PRESTIGE Observational Study

• Sponsor: Medtronic Spinal and Biologics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00875810
• Collaborator: (none)
• Enrollment: 194
• Locations: 27
• Duration (Months): 67
• Patients Per Site: 7.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Degenerative Cervical Disc Disease

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 194 participants
• Time Perspective: Prospective
• Official Title: PRESTIGE Observational Study
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. Duration of Pain Prior to Enrollment [Baseline visit]

   Documentation of duration of pain prior to enrollment

2. Intervertebral Disc Space [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Plzen - Lochotin	Plzen		Czech Republic	32318
2	Hospital Plzen - Lochotin	Plzen		Czech Republic
3	University Clinic Motol	Prague		Czech Republic
4	Agia Olga Hospital	Athens		Greece
5	National Center for Spinal Disorders	Budapest		Hungary	1126
6	National Center for Spinal Disorders	Budapest		Hungary
7	Al-Salam International Hospital	Kuwait City		Kuwait
8	Razi Hospital for Orthopedic Surgery	Kuwait City		Kuwait
9	Al-Salam International Hospital	Kuwait		Kuwait
10	Centrum Rehabilitacji im.prof.M.Weissa "STOCER"	Konstancin-Jeziorna		Poland	05-510
11	Centrum Ksztalcenia I Rehabilitcji	Konstancin		Poland	05-510
12	Centrum Ksztalcenia I Rehabilitcji	Konstancin		Poland
13	Centrum Rehabilitacji im.prof. M.Weissa "STOCER"	Konstancin		Poland
14	State Hospital- Wojewodzkie Centrum	Opole		Poland	45-418
15	Specialist Hospital Prof. Alfreda Sokolowskiego	Szczecin		Poland	70-891
16	Specialist Hospital Prof. Alfreda Sokolowskiego	Szczecin		Poland
17	Orthopaedic University Hospital in Zakopane	Zakopane		Poland	34-500
18	Orthopaedic University Hospital in Zakopane	Zakopane		Poland
19	State Hospital- Szpital Wojewodzki	Zielona Gora		Poland	65-046
20	King Faisal Specialist Hospital & Research Center	Jeddah		Saudi Arabia
21	Neurosurgical Clinic KCS	Belgrade		Serbia	11000
22	Neurosurgical Clinic KCS	Belgrade		Serbia
23	Clinical Center Nis Neurosurgical Clinic	Nis		Serbia	18000
24	Clinical Center Niš	Niš		Serbia
25	Clinical Center of Vojvodina Neurosurgical Clinic	Novi Sad		Serbia	21000
26	Clinical Center of Vojvodina	Novi Sad		Serbia
27	NsP Nové Zámky Hospital	Nové Zamky		Slovakia

Sponsors and Collaborators

• Medtronic Spinal and Biologics

Investigators

• Principal Investigator: Jan Štulik, MUDr, University Clinic Motol

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Spinal and Biologics
• ClinicalTrials.gov Identifier: NCT00875810
• Other Study ID Numbers: PRESTIGE Observational Study
• First Posted: Apr 3, 2009
• Last Update Posted: Jan 28, 2016
• Last Verified: Jan 1, 2016

Study Results

Participant Flow

Arm/Group Title	Cervical Arthroplasty + Prestige LP
Arm/Group Description	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.
Period Title: Overall Study
STARTED	194
Implanted	190
Discharged	177
3 Months Follow up	175
6 Months Follow up	80
12 Months Follow up	112
24 Months Follow up	148
COMPLETED	148
NOT COMPLETED	46

Baseline Characteristics

Arm/Group Title	Cervical Arthroplasty + Prestige LP
Arm/Group Description	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.
Overall Participants	190
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.9 (8.6)
Sex: Female, Male (Count of Participants)
Female	127 66.8%
Male	63 33.2%
Region of Enrollment (participants) [Number]
Serbia	10 5.3%
Saudi Arabia	11 5.8%
Hungary	13 6.8%
Czech Republic	44 23.2%
Slovakia	28 14.7%
Poland	83 43.7%
Kuwait	1 0.5%

Outcome Measures

1. Primary Outcome

Title	EQ-5D
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Cervical Arthroplasty + Prestige LP
Arm/Group Description	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.
Measure Participants	155
Baseline	0.59 (0.22)
3 months Follow up	0.78 (0.16)
6 months Follow up	0.77 (0.20)
12 months Follow up	0.80 (0.19)
24 months Follow up	0.76 (0.21)

2. Secondary Outcome

Title	Duration of Pain Prior to Enrollment
Description	Documentation of duration of pain prior to enrollment
Time Frame	Baseline visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cervical Arthroplasty + Prestige LP
Arm/Group Description	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.
Measure Participants	190
patients with pain for 3-6 months before surgery	22.1
patients with pain for 6-12 months before surgery	21.3
patients with pain for >12 months before surgery	37.4

3. Primary Outcome

Title	Neck Disability Index (NDI) Score
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Cervical Arthroplasty + Prestige LP
Arm/Group Description	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.
Measure Participants	155
Baseline	24.1 (8.6)
3 months Follow up	13.2 (8.9)
6 months Follow up	12.6 (10.2)
12 months Follow up	12.3 (10.0)
24 months	13.4 (10.3)

4. Secondary Outcome

Title	Intervertebral Disc Space
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

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/Group Title	Cervical Arthroplasty + Prestige LP
Arm/Group Description	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.
Measure Participants	96
Baseline	0.22 (0.07)
3 months Follow up	0.41 (0.15)
6 months Follow up	0.42 (0.16)
12 months Follow up	0.40 (0.14)
24 months Follow up	0.39 (0.13)

Adverse Events

Arm/Group Title	Cervical Arthroplasty + Prestige LP
Arm/Group Description	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.
All Cause Mortality
	Cervical Arthroplasty + Prestige LP
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Cervical Arthroplasty + Prestige LP
	Affected / at Risk (%)	# Events
Total	7/190 (3.7%)
General disorders
Wound hematoma	1/190 (0.5%)	1
Musculoskeletal and connective tissue disorders
Lumbar pain	2/190 (1.1%)	3
Arm pain	1/190 (0.5%)	1
Quervain syndrome	1/190 (0.5%)	1
Nervous system disorders
syndroma carpi radialis	1/190 (0.5%)	1
Thoracic spine discopathy	1/190 (0.5%)	1
Other (Not Including Serious) Adverse Events
	Cervical Arthroplasty + Prestige LP
	Affected / at Risk (%)	# Events
Total	40/190 (21.1%)
General disorders
Neck, shoulder and arm pain	24/190 (12.6%)	25
Lumbar pain	16/190 (8.4%)	18

Limitations/Caveats

Low patient compliance at the 6 and 12 months follow up visits

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.