Health Trials

"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)

ConditionsDegenerative Disc DiseaseChronic Low-back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorSpinal Stabilization Technologies

About this trial

This study will be a prospective, open-label, multi-center study including 72 patients that will collect additional safety and efficacy data for the Spinal Stabilization Technologies PerQdisc Nucleus Replacement System.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient is skeletally mature aged 22-70.

Patient has Degenerative Disc Disease (DDD) at one or more levels between L1 and S1 but the discogenic pain must be limited to a single level.

Patient has adequate disc height (6mm) at the level to be treated

Patient has exhausted a minimum of 6 months of conservative treatment for their back (e.g. physical therapy, medications, injections, life style changes, etc).

Disqualifiers

Patient has less than 6 mm of disc height.

Patient has had prior lumbar spine surgery (nucleoplasty at non-index level is considered acceptable).

Patient has had spinal fusion in the lumbar or thoracic intervertebral spaces. Cervical fusion is allowed as long as there are no neurologic deficits in the lower extremities.

Patient has spondyloarthropathy or other spondylolisthesis greater than 2 mm.

Trial design

Design model

Single group

Treatments tested in this trial

  • PerQdisc Nucleus Replacement System

    Device

    Lumbar spine disc nucleus replacement system. All patients meeting all inclusion criteria and no exclusion criteria will be considered for nucleus replacement surgery following a review by the Medical Advisory Board.

Treatment groups

72 Participants
are divided into 1 treatment group
Group A: Lumbar Disc Nucleus ReplacementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Perfromance: ODI

Change in in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool

Time frame
6 months
2

Perfromance: ODI

Change in in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool

Time frame
12 months
3

Performance: VAS

Change in back pain as measured by the 100 - millimeter Visual Analog Scale (VAS)

Time frame
6 months
4

Performance: VAS

Change in back pain as measured by the 100 - millimeter Visual Analog Scale (VAS)

Time frame
12 months

Secondary outcomes

1

Safety: Revision Surgery

Incidence of revision surgery

Time frame
6 months, 12 months, and 5 years
2

Safety: Expulsion & Device Failure

Incidence of device expulsion and device failure following surgery based on follow up X-rays and MRI's

Time frame
5 years
3

Performance: Disc Height

Preservation of intervertebral disc height (in mm) as measured on MRI post-surgery compared to baseline

Time frame
6 months, 12 months, and 5 years
4

Performance: RoM

Preservation of range of movement (expressed in degrees) at the index and adjacent levels at baseline compared to follow-up using flexion/extension radiographs

Time frame
6 months, 12 months, 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Spinal Stabilization Technologies

Lead sponsor

Source ClinicalTrials.gov
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