Trial Outcomes & Findings for DIAM™ Spinal Stabilization System vs. Decompression, Formerly vs. Posterolateral Fusion (NCT NCT00627497)

NCT ID: NCT00627497

Last Updated: 2021-01-05

Results Overview

Rate of overall success is reported as the percentage of partipants who met all of the following criteria: 1. Pain/disability (ODI) success:(Success of ODI is defined as pain/disability improvement according to the definition: Pre-treatment Score - Post-treatment Score ≥ 15); 2. Neurological success (Neurological success is defined as maintenance or improvement in sections of motor, sensory, reflex, and straight leg raise for the time period evaluated); 3. No serious adverse event classified as "surgical treatment associated"; 4. No additional surgical procedure classified as "failure."

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 32 participants
• Primary outcome timeframe: 24 months after operation
• Results posted on: 2021-01-05

Participant Flow

Participant milestones

Measure	DIAM Group1 Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Single-Level Posterior Decompression Patients in this group received a single-level posterior lumbar decompression	DIAM Group2 Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Posterolateral Interbody Fusion Patients in this group received a posterolateral interbody fusion.
Overall Study STARTED	14	12	4	2
Overall Study COMPLETED	13	11	4	2
Overall Study NOT COMPLETED	1	1	0	0

Reasons for withdrawal

Measure	DIAM Group1 Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Single-Level Posterior Decompression Patients in this group received a single-level posterior lumbar decompression	DIAM Group2 Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Posterolateral Interbody Fusion Patients in this group received a posterolateral interbody fusion.
Overall Study Lost to Follow-up	1	1	0	0

Baseline Characteristics

DIAM™ Spinal Stabilization System vs. Decompression, Formerly vs. Posterolateral Fusion

Baseline characteristics by cohort

Measure	DIAM Group1 n=14 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Single-Level Posterior Decompression n=12 Participants Patients in this group received a single-level posterior lumbar decompression	DIAM Group2 n=4 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Posterolateral Interbody Fusion n=2 Participants Patients in this group received a posterolateral interbody fusion.	Total n=32 Participants Total of all reporting groups
Age, Continuous	56.6 years STANDARD_DEVIATION 8.3 • n=5 Participants	54.8 years STANDARD_DEVIATION 9.7 • n=7 Participants	47.8 years STANDARD_DEVIATION 16.1 • n=5 Participants	54.5 years STANDARD_DEVIATION 7.8 • n=4 Participants	54.7 years STANDARD_DEVIATION 9.8 • n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	8 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	14 Participants n=21 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	18 Participants n=21 Participants
