Post-market clinical follow-up (PMCF) Plan for Oyster cage
- Conditions
- M42.12M47.22M48M50.0M50.1M50.2M54.12M54.19Other spondylopathiesCervical disc disorder with myelopathy
- Registration Number
- DRKS00027507
- Lead Sponsor
- Silony Medical GmbH, Clinical Affairs
- Brief Summary
The primary objective of the PMCF Study is to demonstrate the clinical benefit for patients in terms of pain reduction using the Neck Disability Index (NDI) score in comparison pre-op to post-op (3 months follow-up or 12 months follow-up). Analysis of NDI questionnaires demonstrates a significant improvement in pain and limitations in daily life after surgery with the Oyster® ACIF system (3 months FU and 12 months FU; p<0.001, paired ttest). The non-inferiority of the Oyster® ACIF system compared to the listed reference value (reference value of 27 is composed of the reference NDI mean value (20); Koenig et al.) can be demonstrated. The reduction of pain after surgery with the Oyster® ACIF system is supported by the analysis of the NRS cervical spine and the NRS arm. Both show a significant reduction in pain post-op (discharge, 2-4 months FU and 12 months FU) compared to pre-op (p<0.001, paired t-test). No intraoperative complications or revision surgeries have been documented. The incidence of complications after surgery with the Oyster® ACIF system in this PMCF study is 2.86% with no implant related postoperative complications. Analysis of X-ray images shows an increase in intervertebral height and cervical lordosis at discharge and persistently up to 3 months FU. A migration rate of 2.9% occurred, although it should be noted that cage migration does not necessarily have to be categorized as a complication. In general, migrations of less than 3 mm occur without complications, as is the case here. This assessment is confirmed by the primary investigator. Neurological assessment of motor function, pain and sensory function shows improvement of all three after surgery with the Oyster® ACIF system at discharge which persists 3 months after surgery. In summary, the analysis of the data not only demonstrates the clinical benefit to the patient of the Oyster® ACIF system, but also adequately demonstrates that the Oyster® ACIF system fulfils the requirements for clinical safety and performance.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 70
Inclusion criteria
Skeletally mature patients with one of the following indications:
+ Degenerative disc disease (DDD)
+ Prolapsed intervertebral disc and symptomatic cervical
+ Spondylosis
+ Spondylotic myelopathy and foraminal stenosis
+ Spine trauma, lesions and revision surgeries
+ Willingly sign informed consent.
Based on the contra-indications for the device, the following exclusion criteria apply:
+ Spondylosis
+ Overweight (BMI > 40)
+ Implantation in patients with an active infection or pronounced local inflammation in the area of surgery
+ Severe osteoporosis affecting the spine
+ Primary or metastatic tumors affecting the spine
+ Suspected allergy or foreign body reaction to titanium or titanium alloys
+ Patients whose ability to follow postoperative restrictions, precautions and rehabilitation programs is limited
+ Fractures, severe deformities or an instability in the area of surgery
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional outcome measured with the Neck Disability Index (NDI)
- Secondary Outcome Measures
Name Time Method To assess device-related complications of the Oyster® cage, including the <br>+ prevalence of revision surgery, <br>+ unanticipated complications or <br>+ serious adverse device effects or rare events <br>To assess pain relief <br>To assess device performance in terms of restoration of height and cervical lordosis