Metastasis Spine, Metastasis to Bone
Conditions
Brief summary
This study evaluates the effectiveness of the Medtronic OsteoCool™ RF Ablation System.
Detailed description
The OsteoCool™ RF Ablation system has 510k regulatory clearance in the United States, Conformité Européene (CE) mark in Europe, and Health Canada Licence in Canada. The goal of this study is to collect real-world outcomes among a cohort of patients in the US, EUR and CAN with metastatic malignant lesions in a vertebral body, painful metastatic lesions involving bone (in the US, patients with metastatic lesions involving the bone must have failed or were not candidates for standard therapy), and benign bone tumors such as osteoid osteoma who receive treatment with the OsteoCool™ RF Ablation system. Additionally, the study will collect device, procedure and/or therapy related adverse events and device deficiencies. Lastly, subject outcomes (such as pain relief, quality of life, and function) will be evaluated using validated assessment measures.
Interventions
DEVICEOsteoCool™ RF Ablation
The OsteoCool™ RF Ablation system is indicated in the United States (US), Europe (EUR) and Canada (CAN) for patients with metastatic malignant lesions in a vertebral body, painful metastatic lesions involving bone (in the US, patients with metastatic lesions involving the bone must have failed or were not candidates for standard therapy) and benign bone tumors such as osteoid osteomas.
Sponsors
MedtronicNeuro
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Enrollment/Baseline visit, OsteoCool procedure visit and 5 post-procedure visits (3 days, 1 week, 1-, 3-, and 6-month clinic visits) and a final post-procedure study visit (12 months) for a total of 8 study related visits.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Candidate for OsteoCool RF ablation per the labeled indication applicable in their respective country/region 2. A. Metastatic lesions targeted for treatment must be located in the thoracic and/or lumbar vertebral body(ies), periacetabulum, iliac crest, and/or sacrum OR benign bone tumors - no restrictions on location of lesion 3. Report worst pain score ≥4/10 at the target treatment site within the past 24 hours 4. Localized pain resulting from no more than two sites total of metastatic disease 5. Have Karnofsky score ≥40 at enrollment (not applicable for subjects with benign bone tumors) 6. Willing and able to provide a signed and dated informed consent, comply with the study plan, follow up visits and phone calls 7. At least 18 years old at the time of informed consent
Exclusion criteria
1. A. Implanted with heart pacemaker or other implanted electronic device (Europe and Canada only) 2. Use of OsteoCool in vertebral body levels C1-C7 3. Multiple myeloma, solitary plasmacytoma, or primary malignant lesions in the index vertebra or bone 4. Active or incompletely treated local infection at the planned treatment site(s) and/or systemic infection 5. Planned treatment site(s) accompanied by objective evidence of secondary radiculopathy or neurologic compromise 6. Planned treatment site(s) associated with spinal cord compression or canal compromise requiring decompression 7. Fractures due to prostatic cancer or other osteoblastic metastases to the spine. Metastatic lesions originating in the prostate that are osteolytic or mixed origin are eligible for the study 8. Pregnant, breastfeeding, or plan to become pregnant during the study duration 9. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results\* 10. Any condition that would interfere with the subject's ability to comply with study instructions or might confound the study interpretation * Subjects in concurrent studies can only be enrolled with permission from Medtronic. Please contact Medtronic's study manager to determine if the subject can be enrolled in both studies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Worst Pain Score: Thoracic/Lumbar Spine RF Ablation | From Baseline to 3 months post RF ablation | Demonstrate an improvement of worst pain score (WPS) at the target treatment site in the previous 24 hours for subjects with metastatic lesions in only the thoracic and/or lumbar vertebral body(ies) as collected using the Brief Pain Inventory (BPI). The WPS is a single question from the BPI (scored from 0-10; 0=NO PAIN and 10=PAIN AS BAD AS YOU CAN IMAGINE). Lower scores indicate less pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Worst Pain Score: Periacetabulum, Iliac Crest, and/or Sacrum RF Ablation | From Baseline to 3 months post RF ablation | Characterize change in worst pain score (WPS) at the target treatment site in the previous 24 hours for subjects with metastatic lesions in the periacetabulum, iliac crest, and/or sacrum as collected using the Brief Pain Inventory (BPI). Some subjects also had an additional thoracic/lumbar ablation. The WPS is a single question from the BPI (scored from 0-10; 0=NO PAIN and 10=PAIN AS BAD AS YOU CAN IMAGINE). Lower scores indicate less pain. The secondary outcome is based on a mutually exclusive cohort of study subjects as compared to the primary outcome. |
Countries
Canada, France, Germany, Luxembourg, United States
Participant flow
Recruitment details
At the time of the primary objective assessment (Apr 2019), 106 subjects were enrolled. Enrollment ended Feb 2020 with 218 total subjects which allowed for assessment of secondary objective and long-term effectiveness and safety.
