A.L.P.S. Clavicle Plating System PMCF

Clavicle Fracture Clinical Trial

Official title:

A.L.P.S. Clavicle Plating System for Clavicle Fracture Fixation Post-Market Follow-up Study (Implants and Instrumentation)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05327959
• Other study ID #: CMG2020-08T
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 13, 2022
• Est. completion date: March 2027

Study information

• Verified date: December 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 98
• Est. completion date: March 2027
• Est. primary completion date: March 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clavicle Fracture
• Clavicle Injury
• Fractures, Bone

Intervention

Device:
• Clavicle open reduction and internal fixation
Clavicle open reduction and internal fixation using the A.L.P.S. Clavicle Plating System

Locations

Country	Name	City	State
Spain	General Foundation of the University of Valladolid	Valladolid
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	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with fracture healing	Number of subjects with fracture healing will be assessed through 12 months follow-up. Radiologic fracture healing is defined as: Bridging callus or no visible fracture lines on AP and 15-45° cephalic oblique radiographs.	12 months
Secondary	Frequency and Incidence of Adverse Events (Safety)	Monitoring the frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated serious adverse device effects as well as device deficiencies.	12 months
Secondary	Range of Motion - Total shoulder motion	Range of Motion (affected and contralateral), Forward elevation (maximum arm-trunk angle), External rotation (arm comfortably at side), External rotation (arm at 90 degrees of abduction), Internal rotation (thumb to back) spinous process, Cross-body adduction (antecubital fossa to opposite acromion (cm)	12 months
Secondary	Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeons (ASES) Shoulder Score at 12 months follow-up	The ASES scale is 0-100. 100 is the highest score and indicates the greatest function while 0 is the lowest score.	12 months
Secondary	Euroqol Patient Quality of life measured at 12 months follow-up (EQ-5D-5L)	The EuroQol five dimensions questionnaire (EQ-5D-5L) is a five dimensional self-assessment that is comprised of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These five dimensions can be used to index a subject's health utility on a scale of 0 to 1, where 0 is death and 1 is perfect health. The scoring rule for EQ-5D permits scores less than 0, implying that some health states may be worse than death.	12 months