Trial Outcomes & Findings for Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery (NCT NCT00744861)
NCT ID: NCT00744861
Last Updated: 2021-04-02
Results Overview
Fusion success at the treated level was defined as at least 2 of 3 independent blinded radiologists agree all 3 of the following criteria were met. 1. Confirmation of bridging bone based on computed tomography (CT) evidence of a continuous bony connection between the transverse processes on both posterolateral sides, assessed using a numeric grading scale. 2. No evidence of motion defined as \<5° angulation based on flexion and extension radiographs. 3. No evidence of translational movement defined as \<3 mm difference based on flexion and extension radiographs.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
328 participants
Primary outcome timeframe
12 months post treatment start
Results posted on
2021-04-02
Participant Flow
Study conducted in 2 stages: Stage 1 was feasibility phase assessing study treatment and study assessments. LIPUS delivered via Exogen 4000+ device with a single transducer was used for this phase of the study Stage 2 was pivotal phase assessing safety and effectiveness. LIPUS delivered via Exospine device (dual transducers)
Participant milestones
| Measure |
Exogen 4000+ Sham
Inactive LIPUS sham (single transducer)
|
Exogen 4000+
Active LIPUS device (single transducer)
|
Exospine
Active LIPUS device (dual transducers)
|
Exospine Sham
Inactive Exospine device (dual transducers)
|
|---|---|---|---|---|
|
Feasibility Stage 1
STARTED
|
8
|
10
|
0
|
0
|
|
Feasibility Stage 1
COMPLETED
|
7
|
8
|
0
|
0
|
|
Feasibility Stage 1
NOT COMPLETED
|
1
|
2
|
0
|
0
|
|
Pivotal Stage 2
STARTED
|
0
|
0
|
154
|
156
|
|
Pivotal Stage 2
COMPLETED
|
0
|
0
|
52
|
51
|
|
Pivotal Stage 2
NOT COMPLETED
|
0
|
0
|
102
|
105
|
Reasons for withdrawal
| Measure |
Exogen 4000+ Sham
Inactive LIPUS sham (single transducer)
|
Exogen 4000+
Active LIPUS device (single transducer)
|
Exospine
Active LIPUS device (dual transducers)
|
Exospine Sham
Inactive Exospine device (dual transducers)
|
|---|---|---|---|---|
|
Feasibility Stage 1
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
|
Feasibility Stage 1
Pregnancy
|
0
|
1
|
0
|
0
|
|
Pivotal Stage 2
Adverse Event
|
0
|
0
|
6
|
11
|
|
Pivotal Stage 2
Death
|
0
|
0
|
0
|
1
|
|
Pivotal Stage 2
Lost to Follow-up
|
0
|
0
|
13
|
14
|
|
Pivotal Stage 2
Physician Decision
|
0
|
0
|
3
|
1
|
|
Pivotal Stage 2
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Pivotal Stage 2
Withdrawal by Subject
|
0
|
0
|
20
|
14
|
|
Pivotal Stage 2
Study Terminated by Sponsor
|
0
|
0
|
60
|
63
|
Baseline Characteristics
Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery
Baseline characteristics by cohort
| Measure |
Exogen 4000+ Sham
n=8 Participants
Inactive LIPUS sham (single transducer)
|
Exogen 4000+
n=10 Participants
Active LIPUS device (single transducer)
|
Exospine Sham
n=156 Participants
Inactive LIPUS device (dual transducer)
|
Exospine
n=154 Participants
Active LIPUS device (dual transducer)
|
Total
n=328 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
216 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
112 Participants
n=21 Participants
|
|
Age, Continuous
|
53.8 years
STANDARD_DEVIATION 11.55 • n=5 Participants
|
52.4 years
STANDARD_DEVIATION 14.39 • n=7 Participants
|
58.30 years
STANDARD_DEVIATION 13.90 • n=5 Participants
|
56.10 years
STANDARD_DEVIATION 13.57 • n=4 Participants
|
57.20 years
STANDARD_DEVIATION 13.76 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
195 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
133 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
138 Participants
n=4 Participants
|
287 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 months post treatment startPopulation: Full Analysis Set (FAS): all safety subjects with at least one fully adjudicated fusion assessment at the month 12 visit of assessment
Fusion success at the treated level was defined as at least 2 of 3 independent blinded radiologists agree all 3 of the following criteria were met. 1. Confirmation of bridging bone based on computed tomography (CT) evidence of a continuous bony connection between the transverse processes on both posterolateral sides, assessed using a numeric grading scale. 2. No evidence of motion defined as \<5° angulation based on flexion and extension radiographs. 3. No evidence of translational movement defined as \<3 mm difference based on flexion and extension radiographs.
