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

Not Applicable

• Conditions: Clavicle Fracture; Clavicle Injury
• Interventions: Device: Clavicle open reduction and internal fixation

• Registration Number: NCT05327959
• Lead Sponsor: Zimmer Biomet

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.

Study Timeline

• Study First Submitted: 2022-03-10
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-14
• Study Start: 2022-05-13
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-08
• Primary Completion: 2026-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	Clavicle open reduction and internal fixation	The population target is all subjects suffering clavicle fracture suitable for open reduction and internal fixation by the A.L.P.S. Clavicle Plating System in accordance with the IFU.

Primary Outcome Measures

Name	Time	Method
Number of subjects with fracture healing	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Frequency and Incidence of Adverse Events (Safety)	12 months	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.
Range of Motion - Total shoulder motion	12 months	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)
Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeons (ASES) Shoulder Score at 12 months follow-up	12 months	The ASES scale is 0-100. 100 is the highest score and indicates the greatest function while 0 is the lowest score.
Euroqol Patient Quality of life measured at 12 months follow-up (EQ-5D-5L)	12 months	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.

Trial Locations

Locations (5)

Cleveland Clinic Florida; 🇺🇸 Weston, Florida, United States

University of Texas San Antonio; 🇺🇸 San Antonio, Texas, United States

Slocum Research & Education Foundation; 🇺🇸 Eugene, Oregon, United States

University of Michigan - Michigan Medicine; 🇺🇸 Ann Arbor, Michigan, United States

General Foundation of the University of Valladolid; 🇪🇸 Valladolid, Spain