Fractures, Ununited, Fusion of Spine (Disease)
Conditions
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.
Detailed description
The purpose of this clinical registry is to capture current, real-world, bone specific healing data from the medical records of patients being treated with a Biomet® EBI Bone Healing System (BHS), the Biomet® OrthoPak® Non-Invasive Bone Growth Stimulator System, or the Biomet® SpinalPak® Non-Invasive Spine Fusion Stimulator System. This study will provide current data on the effectiveness of these electrical stimulation devices.
Interventions
DEVICEBiomet® EBI Bone Healing System
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.
DEVICEBiomet Orthopak® Non-Invasive Bone Growth Stimulator System
A capacitive coupling electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 24 hours per day.
DEVICEBiomet SpinalPak® Non-Invasive Spine Fusion Stimulator
A capacitive coupling electrical stimulation device used as an adjunctive treatment to lumbar spinal fusion. Designed to be used for 24 hours per day.
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject has agreed to undergo electrical stimulation therapy as prescribed by their physician. 2. Subject has agreed to return to the physician for their physician required follow up visits. 3. Subject will undergo treatment with Biomet's BHS, OrthoPak or SpinalPak devices. 4. 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.
Exclusion criteria
1. Any subject not willing to comply with the physician prescribed treatment program and follow up visit schedule. 2. Any subject not willing to complete the QoL questionnaires.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Assessment of Healing | 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. | Bone healing was assessed on x-rays and/or CT scan. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Quality of life was intended to be measured by 5 scoring systems that ask a range of questions about the patient's pain and function. No quality of life data was captured for any of the patients and as such no quality of life analysis was performed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | Stimulation Group |
|---|---|
| Age, Categorical <=18 years | 2 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 40 years |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Radiographic Assessment of Healing
Bone healing was assessed on x-rays and/or CT scan.
Time frame: 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.
Population: All patients, with one nonunion fracture each, were treated with the Biomet EBI Bone Healing System. Four patients had final healing outcomes reported (two patients with a 5th metatarsal nonunion, one patient with a tibial nonunion and one patient with a fibula nonunion) and all healed in an average time of 2.5 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stimulation Group | Radiographic Assessment of Healing | 100 percentage of healed fractures |
Secondary
Quality of Life Assessment
Quality of life was intended to be measured by 5 scoring systems that ask a range of questions about the patient's pain and function. No quality of life data was captured for any of the patients and as such no quality of life analysis was performed.
Time frame: 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.
Population: No quality of life data was collected for any of the patients enrolled in the study. As such, no analysis was performed on quality of life measures.