Trial Outcomes & Findings for BIO4 Clinical Case Study: Cervical Spine (NCT NCT03077204)

Results Overview

This will be used to monitor the fusion status at 1 year post-op. The fusion states was reported as the number of patients who fused. If fused, then we say "Yes". We counted the number of patients who fused. If all 20 patients fused then we said there were 20 "yes".

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

Post-op 1 year

Results posted on

2022-01-14

Participant Flow

Participant milestones

Participant milestones
Measure	BIO4 Treatment Participants were treated as per the protocol.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BIO4 Treatment n=20 Participants Treatment group consisted of patient undergoing ACDF using BIO4
Age, Categorical <=18 years	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=20 Participants
Age, Categorical >=65 years	4 Participants n=20 Participants
Age, Continuous	57.4 years n=20 Participants
Sex: Female, Male Female	5 Participants n=20 Participants
Sex: Female, Male Male	15 Participants n=20 Participants
Visual Analog Scale	4.7 units on a scale n=20 Participants
Neck Disability Index	35 units on a scale n=20 Participants

PRIMARY outcome

Timeframe: Post-op 1 year

Population: Patients who underwent ACDF using BIO4

This will be used to monitor the fusion status at 1 year post-op. The fusion states was reported as the number of patients who fused. If fused, then we say "Yes". We counted the number of patients who fused. If all 20 patients fused then we said there were 20 "yes".

Outcome measures

Outcome measures
Measure	BIO4 Treatment n=20 Participants Patients undergoing ACDF using BIO4
Radiological Assessment : Fusion Status	20 participants

PRIMARY outcome

Timeframe: Post-op 1 year

Population: Patients who underwent ACDF using BIO4

Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays will be used to access arthrodesis rates at different time intervals. We counted the number of patients who developed arthrodesis. The arthrodesis rate was calculated as the number of patients who developed arthrodesis.

Outcome measures

Outcome measures
Measure	BIO4 Treatment n=20 Participants Patients undergoing ACDF using BIO4
Arthrodesis Rates	0 participants

SECONDARY outcome

Timeframe: Post-op 2~4 weeks

Population: Patients who underwent ACDF using BIO4

As needed, any post-operative surgical revision rates will be accessed. The revision rate was described as the number of patients who had to undergo revision post index surgery

Outcome measures

Outcome measures
Measure	BIO4 Treatment n=20 Participants Patients undergoing ACDF using BIO4
Revision Rates (if Any)	0 participants

SECONDARY outcome

Timeframe: Post-op 3 months

Population: Patients who underwent ACDF using BIO4

As needed, any post-operative surgical revision rates will be accessed. The revision rate was described as the number of patients who had to undergo revision post index surgery

Outcome measures

Outcome measures
Measure	BIO4 Treatment n=20 Participants Patients undergoing ACDF using BIO4
Revision Rates (if Any)	0 participants

SECONDARY outcome

Timeframe: Post-op 6 months

Population: Patients who underwent ACDF using BIO4

As needed, any post-operative surgical revision rates will be accessed. The revision rate was described as the number of patients who had to undergo revision post index surgery

Outcome measures

Outcome measures
Measure	BIO4 Treatment n=20 Participants Patients undergoing ACDF using BIO4
Revision Rates (if Any)	0 participants

SECONDARY outcome

Timeframe: Post-op 1 year

Population: Patients who underwent ACDF using BIO4

As needed, any post-operative surgical revision rates will be accessed. The revision rate was described as the number of patients who had to undergo revision post index surgery

Outcome measures

Outcome measures
Measure	BIO4 Treatment n=20 Participants Patients undergoing ACDF using BIO4
Revision Rates (if Any)	0 participants

SECONDARY outcome

Timeframe: Pre-op

Population: Patients treated with BIO4

Patient reported VAS will be collected at different time intervals. The revision rate was described as the number of patients who had to undergo revision post index surgery. VAS: 0-10 (0=better, 10=worst)

Outcome measures

Outcome measures
Measure	BIO4 Treatment n=20 Participants Patients undergoing ACDF using BIO4
VAS	4.7 units on a scale Interval 0.0 to 8.0

SECONDARY outcome

Timeframe: Post-op 2 ~ 4 weeks

Population: Patients who underwent ACDF using BIO4

Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)

Outcome measures

Outcome measures
Measure	BIO4 Treatment n=20 Participants Patients undergoing ACDF using BIO4
VAS	2.9 units on a scale Interval 0.0 to 7.0

SECONDARY outcome

Timeframe: Post-op 3 months

Population: Patients who underwent ACDF using BIO4

Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)

Outcome measures

Outcome measures
Measure	BIO4 Treatment n=20 Participants Patients undergoing ACDF using BIO4
VAS	2.4 units on a scale Interval 0.0 to 7.0

SECONDARY outcome

Timeframe: Post-op 6 months

Population: Patients who underwent ACDF using BIO4

Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)

Outcome measures

Outcome measures
Measure	BIO4 Treatment n=20 Participants Patients undergoing ACDF using BIO4
VAS	2 units on a scale Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: Post-op 1 year

Population: Patients who underwent ACDF using BIO4

Patient reported VAS will be collected at different time intervals. VAS: 0-10 (0=better, 10=worst)

Outcome measures

Outcome measures
Measure	BIO4 Treatment n=20 Participants Patients undergoing ACDF using BIO4
VAS	1.2 units on a scale Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: Pre-op

Population: Patients who underwent ACDF using BIO4

Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst)

Outcome measures

Outcome measures
Measure	BIO4 Treatment n=20 Participants Patients undergoing ACDF using BIO4
NDI	35 units on a scale Interval 6.0 to 68.0

SECONDARY outcome

Timeframe: Post-op 2~4 weeks

Population: Patients who underwent ACDF using BIO4

Patient reported NDI will be collected at different time intervals NDI: 0-100 (0=better, 100=worst)

Outcome measures

Outcome measures
Measure	BIO4 Treatment n=20 Participants Patients undergoing ACDF using BIO4
NDI	19.1 units on a scale Interval 8.0 to 60.0

SECONDARY outcome

Timeframe: Post-op 3 months

Population: Patients who underwent ACDF using BIO4

Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst)

Outcome measures

Outcome measures
Measure	BIO4 Treatment n=20 Participants Patients undergoing ACDF using BIO4
NDI	20.7 units on a scale Interval 0.0 to 48.0

SECONDARY outcome

Timeframe: Post-op 6 months

Population: Patients who underwent ACDF using BIO4

Patient reported NDI will be collected at different time intervals. NDI: 0-100 (0=better, 100=worst)

Outcome measures

Outcome measures
Measure	BIO4 Treatment n=20 Participants Patients undergoing ACDF using BIO4
NDI	18.7 units on a scale Interval 0.0 to 58.0

SECONDARY outcome

Timeframe: Post-op 1 year

Population: Patients who underwent ACDF using BIO4

Patient reported NDI will be collected at different time intervals. NSI: 0-100 (0=better, 100=worst)

Outcome measures

Outcome measures
Measure	BIO4 Treatment n=20 Participants Patients undergoing ACDF using BIO4
NDI	9.1 units on a scale Interval 0.0 to 36.0

SECONDARY outcome

Timeframe: Pre-op

Population: Patients who underwent ACDF using BIO4

Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays will be used to access arthrodesis rates at different time intervals. The arthrodesis rate was calculated as the number of patients who developed arthrodesis.

Outcome measures

Outcome measures
Measure	BIO4 Treatment n=20 Participants Patients undergoing ACDF using BIO4
Arthrodesis Rates	0 participants

SECONDARY outcome

Timeframe: Post-op 2~4 weeks

Population: Patients who underwent ACDF using BIO4

Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays will be used to access arthrodesis rates at different time intervals. The arthrodesis rate was calculated as the number of patients who developed arthrodesis.

Outcome measures

Outcome measures
Measure	BIO4 Treatment n=20 Participants Patients undergoing ACDF using BIO4
Arthrodesis Rates	0 participants

SECONDARY outcome

Timeframe: Post-op 3 months

Population: Patients who underwent ACDF using BIO4

Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays will be used to access arthrodesis rates at different time intervals. The arthrodesis rate was calculated as the number of patients who developed arthrodesis.

Outcome measures

Outcome measures
Measure	BIO4 Treatment n=20 Participants Patients undergoing ACDF using BIO4
Arthrodesis Rates	0 participants

SECONDARY outcome

Timeframe: Post-op 6 months

Population: Patients who underwent ACDF using BIO4

Anterior-Posterior (AP), lateral and dynamic flexion-extension cervical spine x-rays will be used to access arthrodesis rates at different time intervals. The arthrodesis rate was calculated as the number of patients who developed arthrodesis.

Outcome measures

Outcome measures
Measure	BIO4 Treatment n=20 Participants Patients undergoing ACDF using BIO4
Arthrodesis Rates	0 participants

Adverse Events

BIO4 Treatment

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	BIO4 Treatment n=20 participants at risk Patients undergoing ACDF using BIO4
Infections and infestations Sepsis	5.0% 1/20 • Number of events 1 • 1 year We reviewed mortality in all our 20 patients

Other adverse events

Other adverse events
Measure	BIO4 Treatment n=20 participants at risk Patients undergoing ACDF using BIO4
Surgical and medical procedures Respiratory distress post-surgery	5.0% 1/20 • Number of events 1 • 1 year We reviewed mortality in all our 20 patients

Additional Information

Devender Singh, Research Scientist

Ascension Texas Spine and Scoliosis

Phone: 512 324 3580

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place