Shoulder FracturesNCT02836366
Targon PH+ Follow-Up
An observational study of Shoulder Fractures, run by Aesculap AG at 1 site in Germany.
Trial summary
With this study results of the Targon® PH+ nail, developed for the treatment of humeral head fractures, will be investigated clinically, radiological evaluation is optional. The primary objective of this study is to examine the effect of a plating treatment on the speed of recovery of functional capacity in adult… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Shoulder Fractures
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2016to Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients
Who may be able to join
None listed.
Who cannot join
- multiple comorbidity
- multitrauma (Injury Severity Score > 15)
- prev. surgery on the injured shoulder
- severely deranged function caused by a previous disease head-split proximal humerus fracture
- combined humerus head and shaft fractures
- pseudarthroses
Show all 11Show fewer
- crushed head cap of the humerus head (AO 11 C3 fractures)
- isolated avulsion fracture of a tuberosity
- unwillingness or inability to follow protocol instructions and study requirements (follow-up visits)
- no signed informed consent
- treatment not in line with Instructions for Use (IfU)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Cohort Study of Proximal Humeral Fractures Treated With Targon® PH+
With this study results of the Targon® PH+ nail, developed for the treatment of humeral head fractures, will be investigated clinically, radiological evaluation is optional. The primary objective of this study is to examine the effect of a plating treatment on the speed of recovery of functional capacity in adult patients. Secondary aims are to examine the level of pain, patient satisfaction, shoulder function, quality of life, radiological evaluation and complications.
Targon PH+ is CE certified. The study is a non-interventional cohort study sponsored by Aesculap
- Conditions
- Shoulder Fractures
- Keywords
- Proximal humerus, Fracture, Nailing
- Medical subject headings
- Shoulder Fractures, Fractures, Bone
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity
The DASH score (Disabilities of the Arm, Shoulder, and Hand) will be used to determine the recovery of functional capacity. It provides a summary of the responses on a scale of 0 (no disability) to 100 (severe disability)
Measured: 24 months
Secondary outcomes (5)
Level of pain
10-point Visual Analogue Scale (VAS) from no pain (0) to most extreme pain imaginable (10)
Measured: 3, 12 and 24 months
Patient satisfaction
4 point scale: very satisfied, satisfied, unsatisfied, very unsatisfied
Measured: 24 months
Shoulder Function
Shoulder function outcome is measured with the Constant-Murley score, this score system combines shoulder function tests (65 points) with a subjective evaluation of the patients (35 points) including activities of daily living, level of work
Measured: 12 months, 24 months
Radiological outcome (only if it could be raised in clinical standard)
The X-rays are examined regarding adverse events as screw perforation, screw breakage, cut-out, re-dislocation of the fracture
Measured: 24 months
Adverse Events
Rate of Adverse Events, for example secondary interventions (revisions) that occur within the follow-up period
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder FracturesStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hermann Josef Bail, Prof. Dr., Principal investigator, Klinikum Nürnberg Süd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836366
- Sponsor's protocol ID
- AAG-O-H-1536
- Status last verified
- Jun 2019
- First submitted
- 10 Jun 2016
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Proximal Humeral Fractures Treated With Targon® PH+
- ClinicalTrials.gov ID
- NCT02836366
- Acronym / sponsor ID
- AAG-O-H-1536
- Conditions
- Shoulder Fractures
- Keywords
- Proximal humerus, Fracture, Nailing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- Mar 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 19 Jul 2016 (estimated)
- 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.
With this study results of the Targon® PH+ nail, developed for the treatment of humeral head fractures, will be investigated clinically, radiological evaluation is optional. The primary objective of this study is to examine the effect of a plating treatment on the speed of recovery of functional capacity in adult patients. Secondary aims are to examine the level of pain, patient satisfaction, shoulder function, quality of life, radiological evaluation and complications.
Targon PH+ is CE certified. The study is a non-interventional cohort study sponsored by Aesculap
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- multiple comorbidity
- multitrauma (Injury Severity Score > 15)
- prev. surgery on the injured shoulder
- severely deranged function caused by a previous disease head-split proximal humerus fracture
- combined humerus head and shaft fractures
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
Functional Capacity
Time frame: 24 months
The DASH score (Disabilities of the Arm, Shoulder, and Hand) will be used to determine the recovery of functional capacity. It provides a summary of the responses on a scale of 0 (no disability) to 100 (severe disability)
5 secondary outcomes
Level of pain
Time frame: 3, 12 and 24 months
Patient satisfaction
Time frame: 24 months
Shoulder Function
Time frame: 12 months, 24 months
Radiological outcome (only if it could be raised in clinical standard)
Time frame: 24 months
Adverse Events
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- 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.
Hermann Josef Bail, Prof. Dr. principal investigator
Klinikum Nürnberg Süd
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 Shoulder Fractures, run by Aesculap AG at 1 site in Germany.
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 0 inclusion and 11 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: finished, as of the sponsor's last update on 7 Jun 2019. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional Capacity (time frame: 24 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 7 Jun 2019.