Trial Outcomes & Findings for OptiMesh® for Lumbar Interbody Fusion Trial (OLIF) (NCT NCT00764491)

NCT ID: NCT00764491

Last Updated: 2021-09-16

Results Overview

A Visual Analog Scale (VAS) score was used to evaluate a subject's level of pain. The VAS is a 10 cm pain scale where a score of "0" represents "No Pain" and a score of "10" represents the "Worst Possible" pain. The magnitude of change in the 24-month score compared to the baseline score is calculated. A clinically meaningful change is defined as a 2 unit (cm) reduction at 24-months when compared to pre-op.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 156 participants
• Primary outcome timeframe: 24 month
• Results posted on: 2021-09-16

Participant Flow

Participant milestones

Measure	Optimesh 1500S OptiMesh 1500S, filled with a mixture of demineralized bone matrix (DBM) and cortico-cancellous bone, placed into the interbody space from the posterior approach and supplemental pedicle screws. OptiMesh 1500S: Following disc space preparation the OptiMesh is deployed and filled in accordance with study surgical technique and supplemental instrumentation is provided as an adjunct to fixation.	Structural Allograft Spacer Structural Allograft Spacer with pedicle screws. Structural Allograft Spacer: Following disc space preparation the spacer is placed in accordance with cleared labeling and supplemental instrumentation is provided as an adjunct to fixation.
Overall Study STARTED	123	33
Overall Study COMPLETED	88	16
Overall Study NOT COMPLETED	35	17

Reasons for withdrawal

Measure	Optimesh 1500S OptiMesh 1500S, filled with a mixture of demineralized bone matrix (DBM) and cortico-cancellous bone, placed into the interbody space from the posterior approach and supplemental pedicle screws. OptiMesh 1500S: Following disc space preparation the OptiMesh is deployed and filled in accordance with study surgical technique and supplemental instrumentation is provided as an adjunct to fixation.	Structural Allograft Spacer Structural Allograft Spacer with pedicle screws. Structural Allograft Spacer: Following disc space preparation the spacer is placed in accordance with cleared labeling and supplemental instrumentation is provided as an adjunct to fixation.
Overall Study Lost to Follow-up	35	17

Baseline Characteristics

OptiMesh® for Lumbar Interbody Fusion Trial (OLIF)

Baseline characteristics by cohort

Measure	Optimesh 1500S n=123 Participants OptiMesh 1500S, filled with a mixture of demineralized bone matrix (DBM) and cortico-cancellous bone, placed into the interbody space from the posterior approach and supplemental pedicle screws. OptiMesh 1500S: Following disc space preparation the OptiMesh is deployed and filled in accordance with study surgical technique and supplemental instrumentation is provided as an adjunct to fixation.	Structural Allograft Spacer n=33 Participants Structural Allograft Spacer with pedicle screws. Structural Allograft Spacer: Following disc space preparation the spacer is placed in accordance with cleared labeling and supplemental instrumentation is provided as an adjunct to fixation.	Total n=156 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	104 Participants n=5 Participants	29 Participants n=7 Participants	133 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants	4 Participants n=7 Participants	23 Participants n=5 Participants
Age, Continuous	51.18 Years STANDARD_DEVIATION 12.19 • n=5 Participants	53.91 Years STANDARD_DEVIATION 10.81 • n=7 Participants	51.76 Years STANDARD_DEVIATION 11.93 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	15 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants	18 Participants n=7 Participants	84 Participants n=5 Participants
Region of Enrollment United States	123 participants n=5 Participants	33 participants n=7 Participants	156 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 month

Population: A total of 88 investigational and 16 control subjects completed this question at the 24-month timepoint.

A Visual Analog Scale (VAS) score was used to evaluate a subject's level of pain. The VAS is a 10 cm pain scale where a score of "0" represents "No Pain" and a score of "10" represents the "Worst Possible" pain. The magnitude of change in the 24-month score compared to the baseline score is calculated. A clinically meaningful change is defined as a 2 unit (cm) reduction at 24-months when compared to pre-op.

