Trial Outcomes & Findings for Spineology Clinical Outcomes Trial: An IDE Investigation (NCT NCT02347410)

NCT ID: NCT02347410

Last Updated: 2021-10-20

Results Overview

The primary endpoint of this trial is the rate of Patient Success at 24-months defined as a composite endpoint that includes: 1. Pain -- Clinically meaningful reduction in low back pain Visual Analog Scale (VAS) score at 24-months post-operative. A clinically meaningful reduction is defined as a difference of at least 20 mm compared to pre-op (pre-op score minus post-op score). 2. Function -- Clinically meaningful improvement in function at 24-months post-operative. A clinically meaningful improvement is defined as a reduction of at least 15 points compared to baseline (pre-op Oswestry Disability Index (ODI) score minus the post-op ODI score). 3. Fusion -- Defined as bridging bone demonstrated on computed tomography (CT) scan 4. Safety -- No device-related serious adverse events (SAEs) from intra-op through the 24-month timepoint. For the study to be a success, 68% of subjects need to meet the above success criteria.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 102 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2021-10-20

Participant Flow

Participant milestones

Measure	SIFS Graft Containment Device Investigation Group: Subjects underwent a lumbar interbody fusion using the SIFS Graft Containment Device and supplemental posterior fixation.
Overall Study STARTED	102
Overall Study COMPLETED	98
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Spineology Clinical Outcomes Trial: An IDE Investigation

Baseline characteristics by cohort

Measure	SIFS Graft Containment Device n=102 Participants Investigational SIFS graft containment device: The SIFS mesh is a graft containment and reinforcement device. Following conventional thorough discectomy, the disc space is entered through a small portal in the annulus, the SIFS mesh is introduced, deployed and then filled with bone graft. Bilateral commercially available posterior lumbar fixation is applied.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	71 Participants n=5 Participants
Age, Categorical >=65 years	31 Participants n=5 Participants
Age, Continuous	57.0 Years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	98 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	96 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	102 participants n=5 Participants
Low Back Pain Status	74.1 units on a scale STANDARD_DEVIATION 16.1 • n=5 Participants
Right Leg Pain Status	42.9 units on a scale STANDARD_DEVIATION 34.1 • n=5 Participants
Left Leg Pain Status	52.9 units on a scale STANDARD_DEVIATION 32.4 • n=5 Participants
Back Function Status	53.60 units on a scale STANDARD_DEVIATION 11.7 • n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: A total of 96 subjects achieved a 24-month exam with complete data (data and CT imaging).

The primary endpoint of this trial is the rate of Patient Success at 24-months defined as a composite endpoint that includes:

1. Pain -- Clinically meaningful reduction in low back pain Visual Analog Scale (VAS) score at 24-months post-operative. A clinically meaningful reduction is defined as a difference of at least 20 mm compared to pre-op (pre-op score minus post-op score).

2. Function -- Clinically meaningful improvement in function at 24-months post-operative. A clinically meaningful improvement is defined as a reduction of at least 15 points compared to baseline (pre-op Oswestry Disability Index (ODI) score minus the post-op ODI score).

3. Fusion -- Defined as bridging bone demonstrated on computed tomography (CT) scan

4. Safety -- No device-related serious adverse events (SAEs) from intra-op through the 24-month timepoint.

For the study to be a success, 68% of subjects need to meet the above success criteria.

Outcome measures

Measure	SIFS Investigation Gp n=96 Participants Investigational All subjects treated with the SIFS device, filled with bone graft. Posterior fixation applied.	Participants Working at 24-Month Visit This is a single-arm Investigation. All subjects were treated with the SIFS device. Posterior fixation required.
Overall Success	71 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: The 96 subjects identified represents all subjects that achieved a 24-month study exam. Of the 102 subjects enrolled and treated, 4 subjects exited prior to the 24-month study visit and 2 subjects missed their 24-month evaluation.

A Visual Analog Scale (VAS) score was used to evaluate a subject's level of pain. The VAS is a 100 mm horizontal line where score of "0" represents "No Pain" and a score of "100" represents the "Worst possible" pain. The subject marks a vertical line across the horizontal line representing their pain level. The pain score is obtained by using a ruler to measure where the vertical line intersects the horizontal line. Improvement is defined as a clinically meaningful difference (20 mm reduction) when compared to pre-op. Success for this parameter is evaluated at the 24-month visit.

Outcome measures

Measure	SIFS Investigation Gp n=96 Participants Investigational All subjects treated with the SIFS device, filled with bone graft. Posterior fixation applied.	Participants Working at 24-Month Visit This is a single-arm Investigation. All subjects were treated with the SIFS device. Posterior fixation required.
Mean Low Back Pain Score at 24-months Post-operative	21.8 units on a scale Standard Deviation 24.5	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: The 96 subjects identified represents all subjects that achieved a 24-month study exam. Of the 102 subjects enrolled and treated, 4 subjects exited prior to the 24-month study visit and 2 subjects missed their 24-month evaluation.

