A.L.P.S. Clavicle Plating System PMCF
Running, not enrolling · Not applicable
Conditions studied: Clavicle Fracture, Clavicle Injury
In brief
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 the instrumentation used during surgery.
Key facts
- Study ID
- NCT05327959
- Run by
- Zimmer Biomet
- People needed
- 98
- Starts
- 2022-05-13
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-02-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Cleveland Clinic Florida — Weston, Florida, United States
- University of Michigan - Michigan Medicine — Ann Arbor, Michigan, United States
- Slocum Research & Education Foundation — Eugene, Oregon, United States
- University of Texas San Antonio — San Antonio, Texas, United States
- General Foundation of the University of Valladolid — Valladolid, Spain
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.