Clavicle FractureNCT05327959
A.L.P.S. Clavicle Plating System PMCF
A study testing Clavicle open reduction and internal fixation in people with Clavicle Fracture and Clavicle Injury, run by Zimmer Biomet at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clavicle Fracture, Clavicle Injury
- What is being tested?
- Clavicle open reduction and internal fixation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 13 May 2022to Mar 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
University of Michigan - Michigan Medicine
Ann Arbor, Michigan, 48137
Slocum Research & Education Foundation
Eugene, Oregon, 97401
University of Texas San Antonio
San Antonio, Texas, 78229
Cleveland Clinic Florida
Weston, Florida, 33331
Spain1 site
General Foundation of the University of Valladolid
Valladolid, 47002
About this study
Official title: A.L.P.S. Clavicle Plating System for Clavicle Fracture Fixation Post-Market Follow-up Study (Implants and Instrumentation)
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.
Read the 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.
- Conditions
- Clavicle Fracture, Clavicle Injury
- Being tested
- Clavicle open reduction and internal fixation
- Keywords
- clavicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clavicle open reduction and internal fixationDevice
Clavicle open reduction and internal fixation using the A.L.P.S. Clavicle Plating System
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | 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. Receives: Device: Clavicle open reduction and internal fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (4)
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.
Measured: 12 months
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)
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start13 May 2022
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clavicle FractureStudies 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
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hillary Overholser, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327959
- Sponsor's protocol ID
- CMG2020-08T
- Status last verified
- Feb 2026
- First submitted
- 10 Mar 2022
- 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. Clavicle Plating System for Clavicle Fracture Fixation Post-Market Follow-up Study (Implants and Instrumentation)
- ClinicalTrials.gov ID
- NCT05327959
- Acronym / sponsor ID
- CMG2020-08T
- Conditions
- Clavicle Fracture, Clavicle Injury
- Keywords
- clavicle
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 13 May 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 14 Apr 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Clavicle open reduction and internal fixationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Clavicle open reduction and internal fixationClavicle open reduction and internal fixation using the A.L.P.S. Clavicle Plating System | Device | Treatment Group |
Primary outcome
Number of subjects with fracture healing
Time frame: 12 months
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.
4 secondary outcomes
Frequency and Incidence of Adverse Events (Safety)
Time frame: 12 months
Range of Motion - Total shoulder motion
Time frame: 12 months
Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeons (ASES) Shoulder Score at 12 months follow-up
Time frame: 12 months
Euroqol Patient Quality of life measured at 12 months follow-up (EQ-5D-5L)
Time frame: 12 months
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.
Hillary Overholser study director
Zimmer Biomet
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clavicle open reduction and internal fixation in people with Clavicle Fracture and Clavicle Injury, run by Zimmer Biomet at 5 sites in 2 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 5 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 5 sites in United States, Spain. 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?
Number of subjects with fracture healing (time frame: 12 months). 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.