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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05327959
Other study ID # CMG2020-08T
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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