Post Market Observational Trial for the PerQdisc Nucleus Replacement Device

NCT05105490 | Withdrawn DMC

• 1 other identifier: PerQdisc PMCF1
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Degenerative Disc Disease; Chronic Low-back Pain

Outcome Measures

Primary Outcomes (4)

• PerQdisc Perfomance

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

  6 months post implant

• PerQdisc Perfomance

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

  12 months post implant

• PerQdisc Safety

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

  6 months post implant

• PerQdisc Safety

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

  12 months post implant

Secondary Outcomes (5)

• Incidence of Secondary Surgeries

  6 months, 12 months, and 5 years following surgery

• Maintenance of Disc Height

  6 months, 12 months, and 5 years following surgery

• Maintenance of Range of Motion

  6 months, 12 months, and 5 years following surgery

• Maintenance of Neurologic Status

  6 months, 12 months, and 5 years following surgery

• Use of Pain Medications

  6 months, 12 months, and 5 years following surgery

Study Arms (1)

Chronic Discogenic Low Back Pain

Patient is skeletally mature and between 21 and 60 years of age. Patient has Degenerative Disc Disease (DDD) at one or more levels between L1 and S1 but must have a single level identified as the pain generator. Patient has adequate disc height (6mm) at the level to be treated Patient is not responsive to conservative, non-surgical treatment for back pain.

Drug: PerQdisc

Interventions

PerQdisc DRUG

Observational trial to collect post-market safety and efficacy information in a limited number of human patients

Also known as: PerQdisc Nucleus Replacement System

Chronic Discogenic Low Back Pain

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Skeletally mature patients, age 21-60 years, with chronic low back pain of discogenic origin that is non-responsive to conservative, non-surgical therapy.

You may qualify if:

• Patient is skeletally mature and between 21 and 60 years of age.
• Patient has Degenerative Disc Disease (DDD) at one or more levels between L1 and S1 but must have a single level identified as the pain generator.
• Patient has adequate disc height (6mm) at the level to be treated
• Patient is not responsive to conservative, non-surgical treatment for back pain.
• Patient has signed the approved Informed Consent Form.

You may not qualify if:

• 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.
• Patient has congenital moderate or severe spinal stenosis or epidural lipomatosis.
• Patient has significant facet disease. Significant is defined as pain improvement of 80% or more following image-guided medial branch blocks of the target level according to Spine Intervention Society (SIS) guidelines (diagnostic, contrast controlled).
• Patient has any known active malignancy.
• Patient has previously undergone or currently on immunosuppressive therapy. Steroids used to treat inflammation are allowed.
• Patient has active or local systemic infection.
• Patient has been diagnosed with hepatitis, rheumatoid arthritis, lupus erythematosus, or other autoimmune disease including Acquired Immune Deficiency Syndrome (AIDS), AIDS related Complex (ARC), and Human Immunodeficiency Virus (HIV).
• Patient has diabetes mellitus (Type 1 or 2) requiring daily insulin management.
• Patient has osteopenia of the spine (T-score of -1.0 or lower). A Bone Densiometry (DEXA) scan should be performed to rule out patients considered at risk for osteopenia.
• Patient has morbid obesity defined as a Body Mass Index (BMI) more than 40 or a weight of more than 45 kg (100 lbs.) over ideal body weight.
• Patient has a known allergy to silicone or barium sulfate.
• Patient has a significant disc herniation at the level to be treated. Significant is defined as a large extruded herniation that creates a risk for expulsion.

Sponsors & Collaborators

• Spinal Stabilization Technologies: lead

Study Sites (1)

Donauisar Klinikum Deggendorf

Deggendorf, 94469, Germany

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Michael Hess, MD

  Spinal Stabilization Technologies

  STUDY DIRECTOR

• Jeff Golan, MD

  Spinal Stabilization Technologies

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: November 3, 2021
• Study Start: December 31, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available 1 year after the final patient has completed one-year follow-up. Additional data will be available after the final patient has completed 5 year follow up
• Access Criteria: Data will be shared with investigators from a secure electronic database

Locations

DE (1)