Proximal Humerus FractureNCT05351112
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder 2.0 Fracture System
An observational study of Proximal Humerus Fracture and Posttraumatic Arthrosis After Humeral Head Fracture, run by Zimmer Biomet at 1 site in Spain.
Trial summary
The study is a multicenter, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect long-term data confirming safety, performance and clinical benefits of the Anatomical Shoulder 2.0 Fracture System (Implants and Instrumentation)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proximal Humerus Fracture, Posttraumatic Arthrosis After Humeral Head Fracture, Posttraumatic Necrosis of the Humeral Head
- How many people
- 78 participants
- Where
- 1 siteSpain
- Study dates
- 7 Jul 2022to 21 Jan 2034
- Phase
- Observational
- 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
Study population: The study population will be comprised of a consecutive series of cases implanted with the Anatomical Shoulder 2.0 Fracture System according to Zimmer Biomet's Instruction for Use (IFU) and who meet the inclusion criteria and none of the exclusion criteria.
Who may be able to join
- Patients 18 years or older and skeletally mature
- Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study
- Replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi- and fracture shoulder arthroplasty in treatment of the following:
- Complex 3- and 4- part fractures of the proximal humerus with subluxation of the head fragment
- Complex 3- and 4- part fractures of the proximal humerus with loosening of the spongiosa in the head fragment
- Complex 3- and 4- part fractures of the proximal humerus with additional cross split of the head fragment
Show all 9Show fewer
- Fracture instability after osteosynthesis of 3- and 4-part fracture fragments of the proximal humerus
- Posttraumatic necrosis of the humeral head
- Posttraumatic arthrosis after humeral head fracture
Who cannot join
- Patients who are unwilling or unable to give consent, not willing to return for study required follow-up visits and/or to comply with the follow-up program.
- The patient is known to be pregnant or breastfeeding
- Patients who have any condition that would in the judgment of the Investigator place the patient at undue risk or interfere with the study.
- Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant).
- Patients with plans to relocate during the study follow-up period
- Signs of infection
- Extensive stiffening of the shoulder joint without pain
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Salamenca University Hospital
Salamanca, 37007
Alberto Moreno, Dr
Alberto Moreno, Dr
About this study
Official title: Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Anatomical Shoulderᵀᴹ 2.0 Fracture System (Implants and Instrumentation) - A Retrospective and Prospective Consecutive Series Study
The study is a multicenter, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect long-term data confirming safety, performance and clinical benefits of the Anatomical Shoulder 2.0 Fracture System (Implants and Instrumentation) when used for fracture shoulder arthroplasty. The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcome measures (PROMs) as well as radiographic outcomes.
Read the detailed description
The Anatomical Shoulder 2.0 Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total, hemi and fracture shoulder arthroplasty. The system is intended for long-term implantation into the human shoulder joint to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.
Two sites will be involved in this study. The aim is to include a total of 78 consecutive series cases who received the Anatomical Shoulder 2.0 Fracture starting from 2014. All potential study subjects will be required to participate in the Informed Consent Process.
Baseline data from the preop, intraop and immediate post-op intervals will be available in medical notes and collected retrospectively. During follow-up visits at 1, 3, 5, 7 and 10 years post-op (depending on patients' date of surgery), the patient will be asked to complete patient questionnaires. Moreover, a clinical assessment and a radiographic evaluation will be conducted. In addition, any complications and adverse events will also be collected during these follow-up visits.
- Conditions
- Proximal Humerus Fracture, Posttraumatic Arthrosis After Humeral Head Fracture, Posttraumatic Necrosis of the Humeral Head
- Keywords
- Post-Market Clinical Follow-Up Study, Medical Device, Performance, Safety, Clinical Benefits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who received the Anatomical Shoulder 2.0 Fracture | Anatomical Shoulder 2.0 Fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and frequency of revisions [Product safety based on implant survivorship]
Safety will be assessed by recording and analyzing the incidence and frequency of revisions, complications and adverse events. A Kaplan Meier survival curve will be calculated.
Measured: 3-10 years
Secondary outcomes (4)
Constant and Murley Score
The Constant and Murley score is a 100-point functional shoulder assessment tool in which higher scores reflect increased function. The subjective variables are pain (15 points) and function (activities of daily living - sleep, work, recreation/sport; 20 points), for a total of 35 points. The objective variables are active range of motion (clinician assessment; 40 points) and strength (25 points), for a total of 65 points.
Measured: 3-10 years
Oxford Shoulder Score
The OSS is a self-assessment of shoulder pain and function with 12 items; pain (2), interference with pain (2), and daily functions (8). Each response is answered with a five point Likert scale. The total score is the sum of the 12 items, with lower scores indicating a more favorable outcome.
