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

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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)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Internal Joint Stabilizer Group
STARTED   26 
COMPLETED   24 
NOT COMPLETED   2 
Lost to Follow-up                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E)

Reporting Groups
  Description
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


Baseline Measures
   Internal Joint Stabilizer Group 
Overall Participants Analyzed 
[Units: Participants]
 26 
Age 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed   26 
   57.1  (18.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed   26 
Female      14  53.8% 
Male      12  46.2% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
  
[1] Race and Ethnicity were not collected from any participant.
Height (in) 
[Units: Inches]
Mean (Standard Deviation)
 
Participants Analyzed   26 
   65.8  (4.0) 
Weight (lbs) 
[Units: Lbs]
Mean (Standard Deviation)
 
Participants Analyzed   26 
   188.0  (41.2) 
Side Dominance 
[Units: Participants]
Count of Participants
 
Participants Analyzed   26 
Right Handed      24  92.3% 
Left Handed      1   3.8% 
Ambidextrous      1   3.8% 
Operative Side 
[Units: Participants]
Count of Participants
 
Participants Analyzed   26 
Dominant Hand (including ambidextrous patients)      9  34.6% 
Non-dominant Hand      17  65.4% 
Subluxed or Dislocated 
[Units: Participants]
Count of Participants
 
Participants Analyzed   26 
Subluxed      7  26.9% 
Dislocated      19  73.1% 


  Outcome Measures

1.  Primary:   Broberg Morrey Functional Rating   [ Time Frame: Eight months (6 months post-explant) ]

2.  Primary:   Recurrent Dislocations   [ Time Frame: 8 months (6 month post-explant) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Two patients were lost to follow-up prior to IJS-E implant removal (explant).


  More Information

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
e-mail: AEscagedo@SkeletalDynamics.com



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