Race/Ethnicity, Customized Caucasian	11 participants n=5 Participants	12 participants n=7 Participants	4 participants n=5 Participants	2 participants n=4 Participants	29 participants n=21 Participants
Race/Ethnicity, Customized Black	2 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	2 participants n=21 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants
Race/Ethnicity, Customized Hispanic	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized other	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants
Height	70.1 in. STANDARD_DEVIATION 3.2 • n=5 Participants	66.9 in. STANDARD_DEVIATION 4.4 • n=7 Participants	69.3 in. STANDARD_DEVIATION 4.3 • n=5 Participants	65.5 in. STANDARD_DEVIATION 0.7 • n=4 Participants	68.5 in. STANDARD_DEVIATION 4.0 • n=21 Participants
Weight	209.9 lbs STANDARD_DEVIATION 42.0 • n=5 Participants	187.2 lbs STANDARD_DEVIATION 36.2 • n=7 Participants	194.0 lbs STANDARD_DEVIATION 43.3 • n=5 Participants	144.5 lbs STANDARD_DEVIATION 36.1 • n=4 Participants	195.3 lbs STANDARD_DEVIATION 41.5 • n=21 Participants
Oswestry Disability Index (ODI) Score	52.6 Scores on a scale STANDARD_DEVIATION 9.7 • n=5 Participants	49.6 Scores on a scale STANDARD_DEVIATION 8.4 • n=7 Participants	52.0 Scores on a scale STANDARD_DEVIATION 10.7 • n=5 Participants	44.0 Scores on a scale STANDARD_DEVIATION 2.8 • n=4 Participants	50.9 Scores on a scale STANDARD_DEVIATION 9.0 • n=21 Participants
General Health Status Physical Component Summary (SF- 36 PCS)	27.0 Scores on a scale STANDARD_DEVIATION 7.9 • n=5 Participants	26.6 Scores on a scale STANDARD_DEVIATION 4.7 • n=7 Participants	27.0 Scores on a scale STANDARD_DEVIATION 3.7 • n=5 Participants	24.0 Scores on a scale STANDARD_DEVIATION 1.5 • n=4 Participants	26.7 Scores on a scale STANDARD_DEVIATION 6.0 • n=21 Participants
General Health Status Mental Component Summary (SF-36 MCS)	51.7 Scores on a scale STANDARD_DEVIATION 9.2 • n=5 Participants	49.7 Scores on a scale STANDARD_DEVIATION 10.5 • n=7 Participants	46.0 Scores on a scale STANDARD_DEVIATION 10.7 • n=5 Participants	59.9 Scores on a scale STANDARD_DEVIATION 4.2 • n=4 Participants	50.7 Scores on a scale STANDARD_DEVIATION 9.8 • n=21 Participants
Pain Status Back Pain Score (0-20)	14.1 Scores on a scale STANDARD_DEVIATION 3.1 • n=5 Participants	12.0 Scores on a scale STANDARD_DEVIATION 3.5 • n=7 Participants	15.0 Scores on a scale STANDARD_DEVIATION 3.4 • n=5 Participants	11.5 Scores on a scale STANDARD_DEVIATION 0.7 • n=4 Participants	13.3 Scores on a scale STANDARD_DEVIATION 3.3 • n=21 Participants
Pain Status Leg Pain Score (0-20)	17.2 Scores on a scale STANDARD_DEVIATION 1.5 • n=5 Participants	17.1 Scores on a scale STANDARD_DEVIATION 1.7 • n=7 Participants	16.8 Scores on a scale STANDARD_DEVIATION 3.9 • n=5 Participants	16.0 Scores on a scale STANDARD_DEVIATION 4.2 • n=4 Participants	17.0 Scores on a scale STANDARD_DEVIATION 2.0 • n=21 Participants

