Trial Outcomes & Findings for Follow-up of Post-spinal Implantable Neurostimulator PRECISION® (NCT NCT02208999)

NCT ID: NCT02208999

Last Updated: 2019-11-06

Results Overview

Percentage of patients (de novo implants) having a reduction of usual pain over the past 8 days of at least 50% at 12 and 24 months. The pain was measured with a numerical scale from 0 to 10 (0 = no pain and 10 = most intense pain). This data has been provided by 71 patients at 1 year and by 70 patients at 2 years.

• Recruitment status: COMPLETED
• Target enrollment: 106 participants
• Primary outcome timeframe: From baseline until the end of the study at 24 months.
• Results posted on: 2019-11-06

Participant Flow

Recruitment between December 3, 2015 and October 21, 2015 in 7 French clinical centers

No pre-assignment details

Participant milestones

Measure	Patients Implanted or Reimplanted With Precision All patients included must have been implanted with the neurostimulator Precision.107 patients were included. One of them was excluded because he was less than 18 years old. So 106 patients were analysed: 91 implanted patients (de novo implants) and 15 reimplanted patients (replacement implants)
Overall Study STARTED	106
Overall Study COMPLETED	105
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Patients Implanted or Reimplanted With Precision All patients included must have been implanted with the neurostimulator Precision.107 patients were included. One of them was excluded because he was less than 18 years old. So 106 patients were analysed: 91 implanted patients (de novo implants) and 15 reimplanted patients (replacement implants)
Overall Study Lost to Follow-up	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Implanted Patients n=91 Participants 91 patients de novo implanted with the neurostimulator Precision.	Reimplanted Patients n=15 Participants 15 patients had a replacement with the neurostimulator Precision.	Total n=106 Participants Total of all reporting groups
Age, Continuous	49.5 years STANDARD_DEVIATION 11.0 • n=91 Participants	51.7 years STANDARD_DEVIATION 9.6 • n=15 Participants	49.8 years STANDARD_DEVIATION 10.8 • n=106 Participants
Sex: Female, Male Female	41 Participants n=91 Participants	5 Participants n=15 Participants	46 Participants n=106 Participants
Sex: Female, Male Male	50 Participants n=91 Participants	10 Participants n=15 Participants	60 Participants n=106 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	91 participants n=91 Participants	15 participants n=15 Participants	106 participants n=106 Participants
Indication Irreducible chronic neuropathic pain	85 Participants n=87 Participants • 4 missing data	15 Participants n=15 Participants • 4 missing data	100 Participants n=102 Participants • 4 missing data
Indication Peripheral ischaemic pain	2 Participants n=87 Participants • 4 missing data	0 Participants n=15 Participants • 4 missing data	2 Participants n=102 Participants • 4 missing data
Pain location Unilateral pain	56 Participants n=90 Participants • 1 missing data	5 Participants n=15 Participants • 1 missing data	61 Participants n=105 Participants • 1 missing data
Pain location Bilateral pain	34 Participants n=90 Participants • 1 missing data	10 Participants n=15 Participants • 1 missing data	44 Participants n=105 Participants • 1 missing data
Duration of pain before implant	68.0 Months STANDARD_DEVIATION 68.5 • n=88 Participants • 3 missing data	118.8 Months STANDARD_DEVIATION 101.6 • n=15 Participants • 3 missing data	75.4 Months STANDARD_DEVIATION 75.8 • n=103 Participants • 3 missing data
History of pain surgery	71 Participants n=88 Participants • 3 missing data	13 Participants n=15 Participants • 3 missing data	84 Participants n=103 Participants • 3 missing data
% of patients with a test phase before final implantation	86 Participants n=90 Participants • 1 missing data	9 Participants n=15 Participants • 1 missing data	95 Participants n=105 Participants • 1 missing data
Percentage reduction in pain during the test phase	69.2 percentage STANDARD_DEVIATION 13.8 • n=83 Participants • 95 patients had a phase test and 4 data was missing.	63.8 percentage STANDARD_DEVIATION 11.9 • n=8 Participants • 95 patients had a phase test and 4 data was missing.	68.8 percentage STANDARD_DEVIATION 13.6 • n=91 Participants • 95 patients had a phase test and 4 data was missing.
Electrode insertion pathways Percutaneous	73 Participants n=90 Participants • 1 missing data	6 Participants n=15 Participants • 1 missing data	79 Participants n=105 Participants • 1 missing data
Electrode insertion pathways Laminectomy	16 Participants n=90 Participants • 1 missing data	8 Participants n=15 Participants • 1 missing data	24 Participants n=105 Participants • 1 missing data
Electrode insertion pathways Percutaneous + laminectomy	1 Participants n=90 Participants • 1 missing data	1 Participants n=15 Participants • 1 missing data	2 Participants n=105 Participants • 1 missing data

PRIMARY outcome

Timeframe: From baseline until the end of the study at 24 months.

Population: Implanted patients (de novo implants)

Percentage of patients (de novo implants) having a reduction of usual pain over the past 8 days of at least 50% at 12 and 24 months. The pain was measured with a numerical scale from 0 to 10 (0 = no pain and 10 = most intense pain). This data has been provided by 71 patients at 1 year and by 70 patients at 2 years.

Outcome measures

Measure	Implanted Patients (de Novo Implants) n=71 Participants Primary outcome measure was estimated only in implanted patients (de novo implants)	Percentage of de Novo Patients at 24 Months Percentage of de novo patients with an improvement of at least 30% for pain at 24 months after inclusion
Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 50% of the Overall Average Pain Over the Last 8 Days, Evaluated by Numerical Scale at the First Follow-up Visit, at 1 Year, and 2 Years. % patients with pain reduction >= 50% at &1 year	34.5 percentage of patients Interval 22.2 to 48.6	—
Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 50% of the Overall Average Pain Over the Last 8 Days, Evaluated by Numerical Scale at the First Follow-up Visit, at 1 Year, and 2 Years. % patients with pain reduction >= 50% at 2 years	35.7 percentage of patients Interval 24.6 to 48.1	—

PRIMARY outcome

Timeframe: From baseline until the end of the study at 24 months.

Population: Implanted patients (de novo implants)

The pain was evaluated with a numerical scale from 0 to 10. 0 = no pain and 10 = most intense pain. This data has been provided by 71 patients at 1 year and by 70 patients at 2 years.

Outcome measures

Measure	Implanted Patients (de Novo Implants) n=71 Participants Primary outcome measure was estimated only in implanted patients (de novo implants)	Percentage of de Novo Patients at 24 Months Percentage of de novo patients with an improvement of at least 30% for pain at 24 months after inclusion
Average Pain Score Over the Last 8 Days, Evaluated by Numerical Scale at 1 Year, and at 2 Years. Average pain score for the past 8 days at 1 year	4.5 units on a scale Interval 2.2 to 6.8	—
Average Pain Score Over the Last 8 Days, Evaluated by Numerical Scale at 1 Year, and at 2 Years. Average pain score for the past 8 days at 2 years	4.9 units on a scale Interval 2.4 to 7.4	—

SECONDARY outcome

Timeframe: From baseline until the end of the study at 24 months

Population: Percentage of de novo patients with an improvement of at least 30% for pain at 12 and 24 months after inclusion

Percentage of implanted patients (de novo implants) with an improvement of at least 30% at 12 and 24 months after inclusion for:

• pain at the present time
• usual pain over the past 8 days
• the most severe pain in the last 8 days

Outcome measures

Measure	Implanted Patients (de Novo Implants) n=56 Participants Primary outcome measure was estimated only in implanted patients (de novo implants)	Percentage of de Novo Patients at 24 Months n=71 Participants Percentage of de novo patients with an improvement of at least 30% for pain at 24 months after inclusion
Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 30% of the Overall Average Pain, Evaluated by Numerical Scale Pain at present time	53.7 % of patients Interval 39.6 to 67.4	53.6 % of patients Interval 41.2 to 65.7
Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 30% of the Overall Average Pain, Evaluated by Numerical Scale Usual pain over the past 8 days	54.5 % of patients Interval 40.6 to 68.0	51.4 % of patients Interval 39.2 to 63.6
Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 30% of the Overall Average Pain, Evaluated by Numerical Scale The most severe pain in the last 8 days	46.3 % of patients Interval 32.6 to 60.4	40.6 % of patients Interval 28.9 to 53.1

SECONDARY outcome

Timeframe: From baseline until the end of the study at 24 months

Population: Percentage of de novo patients for whom pain relief before the implantation was "improved" to "very improved" at 12 and 24 months

• Pain relief compared to what the patient with a de novo implant, felt before the implantation at 12 months and at 24 months.

