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Orthopedic Implant

A.L.P.S. Plating System for Shoulder Fracture

N/A

Recruiting

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 primary proximal humerus fracture (Orthopaedic Trauma Association/ American Orthopedic 11-A, B, C) requiring surgical intervention and be eligible for fixation by plate and screws.

Patient must be 18 years of age or older.

Must not have

Delay of surgery for more than 3 weeks.

Patient has a mental or neurologic condition that will not allow for proper informed consent and/or participation in follow-up program.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to confirm the safety and effectiveness of a new system for treating proximal humerus fractures.

Who is the study for?

This trial is for adults over 18 with a fresh shoulder fracture needing surgery, who can follow the study's procedures and are in good health. It's not for those with delayed surgery, mental conditions preventing consent, current substance abuse, active infections, poor bone quality or blood supply issues, sensitivity to foreign materials, prisoners or tumor-related fractures.

What is being tested?

The A.L.P.S. Proximal Humerus Plating System is being tested for safety and performance in treating shoulder fractures. This multicenter study involves patients getting this specific plate-and-screw fixation treatment without randomization or control groups.

What are the potential side effects?

While not explicitly listed here, potential side effects may include pain at the surgical site, infection risks from surgery, possible allergic reactions to implant materials and complications related to bone healing.

Eligibility Criteria

Inclusion Criteria

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

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I need surgery for a major shoulder fracture and can be treated with plates and screws.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My surgery has been postponed for over 3 weeks.

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I am able to understand and follow the study's requirements.

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I currently have an infection.

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My cancer has caused a bone to break.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Re-operation

Secondary study objectives

Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeon Patient Questionnaire

Clinical performance of the device is assessed using x-ray capture

Shoulder range of motion measurement

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients who receive the A.L.P.S. Prox. Humerus Plating Sys.Experimental Treatment1 Intervention

Subjects in need of proximal humerus fracture fixation who met the inclusion/exclusion criteria and received the A.L.P.S. Proximal Humerus Plating System. Subjects can be enrolled prospectively or retrospectively as indicated in the protocol.

0 / 6Eligibility criteria met