PRIMARY outcome

Timeframe: 24 months after operation

Rate of overall success is reported as the percentage of partipants who met all of the following criteria:

1. Pain/disability (ODI) success:(Success of ODI is defined as pain/disability improvement according to the definition: Pre-treatment Score - Post-treatment Score ≥ 15);

2. Neurological success (Neurological success is defined as maintenance or improvement in sections of motor, sensory, reflex, and straight leg raise for the time period evaluated);

3. No serious adverse event classified as "surgical treatment associated";

4. No additional surgical procedure classified as "failure."

Outcome measures

Measure	DIAM Group1 n=13 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Single-Level Posterior Decompression n=11 Participants Patients in this group received a single-level posterior lumbar decompression	DIAM Group2 n=4 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Posterolateral Interbody Fusion n=2 Participants Patients in this group received a posterolateral interbody fusion.
Rate of Overall Success	53.8 percentage of patients	27.3 percentage of patients	100.0 percentage of patients	50.0 percentage of patients

SECONDARY outcome

Timeframe: 24 month after operation

The self-administered Oswestry Disability Index (ODI) Questionnaire was used to assess patient pain and ability to function. The ODI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).

Outcome measures

Measure	DIAM Group1 n=13 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Single-Level Posterior Decompression n=8 Participants Patients in this group received a single-level posterior lumbar decompression	DIAM Group2 n=4 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Posterolateral Interbody Fusion n=2 Participants Patients in this group received a posterolateral interbody fusion.
Oswestry Disability Index (ODI) Score Change of ODI Score at 24 month from baseline	-37.6 Scores on a scale Standard Deviation 19.0	-36.4 Scores on a scale Standard Deviation 14.6	-37.9 Scores on a scale Standard Deviation 11.4	-24.0 Scores on a scale Standard Deviation 19.8
Oswestry Disability Index (ODI) Score Oswestry Disability Index (ODI) Score at baseline	52.6 Scores on a scale Standard Deviation 9.7	49.6 Scores on a scale Standard Deviation 8.4	52.0 Scores on a scale Standard Deviation 10.7	44.0 Scores on a scale Standard Deviation 2.8
Oswestry Disability Index (ODI) Score Oswestry Disability Index (ODI) Score at 24 month	15.6 Scores on a scale Standard Deviation 16.1	13.3 Scores on a scale Standard Deviation 15.6	14.1 Scores on a scale Standard Deviation 10.9	20.0 Scores on a scale Standard Deviation 22.6

SECONDARY outcome

Timeframe: 24 month after operation

Success rate of Oswestry Diability Index Scores is reported as the percentage of participants who met: Pre-treatment Score - Post-treatment Score ≥ 15.

Outcome measures

Measure	DIAM Group1 n=13 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Single-Level Posterior Decompression n=8 Participants Patients in this group received a single-level posterior lumbar decompression	DIAM Group2 n=4 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Posterolateral Interbody Fusion n=2 Participants Patients in this group received a posterolateral interbody fusion.
Success Rate of Oswestry Diability Index Scores	84.6 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	50.0 percentage of participants

SECONDARY outcome

Timeframe: 24 month after operation

Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, reflex, and straight leg raising) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the preoperative evaluation to the time period evaluated.

Outcome measures

Measure	DIAM Group1 n=13 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Single-Level Posterior Decompression n=8 Participants Patients in this group received a single-level posterior lumbar decompression	DIAM Group2 n=4 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Posterolateral Interbody Fusion n=2 Participants Patients in this group received a posterolateral interbody fusion.
Success Rate of Neurological Status	61.5 percentage of particpants	37.5 percentage of particpants	100.0 percentage of particpants	100.0 percentage of particpants

SECONDARY outcome

Timeframe: 24 month after operation

Numerical rating scales are used to evaluate back pain intensity and frequency. Patients will rate their pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, patients will record their back pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." A patient's total pain score will be the sum of pain intensity and frequency scores (0 min, 20 max).

Outcome measures

Measure	DIAM Group1 n=13 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Single-Level Posterior Decompression n=8 Participants Patients in this group received a single-level posterior lumbar decompression	DIAM Group2 n=4 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Posterolateral Interbody Fusion n=2 Participants Patients in this group received a posterolateral interbody fusion.
Back Pain Back Pain Score at baseline	14.1 units on a scale Standard Deviation 3.1	12.0 units on a scale Standard Deviation 3.5	15.0 units on a scale Standard Deviation 3.4	11.5 units on a scale Standard Deviation 0.7
Back Pain Back Pain Score at 24 month	5.4 units on a scale Standard Deviation 5.7	6.9 units on a scale Standard Deviation 7.2	6.5 units on a scale Standard Deviation 4.7	5.0 units on a scale Standard Deviation 2.8
Back Pain Pain Score change at 21 month from baseline	-8.9 units on a scale Standard Deviation 6.2	-5.9 units on a scale Standard Deviation 5.2	-8.5 units on a scale Standard Deviation 5.4	-6.5 units on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: 24 month after operation

Back pain success rate is reported as the percentage of participants whose back pain improvement met: (Pre Score - Post Score)/ Pre Score > 20%.

Outcome measures

Measure	DIAM Group1 n=13 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Single-Level Posterior Decompression n=8 Participants Patients in this group received a single-level posterior lumbar decompression	DIAM Group2 n=4 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Posterolateral Interbody Fusion n=2 Participants Patients in this group received a posterolateral interbody fusion.
Back Pain Success Rate	76.9 percentage of participants	75.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants

SECONDARY outcome

Timeframe: 24 month after operation

Numerical rating scales are used to evaluate leg intensity and frequency. Patients will rate their pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, patients will record their back pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." A patient's total pain score will be the sum of pain intensity and frequency scores (0 min, 20 max).