A subject's back function was assessed by the Oswestry Disability Index (ODI). The ODI is a 10 question survey that evaluates the degree of functional impairment. Completion of the survey yields a score from "0" to "100" points. A score of "0" represents "No disability" and "100" represents "Total disability". A clinically meaningful difference is defined as a 15-point reduction when compared to pre-op. Success for this parameter is evaluated at the 24-month visit.

Outcome measures

Measure	SIFS Investigation Gp n=96 Participants Investigational All subjects treated with the SIFS device, filled with bone graft. Posterior fixation applied.	Participants Working at 24-Month Visit This is a single-arm Investigation. All subjects were treated with the SIFS device. Posterior fixation required.
Mean Back Function Score at 24-months Post-operative	21.0 score on a scale Standard Deviation 19.3	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: The 96 subjects identified represents all subjects that achieved a 24-month study exam. Of the 102 subjects enrolled and treated, 4 subjects exited prior to the 24-month study visit and 2 subjects missed their 24-month evaluation.

A Visual Analog Scale (VAS) score was used to evaluate a subject's level of pain. The VAS is a 100 mm horizontal line where score of "0" represents "No Pain" and a score of "100" represents the "Worst possible" pain. The subject marks a vertical line across the horizontal line representing their pain level. The pain score is obtained by using a ruler to measure where the vertical line intersects the horizontal line. Improvement is defined as a clinically meaningful difference (20 mm reduction) when compared to pre-op. Success for this parameter is evaluated at the 24-month visit.

Outcome measures

Measure	SIFS Investigation Gp n=96 Participants Investigational All subjects treated with the SIFS device, filled with bone graft. Posterior fixation applied.	Participants Working at 24-Month Visit This is a single-arm Investigation. All subjects were treated with the SIFS device. Posterior fixation required.
Mean Right Leg Pain Score at 24-months Post-operative	10.5 units on a scale Standard Deviation 19.5	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Months

Population: The 96 subjects identified represents all subjects that achieved a 24-month study exam. Of the 102 subjects enrolled and treated, 4 subjects exited prior to the 24-month study visit and 2 subjects missed their 24-month evaluation.

A Visual Analog Scale (VAS) score was used to evaluate a subject's level of pain. The VAS is a 100 mm horizontal line where score of "0" represents "No Pain" and a score of "100" represents the "Worst possible" pain. The subject marks a vertical line across the horizontal line representing their pain level. The pain score is obtained by using a ruler to measure where the vertical line intersects the horizontal line. Improvement is defined as a clinically meaningful difference (20 mm reduction) when compared to pre-op. Success for this parameter is evaluated at the 24-month visit.

Outcome measures

Measure	SIFS Investigation Gp n=96 Participants Investigational All subjects treated with the SIFS device, filled with bone graft. Posterior fixation applied.	Participants Working at 24-Month Visit This is a single-arm Investigation. All subjects were treated with the SIFS device. Posterior fixation required.
Mean Left Leg Pain Score at 24-months Post-operative	13.2 units on a scale Standard Deviation 22.6	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: The 96 subjects identified represents all subjects that achieved a 24-month study exam. Of the 102 subjects enrolled and treated, 4 subjects exited prior to the 24-month study visit and 2 subjects missed their 24-month evaluation.

Bridging bone demonstrated on CT scan. Independent Board-certified radiologists determine fusion status.

Outcome measures

Measure	SIFS Investigation Gp n=96 Participants Investigational All subjects treated with the SIFS device, filled with bone graft. Posterior fixation applied.	Participants Working at 24-Month Visit This is a single-arm Investigation. All subjects were treated with the SIFS device. Posterior fixation required.
Number of Participants With Bridging Bone Presence	95 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Intra-Op through 24-month interval

Population: The 102 subjects identified represents all subjects enrolled and treated. All subject safety data through 24-months post-operative, regardless of whether a subject exited the study early, is included in the current data point analysis. Note that only 96 of the 102 subjects enrolled and treated achieved a 24-month study exam (4 subjects exited prior to the 24-month study visit and 2 subjects missed their 24-month evaluation).

Events adjudicated by Independent Spine Surgeon Committee that are determined to be a Device-Related Serious Adverse Event (SAE).

Outcome measures

Measure	SIFS Investigation Gp n=102 Participants Investigational All subjects treated with the SIFS device, filled with bone graft. Posterior fixation applied.	Participants Working at 24-Month Visit This is a single-arm Investigation. All subjects were treated with the SIFS device. Posterior fixation required.
Number of Participants Experiencing a Device-Related Serious Adverse Event	0 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: The 96 subjects identified represents all subjects that achieved a 24-month study exam. Of the 102 subjects enrolled and treated, 4 subjects exited prior to the 24-month study visit and 2 subjects missed their 24-month evaluation.

Rate of subjects that were neurologically improved or maintained compared to baseline

Outcome measures

Measure	SIFS Investigation Gp n=96 Participants Investigational All subjects treated with the SIFS device, filled with bone graft. Posterior fixation applied.	Participants Working at 24-Month Visit This is a single-arm Investigation. All subjects were treated with the SIFS device. Posterior fixation required.
Number of Participants With a Neurological Maintenance or Improvement	92 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: Compared the number of participants working at baseline to the number of participants working at 24-months post-op.

