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The Long-Term Outcomes Study (LTOS) is a multi-center longitudinal cohort study of all patients who received the X-STOP device in the Pivotal Trial, Continued Access Protocol (CAP), or Cross-over Study (COS). It is designed to supplement postmarket safety and effectiveness data to be gathered in a Condition of Approval (CoA) study of a population of patients with moderately impaired physical function who elect to undergo X-STOP surgery.
Evaluate the long term safety and effectiveness of the X-Stop interspinous process decompression system In the patients who received the X-Stop under the IDE. These patients consist of two cohorts to be evaluated: patients who had moderately impaired physical function prior to X-Stop implantation (as determined by a baseline score >2.0 in the physical function (PF) domain of the Zurich claudication questionnaire), and patients who had mildly impaired physical function prior to X-Stop surgery(as determined by a baseline score <=2.0 in the PF domain of the Zurich claudication questionnaire (ZCQ), through the fifth postoperative year. Clinical examination will be performed at each office visit to confirm the absence of neurological complications. X-ray films (AP/lateral views) taken during the fifth postoperative year will, be analyzed to confirm A) maintenance of distraction and B) the absence of radiological evidence of device-related complications. Secondary endpoints will include mean scores from the SF-36, and incidence rates of adverse events, device failures, and secondary surgeries.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| X STOP® Interspinous Process Decompression System | Device | The X STOP is a titanium implant that fits between the spinous processes of the lumbar spine. It is made from Ti-6AI-4V Eli titanium alloy (ISO 5832/3) and consists of two components: a spacer assembly and a wing assembly. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Success Rates (At ≥ 5 Years) | Seven treatment success criteria were defined as follows: clinically significant improvement (at least 0.5 points) in Symptom Severity (SS) domain of Zurich Claudication Questionnaire (ZCQ), clinically significant improvement (at least 0.5 points) in Physical Function (PF) domain of ZCQ, Patient Satisfaction (PS) score of <2.5 points in ZCQ, no additional lumbar spinal stenosis surgery at the index level, maintenance of distraction, no device dislodgement, no device-related complications. All 7 criteria must be met to be considered a treatment success. | 3+ years following first 2 years post-X-STOP implant through IDE study |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Symptom Severity (SS) and Physical Functioning (PF) as Using Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years) | ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment Patient Satisfaction (PS). SS domain is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance). The first 6 questions are scored 1 to 5. Balance disturbance is scored in a 1-3-5 scale. The SS score is the mean of all answered items in the questionnaire ranging from 1to 5. If more than two items were missing, the SS score was considered as missing. PF score is the mean of five physical function questions ranging from 1 to 4. If more than one item were missing, the PF score was considered as missing. In each domain, a lower score represents a better outcome/condition. The change is calculated as the score at 5+ years after X-STOP implantation minus the baseline score. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study | The surgeries that occurred subsequent to the original X-STOP implantation were categorized as revision, removal, reoperation, supplemental fixation, and other. | 3+ years following first 2 years post-X-STOP implant through IDE study |
Inclusion Criteria:
A patient will be admitted into the LTOS program if he/she meets all of the following inclusion criteria:
Exclusion Criteria:
A patient will not be admitted into the LTOS program if he/she meets any of the following exclusion criteria:
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Patients who received implants and completed participation in the Pivotal, CAP, or COS studies and has the implant intact and is willing and able to provide consent and return to the clinic for evaluation or complete study questionnaires.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Mary's Spine Center | San Francisco | California | 94117 | United States | ||
| Neurological & Spine Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17176013 | Background | Hsu KY, Zucherman JF, Hartjen CA, Mehalic TF, Implicito DA, Martin MJ, Johnson DR 2nd, Skidmore GA, Vessa PP, Dwyer JW, Cauthen JC, Ozuna RM. Quality of life of lumbar stenosis-treated patients in whom the X STOP interspinous device was implanted. J Neurosurg Spine. 2006 Dec;5(6):500-7. doi: 10.3171/spi.2006.5.6.500. | |
| 15959362 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Target | Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ). |
| FG001 | Safety | Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Target | Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ). |
