A Clinical Registry to Collect Patient Outcome Date for the BIOMET® Stimulator Systems

Stopped early

Conditions studied: Fusion of Spine (Disease), Fractures, Ununited

In brief

The purpose of this clinical registry is to capture data on an ongoing basis from a population of patients who will use Biomet's BHS, OrthoPak and SpinalPak devices.

Key facts

Study ID

NCT01750840

Run by

Zimmer Biomet

People needed

8

Starts

2012-10-01

Expected to finish

2013-10-01

Last updated by the study team

2017-06-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has agreed to undergo electrical stimulation therapy as prescribed by their physician.
• Subject has agreed to return to the physician for their physician required follow up visits.
• Subject will undergo treatment with Biomet's BHS, OrthoPak or SpinalPak devices.
• Subject has agreed to complete QoL questionnaires prior to starting treatment and at the follow up visit when the physician has determined the subject to be either healed or failed.

You may not qualify if…

• Any subject not willing to comply with the physician prescribed treatment program and follow up visit schedule.
• Any subject not willing to complete the QoL questionnaires.

Where it is running

• Cumberland Orthopedics — Vineland, New Jersey, United States

Full record on ClinicalTrials.gov

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