Outcome measures

Measure	Implanted Patients (de Novo Implants) n=54 Participants Primary outcome measure was estimated only in implanted patients (de novo implants)	Percentage of de Novo Patients at 24 Months n=70 Participants Percentage of de novo patients with an improvement of at least 30% for pain at 24 months after inclusion
Patients' Opinion on the Evolution of Pain	49 Participants	55 Participants

SECONDARY outcome

Timeframe: From baseline until the end of the study at 24 months

Population: Implanted patients (de novo implants) at 12 months and at 24 months with at least one analgesic treatment

Rate of primary implanted patients who took at least one analgesic treatment at each follow-up (at 1 year and at 2 years)

Outcome measures

Measure	Implanted Patients (de Novo Implants) n=56 Participants Primary outcome measure was estimated only in implanted patients (de novo implants)	Percentage of de Novo Patients at 24 Months n=71 Participants Percentage of de novo patients with an improvement of at least 30% for pain at 24 months after inclusion
Evolution of the Use of Other Pain Treatments	42 Participants	54 Participants

SECONDARY outcome

Timeframe: From baseline until the end of the study at 24 months

Population: Percentage of de novo patients with an increase of SF-12 at 12 and 24 months

Percentage of de novo patients with an increase of SF-12 (Short-Form health survey) physical score at 12 and 24 months. An increase of this score indicates an improvement in physical "quality of life.

Outcome measures

Measure	Implanted Patients (de Novo Implants) n=50 Participants Primary outcome measure was estimated only in implanted patients (de novo implants)	Percentage of de Novo Patients at 24 Months n=62 Participants Percentage of de novo patients with an improvement of at least 30% for pain at 24 months after inclusion
Evolution of Quality of Life (SF-12) - Physical Score	30 Participants	38 Participants

SECONDARY outcome

Timeframe: From baseline until the end of the study at 24 months

Population: Percentage of de novo patients willing to restart treatment at each follow-up (at 1 year and at 2 years)

Patients' willingness to restart the treatment at 12 months and at 24 months.

Outcome measures

Measure	Implanted Patients (de Novo Implants) n=49 Participants Primary outcome measure was estimated only in implanted patients (de novo implants)	Percentage of de Novo Patients at 24 Months n=66 Participants Percentage of de novo patients with an improvement of at least 30% for pain at 24 months after inclusion
Patients' Willingness to Restart the Treatment	45 Participants	57 Participants

SECONDARY outcome

Timeframe: From baseline until the end of the study at 24 months

Population: Percentage of de novo patients with anxiety and depression disorders at 12 and 24 months

Evolution of the rate of patients with anxiety and depression disorders at12 and 24 months.

Outcome measures

Measure	Implanted Patients (de Novo Implants) n=54 Participants Primary outcome measure was estimated only in implanted patients (de novo implants)	Percentage of de Novo Patients at 24 Months n=68 Participants Percentage of de novo patients with an improvement of at least 30% for pain at 24 months after inclusion
Percentage of Patients With Anxiety and Depression Disorders	38.9 percentage of included de novo patients Interval 27.6 to 52.8	45.6 percentage of included de novo patients Interval 34.6 to 57.1

SECONDARY outcome

Timeframe: From baseline until the end of the study at 24 months

Population: Percentage of de novo patients with an increase of SF-12 mental score at 12 and 24 months

Percentage of de novo patients with an increase of SF-12 (Short-Form health survey) mental score at 12 and 24 months. An increase of this score indicates an improvement in mental "quality of life.