| BG001 | Safety |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Success Rates (At ≥ 5 Years) | Seven treatment success criteria were defined as follows: clinically significant improvement (at least 0.5 points) in Symptom Severity (SS) domain of Zurich Claudication Questionnaire (ZCQ), clinically significant improvement (at least 0.5 points) in Physical Function (PF) domain of ZCQ, Patient Satisfaction (PS) score of <2.5 points in ZCQ, no additional lumbar spinal stenosis surgery at the index level, maintenance of distraction, no device dislodgement, no device-related complications. All 7 criteria must be met to be considered a treatment success. | Patients who received the X-STOP and 1) completed the IDE trial or CAP/COS under IDE #G990128 or 2) were participating in the CAP/COS program, were eligible for the LTOS study. 55 included in analysis met moderately impaired baseline physical function. 14 had mildly impaired physical function at baseline and were analyzed as separate safety cohort. | Posted | Number | percentage of participants | 3+ years following first 2 years post-X-STOP implant through IDE study |
|
3+ years following first 2 years post-X-STOP implant through IDE study
An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified.
Patients may have had multiple adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Target | Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| arrhythmia | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Department | Medtronic Spine and Biologics | 1800-876-3133 | 6068 | msbkclinicalresearch@medtronic.com |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study |
| Patient Satisfaction (PS) as Assessed by Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years) | ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment Patient Satisfaction (PS). PS score is the mean of 6 questions scored from 1 to 4 if the number of responses exceeded four, a lower score represents a better outcome. Patients with mean scores <2.5 at 5 years postoperative evaluation were considered positive, which implied patient treatment satisfaction. | 3+ years following first 2 years post-X-STOP implant through IDE study |
| Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | Quality of life was assessed by the SF-36 health survey. It includes 8 subdomains (bodily pain, physical functioning, role-physical, general health and vitality, social functioning, role-emotional, and mental health) and 2 component summaries (physical component summary [PCS] and mental component summary [MCS]). Scores for each subdomain and component summary range from 0 "worst" to 100 "best. The change from baseline to the 5 year postoperative visit for each of these domains is presented. | Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study |
| Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study |
| 3+ years following first 2 years post-X-STOP implant through IDE study |
| Scarborough |
| Maine |
| 04074 |
| United States |
| Greater Baltimore Spine Care | Timonium | Maryland | 21093 | United States |
| Neurological Specialist | Norfolk | Virginia | 23510 | United States |
| University Hospital | Madison | Wisconsin | 53792 | United States |
| Zucherman JF, Hsu KY, Hartjen CA, Mehalic TF, Implicito DA, Martin MJ, Johnson DR 2nd, Skidmore GA, Vessa PP, Dwyer JW, Puccio ST, Cauthen JC, Ozuna RM. A multicenter, prospective, randomized trial evaluating the X STOP interspinous process decompression system for the treatment of neurogenic intermittent claudication: two-year follow-up results. Spine (Phila Pa 1976). 2005 Jun 15;30(12):1351-8. doi: 10.1097/01.brs.0000166618.42749.d1. |
Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG000 |
| Target |
Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ). |
| OG001 | Safety | Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ. |
| OG002 | Total | Total patients included target group and safety group. |
|
|
| Secondary | Change in Symptom Severity (SS) and Physical Functioning (PF) as Using Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years) | ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment Patient Satisfaction (PS). SS domain is based on seven questions (overall pain, pain frequency, pain in the back, pain in the leg, numbness, weakness, and balanced disturbance). The first 6 questions are scored 1 to 5. Balance disturbance is scored in a 1-3-5 scale. The SS score is the mean of all answered items in the questionnaire ranging from 1to 5. If more than two items were missing, the SS score was considered as missing. PF score is the mean of five physical function questions ranging from 1 to 4. If more than one item were missing, the PF score was considered as missing. In each domain, a lower score represents a better outcome/condition. The change is calculated as the score at 5+ years after X-STOP implantation minus the baseline score. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study |
|
|
|
| Secondary | Patient Satisfaction (PS) as Assessed by Zurich Claudication Questionnaire (ZCQ) Domain Scores (At ≥ 5 Years) | ZCQ is a validated outcomes instrument specific to lumbar spinal stenosis, and captures data in 3 distinct domains: SS, PF, and post-treatment Patient Satisfaction (PS). PS score is the mean of 6 questions scored from 1 to 4 if the number of responses exceeded four, a lower score represents a better outcome. Patients with mean scores <2.5 at 5 years postoperative evaluation were considered positive, which implied patient treatment satisfaction. | Posted | Mean | Standard Deviation | units on a scale | 3+ years following first 2 years post-X-STOP implant through IDE study |
|
|
|
| Secondary | Change in Quality of Life Using Short Form 36-Question (SF-36) Health Survey (At ≥ 5 Years) | Quality of life was assessed by the SF-36 health survey. It includes 8 subdomains (bodily pain, physical functioning, role-physical, general health and vitality, social functioning, role-emotional, and mental health) and 2 component summaries (physical component summary [PCS] and mental component summary [MCS]). Scores for each subdomain and component summary range from 0 "worst" to 100 "best. The change from baseline to the 5 year postoperative visit for each of these domains is presented. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3+ years following first 2 years post-X-STOP implant through IDE study |
