Back to resultsA.L.P.S. Clavicle Plating System PMCF
Primary Purpose
Clavicle Fracture, Clavicle Injury
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clavicle open reduction and internal fixation
Sponsored by
About this trial
This is an interventional treatment trial for Clavicle Fracture focused on measuring clavicle
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
Sites / Locations
- Cleveland Clinic Florida
- University of Michigan - Michigan Medicine
- Slocum Research & Education Foundation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Group
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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)
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05327959
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 13, 2022 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clavicle Fracture, Clavicle Injury
Keywords
clavicle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
98 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Clavicle open reduction and internal fixation
Intervention Description
Clavicle open reduction and internal fixation using the A.L.P.S. Clavicle Plating System
Primary Outcome Measure Information:
Title
Number of subjects with fracture healing
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Frequency and Incidence of Adverse Events (Safety)
Description
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.
Time Frame
12 months
Title
Range of Motion - Total shoulder motion
Description
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)
Time Frame
12 months
Title
Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeons (ASES) Shoulder Score at 12 months follow-up
Description
The ASES scale is 0-100. 100 is the highest score and indicates the greatest function while 0 is the lowest score.
Time Frame
12 months
Title
Euroqol Patient Quality of life measured at 12 months follow-up (EQ-5D-5L)
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
University of Michigan - Michigan Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48137
Country
United States
Facility Name
Slocum Research & Education Foundation
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A.L.P.S. Clavicle Plating System PMCF
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