Trial Outcomes & Findings for Anterior Bridging Cage With Bone Substitute Versus Localized Autobone in Transforaminal Lumbar Interbody Arthrodesis (NCT NCT02485574)

Results Overview

We used the concept of InCBB (intra-cage bridging bone) to evaluate the fusion status. InCBB was defined as the bridging bone between the upper and lower vertebrae through the void of the cage(s) and divided into right (Rt.) and left (Lt.) InCBB according to the cage position. We graded bridging scores from 0 to 2 based on the degree of completion of the bridging bone in InCBBs (grade 0: no bridging at the superior and inferior endplates; grade 1: incomplete bridging; bridging at the superior or inferior endplate, but with a clear radiolucent line; grade 2: complete bridging).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

69 participants

Primary outcome timeframe

12 month postoperatively

Results posted on

2021-12-08

Participant Flow

Participant milestones

Participant milestones
Measure	All Study Participants - Single Group Consecutive patients with spinal stenosis or spondylolisthesis who planned to undergo single-level transforaminal lumbar interbody fusion (TLIF) with pedicle screw fixation were included. After disc preparation following bilateral decompression with facetectomies, extra-cage bone grafting, consisting of half- mixed each 6 cc of local autobone and synthetic bone, was performed on the prepared anterior disc space bilaterally; then, bilateral cages with different graft compositions (left cage: filled with local autobone, right cage: filled with local autobone þ synthetic bone) were inserted in "same segment". We compared the anterior bone bridging patterns of two cages "at single operated segment" in each patient.
Overall Study STARTED	69
Overall Study COMPLETED	65
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	All Study Participants - Single Group Consecutive patients with spinal stenosis or spondylolisthesis who planned to undergo single-level transforaminal lumbar interbody fusion (TLIF) with pedicle screw fixation were included. After disc preparation following bilateral decompression with facetectomies, extra-cage bone grafting, consisting of half- mixed each 6 cc of local autobone and synthetic bone, was performed on the prepared anterior disc space bilaterally; then, bilateral cages with different graft compositions (left cage: filled with local autobone, right cage: filled with local autobone þ synthetic bone) were inserted in "same segment". We compared the anterior bone bridging patterns of two cages "at single operated segment" in each patient.
Overall Study dropped out because they failed to undergo CT scan at postoperative 12 months	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=69 Participants Consecutive patients with spinal stenosis or spondylolisthesis who planned to undergo single-level transforaminal lumbar interbody fusion (TLIF) with pedicle screw fixation were included. After disc preparation following bilateral decompression with facetectomies, extra-cage bone grafting, consisting of half- mixed each 6 cc of local autobone and synthetic bone, was performed on the prepared anterior disc space bilaterally; then, bilateral cages with different graft compositions (left cage: filled with local autobone, right cage: filled with local autobone þ synthetic bone) were inserted. We compared the anterior bone bridging patterns of two cages in each patient.
Age, Continuous	66.7 years n=69 Participants
Sex: Female, Male Female	45 Participants n=69 Participants
Sex: Female, Male Male	24 Participants n=69 Participants
Region of Enrollment South Korea	65 Participants n=69 Participants
body mass index	25.3 kg/m^2 n=69 Participants

PRIMARY outcome

Timeframe: 12 month postoperatively

We used the concept of InCBB (intra-cage bridging bone) to evaluate the fusion status. InCBB was defined as the bridging bone between the upper and lower vertebrae through the void of the cage(s) and divided into right (Rt.) and left (Lt.) InCBB according to the cage position. We graded bridging scores from 0 to 2 based on the degree of completion of the bridging bone in InCBBs (grade 0: no bridging at the superior and inferior endplates; grade 1: incomplete bridging; bridging at the superior or inferior endplate, but with a clear radiolucent line; grade 2: complete bridging).

