Clinical Trials Logo
  1. Home
  2. Lower Back Pain
  3. NCT03247166
  4. Details
NCT03247166 Clinical Trial

A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System

Lower Back Pain Clinical Trial

Official title:
A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03247166
Other study ID # HYMC-36-17
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 9, 2017
Last updated August 9, 2017
Start date September 2017
Est. completion date September 2019

Study information
Verified date August 2017
Source Hillel Yaffe Medical Center
Contact Ilana Alony, RN
Phone 972-4-6304487
Email ilanaa@hy.health.gov.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The TOPS™ SP System is intended to provide stabilization in skeletally mature patients. The system is designed to afford motion of the spine segment without fusion. The pur0pose of this prospective clinical study is to establish the safety and effectiveness of the TOPS™ System, when used following decompression, in the treatment of lower back and sciatic pain.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 10
Est. completion date September 2019
Est. primary completion date September 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years to 85 Years
Eligibility Inclusion Criteria:

- Patients with symptomatic monosegmental lumbar spinal stenosis or facet arthrosis

- Patients with degenerative spondylolisthesis

- Patients with at least 3 months failed conservative treatment

- Narrowing of the lumbar spinal canal

- Patients with lower back pain or sciatica

Exclusion Criteria:

- Discogenic back pain at TOPS System level

- Back or non-radicular leg pain of unknown etiology at TOPS System level

- Lytic spondylolisthesis at TOPS System level

- More than one motion segment involved in degenerative pathology to the extent that justifies its inclusion in the surgical procedure

- Known allergy to titanium and/or polyurethane

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• TOPS™ System
The TOPS™ System is an alternative to spinal fusion that is designed to stabilize but not fuse the effected vertebrai level to alleviate pain stemming from degenerative joints

Locations
Country Name City State
Israel Hillel Yaffe Medical Center H_adera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Other Safety Subjects with no serious device complications as defined in the radiological protocol 24 months
Primary Pain Improvement Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score 24 months
Primary Function Improvement Subjects having a 15% reduction in the Oswestry Low Back Pain Disability Questionnaire score as compared to their preoperative Oswestry score 24 months
Primary Fusion Prevention The subjects will be considered a failure if fusion occurs as defined in the radiographic protocol 24 months
See also
  Status Clinical Trial Phase
Completed NCT03733886 - Burst Spinal Cord Stimulation for Neuropathic Pain. N/A
Completed NCT02518360 - Osteopathic Treatment in Patients With Low Back Pain: Stabilometry N/A
Completed NCT01692275 - Assessment of Chiropractic Treatment for Low Back Pain and Smoking Cessation in Military Active Duty Personnel. N/A
Active, not recruiting NCT01213953 - Isolation and Authentication of Mesenchymal Stem Cell-like Progenitor Cells From the Degenerated Intervertebral Disc of Lumbar Spine N/A
Completed NCT00750191 - Placebo-controlled Trial of Transdiscal Radiofrequency Annuloplasty Phase 1
Completed NCT01898013 - Neurosteroids as Novel Therapeutic Agents for Chronic Pain in OEF/OIF Veterans Phase 2
Not yet recruiting NCT02920255 - Comparison of Electronic Calipers to Conventional Calipers and X-ray Measurement of Spinal Tilt N/A
Active, not recruiting NCT00905112 - Musculoskeletal and Obstetric Management Study N/A
Recruiting NCT05197010 - Clinical Efficacy of IoMT-based Exercise Program for the Elderly N/A
Completed NCT00361504 - A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain Phase 3
Recruiting NCT06071962 - Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Back Pain Phase 3
Recruiting NCT06072560 - Efficacy and Tolerability of AP707 in Patients With Chronic Back Pain Phase 3
Completed NCT04091607 - Using Music During Lumbar Medial Branch Block Procedure N/A
Enrolling by invitation NCT06104605 - Improving Access to Chiropractic Care in Community Health Centers N/A
Completed NCT03765853 - Randomized Study on the Evaluation of the Regular Practice of Standardized Postures Stretching Postural® in Secondary Prevention of Low Back Pains During Pregnancy. N/A
Completed NCT03393429 - Training Therapy for the Prevention of Back Pain N/A
Completed NCT04238117 - Laser Acupuncture Therapy in Postpartum Low Back Pain N/A
Completed NCT05601843 - Transcutaneous Electrical Nerve Stimulation for Back Pain in the Emergency Department (TENS-ED) N/A
Completed NCT04347265 - Ultrasound-guided Neuromodulation Percutaneous in Lower Back Pain N/A
Not yet recruiting NCT06404788 - Anxiety Level Among Patients With Chronic Low Back Pain