Pre-assignment details
12 of 218 subjects exited prior to RF Ablation (RFA) due to failing in/exclusion criteria, withdrawal of consent, etc. 206 total subjects underwent a single OsteoCool™ RFA procedure. For effectiveness, subjects were separated into 2 study Groups (Thoracic/Lumbar and Periacetabulum/Iliac Crest/Sacrum) based on the location of each subject's ablation(s); subjects were combined for safety.
Participants by arm
| Arm | Count |
|---|---|
| OsteoCool™ RF Ablation in Thoracic/Lumbar Spine Subjects underwent a single OsteoCool™ RF Ablation procedure. All ablations were in the Thoracic/Lumbar Spine. | 184 |
| OsteoCool™ RF Ablation in Periacetabulum/Iliac Crest/Sacrum Subjects underwent a single OsteoCool™ RF Ablation procedure. At least one ablation was in the Periacetabulum/Iliac Crest/Sacrum. Some subjects also had RF Ablation in the Thoracic/Lumbar in the same procedure. | 22 |
| Total | 206 |
Baseline characteristics
| Characteristic | Total | OsteoCool™ RF Ablation in Periacetabulum/Iliac Crest/Sacrum | OsteoCool™ RF Ablation in Thoracic/Lumbar Spine |
|---|---|---|---|
| Age, Continuous | 63.7 years STANDARD_DEVIATION 13 | 65.3 years STANDARD_DEVIATION 9.4 | 63.5 years STANDARD_DEVIATION 13.4 |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment Canada | 31 participants | 4 participants | 27 participants |
| Region of Enrollment France | 6 participants | 0 participants | 6 participants |
| Region of Enrollment Germany | 1 participants | 0 participants | 1 participants |
| Region of Enrollment United States | 168 participants | 18 participants | 150 participants |
| Sex: Female, Male Female | 113 Participants | 8 Participants | 105 Participants |
| Sex: Female, Male Male | 93 Participants | 14 Participants | 79 Participants |
| Wost Pain Score | 7.8 units on a scale STANDARD_DEVIATION 1.7 | 7.9 units on a scale STANDARD_DEVIATION 1.4 | 7.8 units on a scale STANDARD_DEVIATION 1.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 82 / 206 |
| other Total, other adverse events | 0 / 206 |
| serious Total, serious adverse events | 3 / 206 |
Outcome results
Primary
Change of Worst Pain Score: Thoracic/Lumbar Spine RF Ablation
Demonstrate an improvement of worst pain score (WPS) at the target treatment site in the previous 24 hours for subjects with metastatic lesions in only the thoracic and/or lumbar vertebral body(ies) as collected using the Brief Pain Inventory (BPI). The WPS is a single question from the BPI (scored from 0-10; 0=NO PAIN and 10=PAIN AS BAD AS YOU CAN IMAGINE). Lower scores indicate less pain.
Time frame: From Baseline to 3 months post RF ablation
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OsteoCool™ RF Ablation in Thoracic/Lumbar Spine | Change of Worst Pain Score: Thoracic/Lumbar Spine RF Ablation | -4.1 units on a scale |
Comparison: An improvement from baseline to 3 months post radiofrequency ablation in worst pain score will be demonstrated with an outcome which is statistically lower than zero.p-value: <0.0001t-test, 2 sided
Secondary
Change in Worst Pain Score: Periacetabulum, Iliac Crest, and/or Sacrum RF Ablation
Characterize change in worst pain score (WPS) at the target treatment site in the previous 24 hours for subjects with metastatic lesions in the periacetabulum, iliac crest, and/or sacrum as collected using the Brief Pain Inventory (BPI). Some subjects also had an additional thoracic/lumbar ablation. The WPS is a single question from the BPI (scored from 0-10; 0=NO PAIN and 10=PAIN AS BAD AS YOU CAN IMAGINE). Lower scores indicate less pain. The secondary outcome is based on a mutually exclusive cohort of study subjects as compared to the primary outcome.
Time frame: From Baseline to 3 months post RF ablation
| Arm | Measure | Value (MEAN) |
|---|---|---|
| OsteoCool™ RF Ablation in Thoracic/Lumbar Spine | Change in Worst Pain Score: Periacetabulum, Iliac Crest, and/or Sacrum RF Ablation | -4.5 units on a scale |