Trial Outcomes & Findings for A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine (NCT NCT01143324)
NCT ID: NCT01143324
Last Updated: 2019-01-08
Results Overview
The primary objective of the study is to access the short term recovery (from surgery to hospital discharge) since the minimally invasive lumbar fusion techniques are expected to be associated with immediate short-term benefits. Patients undergoing minimally invasive procedures are reported to recover earlier from surgery particularly with a shorter time to first ambulation and shorter discharge as compared to the standard open procedures. Outcome measure timeframe for time from surgery to first ambulation is assessed up to hospital discharge as pts are all ambulated before discharge from the hospital.
COMPLETED
255 participants
From date of Surgery to date of First ambulation, assessed up to hospital discharge.
2019-01-08
Participant Flow
In total 255 patients were enrolled. Three patients were not submitted to a minimally invasive MAST fusion procedure and therefore excluded from further analysis. Number of participants started in the participant flow is 252.
Participant milestones
| Measure |
MAST™ Procedure
Single Arm Study with MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
|
|---|---|
|
Overall Study
STARTED
|
252
|
|
Overall Study
COMPLETED
|
233
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
MAST™ Procedure
Single Arm Study with MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Explant of the device
|
4
|
Baseline Characteristics
A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine
Baseline characteristics by cohort
| Measure |
MAST™ Procedure
n=252 Participants
Single Arm Study with MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
|
|---|---|
|
Age, Continuous
|
53.8 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
142 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
40 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
81 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of Surgery to date of First ambulation, assessed up to hospital discharge.The primary objective of the study is to access the short term recovery (from surgery to hospital discharge) since the minimally invasive lumbar fusion techniques are expected to be associated with immediate short-term benefits. Patients undergoing minimally invasive procedures are reported to recover earlier from surgery particularly with a shorter time to first ambulation and shorter discharge as compared to the standard open procedures. Outcome measure timeframe for time from surgery to first ambulation is assessed up to hospital discharge as pts are all ambulated before discharge from the hospital.
Outcome measures
| Measure |
MAST™ Procedure
n=252 Participants
MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
|
|---|---|
|
Time From Surgery to First Ambulation.
|
1.3 Days from surgery to first ambulation
Standard Deviation 0.5
|
PRIMARY outcome
Timeframe: From date of surgery until date of surgery recovery day assessed up to hospital discharge.The primary objective of the study is to access the short term recovery (from surgery to discharge) since the minimally invasive lumbar fusion techniques are expected to be associated with immediate short-term benefits. Patients undergoing minimally invasive procedures are reported to recover earlier from surgery particularly with a shorter time to first ambulation and shorter discharge as compared to the standard open procedures. Surgery recovery day is defined as the day when patients fulfils following criteria : patient no longer needs intravenous infusion of analgesic drugs, there are no surgery related complications (AEs) impending discharge of patient, patient no longer needs nursing care. The objective of the surgery recovery day assessment is to collect the day when the patient could be discharged based on his actual clinical condition because the effective day of discharge may be prolonged by factors other than the patient's clinical recovery such as social factors.
Outcome measures
| Measure |
MAST™ Procedure
n=252 Participants
MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
|
|---|---|
|
Time to Surgery Recovery Day.
|
3.2 Days
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Baseline, 12 monthsPopulation: The number of analyzed at 12 months only included subjects who had available data.
Relief of Back Pain intensity at 12 months compared to the baseline using the Back Pain Intensity Score assessed on a 10 cm Visual Analog Scale (VAS). The endpoint is the difference between baseline and 12 months of the patient's back-pain intensity score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning 'no pain' and 10cm meaning 'worst possible pain') was used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (12 months - baseline) represents large relief of pain.
Outcome measures
| Measure |
MAST™ Procedure
n=252 Participants
MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
|
|---|---|
|
Back Pain Intensity Visual Analog Scale (VAS) Score as Compared to Baseline.
Pre-operative (N=252)
|
6.2 Units on a scale
Standard Deviation 2.3
|
|
Back Pain Intensity Visual Analog Scale (VAS) Score as Compared to Baseline.
12 Months (N=226)
|
2.9 Units on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline, 12 monthsPopulation: The number of analyzed at 12 months only included subjects who had available data.
