Post-market Study of the TOPS™ System

NCT ID: NCT02234154

Last Updated: 2016-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-05-31

Brief Summary

This Single-Arm Post-Marketing Evaluation will gauge the improvement in function and pain for lumbar spinal stenosis and spondylolisthesis patients with the TOPS System.

Detailed Description

This study is being conducted to evaluate the TOPS™ SP System from ("TOPS™ System" or "TOPS"). TOPS is an alternative to spinal fusion and is designed to stabilize but not fuse the affected vertebral level to alleviate pain stemming from degenerative spondylolisthesis (abnormal/excessive movement of the vertebrae causing pain in the lower back and legs) and spinal stenosis (narrowing of the spinal canal resulting in compression of nerves producing symptoms of pain, numbness and tingling in the legs).

Conditions

Lumbar Spinal Stenosis; Spondylolisthesis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TOPS System

Post Marketing Study

Group Type: OTHER

TOPS System

Intervention Type: DEVICE

Non-randomized study involving implantation of a TOPS via lumbar surgery to decompress and provide stability to the index level.

Interventions

TOPS System

Non-randomized study involving implantation of a TOPS via lumbar surgery to decompress and provide stability to the index level.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age 40-85 years old;
• One or both of the following at a single level from L3 to L5; (1) symptomatic monosegmental lumbar spinal stenosis or facet arthrosis, (2) degenerative spondylolisthesis up to and including grade 1.
• At least three (3) months of failed, conservative treatment prior to surgery (unless deemed inadvisable due to progressive motor weakness or other evidence of rapidly deteriorating condition) including the use of anti-inflammatory medications at maximum specified dosage, administration of epidural/facet injections, rest, heat, electrotherapy and/or physical therapy;
• Narrowing of the lumbar spinal canal (central and/or foramenal) classified as moderate to severe using CT scans/MRI;
• VAS leg pain of at least 40/100;
• Oswestry Disability Index score of at least 40/100;
• Lower back pain or sciatica with or without spinal claudication and
• Psychosocially, mentally and physically able to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.

Exclusion Criteria

• Primary diagnosis of discogenic back pain at the TOPS System level;
• Back or non-radicular leg pain of unknown etiology at the index level;
• Lytic spondylolisthesis at the index level;
• More than one (1) motion segment involved in the degenerative pathology to the extent that justifies its inclusion in the surgical procedure, unless a decompression alone can be done at that level without compromising stability;
• Known allergy to titanium and/or polyurethane;
• Supplemental interbody support required (e.g., bone graft, spacers, VBRs, or fusion cages) at the index level;
• Clinically compromised vertebral bodies at the affected level(s) due to any traumatic, neoplastic, metabolic or infectious pathology;
• Deformity of the spine that would compromise the implant, e.g. scoliosis of greater than ten (10) degrees;
• Morbid obesity defined as a body mass index > 40 or a weight more than 100 lbs. over ideal body weight;
• DEXA bone density measured T score equal to or lower than - 2.0;
• Paget's disease, osteomalacia, osteogenesis imperfecta, thyroid and/or parathyroid gland disorder and/or any other metabolic bone disease;
• Active infection;
• AIDS, HIV, or active hepatitis;
• Rheumatoid arthritis or other autoimmune disease;
• Tuberculosis active or in the past 3 years;
• Active malignancy: unless treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years;
• Medical condntions requiring treatment with any drugs known to potentially interfere with bone/soft tissue healing;
• Pregnant or interested in becoming pregnant in the next 3 years;
• Current chemical/alcohol dependency or significant psychosocial disturbance;
• Cauda equina syndrome or neurogenic bowel/bladder dysfunction;
• Severe arterial insufficiency of the legs, peripheral vascular disease;
• Sustained pathologic fractures of the vertebra or multiple fractures of the vertebra or hip;
• Significant peripheral neuropathy;
• Immunologically suppressed, received steroids > 1 month out of the past year;
• Insulin-dependent diabetes mellitus;
• Life expectancy less than 3 years;
• Waddell signs > 3;
• Currently involved in active spinal litigation OR
• Subject is incarcerated.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Premia Spine

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Masood Shafafy, MD

Role: PRINCIPAL_INVESTIGATOR

Queens Medical Centre Nottingham

Locations

Queens Medical Centre

Nottingham, Nottinghamshire, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Masood Shafafy, MD

Role: CONTACT

massod.shafafy@nuh.nhs.uk

+44 (0)115 9249924 ext. 61024

Facility Contacts

Bronek Boszczyk, MD

Role: primary

bronek.boszczyk@nuh.nhs.uk

+44 (0)115 9249924

Other Identifiers

1513-CL-TP-01 NOT UK

Identifier Type: -

Identifier Source: org_study_id