Outcome measures

Measure	Optimesh 1500S n=88 Participants OptiMesh 1500S, filled with a mixture of demineralized bone matrix (DBM) and cortico-cancellous bone, placed into the interbody space from the posterior approach and supplemental pedicle screws. OptiMesh 1500S: Following disc space preparation the OptiMesh is deployed and filled in accordance with study surgical technique and supplemental instrumentation is provided as an adjunct to fixation.	Structural Allograft Spacer n=16 Participants Structural Allograft Spacer with pedicle screws. Structural Allograft Spacer: Following disc space preparation the spacer is placed in accordance with cleared labeling and supplemental instrumentation is provided as an adjunct to fixation.
Mean Change in Low Back Pain Score at 24-months Compared to Pre-op	-4.0 units on a scale Standard Error 0.57825	-4.0 units on a scale Standard Error 1.50207

PRIMARY outcome

Timeframe: 24 month

Population: A total of 88 investigational and 16 control subjects completed the ODI questionnaire at the 24-month timepoint.

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". The magnitude of change between the two timepoints is reported. A clinically meaningful improvement is defined as a 15 point reduction at 24-months compared to the pre-op score.

Outcome measures

Measure	Optimesh 1500S n=88 Participants OptiMesh 1500S, filled with a mixture of demineralized bone matrix (DBM) and cortico-cancellous bone, placed into the interbody space from the posterior approach and supplemental pedicle screws. OptiMesh 1500S: Following disc space preparation the OptiMesh is deployed and filled in accordance with study surgical technique and supplemental instrumentation is provided as an adjunct to fixation.	Structural Allograft Spacer n=16 Participants Structural Allograft Spacer with pedicle screws. Structural Allograft Spacer: Following disc space preparation the spacer is placed in accordance with cleared labeling and supplemental instrumentation is provided as an adjunct to fixation.
Mean Change in Back Function Score at 24-months Compared to Pre-op	-21.6 score on a scale Standard Error 4.4055	-18.4 score on a scale Standard Error 9.8028

PRIMARY outcome

Timeframe: 24 month

Population: A total of 77 investigational and 10 control subjects achieved the required imaging (x-rays and CT scan) at the 24-month timepoint.

Fusion Success is defined as <5 degrees angulation, <10% translation, and presence of bridging bone on CT.

Outcome measures

Measure	Optimesh 1500S n=77 Participants OptiMesh 1500S, filled with a mixture of demineralized bone matrix (DBM) and cortico-cancellous bone, placed into the interbody space from the posterior approach and supplemental pedicle screws. OptiMesh 1500S: Following disc space preparation the OptiMesh is deployed and filled in accordance with study surgical technique and supplemental instrumentation is provided as an adjunct to fixation.	Structural Allograft Spacer n=10 Participants Structural Allograft Spacer with pedicle screws. Structural Allograft Spacer: Following disc space preparation the spacer is placed in accordance with cleared labeling and supplemental instrumentation is provided as an adjunct to fixation.
Number of Participants Determined to be a Fusion Success at 24 Months Post-operative	71 Participants	10 Participants

PRIMARY outcome

Timeframe: From Intra-op through the 24-month visit

The rate of serious device and procedure related adverse events are compared between the control and treatment arm from intraoperative through 24 months of follow-up.

Outcome measures

Measure	Optimesh 1500S n=123 Participants OptiMesh 1500S, filled with a mixture of demineralized bone matrix (DBM) and cortico-cancellous bone, placed into the interbody space from the posterior approach and supplemental pedicle screws. OptiMesh 1500S: Following disc space preparation the OptiMesh is deployed and filled in accordance with study surgical technique and supplemental instrumentation is provided as an adjunct to fixation.	Structural Allograft Spacer n=33 Participants Structural Allograft Spacer with pedicle screws. Structural Allograft Spacer: Following disc space preparation the spacer is placed in accordance with cleared labeling and supplemental instrumentation is provided as an adjunct to fixation.
Number of Participants With a Serious Device and Procedure Related Adverse Event	14 Participants	6 Participants

SECONDARY outcome

Timeframe: 24-month visit

Population: A total of 78 investigational subjects and 16 control subjects reported right leg pain scores at pre-op and 24-months postoperative.

