NCT02234154

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

April 18, 2016

Status Verified

April 1, 2016

Enrollment Period

2.2 years

First QC Date

September 4, 2014

Last Update Submit

April 14, 2016

Conditions

Lumbar Spinal StenosisSpondylolisthesis

Outcome Measures

Primary Outcomes (1)

  • Improvement in ODI and Improvement in VAS leg score v

    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.

    24 months post implantation

Secondary Outcomes (4)

  • Improvement in back and leg visual analog scales (VAS)

    24 month postoperatively

  • Improvement in ZCQ scores

    24 months postoperatively

  • Quality of life (SF-36)

    24 months postoperatively

  • Maintenance or improvement in neurological symptoms

    24 months postoperatively

Study Arms (1)

TOPS System

OTHER

Post Marketing Study

Device: TOPS System

Interventions

TOPS SystemDEVICE

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

TOPS System

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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;
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queens Medical Centre

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Spinal StenosisSpondylolisthesis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesSpondylolysisSpondylosis

Study Officials

  • Masood Shafafy, MD

    Queens Medical Centre Nottingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Masood Shafafy, MD

CONTACT

+44 (0)115 9249924massod.shafafy@nuh.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2014

First Posted

September 9, 2014

Study Start

December 1, 2014

Primary Completion

March 1, 2017

Study Completion

May 1, 2017

Last Updated

April 18, 2016

Record last verified: 2016-04

Locations

GB(1)