Trial Outcomes & Findings for BioWick SureLock Clinical Outcomes Study (NCT NCT03199391)
NCT ID: NCT03199391
Last Updated: 2022-07-07
Results Overview
The primary endpoint of this study is survivorship (lack of reoperation/device removal) at 12 months postoperative. Implant survivorship for each subject was determined by whether the subject underwent a revision or reoperation of the study device. Survivorship was assessed using a Kaplan-Meier analysis. Possible scores range from 0% (lowest survivorship) to 100% (highest survivorship).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
71 participants
Primary outcome timeframe
12 months
Results posted on
2022-07-07
Participant Flow
Any screened subjects who met any of the exclusion criteria were excluded from participation in this study and were not considered enrolled subjects.
Participant milestones
| Measure |
BioWick SureLock Implant
This arm included all subjects who were implanted with the BioWick SureLock Implant.
|
|---|---|
|
Overall Study
STARTED
|
71
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
BioWick SureLock Implant
This arm included all subjects who were implanted with the BioWick SureLock Implant.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Withdrawal by Subject
|
10
|
Baseline Characteristics
BioWick SureLock Clinical Outcomes Study
Baseline characteristics by cohort
| Measure |
BioWick SureLock Implant
n=71 Participants
This arm will include all subjects who are implanted with the BioWick SureLock Implant.
|
|---|---|
|
Age, Continuous
|
60.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African Origin
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
56 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Indian
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
71 Participants
n=5 Participants
|
|
Duration of Symptoms/Time Since Injury
|
14.9 months
n=5 Participants
|
|
Current tobacco use
No
|
63 Participants
n=5 Participants
|
|
Current tobacco use
Yes
|
8 Participants
n=5 Participants
|
|
Current alcohol use
No
|
33 Participants
n=5 Participants
|
|
Current alcohol use
Yes
|
38 Participants
n=5 Participants
|
|
Prior Shoulder Operations
No
|
49 Participants
n=5 Participants
|
|
Prior Shoulder Operations
Yes
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: In the statistical analysis of the primary effectiveness endpoint of the study, only subjects with evaluable endpoint were used in the statistical analysis, i.e., a complete case analysis.
The primary endpoint of this study is survivorship (lack of reoperation/device removal) at 12 months postoperative. Implant survivorship for each subject was determined by whether the subject underwent a revision or reoperation of the study device. Survivorship was assessed using a Kaplan-Meier analysis. Possible scores range from 0% (lowest survivorship) to 100% (highest survivorship).
Outcome measures
| Measure |
BioWick SureLock Implant
n=71 Participants
This arm will include all subjects who are implanted with the BioWick SureLock Implant.
|
|---|---|
|
Number of Participants Not Requiring Removal or Reoperation of the Implant
|
69 Participants
|
SECONDARY outcome
Timeframe: 3 months, 6 monthsPopulation: In the statistical analysis of the primary effectiveness endpoint of the study, only subjects with evaluable endpoint were used in the statistical analysis, i.e., a complete case analysis.
Implant survivorship (lack of reoperation/device removal) at 3 months and 6 months postoperative. Implant survivorship for each subject was determined by whether the subject underwent a revision or reoperation of the study device. Survivorship was assessed using a Kaplan-Meier analysis. Possible scores range from 0% (lowest survivorship) to 100% (highest survivorship).
Outcome measures
| Measure |
BioWick SureLock Implant
n=71 Participants
This arm will include all subjects who are implanted with the BioWick SureLock Implant.
|
|---|---|
|
Number of Participants Not Requiring Removal or Reoperation of the Implant
3 months
|
69 Participants
|
|
Number of Participants Not Requiring Removal or Reoperation of the Implant
6 months
|
69 Participants
|
SECONDARY outcome
Timeframe: Preoperative, 3 months, 6 months, 1 yearPopulation: The number analyzed at each interval represents the number of subjects who completed the respective follow-up visit, which may be less than the overall number of participants because of missed visits.
Pain and function as measured by the American Society of Shoulder and Elbow Surgeons (ASES) questionnaire. ASES consists of 3 subcomponent scores including pain, instability, and activities of daily living. The pain score can be 0 to 10 with 0 being no pain and 10 being the worst pain imaginable. The instability score can be 0 to 10 with 0 being no instability and 10 being the worst instability imaginable. The activities of daily living consists of 10 questions with ordinal responses of 0, 1, 2, and 3 with 3 involving no limitation and 0 is unable to do. The 3 subcomponents combine to make the overall ASES score which can range from 0 to 100 with 0 being the worst possible score and 100 being the best.
