Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Prestige artificial disc replacement is an alternative treatment option with 16 years of experience addressing the unmet needs of surgical fusion interventions. Previous studies on the PRESTIGE® cervical disc have proven the safety and effectiveness of artificial disc surgery with level I evidence.
The PRESTIGE Observational Study is intended to collect prospectively observational data primarily on the Quality of Life (QoL).
Degenerative cervical disc disease is associated with a very high burden to the patient and the society. If conservative treatment options fail, surgical interventions are the last treatment option.
Symptomatic disc degeneration leads to neck pain, which can radiate to the scapula and arm, with dumbness and tingling, and sometimes grasping and walking difficulties. At an advanced stage, muscle weakness can be observed in the nerve territory.
The quality of life and functionality of patients with therapy-resistant (conservatively treated) severe degeneration of the disc is greatly impaired, as they suffer from intense pain and thus disability. Patients of working age were significantly more impacted by their symptoms than older patients. They are no longer able to fully participate in everyday activities.
Cervical neck pain resulting from degenerative disc disease is associated with a major economic burden for payers.
Traditional cervical surgical decompressions and fusions are currently the most common treatment option. Despite good treatment success rates, fusions are associated with a negative impact on the normal kinematics of the spine, long recuperation times and long absence from work. Prestige artificial disc replacement is an alternative treatment option.
The PRESTIGE Observational Study is intended to collect information on Quality of Life (QoL) prior and after PRESTIGE® Cervical Disc surgery; data on pain prior of participation to the study, drug regiment and X-ray evaluation throughout the course of the study will be obtained. In addition adverse events and economic data will be documented.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| EQ-5D | The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI). EQ-5D is an instrument for measuring health outcome and consists of five dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression and a Visual Analog Scale that can be used as a quantitative measure of health as judged by the patient. Each dimension has 3 levels (no problems = 1, some problems = 2, and extreme problems = 3). The EQ-5D index has an upper limit of 1 that indicates full health (indicated by "no problem" in all domains), whereas 0 represents death. Scores worst than 0 are possible, implying that some health states may be worse than death. | 2 years |
| Neck Disability Index (NDI) Score | The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI). The NDI is a self-reported questionnaire designed to provide information on how neck pain affects the patient's ability to manage in everyday life. It contains questions on 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. NDI results can be presented as a raw score or as a percent. When presenting it as a raw score, each section is scored on a 0 to 5 rating scale and the result is summarized to a total score with a maximum score of 50. This raw score can also be doubled and expressed as a percentage. Zero points or 0% means no activity limitations and 50 points or 100% means complete activity limitation. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Pain Prior to Enrollment | Documentation of duration of pain prior to enrollment | Baseline visit |
| Intervertebral Disc Space | 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with degenerative disc disease (DDD) who are scheduled to receive a cervical arthroplasty.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jan Štulik, MUDr | University Clinic Motol | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Plzen - Lochotin | Pilsen | 32318 | Czechia | |||
| Hospital Plzen - Lochotin |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cervical Arthroplasty + Prestige LP | All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cervical Arthroplasty + Prestige LP | All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc. |
| 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 | EQ-5D | The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI). EQ-5D is an instrument for measuring health outcome and consists of five dimensions: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression and a Visual Analog Scale that can be used as a quantitative measure of health as judged by the patient. Each dimension has 3 levels (no problems = 1, some problems = 2, and extreme problems = 3). The EQ-5D index has an upper limit of 1 that indicates full health (indicated by "no problem" in all domains), whereas 0 represents death. Scores worst than 0 are possible, implying that some health states may be worse than death. | As this is an observational study not all patients completed EQ-5D questionnaires, for this reason the number of participants analyzed is different from the number of patients in the Participant Flow. | Posted | Mean | Standard Deviation | units on a scale | 2 years |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cervical Arthroplasty + Prestige LP | All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lumbar pain | Musculoskeletal and connective tissue disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neck, shoulder and arm pain | General disorders |
