Trial Outcomes & Findings for ReActiv8 Post Market Surveillance Registry (NCT NCT03255200)
NCT ID: NCT03255200
Last Updated: 2024-10-16
Results Overview
Change in low back pain Numerical Rating Scale (NRS) compared to Baseline. The NRS is an 11-point scale where 0 means no pain at all and 10 means worst imaginable pain. Patients were asked to rate their average low back pain in the last 24 hours. Lower scores or reduction in score means an improvement or reduction in pain.
COMPLETED
87 participants
90 days, 180 days, 1 year, 2 years post Activation
2024-10-16
Participant Flow
Participant milestones
| Measure |
ReActiv8
All participants implanted with ReActiv8 at baseline.
|
|---|---|
|
Overall Study
STARTED
|
87
|
|
Overall Study
Implanted
|
87
|
|
Overall Study
Month 3
|
85
|
|
Overall Study
Month 6
|
85
|
|
Overall Study
Year 1
|
80
|
|
Overall Study
Year 2
|
74
|
|
Overall Study
COMPLETED
|
74
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ReActiv8
n=87 Participants
All participants implanted with ReActiv8 at baseline.
|
|---|---|
|
Age, Continuous
|
52.9 years
STANDARD_DEVIATION 13.0 • n=87 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=87 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=87 Participants
|
|
Region of Enrollment
Germany
|
87 participants
n=87 Participants
|
|
Numeric Pain Rating (NRS) Scale
|
7.6 units on a scale
STANDARD_DEVIATION 1.2 • n=87 Participants
|
|
Oswestry Disability Index (ODI)
|
42.4 units on a scale
STANDARD_DEVIATION 15.6 • n=87 Participants
|
|
European Quality of Life - Five Dimensions (EQ-5D)
|
0.5 units on a scale
STANDARD_DEVIATION 0.2 • n=87 Participants
|
|
Opioid Use
|
26 Participants
n=87 Participants
|
|
Pain Duration
|
7.7 years
STANDARD_DEVIATION 7.8 • n=87 Participants
|
|
Body Mass Index (BMI)
|
28.3 kg/m 2
STANDARD_DEVIATION 5.6 • n=87 Participants
|
PRIMARY outcome
Timeframe: 90 days, 180 days, 1 year, 2 years post ActivationPopulation: Of the 87 patients implanted, 84 completed the Day 3 month, 85 completed the Day 6 month, 79 completed the Year 1 visit, and 74 completed the Year 2 visit. Some patients were withdrawn or lost to follow-up.
Change in low back pain Numerical Rating Scale (NRS) compared to Baseline. The NRS is an 11-point scale where 0 means no pain at all and 10 means worst imaginable pain. Patients were asked to rate their average low back pain in the last 24 hours. Lower scores or reduction in score means an improvement or reduction in pain.
Outcome measures
| Measure |
ReActiv8
n=87 Participants
All participants implanted with ReActiv8 at baseline.
|
|---|---|
|
Low Back Pain - Numeric Pain Rating (NRS) Scale
Month 3
|
4.5 units on a scale
Standard Deviation 2.3
|
|
Low Back Pain - Numeric Pain Rating (NRS) Scale
Month 6
|
4.3 units on a scale
Standard Deviation 2.6
|
|
Low Back Pain - Numeric Pain Rating (NRS) Scale
Year 1
|
3.8 units on a scale
Standard Deviation 2.5
|
|
Low Back Pain - Numeric Pain Rating (NRS) Scale
Year 2
|
3.4 units on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Through 2 years post ActivationAll serious device- or procedure-related adverse events.
Outcome measures
| Measure |
ReActiv8
n=87 Participants
All participants implanted with ReActiv8 at baseline.
|
|---|---|
|
Serious Adverse Device Effects
|
0 Participants
|
Adverse Events
ReActiv8
Serious adverse events
| Measure |
ReActiv8
n=87 participants at risk
All participants implanted with ReActiv8 at baseline.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Allergic Urticaria
|
1.1%
1/87 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Stomach pain
|
1.1%
1/87 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Upper back pain
|
1.1%
1/87 • Number of events 1 • 2 years
|
|
Cardiac disorders
Myocardial infarction
|
2.3%
2/87 • Number of events 2 • 2 years
|
|
Infections and infestations
Urinary Tract Infection
|
1.1%
1/87 • Number of events 1 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer
|
1.1%
1/87 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Herniated disc
|
1.1%
1/87 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.3%
2/87 • Number of events 2 • 2 years
|
|
Nervous system disorders
Radiculopathy
|
1.1%
1/87 • Number of events 1 • 2 years
|
|
Nervous system disorders
Vocal cord paresis
|
1.1%
1/87 • Number of events 1 • 2 years
|
|
Reproductive system and breast disorders
Prostatic Hyperplasia
|
1.1%
1/87 • Number of events 1 • 2 years
|
|
Vascular disorders
Arterial Bleeding
|
1.1%
1/87 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Prolapse
|
1.1%
1/87 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Gastroenteritis
|
1.1%
1/87 • Number of events 1 • 2 years
|
|
General disorders
Death; Cause Unknown, Unrelated to Study Treatment
|
1.1%
1/87 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Shoulder Fracture
|
1.1%
1/87 • Number of events 1 • 2 years
|
|
Injury, poisoning and procedural complications
Overdose
|
1.1%
1/87 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
1.1%
1/87 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
1.1%
1/87 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
ReActiv8
n=87 participants at risk
All participants implanted with ReActiv8 at baseline.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Pain Sacroiliac
|
6.9%
6/87 • Number of events 7 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place