Trial Outcomes & Findings for Dynesys Spinal System Post Market 522 Study (NCT NCT01528072)

Last Updated: 2020-01-29

Results Overview

Fusion was defined by meeting three criteria: * rotation \< 5° between motion segments on flexion-extension radiographs * translation \< 3 mm between motion segments on flexion-extension radiographs * presence of bridging bone. Fusion assessment for each patient was categorized as one of the four defined outcomes: fused, not fused, partial fusion, or UA (unable to assess). Efficacy was confirmed by the achievement of fusion in the experimental group when compared to the rate established in a literature control.

Recruitment status

TERMINATED

Study phase

Target enrollment

153 participants

Primary outcome timeframe

24 months post surgery date

Results posted on

2020-01-29

Participant Flow

In the time between signing consent and application of treatment 13 subjects were discontinued. Out of 153 enrolled there were: 5- screen failures; 1- withdraw consent; 5- insurance denials; 2- Removed by investigator.

Participant milestones

Participant milestones
Measure	Dynesys System Dynesys Spinal System will be used for all subjects
Overall Study STARTED	140
Overall Study COMPLETED	66
Overall Study NOT COMPLETED	74

Reasons for withdrawal

Reasons for withdrawal
Measure	Dynesys System Dynesys Spinal System will be used for all subjects
Overall Study Withdrawal by Subject	5
Overall Study Physician Decision	1
Overall Study Determined not eligible by AEAC	1
Overall Study Missed Visit	2
Overall Study Lost to Follow-up	5
Overall Study Explanted	2
Overall Study Site Closure	4
Overall Study Death	2
Overall Study Early Termination of Study	52

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dynesys System n=139 Participants Dynesys Spinal System will be used for all subjects
Age, Continuous	63.9 years STANDARD_DEVIATION 9.9 • n=139 Participants
Sex: Female, Male Female	88 Participants n=139 Participants
Sex: Female, Male Male	51 Participants n=139 Participants
Height	65.7 inches STANDARD_DEVIATION 3.7 • n=139 Participants
Weight	184.6 pounds STANDARD_DEVIATION 39.6 • n=139 Participants
BMI	30 (kg/mg^2) STANDARD_DEVIATION 5.4 • n=139 Participants

PRIMARY outcome

Timeframe: 24 months post surgery date

Population: Sixty-six (66) out of the original 140 implanted subjects completed their 24 month follow up. Sixty-one (61) subjects completed 24month radiograph for analysis of the primary end point.

Outcome measures

Outcome measures
Measure	Dynesys System n=61 Participants Dynesys Spinal System will be used for all subjects.
Fusion Rates Proportion fused	33 Participants
Fusion Rates Proportion not fused	19 Participants
Fusion Rates Proportion with Partial Fusion	5 Participants
Fusion Rates Proportion unable to assess	4 Participants

Adverse Events

Dynesys System

Serious events: 33 serious events

Other events: 71 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Dynesys System n=139 participants at risk Dynesys Spinal System: Dynesys Spinal System will be used for all subjects
Metabolism and nutrition disorders Acidosis	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Immune system disorders Allergic reaction	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Blood and lymphatic system disorders Anemia	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Cardiac disorders Coronary Artery Disease	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Psychiatric disorders Delirium	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Infections and infestations Enterocolitis infectious	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
General disorders Fever	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Musculoskeletal and connective tissue disorders Hip fracture	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Vascular disorders Hypotension	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Gastrointestinal disorders Ileus	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Vascular disorders Other- Iliac artery aneurysm	0.72% 1/139 • Number of events 2 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Nervous system disorders Intracranial hemorrhage	1.4% 2/139 • Number of events 2 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Infections and infestations Meningitis	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Cardiac disorders Myocardial infarction	1.4% 2/139 • Number of events 2 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Musculoskeletal and connective tissue disorders Other- Adjacent level disease	2.9% 4/139 • Number of events 4 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Surgical and medical procedures Other- Bilateral knee arthroplasty	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Other- Mucinous adenocarcinoma	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Infections and infestations Other- Postoperative pneumonia	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Musculoskeletal and connective tissue disorders Other- Spinal stenosis	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Musculoskeletal and connective tissue disorders Other- Total hip arthoroplasty	1.4% 2/139 • Number of events 2 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Renal and urinary disorders Other- Urinary hesitancy	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Injury, poisoning and procedural complications Other- Wound	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Nervous system disorders Pseudomeningocele	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Nervous system disorders Radiculitis	3.6% 5/139 • Number of events 5 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Injury, poisoning and procedural complications Seroma	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Cardiac disorders Sinus bradycardia	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Infections and infestations Skin infection	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Vascular disorders Superficial thrombophlebitis	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Vascular disorders Thromboembolic Event	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Renal and urinary disorders Urinary incontinence	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Vascular disorders Visceral arterial ischemia	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Skin and subcutaneous tissue disorders Other- Incision site necrosis	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.

Other adverse events

Other adverse events
Measure	Dynesys System n=139 participants at risk Dynesys Spinal System: Dynesys Spinal System will be used for all subjects
Gastrointestinal disorders Ileus	1.4% 2/139 • Number of events 2 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Infections and infestations Wound infection	1.4% 2/139 • Number of events 2 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Injury, poisoning and procedural complications Intraoperative neurological injury	3.6% 5/139 • Number of events 5 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Injury, poisoning and procedural complications Wound dehiscence	1.4% 2/139 • Number of events 2 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Musculoskeletal and connective tissue disorders Back pain	7.2% 10/139 • Number of events 10 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Musculoskeletal and connective tissue disorders Pain in extremity	3.6% 5/139 • Number of events 5 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	1.4% 2/139 • Number of events 2 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Musculoskeletal and connective tissue disorders Arthralgia	1.4% 2/139 • Number of events 2 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Musculoskeletal and connective tissue disorders Buttock pain	2.2% 3/139 • Number of events 3 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Nervous system disorders Neuralgia	1.4% 2/139 • Number of events 2 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Nervous system disorders Paresthesia	2.9% 4/139 • Number of events 4 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Nervous system disorders Radiculitis	2.2% 3/139 • Number of events 3 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Vascular disorders Hypotension	1.4% 2/139 • Number of events 2 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Nervous system disorders Other- Adjacent level disease	2.2% 3/139 • Number of events 3 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Nervous system disorders Other- Pain in leg	1.4% 2/139 • Number of events 2 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Nervous system disorders Other- Pain low back	2.9% 4/139 • Number of events 4 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.
Nervous system disorders Other- pain in back	2.2% 3/139 • Number of events 3 • Adverse events were collected from the time of surgery through the participants last visit; up to 48months. Any unfavorable and unintended sign, symptom, or disease associated with the use of an investigational product, whether or not related to the investigational product, taking into consideration the patient history, surgical history, histological analysis as well as explants evaluation. Events may be complications, observations (including radiographic), change in patient condition or related/unrelated death. A change indicating worsening as reported on an assessment is an adverse event.

Additional Information

Clinical Affairs

Zimmer Biomet Spine

Phone: 303-501-8571

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place