NCT03797144: FNS

Fenestrated Screw Study

Terminated NA Results posted Last updated 24 August 2021

What this trial tests

NA trial testing CD HORIZON® Fenestrated Screw System with Fenestrated Screw Cement in Degenerative Spinal Disease in 27 participants. Terminated before completion.

Timeline

18 April 2019

Primary endpoint
15 July 2020

15 July 2020

Quick facts

Lead sponsor	Medtronic Spinal and Biologics
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	18 April 2019
Primary completion	15 July 2020
Estimated completion	15 July 2020
Sites	6 locations across France, Italy, Finland, Greece, Belgium

Drugs / interventions tested

• CD HORIZON® Fenestrated Screw System with Fenestrated Screw Cement

Conditions studied

• Degenerative Spinal Disease — all drugs for Degenerative Spinal Disease →
• Deformity of Spine — all drugs for Deformity of Spine →

Sponsor

Medtronic Spinal and Biologics — full company profile →

Who can join

22 and older, any sex, with Degenerative Spinal Disease or Deformity of Spine. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in ODI (Oswestry Disability Index) at 12 Months Compared to Baseline Primary · Baseline to 12 months

Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a.This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders. ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100. The results are summarized for 21 subjects who were assessed a

Group	Value	95% CI
Degenerative Spinal Disease	46.0
Deformity	17.8

Change in ODI From Baseline at 3 Months Visit Secondary · Baseline, 3 months

Disability associated with thoracic/lumbar spine conditions was assessed using the Oswestry Low Back Pain Disability Questionnaire, which yields the Oswestry Disability Index (ODI), Version 2.1a. \[23\]. This validated instrument is considered one of the principal condition-specific outcome measures used in the management of spinal disorders. ODI is composed by 10 sections. Each section can be scored 0 to 5, 5 being the worst case. The score is calculated by summing the different sections and then doubling the total. Maximum score is 100. The results are summarized for 21 subjects who were a

Baseline

Group	Value	95% CI
Degenerative Spinal Disease	49.7	± 20.0
Deformity	39.6	± 13.0

3 Month

Group	Value	95% CI
Degenerative Spinal Disease	20.9	± 24.9
Deformity	23.0	± 21.7

Change from Baseline

Group	Value	95% CI
Degenerative Spinal Disease	31.5	± 28.9
Deformity	16.6	± 19.3

Change in VAS (Visual Analogue Scale) Back and Leg Pain Score at 3 and 12 Months Follow-up Visit From Baseline Secondary · Baseline, 3, 12 months

Levels of back pain and leg pain were measured using the Visual Analogue Scales (VAS). Subjects were asked to rate the amount of back pain and leg pain they have had in the last week, where 0 is no pain and 10 is the worst pain possible. The results are summarized for 21 subjects who were assessed at Baseline, 19 subjects who completed the 3 months follow up visit and 2 subjects who completed the 12month follow-up visit. The reported VAS was calculated from two timepoints as the value of the baseline point minus the value of the 3 months time point and the value of the baseline minus the valu

Back Pain_Baseline

Group	Value	95% CI
Degenerative Spinal Disease	4.9	± 2.9
Deformity	6.8	± 2.3

Back Pain_3 Months

Group	Value	95% CI
Degenerative Spinal Disease	2.0	± 2.8
Deformity	1.7	± 1.8

Back Pain_Change from Baseline at 3 Months

Group	Value	95% CI
Degenerative Spinal Disease	3.3	± 2.6
Deformity	5.1	± 3.2

Back Pain_12 Months

Group	Value	95% CI
Degenerative Spinal Disease	2.0	± 0.0
Deformity	3.0	± 0.0

Back Pain_Change from Baseline at 12 Months

Group	Value	95% CI
Degenerative Spinal Disease	3.0	± 0.0
Deformity	0.0	± 0.0

Leg Pain_Baseline

Group	Value	95% CI
Degenerative Spinal Disease	7.5	± 2.2
Deformity	7.1	± 2.2

Leg Pain_3 Months

Group	Value	95% CI
Degenerative Spinal Disease	0.9	± 1.3
Deformity	1.3	± 1.8

Leg Pain_Change from Baseline at 3 Months

Group	Value	95% CI
Degenerative Spinal Disease	6.2	± 2.7
Deformity	5.8	± 2.5

Change in EQ-5D 5L (European Quality of Life-5 Dimensions) at 3 and 12 Months From Baseline Secondary · Baseline, 3, 12 months

