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)
Verified date | December 2023 |
Source | Zimmer Biomet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Zimmer Biomet |
United States, Spain,
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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