Status:
ENROLLING_BY_INVITATION
A.L.P.S. Clavicle Plating System PMCF
Lead Sponsor:
Zimmer Biomet
Conditions:
Clavicle Fracture
Clavicle Injury
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A commercially available product clinical study which aims to confirm the safety, performance, and clinical benefits to the patient of the ALPS Clavicle Plating system for both the implant itself and ...
Detailed Description
The objectives of this observational, prospective study with optional retrospective enrollment are to confirm safety, performance and clinical benefits of the A.L.P.S Clavicle Plating System and its i...
Eligibility Criteria
Inclusion
- Patient must be 18 years of age or older.
- Patient must have a clavicle fracture requiring surgical intervention and be eligible for fixation by locking plate and screws.
- Unilateral or Bilateral fractures.
- Patient must be capable of understanding the doctor's explanation, following doctor's instruction, is able to and willing to complete the protocol required follow-up.
- Patient must have a signed IRB/EC approved informed consent.
Exclusion
- Active infection.
- Patients presenting conditions including blood supply limitations, insufficient quantity or quality of bone.
- Patients with mental or neurologic conditions who are unwilling or incapable of giving proper informed consent, following postoperative care instructions.
- Foreign body sensitivity where material sensitivity is suspected, testing is to be completed prior to implantation of the device.
- Patient is a current alcohol or drug abuser
- Patient is a prisoner
- Patient known to be pregnant or breast feeding
- Likely problems with maintaining follow-up program (e.g. patient with no fixed address, long distance, plans to move during course of study)
- Not expected to survive the duration of the follow-up program
Key Trial Info
Start Date :
May 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT05327959
Start Date
May 13 2022
End Date
March 1 2027
Last Update
October 30 2025
Active Locations (5)
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1
Cleveland Clinic Florida
Weston, Florida, United States, 33331
2
University of Michigan - Michigan Medicine
Ann Arbor, Michigan, United States, 48137
3
Slocum Research & Education Foundation
Eugene, Oregon, United States, 97401
4
University of Texas San Antonio
San Antonio, Texas, United States, 78229