Shoulder FracturesNCT02944058
Plate Fixation Versus Intramedullary Nailing of 3 and 4 Part Proximal Humerus Fractures
A study testing Multiloc nail and Philos plate in people with Shoulder Fractures and Humeral Fractures, Proximal, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
The purpose of the project is to compare the management of 3 and 4 part proximal humerus fractures (PHF) with an angular stable plate (Philos) with that of an intramedullary nail (Multiloc) in light of complications, radiological, economical, functional and clinical outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Fractures, Humeral Fractures, Proximal
- What is being tested?
- Multiloc nail and Philos plate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2016to 25 Oct 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 18 years
- Severe displacement, defined as malposition of at least 45⁰ of angular deviation in valgus or 30⁰ in varus in true frontal projection, regardless of whether the fracture is impacted or not. Fractures with more than 50% displacement of the head against the surgical neck
- The greater or lesser tubercles must be fractured in a 3 or 4-part fracture. The degree of displacement is not critical for inclusion.
Who cannot join
- Fracture more than 3 weeks' old
- Caput humeri just a thin shell or split
- Ipsilateral damage that will influence the recovery and scoring systems
- Incapability to protect osteosynthesis, i.e. use of crutches because of injury to lower extremity.
- Pathological fracture
- Neurovascular injury
Show all 17Show fewer
- Open fracture
- Noncompliance
- Congenital anomaly
- Ongoing infectious process around the incision site for plate osteosynthesis
- Systemic disease that may influence healing processes or scoring systems (RA/MS)
- Fracture dislocation
- Substance abuse
- Inability to read and understand Norwegian
- Patients not residing in our catchment area
- Patients with too small humerus diameter to use a nail
- Patient not able to commit and understand written consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Plate Fixation Versus Intramedullary Nailing of 3 and 4 Part Proximal Humerus Fractures. A RCT
The purpose of the project is to compare the management of 3 and 4 part proximal humerus fractures (PHF) with an angular stable plate (Philos) with that of an intramedullary nail (Multiloc) in light of complications, radiological, economical, functional and clinical outcome.
Read the detailed description
Randomized controlled trial (RCT) from Akershus University Hospital in Norway. Randomization between two implants. The investigators will use deltopectoral or deltoid split as surgical access. All patients will have calcar screws and cuff sutures. When lack of bone for example after decompressing valgus compressed fractures, a bone-substitute might be used in the surgeons preference. Follow up in outpatient clinic at 6, 12, 52 and 104 weeks, but also a 5 year follow up is planned. Postoperative radiographs of both shoulders and CT of operated shoulder will be taken.
- Conditions
- Shoulder Fractures, Humeral Fractures, Proximal
- Being tested
- Multiloc nail, Philos plate
- Keywords
- Multiloc, Philos, Locking plate, Straight nail, Randomized controlled trial, 3 and 4 part fractures
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiloc nailProcedure or surgery
Intervention is surgery with Multiloc nail
Philos plateProcedure or surgery
Intervention is surgery with Philos plate
| Study group | Role | What they receive |
|---|---|---|
| Philos plate | Active comparator | Intervention is surgery with Philos plate Receives: Procedure: Philos plate |
| Multiloc nail | Active comparator | Intervention is surgery with Multiloc nail Receives: Procedure: Multiloc nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Disabilities of the Arm, Shoulder and Hand (DASH) Score (questionnaire) Disability of the arm, shoulder and arm score (DASH score)
Quick Dash (questionnaire) the first 6 weeks after surgery, then DASH score (questionnaire for patients to fill out) in follow ups
Measured: 5 years
Secondary outcomes (4)
Constant score (questionnaire)
A questionnaire for the doctor or the physiotherapist to fill out, including registration of: Pain, Power, Range of motion and ADL (x/100, where 100 is best score)
Measured: 5years
Radiological complications
Plate cutout, Nail migration, screw cutout, Reduction of Head shaft angle (HSA)/ Varus subsidence,
Measured: 5 years
Complications
Infection, Avascular necrosis, thrombosis, nerve compression or damage, Pseudoarthrosis
Measured: 5 years
Health economy
Registration of visits to doctor, physiotherapist, sick leave, re-operations
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion24 Oct 2023 (estimated)
- Study completion25 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asbjorn Aroen, University Hospital, Akershus
- Investigators
- Asbjorn AAroen, PhD MD, Study director, Akershus University Hospital, orthopedic unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944058
- Sponsor's protocol ID
- 2016/626
- Status last verified
- Aug 2023
- First submitted
- 17 Oct 2016
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study completion
Publications
Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
PubMed 35727196
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plate Fixation Versus Intramedullary Nailing of 3 and 4 Part Proximal Humerus Fractures. A RCT
- ClinicalTrials.gov ID
- NCT02944058
- Acronym / sponsor ID
- 2016/626
- Conditions
- Shoulder Fractures, Humeral Fractures, Proximal
- Keywords
- Multiloc, Philos, Locking plate, Straight nail, Randomized controlled trial, 3 and 4 part fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- 24 Oct 2023 (estimated)
- Study completion
- 25 Oct 2025 (estimated)
- First posted
- 25 Oct 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.