The EQ-5D 5L (European Quality of Life-5 Dimensions) self-report questionnaire was used to assess health-related quality of life status. The EQ-5D 5L questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels, reflecting "no health problems," "slight health problems," "moderate health problems," "severe health problems," and "extreme health problems." The EQ-5D 5L will be used for calculating EQ-5D index score. The EQ-5D VAS was also utilized to document the subject's self-rated overall health state on

Index score_Baseline

Group	Value	95% CI
Degenerative Spinal Disease	0.24	± 0.25
Deformity	0.39	± 0.19

Index score_3 Months

Group	Value	95% CI
Degenerative Spinal Disease	0.66	± 0.37
Deformity	0.68	± 0.34

Index score_Change from Baseline at 3 Months

Group	Value	95% CI
Degenerative Spinal Disease	0.43	± 0.36
Deformity	0.28	± 0.33

Index score_12 Months

Group	Value	95% CI
Degenerative Spinal Disease	0.910	± 0.0
Deformity	0.910	± 0.0

Index score_Change from Baseline at 12 Months

Group	Value	95% CI
Degenerative Spinal Disease	0.423	± 0.0
Deformity	0.423	± 0.0

Health State score_Baseline

Group	Value	95% CI
Degenerative Spinal Disease	64.8	± 20.3
Deformity	57.5	± 15.9

Health State score_3 Months

Group	Value	95% CI
Degenerative Spinal Disease	72.8	± 21.7
Deformity	82.2	± 16.5

Health State score_Change from Baseline

Group	Value	95% CI
Degenerative Spinal Disease	11.9	± 35.8
Deformity	24.7	± 20.3

Rate of Neurological Success at 12-month Visit Secondary · Baseline to 12 months.

Neurological status is based on 4 sections: motor, sensory, reflexes, and straight leg raising, each comprising several elements. Following scales were used to evaluate neurological status: reflexes (0 = Absent or Trace, 1 = Hyper-reflexic, 2 = Normal), sensory function (Light Touch or Pin Prick L1 to S1; 1 = Absent, 2 = Impaired, 3 = Normal), motor function (using 0-5 scores 0-5 whereas 0= Total Paralysis, 1 = Palpable or Visible Contraction, 2 = Active Movement, Gravity Eliminated, 3 = Active Movement, Against Gravity, 4 = Active Movement, Against Some Resistance and 5 = Active Movement, Aga

Motor Functions_Baseline

Group	Value	95% CI
Degenerative Spinal Disease	5
Deformity	5

Motor Functions_12 Months

Group	Value	95% CI
Degenerative Spinal Disease	5
Deformity	5

Sensory Functions_Baseline

Group	Value	95% CI
Degenerative Spinal Disease	3
Deformity	3

Sensory Functions_12 Months

Group	Value	95% CI
Degenerative Spinal Disease	3
Deformity	3

Reflexes_Baseline

Group	Value	95% CI
Degenerative Spinal Disease	2
Deformity	2

Reflexes_12 Months

Group	Value	95% CI
Degenerative Spinal Disease	2
Deformity	2

Straight Leg Raise_Baseline

Group	Value	95% CI
Degenerative Spinal Disease	2
Deformity	2

Straight Leg Raise_12 Months

Group	Value	95% CI
Degenerative Spinal Disease	2
Deformity	2

Rate of Intraoperative Cement Extravasation/Leakage. Patients Secondary · Surgery to 12 months.

The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures.

Patients with cement extravasation

Group	Value	95% CI
Degenerative Spinal Disease	3
Deformity	5

Patients with symptomatic extravasation

Group	Value	95% CI
Degenerative Spinal Disease	0
Deformity	0

Rate of Intraoperative Cement Extravasation/Leakage. Screws Secondary · Surgery to 12 months.

