Post-market Study of the TOPS™ System

• ClinicalTrials.gov Identifier: NCT02234154
• Recruitment Status: Unknown
• First Posted: September 9, 2014
• Last Update Posted: April 18, 2016
• Sponsor: Premia Spine
• Information provided by (Responsible Party): Premia Spine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lumbar Spinal Stenosis; Spondylolisthesis	Device: TOPS System	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study to Evaluate the Safety and Effectiveness of the TOPS System
• Study Start Date: December 2014
• Estimated Primary Completion Date: March 2017
• Estimated Study Completion Date: May 2017

Arms and Interventions

Arm	Intervention/treatment
TOPS System; Post Marketing Study	Device: TOPS System; Non-randomized study involving implantation of a TOPS via lumbar surgery to decompress and provide stability to the index level.

Outcome Measures

Primary Outcome Measures :

1. Improvement in ODI and Improvement in VAS leg score v [ Time Frame: 24 months post implantation ]
   Composite endpoint - Subjects who exhibit a reduction of 15 percent in their Oswestry Disability Index (ODI) score compared to their preoperative ODI score AND a reduction of at least 20mm (20% improvement) in either of their VAS Leg Score will be considered a success.

Secondary Outcome Measures :

1. Improvement in back and leg visual analog scales (VAS) [ Time Frame: 24 month postoperatively ]
   A failure to meet of any of the secondary endpoints will not be considered a therapeutic failure unless such a failure requires subsequent surgical intervention.
2. Improvement in ZCQ scores [ Time Frame: 24 months postoperatively ]
   A failure to meet of any of the secondary endpoints will not be considered a therapeutic failure unless such a failure requires subsequent surgical intervention.
3. Quality of life (SF-36) [ Time Frame: 24 months postoperatively ]
   A failure to meet of any of the secondary endpoints will not be considered a therapeutic failure unless such a failure requires subsequent surgical intervention.
4. Maintenance or improvement in neurological symptoms [ Time Frame: 24 months postoperatively ]
   A failure to meet of any of the secondary endpoints will not be considered a therapeutic failure unless such a failure requires subsequent surgical intervention.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

IInclusion Criteria - Prospective subjects must meet all of the following criteria to be considered eligible for inclusion in this clinic study:

• 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 - Prospective subjects must not meet any of the exclusion criteria to participate in this clinical study:

• 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.

Contacts and Locations

Contacts

Contact: Masood Shafafy, MD; +44 (0)115 9249924 ext 61024; massod.shafafy@nuh.nhs.uk

Locations

United Kingdom

Queens Medical Centre; Recruiting

Nottingham, Nottinghamshire, United Kingdom, NG7 2UH

Contact: Bronek Boszczyk, MD +44 (0)115 9249924 bronek.boszczyk@nuh.nhs.uk

Principal Investigator: Masood Shafafy, MD

Sponsors and Collaborators

Premia Spine

Investigators

• Principal Investigator: Masood Shafafy, MD; Queens Medical Centre Nottingham

More Information

• Responsible Party: Premia Spine
• ClinicalTrials.gov Identifier: NCT02234154
• Other Study ID Numbers: 1513-CL-TP-01 NOT UK
• First Posted: September 9, 2014
• Last Update Posted: April 18, 2016
• Last Verified: April 2016

Additional relevant MeSH terms:

Spinal Stenosis; Spondylolisthesis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis