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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

September 10, 2013
September 18, 2013
February 16, 2017
April 4, 2017
April 4, 2017
August 2013
June 2015   (Final data collection date for primary outcome measure)
  • Broberg Morrey Functional Rating [ Time Frame: 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 [ Time Frame: 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.
Primary efficacy objective [ Time Frame: Eight months ]
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.
Complete list of historical versions of study NCT01944670 on ClinicalTrials.gov Archive Site
Not Provided
Primary safety objective [ Time Frame: Eight months ]
To determine the number of device related events attributable to the Internal Joint Stabilizer - Elbow (IJS-E).
Not Provided
Not Provided
 
Multi-Center Trial to Evaluate an Internal Joint Stabilizer - Elbow
Multi-Center Trial to Evaluate an Internal Joint Stabilizer - Elbow ("IJS-E")
The purpose of this study is to confirm the safety and effectiveness of the Internal Joint Stabilizer - Elbow.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Trauma
  • Chronic Elbow Dislocation
Device: Internal Joint Stabilizer - Elbow (IJS-E)
Device designed for internal stabilization of the elbow
Experimental: Internal Joint Stabilizer Group
Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E)
Intervention: Device: Internal Joint Stabilizer - Elbow (IJS-E)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
25
September 2015
June 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
21 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01944670
VLP-00015-00RAA
Yes
Not Provided
Not Provided
Skeletal Dynamics, LLC
Skeletal Dynamics, LLC
Not Provided
Principal Investigator: David Ring, MD Massachusetts General Hospital
Skeletal Dynamics, LLC
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP