Clinical trial NCT05327959: A.L.P.S. Clavicle Plating System PMCF
Official title: A.L.P.S. Clavicle Plating System for Clavicle Fracture Fixation Post-Market Follow-up Study (Implants and Instrumentation)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Clavicle Fracture
Clavicle Injury
Keywords: clavicle
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2022-04-14
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 the instrumentation used during surgery.

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 instrumentation by analysis of fracture healing, functional outcome and adverse events.

The safety of the system will be assessed by monitoring the frequency and incidence of adverse events including re-operations. Relation of the events to implant, instrumentation and/or procedure should be specified.

The performance will be evaluated by assessment of fracture/osteotomy healing and functional outcome of all enrolled study subjects.

Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects with fracture healing
timeFrame: 12 months
Secondary outcomes:
measure: Frequency and Incidence of Adverse Events (Safety)
timeFrame: 12 months
measure: Range of Motion - Total shoulder motion
timeFrame: 12 months
measure: Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeons (ASES) Shoulder Score at 12 months follow-up
timeFrame: 12 months
measure: Euroqol Patient Quality of life measured at 12 months follow-up (EQ-5D-5L)
timeFrame: 12 months
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Ann Arbor
country: United States
facility: University of Michigan - Michigan Medicine
state: Michigan
city: Eugene
country: United States
facility: Slocum Research & Education Foundation
state: Oregon
city: San Antonio
country: United States
facility: University of Texas San Antonio
state: Texas
city: Valladolid
country: Spain
facility: General Foundation of the University of Valladolid
Study officials:
References: