OsteoarthritisNCT03626038
Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System
A study testing A.L.P.S. Proximal Humerus Plating System in people with Osteoarthritis and Rheumatoid Arthritis, run by Zimmer Biomet at 7 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Post-Traumatic Arthritis
- What is being tested?
- A.L.P.S. Proximal Humerus Plating System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 19 Jun 2018to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
South Korea3 sites
Korea University Anam Hospital
Seoul, Seoul, 02841
Hallym University Kangnam Sacred Hearth Hospital
Seoul, Seoul, 07441
Inje University Seoul Paik Hospital
Seoul, Seoul, 07441
United States1 site
Foundation for Orthopaedic Research & Education
Tampa, Florida, 33637
Canada1 site
The Research Institute of McGill University Health Centre
Montreal, Quebec, H3G 1A4
Switzerland1 site
Bone and Motion Training and Research Foundation
Granges-Paccot, Granges-Paccot, 1763
About this study
Official title: A.L.P.S. Proximal Humerus Plating System Post-Market Clinical Follow-up Study
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.
Read the 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.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Post-Traumatic Arthritis, Psoriatic Arthritis, Proximal Humeral Fracture
- Being tested
- A.L.P.S. Proximal Humerus Plating System
- Keywords
- Trauma, Medical Device, Performance, Safety, Proximal Humeral Fracture
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Arthritis, Psoriatic, Shoulder Fractures, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A.L.P.S. Proximal Humerus Plating SystemDevice
Anatomically contoured, locking plates that can be customized intra-operatively, multidirectional screws allow for stable fixation for a wide variety of patients.
| Study group | Role | What they receive |
|---|---|---|
| Patients who receive the A.L.P.S. Prox. Humerus Plating Sys. | Experimental | 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. Receives: Device: A.L.P.S. Proximal Humerus Plating System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (3)
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.
Measured: 2 years
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.
Measured: 2 years
Clinical performance of the device is assessed using x-ray capture
X-ray capture will be used to analyze fracture healing
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start19 Jun 2018
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626038
- Sponsor's protocol ID
- CMG2017-59T
- Status last verified
- Feb 2026
- First submitted
- 23 Jul 2018
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A.L.P.S. Proximal Humerus Plating System Post-Market Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT03626038
- Acronym / sponsor ID
- CMG2017-59T
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Post-Traumatic Arthritis, Psoriatic Arthritis, Proximal Humeral Fracture
- Keywords
- Trauma, Medical Device, Performance, Safety, Proximal Humeral Fracture
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who receive the A.L.P.S. Prox. Humerus Plating Sys. | Experimental | Device: A.L.P.S. Proximal Humerus Plating SystemSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A.L.P.S. Proximal Humerus Plating SystemAnatomically contoured, locking plates that can be customized intra-operatively, multidirectional screws allow for stable fixation for a wide variety of patients. | Device | Patients who receive the A.L.P.S. Prox. Humerus Plating Sys. |
Primary outcome
Re-operation
Time frame: 1 year
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.
3 secondary outcomes
Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeon Patient Questionnaire
Time frame: 2 years
Shoulder range of motion measurement
Time frame: 2 years
Clinical performance of the device is assessed using x-ray capture
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A.L.P.S. Proximal Humerus Plating System in people with Osteoarthritis and Rheumatoid Arthritis, run by Zimmer Biomet at 7 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea, United States, Australia, Canada, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-operation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.