Degenerative Cervical Disc Disease
Conditions
Brief summary
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).
Detailed description
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.
Interventions
None listed
Sponsors
Medtronic Spinal and Biologics
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must be willing to sign a Patient Data Release Form. * Patient with degenerative disc disease (DDD) who is scheduled to receive a PRESTIGE® Cervical Disc and fulfills the indications according to the product description.
Exclusion criteria
* Patient fulfills any contraindication according to the product description. * Patient has not reached the age of legal consent according to local laws. * Patient has diabetes. * Patient has Body Mass Index (BMI) \> 35. * Patient has affected disc not between C3/C4 and C6/C7. * Patient with instability of cervical spine. * Patients who will receive extensive decompression.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D | 2 years | 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. |
| Neck Disability Index (NDI) Score | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Pain Prior to Enrollment | Baseline visit | Documentation of duration of pain prior to enrollment |
| Intervertebral Disc Space | 2 years | — |
Countries
Czechia, Greece, Hungary, Kuwait, Poland, Saudi Arabia, Serbia, Slovakia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 190 |
| Total | 190 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Device explanted | 1 |
| Overall Study | Lost to Follow-up | 39 |
| Overall Study | Patient enroled but not implanted | 2 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Cervical Arthroplasty + Prestige LP |
|---|---|
| Age, Continuous | 43.9 years STANDARD_DEVIATION 8.6 |
| Region of Enrollment Czech Republic | 44 participants |
| Region of Enrollment Hungary | 13 participants |
| Region of Enrollment Kuwait | 1 participants |
| Region of Enrollment Poland | 83 participants |
| Region of Enrollment Saudi Arabia | 11 participants |
| Region of Enrollment Serbia | 10 participants |
| Region of Enrollment Slovakia | 28 participants |
| Sex: Female, Male Female | 127 Participants |
| Sex: Female, Male Male | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 40 / 190 |
| serious Total, serious adverse events | 7 / 190 |
Outcome results
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.
Time frame: 2 years
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cervical Arthroplasty + Prestige LP | EQ-5D | Baseline | 0.59 units on a scale | Standard Deviation 0.22 |
| Cervical Arthroplasty + Prestige LP | EQ-5D | 3 months Follow up | 0.78 units on a scale | Standard Deviation 0.16 |
| Cervical Arthroplasty + Prestige LP | EQ-5D | 6 months Follow up | 0.77 units on a scale | Standard Deviation 0.2 |
| Cervical Arthroplasty + Prestige LP | EQ-5D | 12 months Follow up | 0.80 units on a scale | Standard Deviation 0.19 |
| Cervical Arthroplasty + Prestige LP | EQ-5D | 24 months Follow up | 0.76 units on a scale | Standard Deviation 0.21 |
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.
Time frame: 2 years
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cervical Arthroplasty + Prestige LP | Neck Disability Index (NDI) Score | Baseline | 24.1 units on a scale | Standard Deviation 8.6 |
| Cervical Arthroplasty + Prestige LP | Neck Disability Index (NDI) Score | 3 months Follow up | 13.2 units on a scale | Standard Deviation 8.9 |
| Cervical Arthroplasty + Prestige LP | Neck Disability Index (NDI) Score | 6 months Follow up | 12.6 units on a scale | Standard Deviation 10.2 |
| Cervical Arthroplasty + Prestige LP | Neck Disability Index (NDI) Score | 12 months Follow up | 12.3 units on a scale | Standard Deviation 10 |
| Cervical Arthroplasty + Prestige LP | Neck Disability Index (NDI) Score | 24 months | 13.4 units on a scale | Standard Deviation 10.3 |
Secondary
Duration of Pain Prior to Enrollment
Documentation of duration of pain prior to enrollment
Time frame: Baseline visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervical Arthroplasty + Prestige LP | Duration of Pain Prior to Enrollment | patients with pain for 3-6 months before surgery | 22.1 percentage of patients with pain |
| Cervical Arthroplasty + Prestige LP | Duration of Pain Prior to Enrollment | patients with pain for 6-12 months before surgery | 21.3 percentage of patients with pain |
| Cervical Arthroplasty + Prestige LP | Duration of Pain Prior to Enrollment | patients with pain for >12 months before surgery | 37.4 percentage of patients with pain |
Secondary
Intervertebral Disc Space
Time frame: 2 years
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cervical Arthroplasty + Prestige LP | Intervertebral Disc Space | Baseline | 0.22 millimiters | Standard Deviation 0.07 |
| Cervical Arthroplasty + Prestige LP | Intervertebral Disc Space | 3 months Follow up | 0.41 millimiters | Standard Deviation 0.15 |
| Cervical Arthroplasty + Prestige LP | Intervertebral Disc Space | 6 months Follow up | 0.42 millimiters | Standard Deviation 0.16 |
| Cervical Arthroplasty + Prestige LP | Intervertebral Disc Space | 12 months Follow up | 0.40 millimiters | Standard Deviation 0.14 |
| Cervical Arthroplasty + Prestige LP | Intervertebral Disc Space | 24 months Follow up | 0.39 millimiters | Standard Deviation 0.13 |