NCT02139527

Brief Summary

The purpose of the registry is to assess outcomes following treatment with lumbar total disc replacement (TDR) in patients outside the clinical trial setting.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2007

Typical duration for all trials

Status
terminated

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

Study Start

First participant enrolled

May 1, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 15, 2014

Completed
Last Updated

May 15, 2014

Status Verified

May 1, 2014

Enrollment Period

2.3 years

First QC Date

February 11, 2014

Last Update Submit

May 13, 2014

Conditions

Lumbar Degenerative Disc Disease

Keywords

arthroplastyspinalCHARITEPRODISC-LPRODISCdiscreplacementlumbar

Outcome Measures

Primary Outcomes (1)

  • Change in Oswestry Disability Index (ODI) Score

    The ODI assesses several domains of function affected by low back pain. A change of 15 points from baseline is considered a clinical meaningful difference for the individual. The change from pre operative baseline to each follow-up assessment will be calculated.

    3, 6, 12, 24, 36, 48, and 60 months post operative

Interventions

Total Disc ReplacementDEVICE
Also known as: CHARITE™ Artificial Disc, PRODISC®-L Total Disc Replacement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients that undergo lumbar total disc replacement (TDR); this includes patients treated with either the CHARITE disc or the ProDisc-L disc

You may qualify if:

  • Treated with the lumbar TDR.
  • Signed IRB approved consent document.

You may not qualify if:

  • None known.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

Total Disc Replacement

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2014

First Posted

May 15, 2014

Study Start

May 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

May 15, 2014

Record last verified: 2014-05