Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03626038
Registration number
NCT03626038
Ethics application status
Date submitted
23/07/2018
Date registered
10/08/2018
Date last updated
18/12/2024
Titles & IDs
Public title
Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System
Query!
Scientific title
A.L.P.S. Proximal Humerus Plating System Post-Market Clinical Follow-up Study
Query!
Secondary ID [1]
0
0
CMG2017-59T
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis
0
0
Query!
Rheumatoid Arthritis
0
0
Query!
Post-Traumatic Arthritis
0
0
Query!
Psoriatic Arthritis
0
0
Query!
Proximal Humeral Fracture
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Osteoarthritis
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Rheumatoid arthritis
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Musculoskeletal
0
0
0
0
Query!
Other muscular and skeletal disorders
Query!
Injuries and Accidents
0
0
0
0
Query!
Fractures
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Devices - A.L.P.S. Proximal Humerus Plating System
Experimental: Patients who receive the A.L.P.S. Prox. Humerus Plating Sys. - 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.
Treatment: Devices: A.L.P.S. Proximal Humerus Plating System
Anatomically contoured, locking plates that can be customized intra-operatively, multidirectional screws allow for stable fixation for a wide variety of patients.
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Re-operation
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
1 year
Query!
Secondary outcome [1]
0
0
Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeon Patient Questionnaire
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
2 years
Query!
Secondary outcome [2]
0
0
Shoulder range of motion measurement
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
2 years
Query!
Secondary outcome [3]
0
0
Clinical performance of the device is assessed using x-ray capture
Query!
Assessment method [3]
0
0
X-ray capture will be used to analyze fracture healing
Query!
Timepoint [3]
0
0
2 years
Query!
Eligibility
Key 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Not applicable
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Not applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
19/06/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/05/2025
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
135
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
Sydney Adventist Hospital - Wahroonga
Query!
Recruitment postcode(s) [1]
0
0
2076 - Wahroonga
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Florida
Query!
Country [2]
0
0
Canada
Query!
State/province [2]
0
0
Quebec
Query!
Country [3]
0
0
Korea, Republic of
Query!
State/province [3]
0
0
Seoul
Query!
Country [4]
0
0
Switzerland
Query!
State/province [4]
0
0
Granges-Paccot
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Zimmer Biomet
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03626038
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03626038
Download to PDF