Low patient compliance at the 6 and 12 months follow up visits
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cristina Faria | MedtronicSpineECA | +41 21 802 70 00 | cristina.faria@medtronic.com |
Not provided
Not provided
Not provided
Not provided
| Pilsen |
| Czechia |
| University Clinic Motol | Prague | Czechia |
| Agia Olga Hospital | Athens | Greece |
| National Center for Spinal Disorders | Budapest | 1126 | Hungary |
| National Center for Spinal Disorders | Budapest | Hungary |
| Al-Salam International Hospital | Kuwait City | Kuwait |
| Razi Hospital for Orthopedic Surgery | Kuwait City | Kuwait |
| Centrum Rehabilitacji im.prof.M.Weissa "STOCER" | Konstancin-Jeziorna | 05-510 | Poland |
| Centrum Ksztalcenia I Rehabilitcji | Konstancin | 05-510 | Poland |
| Centrum Ksztalcenia I Rehabilitcji | Konstancin | Poland |
| Centrum Rehabilitacji im.prof. M.Weissa "STOCER" | Konstancin | Poland |
| State Hospital- Wojewodzkie Centrum | Opole | 45-418 | Poland |
| Specialist Hospital Prof. Alfreda Sokolowskiego | Szczecin | 70-891 | Poland |
| Specialist Hospital Prof. Alfreda Sokolowskiego | Szczecin | Poland |
| Orthopaedic University Hospital in Zakopane | Zakopane | 34-500 | Poland |
| Orthopaedic University Hospital in Zakopane | Zakopane | Poland |
| State Hospital- Szpital Wojewodzki | Zielona Góra | 65-046 | Poland |
| King Faisal Specialist Hospital & Research Center | Jeddah | Saudi Arabia |
| Neurosurgical Clinic KCS | Belgrade | 11000 | Serbia |
| Neurosurgical Clinic KCS | Belgrade | Serbia |
| Clinical Center Nis Neurosurgical Clinic | Niš | 18000 | Serbia |
| Clinical Center Niš | Niš | Serbia |
| Clinical Center of Vojvodina Neurosurgical Clinic | Novi Sad | 21000 | Serbia |
| Clinical Center of Vojvodina | Novi Sad | Serbia |
| NsP Nové Zámky Hospital | Nové Zamky | Slovakia |
| Patient enroled but not implanted |
|
| Device explanted |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Cervical Arthroplasty + Prestige LP | All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc. |
|
|
| Secondary | Duration of Pain Prior to Enrollment | Documentation of duration of pain prior to enrollment | Posted | Number | percentage of patients with pain | Baseline visit |
|
|
|
| Primary | Neck Disability Index (NDI) Score | The primary objective is the documentation of QoL before and after cervical disc surgery using the PRESTIGE® Cervical Disc System. The QoL will be determined using the EQ-5D questionnaire and the Neck Disability Index (NDI). The NDI is a self-reported questionnaire designed to provide information on how neck pain affects the patient's ability to manage in everyday life. It contains questions on 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. NDI results can be presented as a raw score or as a percent. When presenting it as a raw score, each section is scored on a 0 to 5 rating scale and the result is summarized to a total score with a maximum score of 50. This raw score can also be doubled and expressed as a percentage. Zero points or 0% means no activity limitations and 50 points or 100% means complete activity limitation. | As this is an observational study not all patients completed NDI questionnaires, for this reason the number of participants analyzed is different from the number of patients in the Participant Flow. | Posted | Mean | Standard Deviation | units on a scale | 2 years |
|
|
|
| Secondary | Intervertebral Disc Space | As this is an observational study not all patients had images available for each visit, for this reason the number of participants analyzed is different from the number of patients in the Participant Flow. | Posted | Mean | Standard Deviation | millimiters | 2 years |
|
|
|
| 7 |
| 190 |
| 40 |
| 190 |
| syndroma carpi radialis | Nervous system disorders |
|
| Arm pain | Musculoskeletal and connective tissue disorders |
|
| Quervain syndrome | Musculoskeletal and connective tissue disorders |
|
| Thoracic spine discopathy | Nervous system disorders |
|
| Wound hematoma | General disorders |
|
| Lumbar pain | General disorders |
|
The sponsor can review results communications prior to public release. The sponsor will limit its review to the determination of whether Confidential Information is disclosed and to check for technical correctness.
|
| Title | Measurements |
|---|---|
|
| 12 months Follow up |
|
| 24 months |
|
| Title | Measurements |
|---|---|
|
| 12 months Follow up |
|
| 24 months Follow up |
|