Leg pain intensity (using VAS intensity score) as compared to baseline. Relief of Leg Pain intensity at 12 months compared to the baseline using the Back Pain Intensity Score assessed on a 10 cm Visual Analog Scale (VAS). The endpoint is the difference between baseline and 12 months of the patient's leg-pain intensity score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning 'no pain' and 10cm meaning 'worst possible pain') was used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (12 months - baseline) represents large relief of pain.
Outcome measures
| Measure |
MAST™ Procedure
n=252 Participants
MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
|
|---|---|
|
Leg Pain Intensity VAS Score as Compared to Baseline
Baseline (N=252)
|
5.9 Units on a scale
Standard Deviation 2.8
|
|
Leg Pain Intensity VAS Score as Compared to Baseline
12 months (N=226)
|
2.2 Units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline, 12 monthsPopulation: The number of analyzed at 12 months only included subjects who had available data.
EQ-5D questionnaire as compared to baseline measurement. EQ-5D Index was calculated based on answers provided in the questionnaire. Applicable to a wide range of health conditions and treatments, the EQ-5D provides a simple descriptive profile and a single index value for health status. The EQ-5D-3L consists of the EQ-5D-3L descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The respondent is asked to indicate his/her health state by ticking in the box against the most appropriate statement in each of the 5 dimensions. EQ VAS records the respondent's self-rated health on a vertical 20 cm VAS where the endpoints are labelled 'Best imaginable health state' at the top and 'Worst imaginable health state' at the bottom, having numeric values of 100 and 0 respectively.
Outcome measures
| Measure |
MAST™ Procedure
n=204 Participants
MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
|
|---|---|
|
EQ-5D Questionnaire (When it is a Routine Practice) as Compared to Baseline.
Baseline (N=204)
|
0.34 Units on a scale / Index
Standard Deviation 0.32
|
|
EQ-5D Questionnaire (When it is a Routine Practice) as Compared to Baseline.
12 Months (N=182)
|
0.71 Units on a scale / Index
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: One hundred and thirty one-level patients (=130 LEVELS) and 24 two-level patients (=48 LEVELS) were assessed for fusion at 12 months per CIP defined criteria.
Fusion rate as assessed by the CT Scan or X-Rays, in those sites where this assessment is standard of care.
Outcome measures
| Measure |
MAST™ Procedure
n=178 Number of levels assessed
MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
|
|---|---|
|
Fusion Rate as Assessed by CT Scan or X-Rays, in Those Sites Where This Assessment is Standard of Care.
One level fusion (levels n=130)
|
118 Fused levels
|
|
Fusion Rate as Assessed by CT Scan or X-Rays, in Those Sites Where This Assessment is Standard of Care.
Two level fusion (levels n=48)
|
43 Fused levels
|
SECONDARY outcome
Timeframe: From 6-12 months after the day of surgeryThe number of patients who utilized rehabilitation programs was documented (when required).
Outcome measures
| Measure |
MAST™ Procedure
n=252 Participants
MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
|
|---|---|
|
Number of Patients Who Utilized Rehabilitation Programs
|
61 participants
|
SECONDARY outcome
Timeframe: From baseline until 12 monthsProportion of the patients needing a second intervention at the treated level(s) (reoperation rates).
Outcome measures
| Measure |
MAST™ Procedure
n=252 Participants
MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
|
|---|---|
|
Proportion of Patients Needing a Second Intervention at the Treated Level(s) (Reoperation Rates).
|
3 Participants
|
SECONDARY outcome
Timeframe: From Baseline until 12 monthsProportion of the patients needing intervention at adjacent level(s).
Outcome measures
| Measure |
MAST™ Procedure
n=252 Participants
MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
|
|---|---|
|
Proportion of Patients Needing Intervention at Adjacent Level(s).
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, 12 monthsPopulation: The number of analyzed at 12 months only included subjects who had available data.
Document the change in pain medication consumption one year after surgery , as compared with baseline. The endpoint is the number of participants taking pain medication at baseline and number of participants taking pain medication in the week before the 12 months follow up visit.
Outcome measures
| Measure |
MAST™ Procedure
n=252 Participants
MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
|
|---|---|
|
Document Change in Pain Medication Consumption Over Time as Compared With Baseline. Baseline.
