A.L.P.S. Clavicle Plating System PMCF (NCT05327959) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A.L.P.S. Clavicle Plating System PMCF
United States, Spain98 participantsStarted 2022-05-13
Plain-language 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 the instrumentation used during surgery.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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