Outcome measures
| Measure |
BioWick SureLock Implant
n=71 Participants
This arm will include all subjects who are implanted with the BioWick SureLock Implant.
|
|---|---|
|
American Shoulder and Elbow Surgeons (ASES) Patient Self-Evaluation Score
Preoperative
|
44.2 units on a scale
Standard Deviation 17.1
|
|
American Shoulder and Elbow Surgeons (ASES) Patient Self-Evaluation Score
3 months
|
66.7 units on a scale
Standard Deviation 19.9
|
|
American Shoulder and Elbow Surgeons (ASES) Patient Self-Evaluation Score
6 months
|
82.9 units on a scale
Standard Deviation 15.8
|
|
American Shoulder and Elbow Surgeons (ASES) Patient Self-Evaluation Score
12 months
|
92.5 units on a scale
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: Preoperative, 3 months, 6 months, 1 yearPopulation: The number analyzed at each interval represents the number of subjects who completed the respective follow-up visit, which may be less than the overall number of participants because of missed visits.
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. Possible scores range from 0 (no pain) to 10 (very much pain).
Outcome measures
| Measure |
BioWick SureLock Implant
n=71 Participants
This arm will include all subjects who are implanted with the BioWick SureLock Implant.
|
|---|---|
|
Visual Analogue Scale (VAS) Pain Score
Preoperative
|
5.5 score on a scale
Standard Deviation 2.4
|
|
Visual Analogue Scale (VAS) Pain Score
3 months
|
2.1 score on a scale
Standard Deviation 2.4
|
|
Visual Analogue Scale (VAS) Pain Score
6 months
|
1.2 score on a scale
Standard Deviation 1.6
|
|
Visual Analogue Scale (VAS) Pain Score
1 year
|
0.5 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Preoperative, 3 months, 6 months, 1 yearPopulation: The number analyzed at each interval represents the number of subjects who completed the respective follow-up visit, which may be less than the overall number of participants because of missed visits.
A brief, generic, multi-use, self-administered health survey comprised of 12 items. The instruments are primarily used to measure health-related quality of life, to estimate disease burden, and to evaluate the disease-specific impact on general and selected populations. A higher VR-12 score indicates better health (0-100 scale).
Outcome measures
| Measure |
BioWick SureLock Implant
n=71 Participants
This arm will include all subjects who are implanted with the BioWick SureLock Implant.
|
|---|---|
|
The Veterans RAND 12 (VR-12) Item Health Survey Physical Score
Preoperative
|
35.3 score on a scale
Standard Deviation 8.3
|
|
The Veterans RAND 12 (VR-12) Item Health Survey Physical Score
3 months
|
39.9 score on a scale
Standard Deviation 8.4
|
|
The Veterans RAND 12 (VR-12) Item Health Survey Physical Score
6 months
|
46.7 score on a scale
Standard Deviation 8.7
|
|
The Veterans RAND 12 (VR-12) Item Health Survey Physical Score
1 year
|
49.2 score on a scale
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: Preoperative, 3 months, 6 months, 1 yearPopulation: The number analyzed at each interval represents the number of subjects who completed the respective follow-up visit, which may be less than the overall number of participants because of missed visits.
A brief, generic, multi-use, self-administered health survey comprised of 12 items. The instruments are primarily used to measure health-related quality of life, to estimate disease burden, and to evaluate the disease-specific impact on general and selected populations. A higher VR-12 score indicates better health (0-100 scale).
Outcome measures
| Measure |
BioWick SureLock Implant
n=71 Participants
This arm will include all subjects who are implanted with the BioWick SureLock Implant.
|
|---|---|
|
The Veterans RAND 12 (VR-12) Item Health Survey Mental Score
Preoperative
|
53.7 score on a scale
Standard Deviation 11.3
|
|
The Veterans RAND 12 (VR-12) Item Health Survey Mental Score
3 months
|
54.8 score on a scale
Standard Deviation 11.2
|
|
The Veterans RAND 12 (VR-12) Item Health Survey Mental Score
6 months
|
55.9 score on a scale
Standard Deviation 9.1
|
|
The Veterans RAND 12 (VR-12) Item Health Survey Mental Score
1 year
|
57.0 score on a scale
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Preoperative, 3 months, 6 months, 1 yearPopulation: The number analyzed at each interval represents the number of subjects who completed the respective follow-up visit, which may be less than the overall number of participants because of missed visits.
Range of motion (ROM): The full movement potential of a joint, usually its range of flexion and extension. Normal range for active forward elevation is 150-180 degrees.
