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.

Study Overview

• Status: Completed
• Conditions: Trauma; Chronic Elbow Dislocation
• Intervention / Treatment: Device: Internal Joint Stabilizer - Elbow (IJS-E)

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Broberg Morrey Functional Rating	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.	Eight months (6 months post-explant)
Recurrent Dislocations	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.	8 months (6 month post-explant)

Collaborators and Investigators

• Sponsor: Skeletal Dynamics, LLC
• Investigators: Principal Investigator: David Ring, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: September 10, 2013
• First Submitted That Met QC Criteria: September 12, 2013
• First Posted (Estimate): September 18, 2013

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: February 16, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations
• Other Study ID Numbers: VLP-00015-00RAA