Outcome measures

Measure	Implanted Patients (de Novo Implants) n=50 Participants Primary outcome measure was estimated only in implanted patients (de novo implants)	Percentage of de Novo Patients at 24 Months n=62 Participants Percentage of de novo patients with an improvement of at least 30% for pain at 24 months after inclusion
Evolution of Quality of Life (SF-12) - Mental Score	16 Participants	17 Participants

SECONDARY outcome

Timeframe: From baseline until the end of the study at 24 months

Population: Implanted patients (de novo implants) at 12 months and at 24 months with at least one level 3 analgesic treatment

Mean posology of level 3 analgesics at each follow-up (at 1 year and at 2 years). The posology was estimated in oral morphine equivalent dosage. At 1 year, 14 patients had a level 3 analgesic and at 2 years 18 patients had this type of analgesic. The posology was available for respectively 4 and 16 patients

Outcome measures

Measure	Implanted Patients (de Novo Implants) n=14 Participants Primary outcome measure was estimated only in implanted patients (de novo implants)	Percentage of de Novo Patients at 24 Months n=16 Participants Percentage of de novo patients with an improvement of at least 30% for pain at 24 months after inclusion
Evolution of the Use of Level 3 Analgesics	67.9 MG Standard Deviation 55.4	55.6 MG Standard Deviation 53.9

Adverse Events

Overall Population: Implanted and Reimplanted Patients

Serious events: 36 serious events

Other events: 5 other events

Deaths: 2 deaths

Patients With an Event Related to the Device

Serious events: 10 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Overall Population: Implanted and Reimplanted Patients n=106 participants at risk Patients implanted (de novo implants) or reimplanted (replacement implants) with the neurostimulator Precision	Patients With an Event Related to the Device n=106 participants at risk Patients implanted (de novo implants) or reimplanted (replacement implants) with the neurostimulator Precision and for whom the AE (or SAE) was related to this device
Infections and infestations Infections	7.5% 8/106 • Number of events 15 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.	0.94% 1/106 • Number of events 1 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.
Injury, poisoning and procedural complications electrode displacement / electrode migration	9.4% 10/106 • Number of events 11 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.	0.94% 1/106 • Number of events 2 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.
Injury, poisoning and procedural complications Neurostimulator migration	2.8% 3/106 • Number of events 3 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.	0.00% 0/106 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.
Injury, poisoning and procedural complications Electrode fracture	4.7% 5/106 • Number of events 6 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.	4.7% 5/106 • Number of events 6 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.
Injury, poisoning and procedural complications Extension fracture	0.94% 1/106 • Number of events 1 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.	0.94% 1/106 • Number of events 1 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.
Injury, poisoning and procedural complications Undesirable stimulation	4.7% 5/106 • Number of events 7 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.	0.00% 0/106 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.
Injury, poisoning and procedural complications Loss of efficacy	8.5% 9/106 • Number of events 11 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.	0.94% 1/106 • Number of events 1 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.
Injury, poisoning and procedural complications Difficulty of charging	1.9% 2/106 • Number of events 2 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.	1.9% 2/106 • Number of events 2 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.
Injury, poisoning and procedural complications Other complications	10.4% 11/106 • Number of events 12 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.	0.00% 0/106 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.

Other adverse events

Measure	Overall Population: Implanted and Reimplanted Patients n=106 participants at risk Patients implanted (de novo implants) or reimplanted (replacement implants) with the neurostimulator Precision	Patients With an Event Related to the Device n=106 participants at risk Patients implanted (de novo implants) or reimplanted (replacement implants) with the neurostimulator Precision and for whom the AE (or SAE) was related to this device
Infections and infestations Infection	0.94% 1/106 • Number of events 1 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.	0.00% 0/106 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.
Injury, poisoning and procedural complications Connector problem	0.94% 1/106 • Number of events 1 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.	0.00% 0/106 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.
Injury, poisoning and procedural complications Undesirable stimulation	0.94% 1/106 • Number of events 1 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.	0.00% 0/106 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.
Injury, poisoning and procedural complications Loss of efficacy	0.94% 1/106 • Number of events 1 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.	0.94% 1/106 • Number of events 1 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.
Injury, poisoning and procedural complications High impedence	1.9% 2/106 • Number of events 2 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.	0.94% 1/106 • Number of events 1 • From baseline until the end of the study at 24 months Each investigator reported all adverse events from baseline until the end of the study at 24 months. The events were reviewed by an independent expert, who adjudicated whether each event was device related or not.

Additional Information

Stéphane Bouée, Medical director

CEMKA

Phone: 331.41.87.95.25

Email: stephane.bouee@cemka.fr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place