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

NCT01750840 | Terminated Results

• 1 other identifier: CS-101P
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fusion of Spine (Disease); Fractures, Ununited

Outcome Measures

Primary Outcomes (1)

• Radiographic Assessment of Healing

  Bone healing was assessed on x-rays and/or CT scan.

  The time frame for healing determination was not pre-specified. Patients were evaluated at regular doctors' visits for up to 12 months. The physician determined the time point at which healing occurred for each patient at their regular visits.

Secondary Outcomes (1)

• Quality of Life Assessment

  The quality of life assessment was to be completed at the regular doctor's visit at which the physician determined the patient to be healed. No quality of life data was collected.

Study Arms (1)

Stimulation Group

All patients will receive either the Biomet® EBI Bone Healing System, Biomet OrthoPak® Non-invasive Bone Growth Stimulator System or Biomet SpinalPak® Non-Invasive Spine Fusion Stimulator Systems.

Device: Biomet® EBI Bone Healing System; Device: Biomet Orthopak® Non-Invasive Bone Growth Stimulator System; Device: Biomet SpinalPak® Non-Invasive Spine Fusion Stimulator

Interventions

Biomet® EBI Bone Healing System DEVICE

A pulsed electromagnetic fields electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 3-10 hours per day with a recommended use of 10 hours per day.

Stimulation Group

Biomet Orthopak® Non-Invasive Bone Growth Stimulator System DEVICE

A capacitive coupling electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 24 hours per day.

Stimulation Group

Biomet SpinalPak® Non-Invasive Spine Fusion Stimulator DEVICE

A capacitive coupling electrical stimulation device used as an adjunctive treatment to lumbar spinal fusion. Designed to be used for 24 hours per day.

Stimulation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This clinical registry will be a prospective, multi-center study. Subjects will undergo treatment with Biomet's BHS or OrthoPak devices for non-spinal applications. Subjects will undergo treatment with Biomet's SpinalPak for spinal applications

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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Cumberland Orthopedics

Vineland, New Jersey, 08360, United States

Location

MeSH Terms

Conditions

Disease; Fractures, Ununited

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fractures, Bone; Wounds and Injuries

Results Point of Contact

• Title: Manager of Research
• Organization: Biomet

hallie.murray@zimmerbiomet.com

973-299-9300

Study Officials

• Randy Graham

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: December 17, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: June 19, 2017
• Results First Posted: June 14, 2016

Record last verified: 2017-06

Locations

US (1)