Trial Outcomes & Findings for Radiographic and Clinical Outcomes Following Unilateral or Bilateral Posterior Fixation in MI-TLIF (NCT NCT01996371)

NCT ID: NCT01996371

Last Updated: 2021-11-09

Results Overview

Primary Outcome: To compare bony fusion rates at two years among the three study arms, using the Brantigan, Steffee and Fraser scale. Post-operative CT scans will be evaluated at 24 months for evidence of new solid osseous trabeculations bridging across the interspace.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

24 months

Results posted on

2021-11-09

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1: Unilateral Unilateral pedicle screws Pedicle Screw	Group 2: Ipsilateral Ipsilateral pedicle screws, contralateral facet screw Pedicle Screw	Group 3: Bilateral Bilateral pedicle screws Pedicle Screw
Overall Study STARTED	5	4	6
Overall Study COMPLETED	5	4	6
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Radiographic and Clinical Outcomes Following Unilateral or Bilateral Posterior Fixation in MI-TLIF

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=5 Participants Unilateral pedicle screws Pedicle Screw	Group 2 n=4 Participants Ipsilateral pedicle screws, contralateral facet screw Pedicle Screw	Group 3 n=6 Participants Bilateral pedicle screws Pedicle Screw	Total n=15 Participants Total of all reporting groups
Age, Customized Age · Age: 18-59	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants
Age, Customized Age · Age 60-80	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	15 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	5 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants	15 participants n=4 Participants

PRIMARY outcome

Timeframe: 24 months

Population: Research has been discontinued. Data not collected and therefore not analyzed.

Primary Outcome: To compare bony fusion rates at two years among the three study arms, using the Brantigan, Steffee and Fraser scale. Post-operative CT scans will be evaluated at 24 months for evidence of new solid osseous trabeculations bridging across the interspace.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months, 6 months, 12 months, 24 months

Population: Research has been discontinued. Data not collected and therefore not analyzed.

To compare clinical outcomes among the three study arms utilizing the Visual Analog Scale (VAS) survey. Visual analog scales will be used to assess neck, back, arm, and leg pain. Scores can range from 0 - 10 with higher scores indicating higher levels of pain.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months, 6 months, 12 months, 24 months

Population: Research has been discontinued. Data not collected and therefore not analyzed.

To compare clinical outcomes among the three study arms utilizing the Oswestry Disability Idex (ODI) survey. This survey will be used to assess how back pain affects patients' ability to function in everyday life. Scores can range from 0% to 100% with higher scores indicating higher levels of disturbance in everyday life.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months, 6 months, 12 months, 24 months

Population: Research has been discontinued. Data not collected and therefore not analyzed.

To compare clinical outcomes among the three study arms utilizing the Short Form 36 Health Survey (SF-36). This survey will be used to assess patients' physical and mental health. Scores range from 0 to 100 with higher scores indicating better physical and mental health.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: post-surgery, 6 weeks, 3 months, 6 months, 12 months, 24 months

Population: Research has been discontinued. Data not collected and therefore not analyzed.

Immediate and delayed medical and surgical (including neurological) complications among the three study arms will be compared.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months and 24 months

Population: Research has been discontinued. Data not collected and therefore not analyzed.

Comparison of bony fusion rates at 12 and 24 months among the three study arms, using an X-ray based classification scale.

Outcome measures

Outcome data not reported

Adverse Events

Group 1

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Group 2

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Group 3

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 n=5 participants at risk Unilateral pedicle screws Pedicle Screw	Group 2 n=4 participants at risk Ipsilateral pedicle screws, contralateral facet screw Pedicle Screw	Group 3 n=6 participants at risk Bilateral pedicle screws Pedicle Screw
Musculoskeletal and connective tissue disorders Compression Fracture	20.0% 1/5 • Number of events 1 • Enrollment to 24 Months post surgery	0.00% 0/4 • Enrollment to 24 Months post surgery	0.00% 0/6 • Enrollment to 24 Months post surgery
Vascular disorders Bilateral PEs	0.00% 0/5 • Enrollment to 24 Months post surgery	25.0% 1/4 • Number of events 1 • Enrollment to 24 Months post surgery	0.00% 0/6 • Enrollment to 24 Months post surgery
Musculoskeletal and connective tissue disorders Disc Herniation	0.00% 0/5 • Enrollment to 24 Months post surgery	0.00% 0/4 • Enrollment to 24 Months post surgery	16.7% 1/6 • Number of events 1 • Enrollment to 24 Months post surgery

Other adverse events

Other adverse events
Measure	Group 1 n=5 participants at risk Unilateral pedicle screws Pedicle Screw	Group 2 n=4 participants at risk Ipsilateral pedicle screws, contralateral facet screw Pedicle Screw	Group 3 n=6 participants at risk Bilateral pedicle screws Pedicle Screw
Nervous system disorders Acute Chronic Back and/or Leg Pain	20.0% 1/5 • Number of events 1 • Enrollment to 24 Months post surgery	25.0% 1/4 • Number of events 1 • Enrollment to 24 Months post surgery	50.0% 3/6 • Number of events 3 • Enrollment to 24 Months post surgery
Immune system disorders Allergic Reaction to dilaudid	0.00% 0/5 • Enrollment to 24 Months post surgery	25.0% 1/4 • Number of events 1 • Enrollment to 24 Months post surgery	0.00% 0/6 • Enrollment to 24 Months post surgery
Respiratory, thoracic and mediastinal disorders ED Visit - Bronchitis/asthma attack	0.00% 0/5 • Enrollment to 24 Months post surgery	25.0% 1/4 • Number of events 1 • Enrollment to 24 Months post surgery	0.00% 0/6 • Enrollment to 24 Months post surgery
Musculoskeletal and connective tissue disorders RTC Impingement	20.0% 1/5 • Number of events 1 • Enrollment to 24 Months post surgery	0.00% 0/4 • Enrollment to 24 Months post surgery	0.00% 0/6 • Enrollment to 24 Months post surgery
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.00% 0/5 • Enrollment to 24 Months post surgery	0.00% 0/4 • Enrollment to 24 Months post surgery	16.7% 1/6 • Number of events 1 • Enrollment to 24 Months post surgery

Additional Information

Shelby Miracle

OhioU

Phone: 614-366-1648

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place