PerQdisc PMCF1 is a post-market clinical follow-up observational trial to follow subjects receiving a PerQdisc spinal implant for a duration of 5 years.
This study will be a prospective, open-label, multi-center post-market observational study including 72 patients that will collect additional safety and efficacy data for the Spinal Stabilization Technologies PerQdisc Nucleus Replacement System. Primary endpoints will be used to assess the safety and efficacy of the PerQdisc device.
Study Type
OBSERVATIONAL
Observational trial to collect post-market safety and efficacy information in a limited number of human patients
Donauisar Klinikum Deggendorf
Deggendorf, Germany
PerQdisc Perfomance
Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool
Time frame: 6 months post implant
PerQdisc Perfomance
Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool
Time frame: 12 months post implant
PerQdisc Safety
Incidence of device expulsion and device fracture following surgery based on follow up X-rays and MRI's
Time frame: 6 months post implant
PerQdisc Safety
Incidence of device expulsion and device fracture following surgery based on follow up x-rays and MRI's
Time frame: 12 months post implant
Incidence of Secondary Surgeries
Incidence of revision surgery at the index level or other secondary lumbar surgery at a non-index level
Time frame: 6 months, 12 months, and 5 years following surgery
Maintenance of Disc Height
Intervertebral disc height (in mm) as measured on MRI post-surgery compared to baseline
Time frame: 6 months, 12 months, and 5 years following surgery
Maintenance of Range of Motion
Measurement of range of motion (expressed in degrees) at the index and adjacent levels at baseline compared to post-surgical follow-up using flexion/extension x-rays.
Time frame: 6 months, 12 months, and 5 years following surgery
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Maintenance of Neurologic Status
Physical assessment evaluating nerve compression at baseline and post-surgical follow up using pain, motor strength, and sensation feedback from the patient on a 0 (no compression) to 5 (major compression) scale.
Time frame: 6 months, 12 months, and 5 years following surgery
Use of Pain Medications
Change in level of pain medication used comparing baseline to follow up visits based on a medication scale ranging from 0 to 4. 0 (no meds) to 4 (high dose opioids)
Time frame: 6 months, 12 months, and 5 years following surgery