Right leg pain assessed by subject response on Visual Analog Scale (0-10 cm) where "0" represents "No pain" and "10" represents "Worst pain". The magnitude of change at 24-months compared to baseline is reported. A clinically relevant improvement is defined as a 2 cm reduction at 24-months compared to pre-op.

Outcome measures

Measure	Optimesh 1500S n=78 Participants OptiMesh 1500S, filled with a mixture of demineralized bone matrix (DBM) and cortico-cancellous bone, placed into the interbody space from the posterior approach and supplemental pedicle screws. OptiMesh 1500S: Following disc space preparation the OptiMesh is deployed and filled in accordance with study surgical technique and supplemental instrumentation is provided as an adjunct to fixation.	Structural Allograft Spacer n=16 Participants Structural Allograft Spacer with pedicle screws. Structural Allograft Spacer: Following disc space preparation the spacer is placed in accordance with cleared labeling and supplemental instrumentation is provided as an adjunct to fixation.
Right Leg Pain Score--Change From Preop at the 24-month Timepoint	-2.6 units on a scale Standard Error 0.4	-2.0 units on a scale Standard Error 0.6

SECONDARY outcome

Timeframe: 24-month visit

Population: A total of 82 investigational subjects and 16 control subjects reported left leg pain scores at both pre-op and 24-months postoperative.

Left leg pain assessed by subject response on Visual Analog Scale (0-10cm) where "0" represents "No left leg pain" and "10" represents "Worst Pain". The magnitude of change at 24-months post-operative compared to the baseline score is reported. A clinically relevant improvement is defined as a 2 cm reduction at 24-months compared to pre-op.

Outcome measures

Measure	Optimesh 1500S n=82 Participants OptiMesh 1500S, filled with a mixture of demineralized bone matrix (DBM) and cortico-cancellous bone, placed into the interbody space from the posterior approach and supplemental pedicle screws. OptiMesh 1500S: Following disc space preparation the OptiMesh is deployed and filled in accordance with study surgical technique and supplemental instrumentation is provided as an adjunct to fixation.	Structural Allograft Spacer n=16 Participants Structural Allograft Spacer with pedicle screws. Structural Allograft Spacer: Following disc space preparation the spacer is placed in accordance with cleared labeling and supplemental instrumentation is provided as an adjunct to fixation.
Left Leg Pain--Change From Preop at the 24-month Timepoint	-2.5 units on a scale Standard Error 0.4	-2.5 units on a scale Standard Error 0.8

SECONDARY outcome

Timeframe: 24-month visit

Population: Patient satisfaction was not obtained in the early portion of this study. Therefore, a total of 39 investigational subjects and 16 control subjects that were enrolled in the latter portion of the study contributed responses to this question.

Subjects were asked to rate their satisfaction with their surgical procedure as "Very Satisfied", "Somewhat Satisfied", "Somewhat Dissatisfied" or "Very Dissatisfied" with their procedure

Outcome measures

Measure	Optimesh 1500S n=39 Participants OptiMesh 1500S, filled with a mixture of demineralized bone matrix (DBM) and cortico-cancellous bone, placed into the interbody space from the posterior approach and supplemental pedicle screws. OptiMesh 1500S: Following disc space preparation the OptiMesh is deployed and filled in accordance with study surgical technique and supplemental instrumentation is provided as an adjunct to fixation.	Structural Allograft Spacer n=16 Participants Structural Allograft Spacer with pedicle screws. Structural Allograft Spacer: Following disc space preparation the spacer is placed in accordance with cleared labeling and supplemental instrumentation is provided as an adjunct to fixation.
Number of Participants Rating Their Procedure as Very Satisfied or Somewhat Satisfied at 24-months Postoperative	37 Participants	13 Participants

