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

NCT01944670 | Completed Results DMC

• 1 other identifier: VLP-00015-00RAA
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Trauma; Chronic Elbow Dislocation

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

Internal Joint Stabilizer Group

EXPERIMENTAL

Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E)

Device: Internal Joint Stabilizer - Elbow (IJS-E)

Interventions

Internal Joint Stabilizer - Elbow (IJS-E) DEVICE

Device designed for internal stabilization of the elbow

Internal Joint Stabilizer Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Skeletal Dynamics, LLC: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Limitations and Caveats

Two patients were lost to follow-up prior to IJS-E implant removal (explant).

Results Point of Contact

• Title: Ana Escagedo
• Organization: Skeletal Dynamics, LLC

AEscagedo@SkeletalDynamics.com

305-596-7585

Study Officials

• David Ring, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: September 18, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 4, 2017
• Results First Posted: April 4, 2017

Record last verified: 2017-02

Locations

US (1)