Chronic Elbow Dislocation, Trauma
Conditions
Brief summary
The purpose of this study is to confirm the safety and effectiveness of the Internal Joint Stabilizer - Elbow.
Interventions
DEVICEInternal Joint Stabilizer - Elbow (IJS-E)
Device designed for internal stabilization of the elbow
Sponsors
Skeletal Dynamics, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* The subject is \>21 years of age. * The subject is considered a candidate for the Internal Joint Stabilizer -Elbow (IJS-E) under one of the following indications: * Subjects where either the elbow sublocates or dislocates after repairing the injured ligaments and/or bones * The elbow has been subluxated or dislocated for more than 10 days prior to surgery * The elbow subluxes or dislocates after surgical repair/reconstruction * The subject has sufficient quantity or quality of bone. Specifically there is sufficient trochlea of the distal humerus and of sufficient quality that the axis pin of the IJS-E has a secure hold as judged by the surgeon intra-operatively. Also, the screws placed in the ulna must be judged by the surgeon to have sufficient hold. * The subject or legal guardian has been informed of the nature of the study, agrees to its provisions, and has provided informed written consent. * The subject is willing to be available for the appropriate follow-up for the duration of the study.
Exclusion criteria
* The subject has one of the following conditions: * Presents with limited elbow motion as opposed to instability (subjects where instability is created through surgical release for chronic limitation of movement, soft tissue release, removal of adhesions and heterotopic ossification and/or fascial interposition will be excluded). * Active infection, suspicion of colonization or quiescent infection * Bacteremia * Bone loss greater than 30% of the total articulation or involving an entire column of the distal humerus * The subject has less than 50% of the height of the coronoid remaining, based on lateral x-ray view * Osteoporosis to the degree that the screws that insert into the ulna loosen during implantation * Material sensitivity to titanium or cobalt chrome * The subject has imminent, known issues related to life expectancy. * The subject is unable and/or unwilling to cooperate with study procedures, a rehabilitative program, or required follow-up visits. * The subject has a condition that may interfere with the outcome or impede healing. * The subject, in the opinion of the Clinical Investigator, has an existing condition that indicates he/she is not a good candidate for the study. * The subject is unable or unwilling to give informed consent and/or who has no responsible family member willing to give consent. * The subject is transient and has no fixed address. * The subject is a prisoner. * The subject is \<21 years of age, or \>21 years of age but skeletally immature.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Broberg Morrey Functional Rating | Eight months (6 months post-explant) | 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. |
| Recurrent Dislocations | 8 months (6 month post-explant) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Internal Joint Stabilizer Group | — |
|---|---|---|
| Age, Continuous | 57.1 years STANDARD_DEVIATION 18.6 | — |
| Height (in) | 65.8 inches STANDARD_DEVIATION 4 | — |
| Operative Side Dominant Hand (including ambidextrous patients) | 9 Participants | — |
| Operative Side Non-dominant Hand | 17 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 14 Participants | — |
| Sex: Female, Male Male | 12 Participants | — |
| Side Dominance Ambidextrous | 1 Participants | — |
| Side Dominance Left Handed | 1 Participants | — |
| Side Dominance Right Handed | 24 Participants | — |
| Subluxed or Dislocated Dislocated | 19 Participants | — |
| Subluxed or Dislocated Subluxed | 7 Participants | — |
| Weight (lbs) | 188.0 lbs STANDARD_DEVIATION 41.2 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Broberg Morrey Functional Rating
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.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Who Completed the Study | Broberg Morrey Functional Rating | Broberg Morrey Score of Excellent | 14 Participants |
| Participants Who Completed the Study | Broberg Morrey Functional Rating | Broberg Morrey Score of Good | 8 Participants |
| Participants Who Completed the Study | Broberg Morrey Functional Rating | Broberg Morrey Score of Fair | 1 Participants |
| Participants Who Completed the Study | Broberg Morrey Functional Rating | Broberg Morrey Score of Poor | 1 Participants |
Primary
Recurrent Dislocations
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants Who Completed the Study | Recurrent Dislocations | 0 Participants |