Humeral Fracture, ProximalNCT03358784
Comparison of Hemi-shoulder Arthroplasty and PHILOS in Treating Three or Four-part Fractures of Proximal Humerus
An observational study of Humeral Fracture, Proximal, run by Peking University People's Hospital.
Trial summary
To explore clinical effectiveness of PHILOS plate fixation and hemi-shoulder arthroplasty in treating three or four-part fractures of proximal humerus Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Humeral Fracture, Proximal
- What is being tested?
- Hemi-shoulder Arthroplasty and PHILOS Plate
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 5 Mar 2018to 1 Mar 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 to 85 years
- All sexes
- Adult, Older adult
Study population: patients with three or four part fractures of proximal humerus, who agreed to receive surgery.
Who may be able to join
- three or four part fractures of proximal humerus
Who cannot join
- Severe comminuted fractures of proximal humerus
- past history of injured-side shoulder surgery
- Patients who cannot tolerate surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multi-center Study on Comparison of Hemi-shoulder Arthroplasty and PHILOS in Treating Three or Four-part Fractures of Proximal Humerus.
To explore clinical effectiveness of PHILOS plate fixation and hemi-shoulder arthroplasty in treating three or four-part fractures of proximal humerus
Read the detailed description
From April 2015 and April 2017, patients from multi-center aged over 60 years old with three and four-part fractures of proximal humerus were treated with Proximal Humerus Internal Locking System(PHILOS) and hemi-shoulder arthroplasty in multi-center. All the patients received the same rehabilitation course. At 6 months after surgery, postoperative complications were observed, EQ-5D was used to evaluate quality of life, and ASES score was used to assess functional outcomes.
- Conditions
- Humeral Fracture, Proximal
- Being tested
- Hemi-shoulder Arthroplasty, PHILOS Plate
- Keywords
- Humeral Fractures, Proximal, Arthroplasty, Shoulder Replacement, Bone Plates
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemi-shoulder ArthroplastyProcedure or surgery
Hemi-shoulder Arthroplasty treating three or four-part fractures of proximal humerus
PHILOS PlateProcedure or surgery
PHILOS plate treating three or four-part fractures of proximal humerus
| Study group | Role | What they receive |
|---|---|---|
| PHILOS Plate | three or four-part fractures of proximal humerus treated with internal fixation Receives: Procedure: PHILOS Plate | |
| Hemi-shoulder arthroplasty | three or four-part fractures of proximal humerus treated with hemi-shoulder arthroplasty Receives: Procedure: Hemi-shoulder Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Postoperative complications were observed
Measured: 6 months after surgery
Secondary outcomes (2)
EQ-5D
EQ-5D was used to evaluate quality of life
Measured: 6 months after surgery
ASES score
ASES was used to assess functional outcomes
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start5 Mar 2018 (estimated)
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humeral Fracture, ProximalStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Peixun, Peking University People's Hospital
- Investigators
- Peixun Zhang, MD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358784
- Sponsor's protocol ID
- PUPH2017PHF
- Status last verified
- Nov 2017
- First submitted
- 26 Nov 2017
- Last updated
- 2 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Study on Comparison of Hemi-shoulder Arthroplasty and PHILOS in Treating Three or Four-part Fractures of Proximal Humerus.
- ClinicalTrials.gov ID
- NCT03358784
- Acronym / sponsor ID
- PUPH2017PHF
- Conditions
- Humeral Fracture, Proximal
- Keywords
- Humeral Fractures, Proximal, Arthroplasty, Shoulder Replacement, Bone Plates
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 5 Mar 2018 (estimated)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 2 Dec 2017 (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.
To explore clinical effectiveness of PHILOS plate fixation and hemi-shoulder arthroplasty in treating three or four-part fractures of proximal humerus
Detailed description
From April 2015 and April 2017, patients from multi-center aged over 60 years old with three and four-part fractures of proximal humerus were treated with Proximal Humerus Internal Locking System(PHILOS) and hemi-shoulder arthroplasty in multi-center. All the patients received the same rehabilitation course. At 6 months after surgery, postoperative complications were observed, EQ-5D was used to evaluate quality of life, and ASES score was used to assess functional outcomes.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PHILOS Plate | – | Procedure: PHILOS Platethree or four-part fractures of proximal humerus treated with internal fixation |
| Hemi-shoulder arthroplasty | – | Procedure: Hemi-shoulder Arthroplastythree or four-part fractures of proximal humerus treated with hemi-shoulder arthroplasty |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with three or four part fractures of proximal humerus, who agreed to receive surgery.
Key inclusion criteria (1 listed)
- three or four part fractures of proximal humerus
Key exclusion criteria (3 listed)
- Severe comminuted fractures of proximal humerus
- past history of injured-side shoulder surgery
- Patients who cannot tolerate surgery
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 |
|---|---|---|
| Hemi-shoulder ArthroplastyHemi-shoulder Arthroplasty treating three or four-part fractures of proximal humerus | Procedure or surgery | Hemi-shoulder arthroplasty |
| PHILOS PlatePHILOS plate treating three or four-part fractures of proximal humerus | Procedure or surgery | PHILOS Plate |
Primary outcome
Postoperative complications
Time frame: 6 months after surgery
Postoperative complications were observed
2 secondary outcomes
EQ-5D
Time frame: 6 months after surgery
ASES score
Time frame: 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- 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.
Peixun Zhang, MD principal investigator
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Humeral Fracture, Proximal, run by Peking University People's Hospital.
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 1 inclusion and 3 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 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Yichong Zhang, MD (15210802766, 875274428@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: 6 months after surgery). 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 2 Dec 2017.