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

Trauma Clinical Trial

Official title:

Multi-Center Trial to Evaluate an Internal Joint Stabilizer - Elbow ("IJS-E")

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01944670
• Other study ID #: VLP-00015-00RAA
• Status: Active, not recruiting
• Phase: N/A
• First received: September 10, 2013
• Last updated: November 19, 2014
• Start date: August 2013

Study information

• Verified date: November 2014
• Source: Skeletal Dynamics, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Elbow Dislocation
• Dislocations
• Trauma

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Skeletal Dynamics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary efficacy objective	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.	Eight months	No
Secondary	Primary safety objective	To determine the number of device related events attributable to the Internal Joint Stabilizer - Elbow (IJS-E).	Eight months	Yes