Compared the number of participants working at 24-months to number of subjects working at baseline

Outcome measures

Measure	SIFS Investigation Gp n=102 Participants Investigational All subjects treated with the SIFS device, filled with bone graft. Posterior fixation applied.	Participants Working at 24-Month Visit n=96 Participants This is a single-arm Investigation. All subjects were treated with the SIFS device. Posterior fixation required.
Number of Participants Working	54 Participants	46 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 Months

Population: The 96 subjects identified represents all subjects that achieved a 24-month study exam. Of the 102 subjects enrolled and treated, 4 subjects exited prior to the 24-month study visit and 2 subjects missed their 24-month evaluation.

Narcotic pain medication use for back pain was compared to baseline.

Outcome measures

Measure	SIFS Investigation Gp n=96 Participants Investigational All subjects treated with the SIFS device, filled with bone graft. Posterior fixation applied.	Participants Working at 24-Month Visit This is a single-arm Investigation. All subjects were treated with the SIFS device. Posterior fixation required.
Number of Participants With Narcotic Pain Medication	17 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At the conclusion of the surgical procedure, an average of 2.6 hours

Blood loss (cc) reported for the surgical procedure.

Outcome measures

Measure	SIFS Investigation Gp n=102 Participants Investigational All subjects treated with the SIFS device, filled with bone graft. Posterior fixation applied.	Participants Working at 24-Month Visit This is a single-arm Investigation. All subjects were treated with the SIFS device. Posterior fixation required.
Blood Loss	137.3 cubic centimeters of blood (cc) Standard Deviation 217.4	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At the conclusion of the surgical procedure

Operative time (from incision to closure).

Outcome measures

Measure	SIFS Investigation Gp n=102 Participants Investigational All subjects treated with the SIFS device, filled with bone graft. Posterior fixation applied.	Participants Working at 24-Month Visit This is a single-arm Investigation. All subjects were treated with the SIFS device. Posterior fixation required.
Duration of Surgery	2.6 hours Standard Deviation 0.9	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From admission through discharge, an average of 2 days

Number of days subject was in the hospital (from admission to discharge).

Outcome measures

Measure	SIFS Investigation Gp n=102 Participants Investigational All subjects treated with the SIFS device, filled with bone graft. Posterior fixation applied.	Participants Working at 24-Month Visit This is a single-arm Investigation. All subjects were treated with the SIFS device. Posterior fixation required.
Duration of Hospital Stay	2.3 days Standard Deviation 1.2	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 24-Months

Subjects rating their procedure as excellent or good

Outcome measures

Measure	SIFS Investigation Gp n=96 Participants Investigational All subjects treated with the SIFS device, filled with bone graft. Posterior fixation applied.	Participants Working at 24-Month Visit This is a single-arm Investigation. All subjects were treated with the SIFS device. Posterior fixation required.
Patient Satisfaction	88 Participants	—

Adverse Events

Investigation Group

Serious events: 12 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Investigation Group n=102 participants at risk This is a single-arm investigation. All subjects were treated with the SIFS device filled with bone graft. Posterior fixation required.
Surgical and medical procedures Stenosis	3.9% 4/102 • Number of events 4 • From Intraoperative through 24-months postoperative. All events were adjudicated by independent spine surgeon committee (not investigators).
Surgical and medical procedures Dural leak	0.98% 1/102 • Number of events 1 • From Intraoperative through 24-months postoperative. All events were adjudicated by independent spine surgeon committee (not investigators).
Respiratory, thoracic and mediastinal disorders Pulmonary thromboembolism	0.98% 1/102 • Number of events 1 • From Intraoperative through 24-months postoperative. All events were adjudicated by independent spine surgeon committee (not investigators).
Surgical and medical procedures Hematoma	0.98% 1/102 • Number of events 1 • From Intraoperative through 24-months postoperative. All events were adjudicated by independent spine surgeon committee (not investigators).
Surgical and medical procedures Adjacent level disease	2.0% 2/102 • Number of events 2 • From Intraoperative through 24-months postoperative. All events were adjudicated by independent spine surgeon committee (not investigators).
Musculoskeletal and connective tissue disorders Contralateral leg pain	0.98% 1/102 • Number of events 1 • From Intraoperative through 24-months postoperative. All events were adjudicated by independent spine surgeon committee (not investigators).
Surgical and medical procedures Device improper placement	0.98% 1/102 • Number of events 1 • From Intraoperative through 24-months postoperative. All events were adjudicated by independent spine surgeon committee (not investigators).
Musculoskeletal and connective tissue disorders Back and leg pain	0.98% 1/102 • Number of events 1 • From Intraoperative through 24-months postoperative. All events were adjudicated by independent spine surgeon committee (not investigators).

Other adverse events

Adverse event data not reported

Additional Information

Rose Griffith, Sr. Director, Clinical Affairs

Spineology

Phone: 6512568503

Email: Rgriffith@spineology.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place