Spinal MetastasesNCT01865942
Surgical Spinal Decompression of Metastatic Spinal Cord Compression, Minimal Access Versus Open Surgery
A study testing open surgery and Minimal access surgery in people with Spinal Metastases, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Spinal Metastases
- What is being tested?
- open surgery and Minimal access surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Aug 2014to 30 Mar 2017
- Phase
- Interventional
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic spinal cord compression with a metastasis from Th5-L3 Tokuhashi above 4
Who cannot join
- Need for radical treatment and not only palliative
- Need for surgical stabilization in a region lower then L3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Spinal Decompression of Metastatic Spinal Cord Compression, Minimal Access Versus Open Surgery. A Randomized Clinical Trial.
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.
Read the detailed description
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.
- Conditions
- Spinal Metastases
- Being tested
- open surgery, Minimal access surgery
- Keywords
- spinal metastases, spine surgery, metastatic spinal cord compression, EQ-5D, HRQOL
- Medical subject headings
- Spinal Cord Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open surgeryProcedure or surgery
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.
Minimal access surgeryProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| open surgery | Active comparator | One arm receives open surgery. In our department open surgery is considered as the standard procedure since all spine surgeons are preforming this operation. Receives: Procedure: open surgery |
| Minimal access surgery | Active comparator | 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. Receives: Procedure: Minimal access surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding
The investigators compare the bleeding for each treatment modality during the operation.
Measured: intraoperative
Secondary outcomes (1)
Health related quality of life measured with questionnaire EQ-5D and QLQ-C30
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.
Measured: before intervention and six months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study start28 Aug 2014
- Primary completion2 Jan 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spinal MetastasesStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Søren Schmidt Morgen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Søren Schmidt Morgen, MD, Principal investigator, Spine Section, Department of Orthopedic Surgery, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865942
- Sponsor's protocol ID
- H-2-2011-050
- Status last verified
- Mar 2017
- First submitted
- 4 Apr 2013
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rodriguez-Vela J, Lobo-Escolar A, Joven-Aliaga E, Herrera A, Vicente J, Sunen E, Loste A, Tabuenca A. Perioperative and short-term advantages of mini-open approach for lumbar spinal fusion. Eur Spine J. 2009 Aug;18(8):1194-201. doi: 10.1007/s00586-009-1010-0. Epub 2009 Apr 28.
PubMed 19399538Falicov A, Fisher CG, Sparkes J, Boyd MC, Wing PC, Dvorak MF. Impact of surgical intervention on quality of life in patients with spinal metastases. Spine (Phila Pa 1976). 2006 Nov 15;31(24):2849-56. doi: 10.1097/01.brs.0000245838.37817.40.
PubMed 17108840Kim KT, Lee SH, Suk KS, Bae SC. The quantitative analysis of tissue injury markers after mini-open lumbar fusion. Spine (Phila Pa 1976). 2006 Mar 15;31(6):712-6. doi: 10.1097/01.brs.0000202533.05906.ea.
PubMed 16540878Ringel F, Stoffel M, Stuer C, Meyer B. Minimally invasive transmuscular pedicle screw fixation of the thoracic and lumbar spine. Neurosurgery. 2006 Oct;59(4 Suppl 2):ONS361-6; discussion ONS366-7. doi: 10.1227/01.NEU.0000223505.07815.74.
PubMed 17041505
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Spinal Decompression of Metastatic Spinal Cord Compression, Minimal Access Versus Open Surgery. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT01865942
- Acronym / sponsor ID
- H-2-2011-050
- Conditions
- Spinal Metastases
- Keywords
- spinal metastases, spine surgery, metastatic spinal cord compression, EQ-5D, HRQOL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 28 Aug 2014 (actual)
- Primary completion
- 2 Jan 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 31 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open surgery | Active comparator | Procedure: open surgeryOne arm receives open surgery. In our department open surgery is considered as the standard procedure since all spine surgeons are preforming this operation. |
| Minimal access surgery | Active comparator | Procedure: Minimal access surgeryWe 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Metastatic spinal cord compression with a metastasis from Th5-L3 Tokuhashi above 4
Key exclusion criteria (2 listed)
- Need for radical treatment and not only palliative
- Need for surgical stabilization in a region lower then L3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| open surgeryThe 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. | Procedure or surgery | open surgery |
| Minimal access surgeryThe 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. | Procedure or surgery | Minimal access surgery |
Primary outcome
Bleeding
Time frame: intraoperative
The investigators compare the bleeding for each treatment modality during the operation.
1 secondary outcome
Health related quality of life measured with questionnaire EQ-5D and QLQ-C30
Time frame: before intervention and six months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Background: PubMed 19399538Rodriguez-Vela J, Lobo-Escolar A, Joven-Aliaga E, Herrera A, Vicente J, Sunen E, Loste A, Tabuenca A. Perioperative and short-term advantages of mini-open approach for lumbar spinal fusion. Eur Spine J. 2009 Aug;18(8):1194-201. doi: 10.1007/s00586-009-1010-0. Epub 2009 Apr 28.
- Background: PubMed 17108840Falicov A, Fisher CG, Sparkes J, Boyd MC, Wing PC, Dvorak MF. Impact of surgical intervention on quality of life in patients with spinal metastases. Spine (Phila Pa 1976). 2006 Nov 15;31(24):2849-56. doi: 10.1097/01.brs.0000245838.37817.40.
- Background: PubMed 16540878Kim KT, Lee SH, Suk KS, Bae SC. The quantitative analysis of tissue injury markers after mini-open lumbar fusion. Spine (Phila Pa 1976). 2006 Mar 15;31(6):712-6. doi: 10.1097/01.brs.0000202533.05906.ea.
- Background: PubMed 17041505Ringel F, Stoffel M, Stuer C, Meyer B. Minimally invasive transmuscular pedicle screw fixation of the thoracic and lumbar spine. Neurosurgery. 2006 Oct;59(4 Suppl 2):ONS361-6; discussion ONS366-7. doi: 10.1227/01.NEU.0000223505.07815.74.
Related trials for Spinal Metastases
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Active, not recruitingObservational study
The Effect of Magnesium on Post-spinal Headaches
Post-spinal Headache
Active, not recruitingPhase 3
Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
Melanoma, Ovarian Cancer
RecruitingPhase 2/3
Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPH
Postdural Puncture Headache (PDPH)
Active, not recruitingPhase 2
Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions
Spinal Metastases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Søren Schmidt Morgen, MD principal investigator
Spine Section, Department of Orthopedic Surgery, Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing open surgery and Minimal access surgery in people with Spinal Metastases, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 4 Apr 2017. 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 Denmark. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding (time frame: intraoperative). 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 NCT01865942, which also lists 4 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 4 Apr 2017.