Trial Outcomes & Findings for A Clinical Registry to Collect Patient Outcome Date for the BIOMET® Stimulator Systems (NCT NCT01750840)
NCT ID: NCT01750840
Last Updated: 2017-06-19
Results Overview
Bone healing was assessed on x-rays and/or CT scan.
TERMINATED
8 participants
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.
2017-06-19
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
Baseline Characteristics
A Clinical Registry to Collect Patient Outcome Date for the BIOMET® Stimulator Systems
Baseline characteristics by cohort
| Measure |
Stimulation Group
n=8 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
40 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Bone healing was assessed on x-rays and/or CT scan.
Outcome measures
| Measure |
Stimulation Group
n=4 Fractures
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.
|
|---|---|
|
Radiographic Assessment of Healing
|
100 percentage of healed fractures
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Stimulation Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place