Outcome measures
| Measure |
Exospine Sham
n=74 Participants
Exospine Inactive: dual transducers
|
Exospine Active
n=85 Participants
Exospine active: dual transducers
|
|---|---|---|
|
Number of Participants With Posterolateral Fusion Success at the Treated Level
|
25 participants
|
28 participants
|
Adverse Events
Exogen 4000+ Sham
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Exogen 4000+
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Exospine Sham
Serious events: 23 serious events
Other events: 56 other events
Deaths: 0 deaths
Exospine
Serious events: 18 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exogen 4000+ Sham
n=8 participants at risk
Stage 1 Feasibility: Exogen 4000+ sham, inactive single transducer
|
Exogen 4000+
n=10 participants at risk
Stage 1 Feasibility: Exogen 4000+, active single transducer
|
Exospine Sham
n=156 participants at risk
Stage 2 Pivotal: Exospine sham dual transducers
|
Exospine
n=154 participants at risk
Stage 2 Pivotal: Exospine active dual transducers
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Cardiac disorders
Atrial fibrilation
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.64%
1/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.64%
1/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.64%
1/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Congenital, familial and genetic disorders
Meningocele
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.64%
1/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.64%
1/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
General disorders
Chest pain
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Infections and infestations
Cellulitis
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.64%
1/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.64%
1/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Infections and infestations
Incision site infection
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Infections and infestations
Purulen discharge
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.64%
1/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Infections and infestations
Viral infection
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Infections and infestations
Wound infection
|
12.5%
1/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Injury, poisoning and procedural complications
Failure of implant
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
1.3%
2/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.64%
1/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.64%
1/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
1.3%
2/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
1.3%
2/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.64%
1/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.64%
1/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.64%
1/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage IV
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.64%
1/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Nervous system disorders
Convulsion
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Nervous system disorders
Migraine
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.64%
1/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Nervous system disorders
Stupor
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.64%
1/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.64%
1/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Psychiatric disorders
Depression
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
1.3%
2/154 • 12 months post treatment start
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.64%
1/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.64%
1/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
1.3%
2/154 • 12 months post treatment start
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.64%
1/156 • 12 months post treatment start
|
0.65%
1/154 • 12 months post treatment start
|
|
Vascular disorders
Arterial stenosis limb
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.64%
1/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
Other adverse events
| Measure |
Exogen 4000+ Sham
n=8 participants at risk
Stage 1 Feasibility: Exogen 4000+ sham, inactive single transducer
|
Exogen 4000+
n=10 participants at risk
Stage 1 Feasibility: Exogen 4000+, active single transducer
|
Exospine Sham
n=156 participants at risk
Stage 2 Pivotal: Exospine sham dual transducers
|
Exospine
n=154 participants at risk
Stage 2 Pivotal: Exospine active dual transducers
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
4.5%
7/156 • 12 months post treatment start
|
3.2%
5/154 • 12 months post treatment start
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
37.5%
3/8 • 12 months post treatment start
|
40.0%
4/10 • 12 months post treatment start
|
10.9%
17/156 • 12 months post treatment start
|
16.2%
25/154 • 12 months post treatment start
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
12.2%
19/156 • 12 months post treatment start
|
11.0%
17/154 • 12 months post treatment start
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
37.5%
3/8 • 12 months post treatment start
|
20.0%
2/10 • 12 months post treatment start
|
10.3%
16/156 • 12 months post treatment start
|
12.3%
19/154 • 12 months post treatment start
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.5%
1/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
1.3%
2/156 • 12 months post treatment start
|
3.9%
6/154 • 12 months post treatment start
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
2.6%
4/156 • 12 months post treatment start
|
2.6%
4/154 • 12 months post treatment start
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
2.6%
4/156 • 12 months post treatment start
|
1.3%
2/154 • 12 months post treatment start
|
|
Nervous system disorders
Hypoaesthesia
|
25.0%
2/8 • 12 months post treatment start
|
10.0%
1/10 • 12 months post treatment start
|
7.1%
11/156 • 12 months post treatment start
|
9.1%
14/154 • 12 months post treatment start
|
|
Nervous system disorders
Paraesthesia
|
12.5%
1/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
3.2%
5/156 • 12 months post treatment start
|
3.2%
5/154 • 12 months post treatment start
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.64%
1/156 • 12 months post treatment start
|
2.6%
4/154 • 12 months post treatment start
|
|
Injury, poisoning and procedural complications
Incision site complication
|
0.00%
0/8 • 12 months post treatment start
|
10.0%
1/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
12.5%
1/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/8 • 12 months post treatment start
|
10.0%
1/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
12.5%
1/8 • 12 months post treatment start
|
0.00%
0/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Musculoskeletal and connective tissue disorders
Ligament sprain
|
0.00%
0/8 • 12 months post treatment start
|
10.0%
1/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/8 • 12 months post treatment start
|
10.0%
1/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/8 • 12 months post treatment start
|
10.0%
1/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Nervous system disorders
Radicular pain
|
0.00%
0/8 • 12 months post treatment start
|
10.0%
1/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
|
Nervous system disorders
Radiculitis
|
0.00%
0/8 • 12 months post treatment start
|
10.0%
1/10 • 12 months post treatment start
|
0.00%
0/156 • 12 months post treatment start
|
0.00%
0/154 • 12 months post treatment start
|
Additional Information
Manager Clinical Affairs
Bioventus LLC
Phone: 1-800-396-4325
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place