Outcome measures

Outcome measures
Measure	Left Cage- Auto Bone n=65 Participants Consecutive patients with spinal stenosis or spondylolisthesis who planned to undergo single-level transforaminal lumbar interbody fusion (TLIF) with pedicle screw fixation were included. After disc preparation following bilateral decompression with facetectomies, extra-cage bone grafting, consisting of half- mixed each 6 cc of local autobone and synthetic bone, was performed on the prepared anterior disc space bilaterally. At the operated segment, left cage was filled with auto bone only.	Right Cage- Auto Local Bone Mixed With β-calcium Phosphate + Hydroxyapatite n=65 Participants Consecutive patients with spinal stenosis or spondylolisthesis who planned to undergo single-level transforaminal lumbar interbody fusion (TLIF) with pedicle screw fixation were included. After disc preparation following bilateral decompression with facetectomies, extra-cage bone grafting, consisting of half- mixed each 6 cc of local autobone and synthetic bone, was performed on the prepared anterior disc space bilaterally. At the operated segment, right cage was filled with auto local bone mixed with β-calcium phosphate + hydroxyapatite.
InCBB of Both Cages	1.48 score on a scale Interval 1.44 to 1.53	1.43 score on a scale Interval 1.39 to 1.48

SECONDARY outcome

Timeframe: 12 month postoperatively

We defined ABB as the bridging bone between the extra-cage grafted bone and intra-cage grafted bone through the holes in each cage. Since the cages used in this study each have 4 anterior holes, there can be a minimum of 0 and a maximum of 8 ABBs in a patient.

Outcome measures

Outcome measures
Measure	Left Cage- Auto Bone n=65 Participants Consecutive patients with spinal stenosis or spondylolisthesis who planned to undergo single-level transforaminal lumbar interbody fusion (TLIF) with pedicle screw fixation were included. After disc preparation following bilateral decompression with facetectomies, extra-cage bone grafting, consisting of half- mixed each 6 cc of local autobone and synthetic bone, was performed on the prepared anterior disc space bilaterally. At the operated segment, left cage was filled with auto bone only.	Right Cage- Auto Local Bone Mixed With β-calcium Phosphate + Hydroxyapatite n=65 Participants Consecutive patients with spinal stenosis or spondylolisthesis who planned to undergo single-level transforaminal lumbar interbody fusion (TLIF) with pedicle screw fixation were included. After disc preparation following bilateral decompression with facetectomies, extra-cage bone grafting, consisting of half- mixed each 6 cc of local autobone and synthetic bone, was performed on the prepared anterior disc space bilaterally. At the operated segment, right cage was filled with auto local bone mixed with β-calcium phosphate + hydroxyapatite.
ABB (Anterior Bone Bridging) Between Cage and Anterior Grafted Bone	1.80 number of anterior holes Interval 1.68 to 1.92	1.85 number of anterior holes Interval 1.72 to 1.97

OTHER_PRE_SPECIFIED outcome

Timeframe: postoperative 1 year

Population: Of the total 65 patients, 56 were classified as having interbody fusion, and 9 were classified as not having interbody fusion.

The Oswestry Disability Index (ODI) is an index used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.

Outcome measures

Outcome measures
Measure	Left Cage- Auto Bone n=56 Participants Consecutive patients with spinal stenosis or spondylolisthesis who planned to undergo single-level transforaminal lumbar interbody fusion (TLIF) with pedicle screw fixation were included. After disc preparation following bilateral decompression with facetectomies, extra-cage bone grafting, consisting of half- mixed each 6 cc of local autobone and synthetic bone, was performed on the prepared anterior disc space bilaterally. At the operated segment, left cage was filled with auto bone only.	Right Cage- Auto Local Bone Mixed With β-calcium Phosphate + Hydroxyapatite n=9 Participants Consecutive patients with spinal stenosis or spondylolisthesis who planned to undergo single-level transforaminal lumbar interbody fusion (TLIF) with pedicle screw fixation were included. After disc preparation following bilateral decompression with facetectomies, extra-cage bone grafting, consisting of half- mixed each 6 cc of local autobone and synthetic bone, was performed on the prepared anterior disc space bilaterally. At the operated segment, right cage was filled with auto local bone mixed with β-calcium phosphate + hydroxyapatite.
ODI Change (Preoperative ODI Score - Postoperative 1 Year ODI Score)	45.53 score on a scale Interval 43.29 to 47.9	35.19 score on a scale Interval 32.92 to 37.4

Adverse Events

Left Cage- Auto Bone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Right Cage- Auto Local Bone Mixed With β-calcium Phosphate + Hydroxyapatite

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kwang-Sup Song

Chung-Ang University hospital

Phone: +82-1037616503

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place