Outcome measures

Measure	DIAM Group1 n=13 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Single-Level Posterior Decompression n=8 Participants Patients in this group received a single-level posterior lumbar decompression	DIAM Group2 n=4 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Posterolateral Interbody Fusion n=2 Participants Patients in this group received a posterolateral interbody fusion.
Leg Pain Pain Score change at 24 month from baseline	-11.7 units on a scale Standard Deviation 6.5	-8.8 units on a scale Standard Deviation 9.0	-14.8 units on a scale Standard Deviation 6.6	-13.0 units on a scale Standard Deviation 0.0
Leg Pain Leg Pain at baseline	17.2 units on a scale Standard Deviation 1.5	17.1 units on a scale Standard Deviation 1.7	16.8 units on a scale Standard Deviation 3.9	16.0 units on a scale Standard Deviation 4.2
Leg Pain Leg pain at 24 month	5.7 units on a scale Standard Deviation 6.5	8.5 units on a scale Standard Deviation 9.2	2.0 units on a scale Standard Deviation 2.7	3.0 units on a scale Standard Deviation 4.2

SECONDARY outcome

Timeframe: 24 month after operation

Leg pain success rate is reported as the percentage of participants whose leg pain improvement met: (Pre Score - Post Score)/ Pre Score > 20%.

Outcome measures

Measure	DIAM Group1 n=13 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Single-Level Posterior Decompression n=8 Participants Patients in this group received a single-level posterior lumbar decompression	DIAM Group2 n=4 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Posterolateral Interbody Fusion n=2 Participants Patients in this group received a posterolateral interbody fusion.
Leg Pain Success Rate	84.6 percentage of participant	62.5 percentage of participant	100.0 percentage of participant	100.0 percentage of participant

SECONDARY outcome

Timeframe: 24 month after operation

The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life.

Outcome measures

Measure	DIAM Group1 n=13 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Single-Level Posterior Decompression n=8 Participants Patients in this group received a single-level posterior lumbar decompression	DIAM Group2 n=4 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Posterolateral Interbody Fusion n=2 Participants Patients in this group received a posterolateral interbody fusion.
General Health Status (SF-36) Physical Component Summary (PCS) Score at baseline	27.0 Scores on a scale Standard Deviation 7.9	26.6 Scores on a scale Standard Deviation 4.7	27.0 Scores on a scale Standard Deviation 3.7	24.0 Scores on a scale Standard Deviation 1.5
General Health Status (SF-36) Physical Component Summary (PCS) Score at 24 month	44.7 Scores on a scale Standard Deviation 12.1	44.4 Scores on a scale Standard Deviation 11.8	45.2 Scores on a scale Standard Deviation 12.6	46.6 Scores on a scale Standard Deviation 11.3
General Health Status (SF-36) PCS Score Change at 24 month from baseline	17.2 Scores on a scale Standard Deviation 12	17.5 Scores on a scale Standard Deviation 12.4	18.1 Scores on a scale Standard Deviation 11.6	22.6 Scores on a scale Standard Deviation 9.8
General Health Status (SF-36) Mental Component Summary (MCS) Score at baseline	51.7 Scores on a scale Standard Deviation 9.2	49.7 Scores on a scale Standard Deviation 10.5	46.0 Scores on a scale Standard Deviation 10.7	59.9 Scores on a scale Standard Deviation 4.2
General Health Status (SF-36) Mental Component Summary (MCS) Score at 24 month	54.9 Scores on a scale Standard Deviation 8.8	56.7 Scores on a scale Standard Deviation 9.3	55.4 Scores on a scale Standard Deviation 2.8	53.9 Scores on a scale Standard Deviation 4.1
General Health Status (SF-36) MCS Score Change at 24 month from baseline	3.6 Scores on a scale Standard Deviation 9.3	2.7 Scores on a scale Standard Deviation 6.7	9.4 Scores on a scale Standard Deviation 9.2	-6.0 Scores on a scale Standard Deviation 0.1

SECONDARY outcome

Timeframe: 24 month after operation

Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rates of SF-36 PCS and MCS for DIAM Device vs. Single-Level Posterior Decompression were defined as: (Post Score - Pre Score) / Pre Score>= 20%. The success rates of SF-36 PCS and MCS for DIAM vs. Posterolateral Interbody Fusion were defined as: Post Score - Pre Score >= 0.

