TraumaNCT01944670

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

A study testing Internal Joint Stabilizer - Elbow (IJS-E) in people with Trauma and Chronic Elbow Dislocation, run by Skeletal Dynamics, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for: Trauma, Chronic Elbow Dislocation
What is being tested?: Internal Joint Stabilizer - Elbow (IJS-E)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: Aug 2013to Sep 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: 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.

Conditions: Trauma, Chronic Elbow Dislocation
Being tested: Internal Joint Stabilizer - Elbow (IJS-E)
Medical subject headings: Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01944670
Study group	Role	What they receive
Internal Joint Stabilizer Group	Experimental	Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E) Receives: Device: Internal Joint Stabilizer - Elbow (IJS-E)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 8 months (6 month post-explant)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2013Sep 2015

First posted18 Sep 2013 (estimated)
Study startAug 2013
Primary completionJun 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for TraumaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01944670
Sponsor's protocol ID: VLP-00015-00RAA
Status last verified: Feb 2017
First submitted: 10 Sep 2013
Last updated: 4 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-Center Trial to Evaluate an Internal Joint Stabilizer - Elbow ("IJS-E")
ClinicalTrials.gov ID: NCT01944670
Acronym / sponsor ID: VLP-00015-00RAA
Conditions: Trauma, Chronic Elbow Dislocation
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Skeletal Dynamics, LLCIndustry (pharma, biotech, devices)
Study start: Aug 2013
Primary completion: Jun 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 18 Sep 2013 (estimated)
Results: Posted 4 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Internal Joint Stabilizer Group	Experimental	Device: Internal Joint Stabilizer - Elbow (IJS-E)Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E)

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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:
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.

Key exclusion criteria (16 listed)

The subject has one of the following conditions:
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Internal Joint Stabilizer - Elbow (IJS-E)Device designed for internal stabilization of the elbow	Device	Internal Joint Stabilizer Group

Primary outcome

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.

Results and safety

Results posted to the registry on 4 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Internal Joint Stabilizer Group	26	24

Primary outcome: Broberg Morrey Functional Rating

Time frame: Eight months (6 months post-explant). Count of participants. Unit: Participants

Measure	Participants Who Completed the Study n = 24
Broberg Morrey Score of Excellent	14
Broberg Morrey Score of Good	8
Broberg Morrey Score of Fair	1
Broberg Morrey Score of Poor	1

Population analysed: Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E) who completed the study (have final follow-up data). Excludes patients who were lost to follow-up.

Primary outcome: Recurrent Dislocations

Time frame: 8 months (6 month post-explant). Count of participants. Unit: Participants

Measure	Participants Who Completed the Study n = 24
Value	0

Population analysed: Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E) who completed the study (have final follow-up data). Excludes patients who were lost to follow-up.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants Who Completed the Study	0 of 24 (0%)	1 of 24 (4.2%)	Not reported

Limitations and caveats (from the sponsor): Two patients were lost to follow-up prior to IJS-E implant removal (explant).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Ring, MD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Internal Joint Stabilizer - Elbow (IJS-E) in people with Trauma and Chronic Elbow Dislocation, run by Skeletal Dynamics, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Broberg Morrey Functional Rating (time frame: Eight months (6 months post-explant)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01944670.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.