The rate of intraoperative cement extravasation/leakage as directly assessed by the physician during the surgery or in the post-operative follow-up with imaging procedures.

Number of Cemented Fenestrated Screws

Group	Value	95% CI
Degenerative Spinal Disease	39
Deformity	97

Fenestrated Screws with cement extravasation

Group	Value	95% CI
Degenerative Spinal Disease	3
Deformity	8

Fenestrated screws with symptomatic cement extravasation

Group	Value	95% CI
Degenerative Spinal Disease	0
Deformity	0

Device and/or Procedure Related Adverse Events Through 12 Months. Secondary · Surgery to 12 months.

The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020. Adverse event relation to the study procedure and to the device was classified by the investigator and by the sponsor as not related, unlikely, possible, probable and causal relationship. For the reporting below, AEs classified as having possible, probable and causal relationship are considered as device and/or procedure related. Sponsor assessment is reported if different from the Investigator assessment 21 subjects were assessed at Baseline,19 subjects completed the 3 month follow-u

Adverse Event (AE)

Group	Value	95% CI
Degenerative Spinal Disease	2
Deformity	8

Serious Adverse Event (SAE)

Group	Value	95% CI
Degenerative Spinal Disease	1
Deformity	6

Serious Adverse Device Effect (SADE)

Group	Value	95% CI
Degenerative Spinal Disease	1
Deformity	5

Unexpected Serious Adverse Device Effect (USADE)

Group	Value	95% CI
Degenerative Spinal Disease	0
Deformity	0

SAEs Related to Procedure

Group	Value	95% CI
Degenerative Spinal Disease	0
Deformity	5

SAEs Related to Access System

Group	Value	95% CI
Degenerative Spinal Disease	0
Deformity	0

SAEs Related to Cage/Interbody

Group	Value	95% CI
Degenerative Spinal Disease	0
Deformity	0

SAEs Related to Anterior Plate

Group	Value	95% CI
Degenerative Spinal Disease	0
Deformity	0

Rate of Secondary Spinal Surgeries at Index and/or Adjacent Level(s), Resulting From an AE up to 12 Months After Surgery Secondary · Surgery to 12 months.

When a patient requires additional surgery at the index and/or adjacent level(s), it can be an indicator of insufficient outcomes of the initial surgery. Secondary spinal surgical procedures resulted from AE(s) could be classified into four categories: revision, removal, reoperation, and other. One subject belonging to the Deformity group underwent a reoperation for a foraminal stenosis at index level L5-S1.

Group	Value	95% CI
Degenerative Spinal Disease	0
Deformity	1

Radiographic Confirmation of Stabilization of the Pedicle Screw Instrumentation at 12-month Visit. Secondary · Surgery to 12 months.

The surgeon or hospital radiologist reviewed radiographs and or CT's to assess for evidence of instability of the pedicle screw instrumentation at 12 months. The following were considered as signs of instrumentation instability: * Screw pullout * Screw loosening * Screw toggle

Group	Value	95% CI
Degenerative Spinal Disease	1
Deformity	1
Degenerative Spinal Disease	0
Deformity	0

Radiographic Fusion at 12-month Visit for Those Subjects Where Fusion Was Intended. Secondary · Surgery to 12 months.

The surgeon or hospital radiologist determined fusion status for those subjects where fusion was intended. The fusion assessment for each subject was collected at 12 months, preferably by collecting a CT-scan, alternatively fusion could also be collected through X-rays. The criterion for fusion when assessed through a CT-scan is bony bridging and when assessed through X-rays the criteria bony bridging, no motion (\<4˚) in Flexion/Extension views, and integrity of the instrumentation (implanted devices). A partial fusion (not meeting these criteria) should have been recorded as "No fusion succ

Group	Value	95% CI
Degenerative Spinal Disease	0
Deformity	0
Degenerative Spinal Disease	0
Deformity	0
Degenerative Spinal Disease	1
Deformity	1