Outcome measures

Measure	DIAM Group1 n=13 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Single-Level Posterior Decompression n=8 Participants Patients in this group received a single-level posterior lumbar decompression	DIAM Group2 n=4 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Posterolateral Interbody Fusion n=2 Participants Patients in this group received a posterolateral interbody fusion.
Success Rate of SF-36 Health Survey Success Rate of PCS	76.9 percentage of participants	75.0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants
Success Rate of SF-36 Health Survey Success Rate of MCS	30.8 percentage of participants	12.5 percentage of participants	100.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: at the time of operation

Outcome measures

Measure	DIAM Group1 n=14 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Single-Level Posterior Decompression n=12 Participants Patients in this group received a single-level posterior lumbar decompression	DIAM Group2 n=4 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Posterolateral Interbody Fusion n=2 Participants Patients in this group received a posterolateral interbody fusion.
Operative Time	1.8 hrs Standard Deviation 0.7	1.1 hrs Standard Deviation 0.6	1.2 hrs Standard Deviation 0.5	2.4 hrs Standard Deviation 0.9

SECONDARY outcome

Timeframe: At the time of operation

Outcome measures

Measure	DIAM Group1 n=14 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Single-Level Posterior Decompression n=12 Participants Patients in this group received a single-level posterior lumbar decompression	DIAM Group2 n=4 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Posterolateral Interbody Fusion n=2 Participants Patients in this group received a posterolateral interbody fusion.
Blood Loss	82.5 ml Standard Deviation 68.6	77.9 ml Standard Deviation 108.9	57.5 ml Standard Deviation 29.9	155.0 ml Standard Deviation 63.6

SECONDARY outcome

Timeframe: At the time of discharge

Outcome measures

Measure	DIAM Group1 n=14 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Single-Level Posterior Decompression n=12 Participants Patients in this group received a single-level posterior lumbar decompression	DIAM Group2 n=4 Participants Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Posterolateral Interbody Fusion n=2 Participants Patients in this group received a posterolateral interbody fusion.
Hospital Stay	1.4 days Standard Deviation 0.9	1.6 days Standard Deviation 1.0	2.0 days Standard Deviation 1.2	3.5 days Standard Deviation 0.7

Adverse Events

DIAM Group1

Serious events: 5 serious events

Other events: 12 other events

Deaths: 0 deaths

Single-Level Posterior Decompression

Serious events: 7 serious events

Other events: 11 other events

Deaths: 0 deaths

DIAM Group2

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Posterolateral Interbody Fusion

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	DIAM Group1 n=14 participants at risk Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Single-Level Posterior Decompression n=12 participants at risk Patients in this group received a single-level posterior lumbar decompression	DIAM Group2 n=4 participants at risk Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Posterolateral Interbody Fusion n=2 participants at risk Patients in this group received a posterolateral interbody fusion.
Injury, poisoning and procedural complications Accidental Injury/ Muscle strain	0.00% 0/14 • 24 month	8.3% 1/12 • Number of events 1 • 24 month	0.00% 0/4 • 24 month	0.00% 0/2 • 24 month
Cardiac disorders Cardiovascular	7.1% 1/14 • Number of events 1 • 24 month	8.3% 1/12 • Number of events 1 • 24 month	0.00% 0/4 • 24 month	0.00% 0/2 • 24 month
Musculoskeletal and connective tissue disorders Cervical spine event	7.1% 1/14 • Number of events 1 • 24 month	0.00% 0/12 • 24 month	0.00% 0/4 • 24 month	0.00% 0/2 • 24 month
Injury, poisoning and procedural complications Dural injury	0.00% 0/14 • 24 month	16.7% 2/12 • Number of events 2 • 24 month	0.00% 0/4 • 24 month	0.00% 0/2 • 24 month
Gastrointestinal disorders Gastrointestinal-other	7.1% 1/14 • Number of events 1 • 24 month	0.00% 0/12 • 24 month	0.00% 0/4 • 24 month	0.00% 0/2 • 24 month
Injury, poisoning and procedural complications Incision-related	7.1% 1/14 • Number of events 1 • 24 month	0.00% 0/12 • 24 month	0.00% 0/4 • 24 month	0.00% 0/2 • 24 month
Infections and infestations Infection	0.00% 0/14 • 24 month	8.3% 1/12 • Number of events 2 • 24 month	0.00% 0/4 • 24 month	0.00% 0/2 • 24 month
Musculoskeletal and connective tissue disorders Low extremity not of back etiology	7.1% 1/14 • Number of events 1 • 24 month	0.00% 0/12 • 24 month	0.00% 0/4 • 24 month	0.00% 0/2 • 24 month
Nervous system disorders Neurological	14.3% 2/14 • Number of events 2 • 24 month	0.00% 0/12 • 24 month	0.00% 0/4 • 24 month	0.00% 0/2 • 24 month
General disorders Other	7.1% 1/14 • Number of events 1 • 24 month	8.3% 1/12 • Number of events 2 • 24 month	0.00% 0/4 • 24 month	0.00% 0/2 • 24 month
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/14 • 24 month	8.3% 1/12 • Number of events 1 • 24 month	0.00% 0/4 • 24 month	0.00% 0/2 • 24 month
Musculoskeletal and connective tissue disorders Spinal event at target level	7.1% 1/14 • Number of events 1 • 24 month	25.0% 3/12 • Number of events 3 • 24 month	0.00% 0/4 • 24 month	0.00% 0/2 • 24 month
Musculoskeletal and connective tissue disorders Upper extremity pain	7.1% 1/14 • Number of events 1 • 24 month	8.3% 1/12 • Number of events 1 • 24 month	0.00% 0/4 • 24 month	0.00% 0/2 • 24 month
Renal and urinary disorders Urogenital	0.00% 0/14 • 24 month	0.00% 0/12 • 24 month	25.0% 1/4 • Number of events 1 • 24 month	50.0% 1/2 • Number of events 1 • 24 month

