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NCT05101057

A Retrospective Study to Examine the Effect of CMF Stimulation on Primary ACDF Patients

Status unknown Last updated 7 December 2021
What this trial tests

trial testing SpinalogicTM Bone Graft Stimulator in Degeneration of Cervical Intervertebral Disc in 400 participants. Status unknown.

Timeline
15 November 2021
Primary endpoint
1 March 2022
1 June 2022

Quick facts

Lead sponsorEncore Medical, L.P.
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment400
Start date15 November 2021
Primary completion1 March 2022
Estimated completion1 June 2022
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Encore Medical, L.P.

Who can join

Adults 18 to 75, any sex, with Degeneration of Cervical Intervertebral Disc. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A retrospective parallel group comparison study to support expansion of the indication of the company's FDA approved Spinalogic™ device to include the cervical spine. The SpinalogicTM device was initially approved by FDA as an adjunct to one- or two-level lumbar fusion (P910066/S011). It is a non-invasive bone growth stimulator (BGS) that generates a combined magnetic field (CMF) that has been proven to accelerate bone healing and fusion in the lumbar spine.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Encore Medical, L.P. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05101057.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing