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Implant

Clavicle Plate for Collarbone Fracture

N/A

Waitlist Available

Research Sponsored by Zimmer Biomet

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must have a clavicle fracture requiring surgical intervention and be eligible for fixation by locking plate and screws

Patient must be 18 years of age or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial looks at the safety and effectiveness of a clavicle plate for treating broken collarbones.

Who is the study for?

This trial is for adults over 18 with a broken collarbone needing surgery. They must understand and follow the study's procedures and agree to all follow-ups. It's not for those unable or unwilling to consent, prisoners, pregnant or breastfeeding individuals, people unlikely to complete the follow-up, with active infections, metal sensitivities without prior testing, poor bone quality/quantity, or substance abuse issues.Check my eligibility

What is being tested?

The A.L.P.S. Clavicle Plating System PMCF trial tests the safety and effectiveness of a clavicle plating system used in surgical repair of collarbone fractures. The focus is on how well both the implant and surgical instruments work during this procedure.See study design

What are the potential side effects?

While specific side effects are not listed here, typical risks from such surgeries may include pain at the site of surgery, infection risk due to implantation of foreign material into the body, possible allergic reactions if there's an undetected metal sensitivity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need surgery for my broken clavicle using a plate and screws.

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I am 18 years old or older.

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I have a fracture in one or both of my limbs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of subjects with fracture healing

Secondary outcome measures

Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeons (ASES) Shoulder Score at 12 months follow-up

Euroqol Patient Quality of life measured at 12 months follow-up (EQ-5D-5L)

Frequency and Incidence of Adverse Events (Safety)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment GroupExperimental Treatment1 Intervention

The population target is all subjects suffering clavicle fracture suitable for open reduction and internal fixation by the A.L.P.S. Clavicle Plating System in accordance with the IFU.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Zimmer BiometLead Sponsor

373 Previous Clinical Trials

67,299 Total Patients Enrolled

Media Library

ALPS Clavicle Plating System (Implant) Clinical Trial Eligibility Overview. Trial Name: NCT05327959 — N/A

Collarbone Fracture Research Study Groups: Treatment Group

Collarbone Fracture Clinical Trial 2023: ALPS Clavicle Plating System Highlights & Side Effects. Trial Name: NCT05327959 — N/A

ALPS Clavicle Plating System (Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05327959 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollment opportunities open for this experimentation?

"Clinicaltrials.gov divulges that this medical study, posted on May 13th 2022 and last updated August 10th 2022, is not currently recruiting participants. Nonetheless, there are presently 349 other trials actively looking for patients to join their program."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A.L.P.S. Clavicle Plating System PMCF

2022. "A.L.P.S. Clavicle Plating System PMCF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05327959.