Other adverse events

Measure	DIAM Group1 n=14 participants at risk Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Single-Level Posterior Decompression n=12 participants at risk Patients in this group received a single-level posterior lumbar decompression	DIAM Group2 n=4 participants at risk Patients in this group were implanted DIAM Spinal Stabilization System using a posterior surgical approach.	Posterolateral Interbody Fusion n=2 participants at risk Patients in this group received a posterolateral interbody fusion.
Injury, poisoning and procedural complications Accidental injury / muscle strain	0.00% 0/14 • 24 month	8.3% 1/12 • Number of events 1 • 24 month	25.0% 1/4 • Number of events 1 • 24 month	0.00% 0/2 • 24 month
Immune system disorders Allergic reaction	0.00% 0/14 • 24 month	8.3% 1/12 • Number of events 1 • 24 month	0.00% 0/4 • 24 month	0.00% 0/2 • 24 month
Musculoskeletal and connective tissue disorders Back and/or leg pain	21.4% 3/14 • Number of events 3 • 24 month	25.0% 3/12 • Number of events 3 • 24 month	50.0% 2/4 • Number of events 2 • 24 month	0.00% 0/2 • 24 month
Cardiac disorders Cadiovascular	7.1% 1/14 • Number of events 1 • 24 month	8.3% 1/12 • Number of events 1 • 24 month	0.00% 0/4 • 24 month	0.00% 0/2 • 24 month
Psychiatric disorders Depression	0.00% 0/14 • 24 month	16.7% 2/12 • Number of events 2 • 24 month	0.00% 0/4 • 24 month	0.00% 0/2 • 24 month
Injury, poisoning and procedural complications Dural injury	0.00% 0/14 • 24 month	8.3% 1/12 • Number of events 1 • 24 month	0.00% 0/4 • 24 month	0.00% 0/2 • 24 month
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/14 • 24 month	0.00% 0/12 • 24 month	25.0% 1/4 • Number of events 1 • 24 month	0.00% 0/2 • 24 month
General disorders Elevated temperature without infection	7.1% 1/14 • Number of events 1 • 24 month	0.00% 0/12 • 24 month	25.0% 1/4 • Number of events 1 • 24 month	0.00% 0/2 • 24 month
Endocrine disorders Endocrine	7.1% 1/14 • Number of events 1 • 24 month	8.3% 1/12 • Number of events 1 • 24 month	0.00% 0/4 • 24 month	0.00% 0/2 • 24 month
Blood and lymphatic system disorders Hematological	7.1% 1/14 • Number of events 1 • 24 month	0.00% 0/12 • 24 month	0.00% 0/4 • 24 month	0.00% 0/2 • 24 month
Injury, poisoning and procedural complications Incision-related	14.3% 2/14 • Number of events 2 • 24 month	0.00% 0/12 • 24 month	0.00% 0/4 • 24 month	50.0% 1/2 • Number of events 1 • 24 month
Musculoskeletal and connective tissue disorders Lower extremity not of back etiology	21.4% 3/14 • Number of events 6 • 24 month	25.0% 3/12 • Number of events 3 • 24 month	25.0% 1/4 • Number of events 1 • 24 month	50.0% 1/2 • Number of events 1 • 24 month
Musculoskeletal and connective tissue disorders Neck and arm pain	0.00% 0/14 • 24 month	8.3% 1/12 • Number of events 1 • 24 month	0.00% 0/4 • 24 month	0.00% 0/2 • 24 month
Nervous system disorders Neurological	14.3% 2/14 • Number of events 5 • 24 month	25.0% 3/12 • Number of events 6 • 24 month	25.0% 1/4 • Number of events 2 • 24 month	0.00% 0/2 • 24 month
General disorders Other	7.1% 1/14 • Number of events 1 • 24 month	16.7% 2/12 • Number of events 2 • 24 month	0.00% 0/4 • 24 month	0.00% 0/2 • 24 month
General disorders Other pain	0.00% 0/14 • 24 month	8.3% 1/12 • Number of events 1 • 24 month	25.0% 1/4 • Number of events 1 • 24 month	0.00% 0/2 • 24 month
Musculoskeletal and connective tissue disorders Spinal event at other lumbar level (s)	14.3% 2/14 • Number of events 2 • 24 month	8.3% 1/12 • Number of events 1 • 24 month	0.00% 0/4 • 24 month	50.0% 1/2 • Number of events 1 • 24 month
Musculoskeletal and connective tissue disorders Spinal event at target level	35.7% 5/14 • Number of events 6 • 24 month	25.0% 3/12 • Number of events 3 • 24 month	0.00% 0/4 • 24 month	0.00% 0/2 • 24 month
Injury, poisoning and procedural complications Trauma	7.1% 1/14 • Number of events 3 • 24 month	8.3% 1/12 • Number of events 1 • 24 month	0.00% 0/4 • 24 month	0.00% 0/2 • 24 month
Musculoskeletal and connective tissue disorders Upper extremity pain	0.00% 0/14 • 24 month	16.7% 2/12 • Number of events 3 • 24 month	25.0% 1/4 • Number of events 1 • 24 month	0.00% 0/2 • 24 month
Renal and urinary disorders Urogenital	7.1% 1/14 • Number of events 1 • 24 month	0.00% 0/12 • 24 month	0.00% 0/4 • 24 month	0.00% 0/2 • 24 month
Musculoskeletal and connective tissue disorders Vertebral fracture	7.1% 1/14 • Number of events 1 • 24 month	0.00% 0/12 • 24 month	0.00% 0/4 • 24 month	0.00% 0/2 • 24 month

Additional Information

Clinical Department

Medtrionic spinal and biologics

Phone: 1800-876-3133

Email: msbkclinicalresearch@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PI must provide the sponsor a copy of the results communication ninety (90) days prior to submission or disclosure. The sponsor shall not censor the results communication beyond the protection of confidential information. Investigator agrees to delete confidential information prior to any submission, publication, presentation or other disclosure. The sponsor can embargo results communications up to sixty (60) days.
• Publication restrictions are in place

Restriction type: OTHER