Outcome measures
| Measure |
BioWick SureLock Implant
n=71 Participants
This arm will include all subjects who are implanted with the BioWick SureLock Implant.
|
|---|---|
|
Range of Motion (ROM) - Active Forward Elevation
Preoperative
|
116.1 degrees
Standard Deviation 42.1
|
|
Range of Motion (ROM) - Active Forward Elevation
3 months
|
132.1 degrees
Standard Deviation 30.8
|
|
Range of Motion (ROM) - Active Forward Elevation
6 months
|
153.4 degrees
Standard Deviation 23.3
|
|
Range of Motion (ROM) - Active Forward Elevation
1 year
|
162.1 degrees
Standard Deviation 18.7
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All enrolled subjects were analyzed for device safety through the end of their study participation.
Safety evaluations were based on the frequency and incidence of device-related adverse events. Device-related adverse events included all reported adverse events classified as "Definitely" or "Possibly" related to the device. Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine collection occurred at each visit (3 months, 6 months, and 1 year). Additional details of reports of adverse events can be found in the Adverse Events section of the posted results.
Outcome measures
| Measure |
BioWick SureLock Implant
n=71 Participants
This arm will include all subjects who are implanted with the BioWick SureLock Implant.
|
|---|---|
|
Device Safety
|
8 device-related adverse events
|
Adverse Events
BioWick SureLock Implant
Serious events: 5 serious events
Other events: 29 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
BioWick SureLock Implant
n=71 participants at risk
This arm will include all subjects who are implanted with the BioWick SureLock Implant.
|
|---|---|
|
Infections and infestations
Stepped on a nail with right foot.
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
Increased pain, loose rotator cuff anchor (non-study device)
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Gastrointestinal disorders
Bowel obstruction
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Cardiac disorders
Chest pain and received heart catheter
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Cardiac disorders
Chest pain
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
Left knee OA
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Respiratory, thoracic and mediastinal disorders
Subject death after no longer able to breathe
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
Other adverse events
| Measure |
BioWick SureLock Implant
n=71 participants at risk
This arm will include all subjects who are implanted with the BioWick SureLock Implant.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Tear and retraction of entire supraspinatus tendon
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
Adhesive capsulitis
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
3 month MRI shows recurrent full-thickness tear of the supraspinatus
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
Right rotator cuff tear
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
Worsening of left shoulder pain
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
Patient is stiff at 3 month and 6 month visit
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
Tightness in trigger points within the cervical paraspinous muscles and levator scapular muscle
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
Right (contralateral) shoulder pain after fall
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Nervous system disorders
Neck pain - post op cervical discectomy
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
Full thickness defect of the anterior supraspinatus tendon just medial to the biowick anchors
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
Left shoulder pain with certain movements
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
Patient presented with ipsilateral bursitis/adhesive capsulitis
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
General disorders
Headaches for 2 weeks
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
Patient healed quickly and subsequently developed capsulitis
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
Right shoulder pain
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
Medial meniscus tear on right knee
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
Patient fell off bike and ruptured his achilles tendon
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
General disorders
Metal shaving in left 3rd toe
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
Increased pain in right shoulder and neck radiating to fingers
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Respiratory, thoracic and mediastinal disorders
Presented to the ed with complaints of cough and wheezing x 2 weeks
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
At 3 month visit, patient is noted to be stiff
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Skin and subcutaneous tissue disorders
Melanoma excision on right shoulder
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
Patient developed lateral epicondylitis of right humerus
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
6 month MRI report notes a re-tear of the supraspinatus and associated bursal-sided fluid build-up
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Nervous system disorders
Sharp stabbing pain down middle of back. Preexisting back pain got much worse right after surgery
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
Adhesive capsulitis/arthro fibrosis diagnosed.
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
Loosened posterior superior anchor with fluid collection and retraction.
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Nervous system disorders
Worsening of lumbar degenerative disc disease
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
Capsulitis/stiffness. Required cortisone injection
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
3/4 weeks post-op, patient developed erythema. Required surgical debridement and ROH.
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
Patient presented to the pain clinic with known history of migraine headaches
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
New full-thickness tear at the supraspinatus/infraspinatus junction from shoveling.
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Nervous system disorders
Low back pain with radiation into left thigh
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Nervous system disorders
Neck pain and decreased ROM related to degenerative cervical disc disease
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
3 month MRI reports recurrent tear which becomes symptomatic sometimes
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
R shoulder pain/difficulty with throwing activities and shoulder movement
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Renal and urinary disorders
Urinary retention
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
|
Musculoskeletal and connective tissue disorders
New tenderness of left shoulder
|
1.4%
1/71 • 3 months, 6 months, and 1 year
Adverse event data were collected throughout the entire duration of the study from enrollment thru subject completion. Routine adverse event collection occurred at each visit (3 months, 6 months, and 1 year).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place