ClinicalTrials.gov
ClinicalTrials.gov Menu

Multi-Center Trial to Evaluate an Internal Joint Stabilizer - Elbow

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01944670
Recruitment Status : Completed
First Posted : September 18, 2013
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Skeletal Dynamics, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Trauma
Chronic Elbow Dislocation
Intervention Device: Internal Joint Stabilizer - Elbow (IJS-E)
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Internal Joint Stabilizer Group
Hide Arm/Group Description

Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E)

Internal Joint Stabilizer - Elbow (IJS-E): Device designed for internal stabilization of the elbow

Period Title: Overall Study
Started 26
Completed 24
Not Completed 2
Reason Not Completed
Lost to Follow-up             2
Arm/Group Title Internal Joint Stabilizer Group
Hide Arm/Group Description

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 Number of Baseline Participants 26
Hide Baseline Analysis Population Description
Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants
57.1  (18.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
14
  53.8%
Male
12
  46.2%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Height (in)  
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 26 participants
65.8  (4.0)
Weight (lbs)  
Mean (Standard Deviation)
Unit of measure:  Lbs
Number Analyzed 26 participants
188.0  (41.2)
Side Dominance  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Right Handed
24
  92.3%
Left Handed
1
   3.8%
Ambidextrous
1
   3.8%
Operative Side  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Dominant Hand (including ambidextrous patients)
9
  34.6%
Non-dominant Hand
17
  65.4%
Subluxed or Dislocated  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Subluxed
7
  26.9%
Dislocated
19
  73.1%
1.Primary Outcome
Title Broberg Morrey Functional Rating
Hide Description

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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Participants Who Completed the Study
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 24
Measure Type: Count of Participants
Unit of Measure: Participants
Broberg Morrey Score of Excellent
14
  58.3%
Broberg Morrey Score of Good
8
  33.3%
Broberg Morrey Score of Fair
1
   4.2%
Broberg Morrey Score of Poor
1
   4.2%
2.Primary Outcome
Title Recurrent Dislocations
Hide Description

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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Participants Who Completed the Study
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 24
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Participants Who Completed the Study
Hide Arm/Group Description

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

All-Cause Mortality
Participants Who Completed the Study
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Participants Who Completed the Study
Affected / at Risk (%)
Total   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Participants Who Completed the Study
Affected / at Risk (%)
Total   1/24 (4.17%) 
Infections and infestations   
Inflammation  [1]  1/24 (4.17%) 
Indicates events were collected by systematic assessment
[1]
Inflammation was observed at the explant site 10 days after the implantation in one patient. The surrounding tissue was cultured negative for infection, but the subject was treated with antibiotics as a precaution.
Two patients were lost to follow-up prior to IJS-E implant removal (explant).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Ana Escagedo
Organization: Skeletal Dynamics, LLC
Phone: 305-596-7585
Responsible Party: Skeletal Dynamics, LLC
ClinicalTrials.gov Identifier: NCT01944670     History of Changes
Other Study ID Numbers: VLP-00015-00RAA
First Submitted: September 10, 2013
First Posted: September 18, 2013
Results First Submitted: February 16, 2017
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017