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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Skeletal Dynamics, LLC
Sponsor:
Information provided by (Responsible Party):
Skeletal Dynamics, LLC
ClinicalTrials.gov Identifier:
NCT01944670
First received: September 10, 2013
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to confirm the safety and effectiveness of the Internal Joint Stabilizer - Elbow.


Condition Intervention
Trauma
Chronic Elbow Dislocation
Device: Internal Joint Stabilizer - Elbow (IJS-E)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-Center Trial to Evaluate an Internal Joint Stabilizer - Elbow ("IJS-E")

Resource links provided by NLM:


Further study details as provided by Skeletal Dynamics, LLC:

Primary Outcome Measures:
  • Primary efficacy objective [ Time Frame: Eight months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Primary safety objective [ Time Frame: Eight months ] [ Designated as safety issue: Yes ]
    To determine the number of device related events attributable to the Internal Joint Stabilizer - Elbow (IJS-E).


Estimated Enrollment: 25
Study Start Date: August 2013
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Internal Joint Stabilizer Group
Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E)
Device: Internal Joint Stabilizer - Elbow (IJS-E)
Device designed for internal stabilization of the elbow

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01944670

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Emily Thornton    617-726-1569    erthornton@partners.org   
Sponsors and Collaborators
Skeletal Dynamics, LLC
Investigators
Principal Investigator: David Ring, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Skeletal Dynamics, LLC
ClinicalTrials.gov Identifier: NCT01944670     History of Changes
Other Study ID Numbers: VLP-00015-00RAA
Study First Received: September 10, 2013
Last Updated: September 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dislocations
Wounds and Injuries

ClinicalTrials.gov processed this record on September 16, 2014