Back to resultsPost Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System
Primary Purpose
Osteoarthritis, Rheumatoid Arthritis, Post-Traumatic Arthritis
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
A.L.P.S. Proximal Humerus Plating System
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Trauma, Medical Device, Performance, Safety, Proximal Humeral Fracture
Eligibility Criteria
Inclusion Criteria:
- Patient must be 18 years of age or older.
- Patient must have a primary proximal humerus fracture (Orthopaedic Trauma Association/ American Orthopedic 11-A, B, C) requiring surgical intervention and be eligible for fixation by plate and screws.
- Patients with failed conservative treatment within 3 weeks since injury.
- Patient must be able and willing to complete the protocol required follow-up.
- Patient must have a signed Institutional Review Board/Ethics Committee approved informed consent.
- Patient must be in a good nutritional state
Exclusion Criteria:
- Delay of surgery for more than 3 weeks.
- Tumor induced fractures
- Patient is a prisoner.
- Pregnancy/ breast feeding
- Patient is a current alcohol or drug abuser.
- Patient has a mental or neurologic condition that will not allow for proper informed consent and/or participation in follow-up program.
- Patient has an active infection.
- Patient conditions including limitations in blood supply, obesity, or insufficient quantity or quality of bone stock.
- Patient is sensitive to foreign body material.
Sites / Locations
- Foundation for Orthopaedic Research & Education
- The Research Institute of McGill University Health CentreRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients who receive the A.L.P.S. Prox. Humerus Plating Sys.
Arm Description
Subjects in need of proximal humerus fracture fixation who met the inclusion/exclusion criteria and received the A.L.P.S. Proximal Humerus Plating System. Subjects can be enrolled prospectively or retrospectively as indicated in the protocol.
Outcomes
Primary Outcome Measures
Re-operation
Re--operation within the first year post-initial surgery due to screw perforation of the humeral head, secondary displacement or impingement to relieve pain and/or improve function.
Secondary Outcome Measures
Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeon Patient Questionnaire
Pain, function and activities of daily living are measured. The American Shoulder and Elbow Surgeon (ASES) scale is 0 to 100. 100 is the highest score and indicates the greatest function while 0 is the lowest score.
Shoulder range of motion measurement
Shoulder range of motion is assessed in degrees of directional movement. This will be measured during a physical exam by the investigator. Values measured include active and passive range of motion.
Clinical performance of the device is assessed using x-ray capture
X-ray capture will be used to analyze fracture healing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03626038
Brief Title
Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System
Official Title
A.L.P.S. Proximal Humerus Plating System Post-Market Clinical Follow-up Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 19, 2018 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
July 2024 (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
This study is a multicenter, prospective, non-randomized, non-controlled post-market clinical follow-up study. The primary objective of this study is to confirm the safety and performance of the A.L.P.S. Proximal Humerus Plating System applied in proximal humerus fracture treatment.
Detailed Description
The A.L.P.S. Proximal Humerus Plating System was developed to provide another surgical option for proximal humerus fracture fixation. The aim of the A.L.P.S. Proximal Humerus Plating System is to provide increased fracture stability while simultaneously increasing range of motion and decreasing the likelihood of screw perforation.
A minimum of 7 and maximum of 10 sites globally will be involved in this study. This number of clinical sites will allow for a better generalization of study data as well as allow for consistency to be developed across multiple regions. 135 implants will be included into the study. Each site will be allowed to enroll 27 humeri. Enrollment is competitive. All potential study subjects will be required to participate in the Informed Consent process.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Rheumatoid Arthritis, Post-Traumatic Arthritis, Psoriatic Arthritis, Proximal Humeral Fracture
Keywords
Trauma, Medical Device, Performance, Safety, Proximal Humeral Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
135 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients who receive the A.L.P.S. Prox. Humerus Plating Sys.
Arm Type
Experimental
Arm Description
Subjects in need of proximal humerus fracture fixation who met the inclusion/exclusion criteria and received the A.L.P.S. Proximal Humerus Plating System.
Subjects can be enrolled prospectively or retrospectively as indicated in the protocol.
Intervention Type
Device
Intervention Name(s)
A.L.P.S. Proximal Humerus Plating System
Intervention Description
Anatomically contoured, locking plates that can be customized intra-operatively, multidirectional screws allow for stable fixation for a wide variety of patients.
Primary Outcome Measure Information:
Title
Re-operation
Description
Re--operation within the first year post-initial surgery due to screw perforation of the humeral head, secondary displacement or impingement to relieve pain and/or improve function.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeon Patient Questionnaire
Description
Pain, function and activities of daily living are measured. The American Shoulder and Elbow Surgeon (ASES) scale is 0 to 100. 100 is the highest score and indicates the greatest function while 0 is the lowest score.
Time Frame
2 years
Title
Shoulder range of motion measurement
Description
Shoulder range of motion is assessed in degrees of directional movement. This will be measured during a physical exam by the investigator. Values measured include active and passive range of motion.
Time Frame
2 years
Title
Clinical performance of the device is assessed using x-ray capture
Description
X-ray capture will be used to analyze fracture healing
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient must be 18 years of age or older.
Patient must have a primary proximal humerus fracture (Orthopaedic Trauma Association/ American Orthopedic 11-A, B, C) requiring surgical intervention and be eligible for fixation by plate and screws.
Patients with failed conservative treatment within 3 weeks since injury.
Patient must be able and willing to complete the protocol required follow-up.
Patient must have a signed Institutional Review Board/Ethics Committee approved informed consent.
Patient must be in a good nutritional state
Exclusion Criteria:
Delay of surgery for more than 3 weeks.
Tumor induced fractures
Patient is a prisoner.
Pregnancy/ breast feeding
Patient is a current alcohol or drug abuser.
Patient has a mental or neurologic condition that will not allow for proper informed consent and/or participation in follow-up program.
Patient has an active infection.
Patient conditions including limitations in blood supply, obesity, or insufficient quantity or quality of bone stock.
Patient is sensitive to foreign body material.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Boylan
Phone
574-527-7934
Email
ryan.boylan@zimmerbiomet.com
Facility Information:
Facility Name
Foundation for Orthopaedic Research & Education
City
Tampa
State/Province
Florida
ZIP/Postal Code
33637
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The Research Institute of McGill University Health Centre
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Amedeo
Phone
514-934-1934
Ext
43386
Email
Mary.Amedeo@MUHC.MCGILL.CA
First Name & Middle Initial & Last Name & Degree
Rudolf Reindl, M.D.
First Name & Middle Initial & Last Name & Degree
Gregory Berry, M.D.
First Name & Middle Initial & Last Name & Degree
Mitchell Bernstein, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System
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