is made of: carbon-PEEK or titanium. The study group will be patients stabilized with carbon implants, and the control group will be those who will have titanium implants.

Study population: The study includes adult patients with metastatic spine disease, with a known or unknown primary tumor, qualified for SBRT and surgical treatment.

Assumed effects: It is assumed that the treatment proposed in the project would extend progression free survival by several months or achieve local control in an additional 5% of patients. Moreover, by improving the quality of imaging, earlier diagnosis of local recurrences and implementation of appropriate locoregional treatment would be possible.

Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease

Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease and Stereotactic Radiotherapy

The use of convergence factor assessment will allow for comparison of similarity in planned SBRT between all groups. This will allow an indirect assessment of difficulties in planning treatment by a radiotherapist using objective tools.

Using a numerical scale from 0-10, the radiotherapist will assess the difficulty of planning, tumor coverage, and delineation of the spinal cord depending on the group assessed in the study.

Titanium instrumentation generates significant artifacts in radiological imaging used for radiotherapy planning. The use of opaque, radiolucent material allows for radiotherapy planning to cover a smaller area. This may reduce the incidence of radiation-related complications in nearby organs (OAR - organ at risk). These complications will be assessed by the radiation therapist according to the standardized NCI CTC scale. Potentially smaller quantity of organ complications could be an advantage supporting the use of carbon implants.

Titanium and carbon fiber show similar biocompatibility. The biomechanical properties of these materials are also similar. In vitro studies have shown a similar effect failure rate of carbon pedicle screws compared to standard titanium ones. However, carbon rods have greater flexibility and structure connected using these may show more frequent loosening in vivo, especially in cases with impaired sagittal balance. This was not an issue analyzed in the literature. The frequency of instrument failure is of great importance for clinical practice because most such cases require operative revision.

One of the goals of surgical treatment is to treat mechanical pain caused by segmental instability. SBRT is a good method of treating biological pain. There are no comparisons of analgesic effects between transpedicular systems. Greater pain reduction allows for more effective and longer ability to walk, lower consumption of painkillers, and lower incidence of complications related to immobilization (thrombosis, bedsores, respiratory infections), which also has pharmacoeconomic implications.

Postoperative wound infections are an inherent complication of surgical procedures. The longer the procedure, the more often inflammatory complications are observed, especially in oncological population, which has a higher average age of treated patients, a greater number of burdens, frequent immunosuppression due to systemic treatment, and malnutrition in the form of decreased biochemical parameters (total protein and albumin). Titanium has good properties in this aspect. Bacterial biofilms, is rarely formed on it, which means that patients can be treated more often without the need to remove the implants. It is unclear how carbon fiber system will perform in these cases. There are not made of metal, but of carbon fiber embedded in polymer. Assessment of the frequency of inflammatory complications and their course will provide the answer to whether This instrumentation allows for a similar management strategy in clinical settings.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Surgical Spinal Decompression of Metastatic Spinal Cord Compression, Minimal Access Versus Open Surgery	NCT01865942	Spinal Metastas...	open surgery Minimal access ...	18 Years - 99 Years	Rigshospitalet, Denmark
Carbon Fiber Transpedicular Screws in Treatment of Spinal Metastatic Disease	NCT06293157	Metastatic Spin... Metastasis Spin...	Transpedicular ... Transpedicular ... Stereotactic bo...	18 Years -	Copernicus Memorial Hospital

Spots Global Cancer Trial Database for metastatic spinal cord compression