Clinical Trials Logo
  1. Home
  2. Back Pain
  3. NCT05732818

Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy 3 — LOPAIN3  

Back Pain Clinical Trial

Official title:
Clinical Investigation Plan First in Human Trial Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy "LOPAIN3"

Clinical Trial Summary

This study is a First in Human, prospective, multi-center clinical study intended to collect safety and performance information for the Spinal Stabilization Technologies PerQdisc® Nucleus Replacement System and procedure concurrently following a successful discectomy using a minimally invasive posterolateral (MIPL) approach. Patients that are at least 21 years or older, presenting with symptomatic radiculopathy from a focal lumbar disc herniation that requires surgical decompression will be included in this study.

Clinical Trial Description

The PerQdisc® Nucleus Replacement System is comprised of an in situ formed silicone-based prosthesis with its delivery system, implant fill device, dispenser gun, a disc access system and two different imaging balloons. For this trial, the PerQdisc® will be implanted using minimally invasive posterolateral (MIPL) approach. The implanted device provides an effective means of replacing dysfunctional nucleus pulposus while supporting the native annulus fibrosis to bridge annular defects. Patients that suffer clinically significant lumbar disc herniations currently undergo discectomy procedures to relieve nerve root compression. The standard discectomy procedure does not correct the annular defect associated with the herniation and is associated with a risk for re-herniation. In addition, the progressive loss of disc height and overall lack of disc turgor and weight bearing capacity is thought to be associated with downstream degenerative changes that may lead to chronic low back pain and premature spondylosis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05732818
Study type Interventional
Source Spinal Stabilization Technologies
Contact
Status Recruiting
Phase N/A
Start date November 4, 2022
Completion date April 1, 2027
View Details
See also
  Status Clinical Trial Phase
Completed NCT05982483 - Erector Spinae Plane Block vs. Usual Care for ED Patients With Mechanical Back Pain N/A
Completed NCT04744246 - Muscle Activity During Load Carriage in ROTC Cadets N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Active, not recruiting NCT03680846 - Comparison of HF10 Therapy Combined With CMM to CMM Alone in the Treatment of Non-Surgical Refractory Back Pain N/A
Completed NCT05597189 - Clinical Study for Palliative/Preventive Treatment of Chronic Back Pain N/A
Completed NCT05342181 - Static and Dynamic Core Stability Exercises in Potpartum Back Pain N/A
Completed NCT02955342 - Back and Neck Pain in Adolescence
Completed NCT02704845 - Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain N/A
Not yet recruiting NCT02536274 - "Examination of the Impact of a Dynamic Flexion Orthosis (Dynaflex®Ottobock) or of a Back Bandage (Lumbo Sensa®Ottobock) on the Voluntary Activation of the Back Muscles in Patients With Specific Back Pain" N/A
Recruiting NCT02237105 - The Effect of Cognitive Behavioral Therapy on the Outcome of Spinal Surgery N/A
Enrolling by invitation NCT02485795 - Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management N/A
Completed NCT02254694 - The Influence of High Heeled Shoes on the Sagittal Balance of the Spine and Whole Body N/A
Completed NCT02609009 - Back Pain and Spinal Manipulation in Adolescent Scoliosis N/A
Terminated NCT02239627 - Epidural Clonidine Versus Corticosteroid for Low Back Pain N/A
Completed NCT00986180 - NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain Phase 3
Completed NCT00771758 - Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis Phase 3
Terminated NCT00769626 - Standardizing Management of Patients With Low Back Pain in Primary Care and Physical Therapy Phase 3
Withdrawn NCT00231374 - Measure of Cerebrospinal Fluid (CSF) Pressure Variation With Patient Positioning N/A
Completed NCT00103675 - Sensor Measurement of Acupuncture Needle Manipulation Phase 1
Completed NCT00454064 - Cognitive-behavioural Treatment of Chronic Back Pain Phase 3