Trial Outcomes & Findings for Multi-Center Trial to Evaluate an Internal Joint Stabilizer - Elbow (NCT NCT01944670)
NCT ID: NCT01944670
Last Updated: 2017-04-04
Results Overview
To confirm that the Internal Joint Stabilizer - Elbow (IJS-E) provides temporary stabilization of the elbow joint and allows functional recovery after trauma or chronic dislocation. The study is deemed a success if the at least 75% of patients receive a Broberg Morrey Functinoal Rating of Fair or better.
COMPLETED
NA
26 participants
Eight months (6 months post-explant)
2017-04-04
Participant Flow
Participant milestones
| Measure |
Internal Joint Stabilizer Group
Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E)
Internal Joint Stabilizer - Elbow (IJS-E): Device designed for internal stabilization of the elbow
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Internal Joint Stabilizer Group
Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E)
Internal Joint Stabilizer - Elbow (IJS-E): Device designed for internal stabilization of the elbow
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Internal Joint Stabilizer Group
n=26 Participants
Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E)
Internal Joint Stabilizer - Elbow (IJS-E): Device designed for internal stabilization of the elbow
|
|---|---|
|
Age, Continuous
|
57.1 years
STANDARD_DEVIATION 18.6 • n=26 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=26 Participants
|
|
Height (in)
|
65.8 inches
STANDARD_DEVIATION 4.0 • n=26 Participants
|
|
Weight (lbs)
|
188.0 lbs
STANDARD_DEVIATION 41.2 • n=26 Participants
|
|
Side Dominance
Right Handed
|
24 Participants
n=26 Participants
|
|
Side Dominance
Left Handed
|
1 Participants
n=26 Participants
|
|
Side Dominance
Ambidextrous
|
1 Participants
n=26 Participants
|
|
Operative Side
Dominant Hand (including ambidextrous patients)
|
9 Participants
n=26 Participants
|
|
Operative Side
Non-dominant Hand
|
17 Participants
n=26 Participants
|
|
Subluxed or Dislocated
Subluxed
|
7 Participants
n=26 Participants
|
|
Subluxed or Dislocated
Dislocated
|
19 Participants
n=26 Participants
|
PRIMARY outcome
Timeframe: Eight months (6 months post-explant)Population: Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E) who completed the study (have final follow-up data). Excludes patients who were lost to follow-up.
To confirm that the Internal Joint Stabilizer - Elbow (IJS-E) provides temporary stabilization of the elbow joint and allows functional recovery after trauma or chronic dislocation. The study is deemed a success if the at least 75% of patients receive a Broberg Morrey Functinoal Rating of Fair or better.
Outcome measures
| Measure |
Participants Who Completed the Study
n=24 Participants
Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E) who completed the study (have final follow-up data)
Internal Joint Stabilizer - Elbow (IJS-E): Device designed for internal stabilization of the elbow
|
|---|---|
|
Broberg Morrey Functional Rating
Broberg Morrey Score of Excellent
|
14 Participants
|
|
Broberg Morrey Functional Rating
Broberg Morrey Score of Good
|
8 Participants
|
|
Broberg Morrey Functional Rating
Broberg Morrey Score of Fair
|
1 Participants
|
|
Broberg Morrey Functional Rating
Broberg Morrey Score of Poor
|
1 Participants
|
PRIMARY outcome
Timeframe: 8 months (6 month post-explant)Population: Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E) who completed the study (have final follow-up data). Excludes patients who were lost to follow-up.
To confirm that the Internal Joint Stabilizer - Elbow (IJS-E) provides temporary stabilization of the elbow joint and allows functional recovery after trauma or chronic dislocation. The study is deemed a success if the at least 75% of patients do not have a recurrent dislocation while using the IJS-E or after removal of the IJS-E.
Outcome measures
| Measure |
Participants Who Completed the Study
n=24 Participants
Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E) who completed the study (have final follow-up data)
Internal Joint Stabilizer - Elbow (IJS-E): Device designed for internal stabilization of the elbow
|
|---|---|
|
Recurrent Dislocations
|
0 Participants
|
Adverse Events
Participants Who Completed the Study
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Participants Who Completed the Study
n=24 participants at risk
Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E) who completed the study (have final follow-up data)
Internal Joint Stabilizer - Elbow (IJS-E): Device designed for internal stabilization of the elbow
|
|---|---|
|
Infections and infestations
Inflammation
|
4.2%
1/24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place