Measured: 3-10 years
EuroQol Five Dimensions Questionnaire
The EQ-5D measures 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with a total of 5 questions. It is accompanied by the patient's self-assessment with the VAS.
Each dimension is assigned one of three discrete levels for evaluation on the day of administration:
Level 1 - No problems, no disability Level 2 - Some problems, moderate disability Level 3 - A lot of problems, severe disability
The final score is a five digit composite of the responses ranging between 33333 - 11111 with 243 possible combinations in between
Measured: 3-10 years
X-rays
Performance and clinical benefits will be assessed by radiographic evaluation. Radiographs (A/P and axillary view) of the operated shoulder will be taken at each interval.
Measured: 3-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start7 Jul 2022
- Primary completion21 Jan 2034 (estimated)
- Study completion21 Jan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Humerus 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hassan Achakri, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351112
- Sponsor's protocol ID
- MDRG2017-89MS-44E
- Status last verified
- Aug 2025
- First submitted
- 17 Feb 2022
- Last updated
- 17 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Anatomical Shoulderᵀᴹ 2.0 Fracture System (Implants and Instrumentation) - A Retrospective and Prospective Consecutive Series Study
- ClinicalTrials.gov ID
- NCT05351112
- Acronym / sponsor ID
- MDRG2017-89MS-44E
- Conditions
- Proximal Humerus Fracture, Posttraumatic Arthrosis After Humeral Head Fracture, Posttraumatic Necrosis of the Humeral Head
- Keywords
- Post-Market Clinical Follow-Up Study, Medical Device, Performance, Safety, Clinical Benefits
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 21 Jan 2034 (estimated)
- Study completion
- 21 Jan 2034 (estimated)
- First posted
- 28 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.
The study is a multicenter, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect long-term data confirming safety, performance and clinical benefits of the Anatomical Shoulder 2.0 Fracture System (Implants and Instrumentation) when used for fracture shoulder arthroplasty. The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcome measures (PROMs) as well as radiographic outcomes.
Detailed description
The Anatomical Shoulder 2.0 Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total, hemi and fracture shoulder arthroplasty. The system is intended for long-term implantation into the human shoulder joint to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.
Two sites will be involved in this study. The aim is to include a total of 78 consecutive series cases who received the Anatomical Shoulder 2.0 Fracture starting from 2014. All potential study subjects will be required to participate in the Informed Consent Process.
Baseline data from the preop, intraop and immediate post-op intervals will be available in medical notes and collected retrospectively. During follow-up visits at 1, 3, 5, 7 and 10 years post-op (depending on patients' date of surgery), the patient will be asked to complete patient questionnaires. Moreover, a clinical assessment and a radiographic evaluation will be conducted. In addition, any complications and adverse events will also be collected during these follow-up visits.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who received the Anatomical Shoulder 2.0 Fracture | – | –Anatomical Shoulder 2.0 Fracture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be comprised of a consecutive series of cases implanted with the Anatomical Shoulder 2.0 Fracture System according to Zimmer Biomet's Instruction for Use (IFU) and who meet the inclusion criteria and none of the exclusion criteria.
Key inclusion criteria (9 listed)
- Patients 18 years or older and skeletally mature
- Patients capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study
- Replacement of the proximal humerus and the glenoid articular surface of the scapula during total-, hemi- and fracture shoulder arthroplasty in treatment of the following:
Key exclusion criteria (7 listed)
- Patients who are unwilling or unable to give consent, not willing to return for study required follow-up visits and/or to comply with the follow-up program.
- The patient is known to be pregnant or breastfeeding
- Patients who have any condition that would in the judgment of the Investigator place the patient at undue risk or interfere with the study.
- Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant).
- Patients with plans to relocate during the study follow-up period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence and frequency of revisions [Product safety based on implant survivorship]
Time frame: 3-10 years
Safety will be assessed by recording and analyzing the incidence and frequency of revisions, complications and adverse events. A Kaplan Meier survival curve will be calculated.
4 secondary outcomes
Constant and Murley Score
Time frame: 3-10 years
Oxford Shoulder Score
Time frame: 3-10 years
EuroQol Five Dimensions Questionnaire
Time frame: 3-10 years
X-rays
Time frame: 3-10 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 17 Aug 2025.
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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.
Hassan Achakri study director
Zimmer Biomet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proximal Humerus Fracture and Posttraumatic Arthrosis After Humeral Head Fracture, run by Zimmer Biomet at 1 site in Spain.
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 9 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Contact Julie Nicoux (+33 06 72 61 35 02, julie.nicoux@zimmerbiomet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and frequency of revisions [Product safety based on implant survivorship] (time frame: 3-10 years). 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 17 Aug 2025.