Participants taking medication at baseline N=252
|
185 Participants
|
|
Document Change in Pain Medication Consumption Over Time as Compared With Baseline. Baseline.
Participants taking medication at 12 months N=233
|
107 Participants
|
SECONDARY outcome
Timeframe: From Baseline until 12 monthsDocument the Adverse Events occurrence throughout the study. All adverse events have been included regardless visit windowing.
Outcome measures
| Measure |
MAST™ Procedure
n=252 Participants
MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
|
|---|---|
|
Document Adverse Events Occurrence Throughout the Study.
|
125 Number of reported adverse events
|
SECONDARY outcome
Timeframe: Baseline, 12 monthsPopulation: The number of analyzed at 12 months only included subjects who had available data.
Oswestry Disability Index (ODI) 12 months after the surgery as compared to baseline. The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 100; 0 meaning 'no disability' and 100 meaning 'maximum disability'.
Outcome measures
| Measure |
MAST™ Procedure
n=251 Participants
MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
|
|---|---|
|
ODI Difference 12 Months After the Surgery as Compared to Baseline.
Baseline (N=251)
|
45.5 Units on a scale
Standard Deviation 15.4
|
|
ODI Difference 12 Months After the Surgery as Compared to Baseline.
12 Month (N=226)
|
22.4 Units on a scale
Standard Deviation 18.8
|
SECONDARY outcome
Timeframe: 12 months after the surgeryPopulation: The analyzed subjects at 12 months only included the subjects who had available data.
Document number of participants that returned to work 12 months after surgery.
Outcome measures
| Measure |
MAST™ Procedure
n=252 Participants
MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
|
|---|---|
|
Number of Patients That Returned to Work 12months After the Surgery.
Number of participants working at baseline(N=252)
|
79 Participants currently working
|
|
Number of Patients That Returned to Work 12months After the Surgery.
Number of participants working at 12 months (N=227
|
97 Participants currently working
|
Adverse Events
MAST™ Procedure
Serious adverse events
| Measure |
MAST™ Procedure
n=252 participants at risk
MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
|
|---|---|
|
Vascular disorders
Hypotension
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.6%
4/252 • Number of events 4 • 1 year.
|
|
Vascular disorders
Circulatory collapse
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Nervous system disorders
Polyneuropathy
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Surgical and medical procedures
Bladder neck suspension
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Injury, poisoning and procedural complications
Confusion postoperative
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Infections and infestations
Urosepsis
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
4/252 • Number of events 4 • 1 year.
|
|
Nervous system disorders
Spinal haematoma
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Immune system disorders
Hypersensitivity
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Cardiac disorders
Myocardial infarction
|
0.40%
1/252 • Number of events 1 • 1 year.
|
Other adverse events
| Measure |
MAST™ Procedure
n=252 participants at risk
MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.9%
25/252 • Number of events 31 • 1 year.
|
|
Eye disorders
Cataract
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Injury, poisoning and procedural complications
Dural tear
|
1.6%
4/252 • Number of events 4 • 1 year.
|
|
General disorders
Pyrexia
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Nervous system disorders
Headache
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Vascular disorders
Hypertension
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Nervous system disorders
Hypoesthesia
|
1.2%
3/252 • Number of events 3 • 1 year.
|
|
General disorders
Implant site effusion
|
0.79%
2/252 • Number of events 2 • 1 year.
|
|
Infections and infestations
Incision site abscess
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.7%
22/252 • Number of events 30 • 1 year.
|
|
Nervous system disorders
Lumbar radiculopathy
|
1.2%
3/252 • Number of events 3 • 1 year.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
4/252 • Number of events 4 • 1 year.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
4/252 • Number of events 4 • 1 year.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
3/252 • Number of events 3 • 1 year.
|
|
Ear and labyrinth disorders
Vertigo
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Gastrointestinal disorders
Vomiting
|
0.79%
2/252 • Number of events 2 • 1 year.
|
|
Infections and infestations
Wound infection
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.40%
1/252 • Number of events 1 • 1 year.
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.40%
1/252 • Number of events 1 • 1 year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Confidential Disclosure Agreements were signed by all investigators. The information had to be kept confidential and investigators agreed not to disclose information to any third party.
- Publication restrictions are in place
Restriction type: OTHER