|
|
|
| Other Pre-specified | Number of Patients With Subsequent Lumbar Spinal Surgeries That Occurred During the Study | The surgeries that occurred subsequent to the original X-STOP implantation were categorized as revision, removal, reoperation, supplemental fixation, and other. | Posted | Number | participants | 3+ years following first 2 years post-X-STOP implant through IDE study |
|
|
|
| Other Pre-specified | Number of Patients With Device/Procedure Related Adverse Events That Occurred During the Study | Posted | Number | participants | 3+ years following first 2 years post-X-STOP implant through IDE study |
|
|
|
| 11 |
| 55 |
| 48 |
| 55 |
| EG001 | Safety | Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ. | 4 | 14 | 13 | 14 |
| EG002 | Total | Total patients included target group and safety group. | 15 | 69 | 61 | 69 |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
|
| Device dislocation | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA 12.0 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Gastrointestinal arteriovenous malformation | Congenital, familial and genetic disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Portal hypertensive gastropathy | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Varices oesophageal | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Device deployment issue | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Device failure | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Hypertrophy | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Periprosthetic fracture | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Spinal claudication | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Cardiac pacemaker insertion | Surgical and medical procedures | MedDRA 12.0 | Non-systematic Assessment |
|
| Hip surgery | Surgical and medical procedures | MedDRA 12.0 | Non-systematic Assessment |
|
| Intervertebral disc operation | Surgical and medical procedures | MedDRA 12.0 | Non-systematic Assessment |
|
| Spinal fusion surgery | Surgical and medical procedures | MedDRA 12.0 | Non-systematic Assessment |
|
| atrial fibrillation | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| coronary artery disease | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| myocardial infarction | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| factor v leiden mutation | Congenital, familial and genetic disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| deafness neurosensory | Ear and labyrinth disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| hypoacusis | Ear and labyrinth disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| acromegaly | Endocrine disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| thyroid disorder | Endocrine disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| cataract | Eye disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| glaucoma | Eye disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| macular degeneration | Eye disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| constipation | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| dysphagia | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| haemorrhoids | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| inguinal hernia | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| oesophageal stenosis | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| vomiting | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| asthenia | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| chills | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| drug withdrawal syndrome | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| fatigue | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| feeling abnormal | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| hernia | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| oedema peripheral | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| pain | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| polyp | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| multiple allergies | Immune system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| bronchitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| cellulitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| cystitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| influenza | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| pneumonia | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| urinary tract infection | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| ankle fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
|
| clavicle fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
|
| contusion | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
|
| excoriation | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
|
| fall | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
|
| femur fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
|
| ligament rupture | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
|
| lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
|
| pelvic fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
|
| post-traumatic pain | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
|
| road traffic accident | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