Adverse Events

Optimesh 1500S

Serious events: 14 serious events

Other events: 19 other events

Deaths: 3 deaths

Structural Allograft Spacer

Serious events: 6 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Optimesh 1500S n=123 participants at risk OptiMesh 1500S, filled with a mixture of demineralized bone matrix (DBM) and cortico-cancellous bone, placed into the interbody space from the posterior approach and supplemental pedicle screws. OptiMesh 1500S: Following disc space preparation the OptiMesh is deployed and filled in accordance with study surgical technique and supplemental instrumentation is provided as an adjunct to fixation.	Structural Allograft Spacer n=33 participants at risk Structural Allograft Spacer with pedicle screws. Structural Allograft Spacer: Following disc space preparation the spacer is placed in accordance with cleared labeling and supplemental instrumentation is provided as an adjunct to fixation.
Surgical and medical procedures Hematoma	0.81% 1/123 • Number of events 1 • Intraoperative through 24-months postoperative	0.00% 0/33 • Intraoperative through 24-months postoperative
Surgical and medical procedures Pseudoarthrosis	5.7% 7/123 • Number of events 9 • Intraoperative through 24-months postoperative	3.0% 1/33 • Number of events 1 • Intraoperative through 24-months postoperative
Surgical and medical procedures Infection	1.6% 2/123 • Number of events 2 • Intraoperative through 24-months postoperative	3.0% 1/33 • Number of events 1 • Intraoperative through 24-months postoperative
Musculoskeletal and connective tissue disorders Adjacent Level Degeneration	0.81% 1/123 • Number of events 1 • Intraoperative through 24-months postoperative	6.1% 2/33 • Number of events 2 • Intraoperative through 24-months postoperative
Surgical and medical procedures Screw Irritation	2.4% 3/123 • Number of events 3 • Intraoperative through 24-months postoperative	0.00% 0/33 • Intraoperative through 24-months postoperative
Musculoskeletal and connective tissue disorders Disc Herniation	100.0% 2/2 • Number of events 2 • Intraoperative through 24-months postoperative	3.0% 1/33 • Intraoperative through 24-months postoperative
Musculoskeletal and connective tissue disorders Spinal Stenosis	0.00% 0/123 • Intraoperative through 24-months postoperative	6.1% 2/33 • Number of events 2 • Intraoperative through 24-months postoperative

Other adverse events

Measure	Optimesh 1500S n=123 participants at risk OptiMesh 1500S, filled with a mixture of demineralized bone matrix (DBM) and cortico-cancellous bone, placed into the interbody space from the posterior approach and supplemental pedicle screws. OptiMesh 1500S: Following disc space preparation the OptiMesh is deployed and filled in accordance with study surgical technique and supplemental instrumentation is provided as an adjunct to fixation.	Structural Allograft Spacer n=33 participants at risk Structural Allograft Spacer with pedicle screws. Structural Allograft Spacer: Following disc space preparation the spacer is placed in accordance with cleared labeling and supplemental instrumentation is provided as an adjunct to fixation.
Surgical and medical procedures Lateral femoral cutaneous nerve injury secondary to intra-op positioning on table	8.1% 10/123 • Number of events 10 • Intraoperative through 24-months postoperative	0.00% 0/33 • Intraoperative through 24-months postoperative
Musculoskeletal and connective tissue disorders Low Back Pain	7.3% 9/123 • Number of events 9 • Intraoperative through 24-months postoperative	18.2% 6/33 • Number of events 6 • Intraoperative through 24-months postoperative

Additional Information

Rose Griffith, Sr. Director, Clinical Affairs

Spineology

Phone: 651-256-8503

Email: Rgriffith@spineology.com

Results disclosure agreements

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