For Deformity Subjects Only: Change in Sagittal Spinopelvic Parameters From Baseline at the 12-month Visit. Secondary · Baseline to 12 months

Collection of spinopelvic parameters can show if patient's spine is balanced or not prior to and after surgery. Any evolution of parameters after the surgery can indicate a change in spinopelvic alignment or a mechanism of regulation/compensation due to an evolution of the spinal alignment. The following spinopelvic alignment parameters were assessed in the deformity patients on standing, frontal and sagittal full spine X-ray: * Sagittal alignment - Regional parameters: Thoracic Kyphosis (TK), Thoracolumbar kyphosis (TLK), and Lumbar lordosis (LL). * Sagittal spinopelvic parameters: Pelvic

Baseline Thoracic Kyphosis (TK) (degrees)

Group	Value	95% CI
Deformity	66

12-months Thoracic Kyphosis (TK) (degrees)

Group	Value	95% CI
Deformity	78

Baseline Thoracolumbar kyphosis (TLK) (degrees)

Group	Value	95% CI
Deformity	41

12-months Thoracolumbar kyphosis (TLK) (degrees)

Group	Value	95% CI
Deformity	5

Baseline Lumbar lordosis (LL) (degrees)

Group	Value	95% CI
Deformity	50

12-months Lumbar Lordosis (LL) (degrees)

Group	Value	95% CI
Deformity	58

Baseline Pelvic Incidence (PI) (degrees)

Group	Value	95% CI
Deformity	46

12-months Pelvic Incidence (PI) (degrees)

Group	Value	95% CI
Deformity	50

Adverse events — posted to ClinicalTrials.gov

Time frame: The adverse events (AEs) were collected from the spinal surgery up to the study cut-off date of 15 JUL 2020 (12 months). At this study cut-off date: - 2 Degenerative Spinal Disease (DSD) patients completed their surgery visit - 8 DSD patients completed up to their 3 month follow-up visit - 1 DSD patient completed up to their 12 month follow-up visit - 9 Deformity patients completed up to their 3-month follow-up visit - 1 Deformity patient completed up to their 12 month follow-up visit. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Degenerative Spinal Disease

Serious: 1/11 (9%)

Deaths: 0/11

Deformity

Serious: 4/10 (40%)

Deaths: 0/10

Serious adverse events (7 terms)

Reaction	System	Degenerative Spinal Disease	Deformity
SPINAL CSF LEAK	Nervous system disorders	—	—
PULMONARY EDEMA	Respiratory, thoracic and mediastinal disorders	—	—
FORAMINAL STENOSIS	Musculoskeletal and connective tissue disorders	—	—
INCISION WOUND DEHISCENCE	Injury, poisoning and procedural complications	—	—
SPINAL FRACTURE AT LEVEL T12	Injury, poisoning and procedural complications	—	—
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	—	—
INGUINAL HERNIA	Gastrointestinal disorders	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Degenerative Spinal Disease	Deformity
PROXIMAL JUNCTIONAL KYPHOSIS	Injury, poisoning and procedural complications	—	—
ANXIETY	Psychiatric disorders	—	—
HEMATOMA AT INDEX LEVEL CAUSING FEVER ABOVE 37.8°C	Vascular disorders	—	—

Most-reported serious reactions: SPINAL CSF LEAK, PULMONARY EDEMA, FORAMINAL STENOSIS, INCISION WOUND DEHISCENCE, SPINAL FRACTURE AT LEVEL T12, PULMONARY EMBOLISM, INGUINAL HERNIA.

Data from ClinicalTrials.gov NCT03797144 adverse events section.

Sponsor's own description

The primary objective of this post-market study is to demonstrate that Oswestry disability index (ODI) score improved significantly at 12 months post-operatively as compared to baseline for each indication (degenerative spinal disease and deformity) in subjects with compromised bone quality, who will receive a surgical procedure requiring posterior stabilization and/or immobilization of one or more spinal segments using CD HORIZON® Fenestrated Screw Spinal System with Fenestrated Screw Cement.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.