The purpose of the project is to compare the management of 3 and 4 part proximal humerus fractures (PHF) with an angular stable plate (Philos) with that of an intramedullary nail (Multiloc) in light of complications, radiological, economical, functional and clinical outcome.
Detailed description
Randomized controlled trial (RCT) from Akershus University Hospital in Norway. Randomization between two implants. The investigators will use deltopectoral or deltoid split as surgical access. All patients will have calcar screws and cuff sutures. When lack of bone for example after decompressing valgus compressed fractures, a bone-substitute might be used in the surgeons preference. Follow up in outpatient clinic at 6, 12, 52 and 104 weeks, but also a 5 year follow up is planned. Postoperative radiographs of both shoulders and CT of operated shoulder will be taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Philos plate | Active comparator | Procedure: Philos plateIntervention is surgery with Philos plate |
| Multiloc nail | Active comparator | Procedure: Multiloc nailIntervention is surgery with Multiloc nail |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients > 18 years
- Severe displacement, defined as malposition of at least 45⁰ of angular deviation in valgus or 30⁰ in varus in true frontal projection, regardless of whether the fracture is impacted or not. Fractures with more than 50% displacement of the head against the surgical neck
- The greater or lesser tubercles must be fractured in a 3 or 4-part fracture. The degree of displacement is not critical for inclusion.
Key exclusion criteria (17 listed)
- Fracture more than 3 weeks' old
- Caput humeri just a thin shell or split
- Ipsilateral damage that will influence the recovery and scoring systems
- Incapability to protect osteosynthesis, i.e. use of crutches because of injury to lower extremity.
- Pathological fracture
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 |
|---|---|---|
| Multiloc nailIntervention is surgery with Multiloc nail | Procedure or surgery | Multiloc nail |
| Philos plateIntervention is surgery with Philos plate | Procedure or surgery | Philos plate |
Primary outcome
The Disabilities of the Arm, Shoulder and Hand (DASH) Score (questionnaire) Disability of the arm, shoulder and arm score (DASH score)
Time frame: 5 years
Quick Dash (questionnaire) the first 6 weeks after surgery, then DASH score (questionnaire for patients to fill out) in follow ups
4 secondary outcomes
Constant score (questionnaire)
Time frame: 5years
Radiological complications
Time frame: 5 years
Complications
Time frame: 5 years
Health economy
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Derived from this study: PubMed 35727196Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study completion
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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.
Asbjorn AAroen, PhD MD study director
Akershus University Hospital, orthopedic unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiloc nail and Philos plate in people with Shoulder Fractures and Humeral Fractures, Proximal, run by University Hospital, Akershus at 1 site in Norway.
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 3 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 15 Aug 2023. 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 Norway. 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?
Results are not available in the source record.
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?
The Disabilities of the Arm, Shoulder and Hand (DASH) Score (questionnaire) Disability of the arm, shoulder and arm score (DASH score) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02944058, which also lists 1 linked publication.
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 15 Aug 2023.