|
| spinal fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
|
| upper limb fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
|
| wound complication | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
|
| pedal pulse decreased | Investigations | MedDRA 12.0 | Non-systematic Assessment |
|
| diabetes mellitus | Metabolism and nutrition disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| gout | Metabolism and nutrition disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| hypocholesterolaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| arthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| back disorder | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| bursitis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| polychondritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| tendon pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
|
| lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
|
| malignant neoplasm of eye | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
|
| multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
|
| pituitary tumor benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
|
| prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
|
| amnesia | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| ataxia | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| carotid artery stenosis | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| carpal tunnel syndrome | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| cerebrovascular accident | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| cognitive disorder | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| cubital tunnel syndrome | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| headache | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| hypoaesthesia | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| neuropathy peripheral | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| occipital neuralgia | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| parkinson's disease | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| peroneal nerve palsy | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| radicular pain | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| sciatica | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| spinal claudication | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| transient ischaemic attack | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| vascular dementia | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| anxiety | Psychiatric disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| depression | Psychiatric disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| depressive symptom | Psychiatric disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| insomnia | Psychiatric disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| incontinence | Renal and urinary disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| pollakiuria | Renal and urinary disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| proteinuria | Renal and urinary disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| prostatomegaly | Reproductive system and breast disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| night sweats | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| bladder repair | Surgical and medical procedures | MedDRA 12.0 | Non-systematic Assessment |
|
| cholecystectomy | Surgical and medical procedures | MedDRA 12.0 | Non-systematic Assessment |
|
| corneal transplant | Surgical and medical procedures | MedDRA 12.0 | Non-systematic Assessment |
|
| hip arthroplasty | Surgical and medical procedures | MedDRA 12.0 | Non-systematic Assessment |
|
| injection | Surgical and medical procedures | MedDRA 12.0 | Non-systematic Assessment |
|
| knee arthroplasty | Surgical and medical procedures | MedDRA 12.0 | Non-systematic Assessment |
|
| knee operation | Surgical and medical procedures | MedDRA 12.0 | Non-systematic Assessment |
|
| partial lung resection | Surgical and medical procedures | MedDRA 12.0 | Non-systematic Assessment |
|
| spinal operation | Surgical and medical procedures | MedDRA 12.0 | Non-systematic Assessment |
|
| stent placement | Surgical and medical procedures | MedDRA 12.0 | Non-systematic Assessment |
|
| wound treatment | Surgical and medical procedures | MedDRA 12.0 | Non-systematic Assessment |
|
| aortic aneurysm | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| deep vein thrombosis | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| hot flush | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| hypertension | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| intermittent claudication | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| peripheral artery aneurysm | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| phlebitis | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| varicose vein | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
|
Not provided
|
|
| MCS (n=49, 13, 62) |
|
| Mental Health (n=52, 14, 66) |
|
| PCS (n=49, 13, 62) |
|
| Physical Functioning (n=52, 14, 66) |
|
| Role-Emotional (n=50, 13, 63) |
|
| Role-Physical (n=50, 14, 64) |
|
| Social Functioning (n=52, 14, 66) |
|
| Vitality (n=52, 14, 66) |
|
|
| Number of Patients with Removal |
|
| Number of Patients with Re-operations |
|
| Number of Patients with Supplemental Fixations |
|
| Number of Patients with other subsequent surgeries |
|
| Title | Measurements |
|---|---|
|
| Implant & Procedure related |
|
| Undetermined |
|
| Not related |
|