Implant ComplicationNCT04622852
Pegs for Osteofixation of Proximal Humeral Fractures
An observational study of Implant Complication and Proximal Humeral Fracture, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Patients treated operative for Proximal humeral fractures with angular stable device (Philos plate or ALPS-PHP) Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Implant Complication, Proximal Humeral Fracture, Avascular Necrosis of Humerus
- What is being tested?
- Open reduction internal fixation (ORIF) with an angular stable plate
- Type of treatment
- Medical device
- How many people
- 38 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jul 2017to 1 Aug 2021
- 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 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to hospital with an acute PHF for surgical treatment
Who may be able to join
- Acute proximal humeral fracture
- AO/OTA type 11-B2 or 11C2
Who cannot join
- Not eligible to surgical treatment
- Non-compliant
- Former shoulder fracture or symptomatic shoulder illness
- Drug abuser
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Are Pegs Better Than Screw for Osteofixation of Proximal Humeral Fractures?
Patients treated operative for Proximal humeral fractures with angular stable device (Philos plate or ALPS-PHP)
Read the detailed description
From a cohort of patients treated for displaced Proximal humeral fractures (PHF) in the period July 2017 - August 2019 patients with the 11-B2 and 11-C2 PHF according to AO/OTA 2007 fracture classification were selected according to age and gender to be compared with patients operated with a Philos plate within the same fracture group, age and gender to be matched for adverse events:
- Radiographic evidence of penetration of pegs (ALPS-PHP) or screws (Philos) into the glenohumeral joint (primary outcome) and
- Avascular head necrosis / sinking / need of re-surgery
- Clinical PROMS
- Being tested
- Open reduction internal fixation (ORIF) with an angular stable plate
- Keywords
- Humeral head, Screw penetration, Peg penetration, Avascular necrosis
- Medical subject headings
- Shoulder Fractures, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open reduction internal fixation (ORIF) with an angular stable plateDevice
Operative treatment of proximal humeral fracture
| Study group | Role | What they receive |
|---|---|---|
| Group A: ALPS-PHP device | Patients operated with angular stable plate for displaced PHF with an ALPS plate Receives: Device: Open reduction internal fixation (ORIF) with an angular stable plate | |
| Group B: Philos device | Patients operated with angular stable plate for displaced PHF with a Philos plate Receives: Device: Open reduction internal fixation (ORIF) with an angular stable plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peg penetration into glenohumeral joint
Radiographic or CT verified peg penetration
Measured: 12 months
Screw penetration into glenohumeral joint
Radiographic or CT verified screw penetration
Measured: 12 months
Secondary outcomes (4)
Humeral head deformation
Avascular head necrosis or Sinking
Measured: 12 months
Shoulder function
Constant-Murley score
Measured: 12 months
Self reported shoulder function
Oxford scoulder score
Measured: 12 months
Quality of life
Generic 15D score
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 posted10 Nov 2020
- Study start1 Jul 2017
- Primary completion1 Sep 2020
- Study completion1 Aug 2021
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 Implant ComplicationStudies of the same condition, open and under way.
- More trials run by Oslo University 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tore Fjalestad, Oslo University Hospital
- Investigators
- Tore Fjalestad, MD, PhD., Principal investigator, Oslo University Hospital, Ortophaedic Dept.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622852
- Sponsor's protocol ID
- 2017/681
- Status last verified
- Sep 2021
- First submitted
- 3 Nov 2020
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No plan has been decided
Publications
Bones I, Karlberg AC, Liljeholm M, Fraser AN, Madsen JE, Fjalestad T. Pegs not superior to screws for fixation of fractures of the proximal humerus. J Orthop Surg Res. 2022 Feb 2;17(1):66. doi: 10.1186/s13018-022-02947-3.
PubMed 35109905
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Pegs Better Than Screw for Osteofixation of Proximal Humeral Fractures?
- ClinicalTrials.gov ID
- NCT04622852
- Acronym / sponsor ID
- 2017/681
- Keywords
- Humeral head, Screw penetration, Peg penetration, Avascular necrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 10 Nov 2020 (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.
Patients treated operative for Proximal humeral fractures with angular stable device (Philos plate or ALPS-PHP)
Detailed description
From a cohort of patients treated for displaced Proximal humeral fractures (PHF) in the period July 2017 - August 2019 patients with the 11-B2 and 11-C2 PHF according to AO/OTA 2007 fracture classification were selected according to age and gender to be compared with patients operated with a Philos plate within the same fracture group, age and gender to be matched for adverse events:
- Radiographic evidence of penetration of pegs (ALPS-PHP) or screws (Philos) into the glenohumeral joint (primary outcome) and
- Avascular head necrosis / sinking / need of re-surgery
- Clinical PROMS
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: ALPS-PHP device | – | Device: Open reduction internal fixation (ORIF) with an angular stable platePatients operated with angular stable plate for displaced PHF with an ALPS plate |
| Group B: Philos device | – | Device: Open reduction internal fixation (ORIF) with an angular stable platePatients operated with angular stable plate for displaced PHF with a Philos plate |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to hospital with an acute PHF for surgical treatment
Key inclusion criteria (2 listed)
- Acute proximal humeral fracture
- AO/OTA type 11-B2 or 11C2
Key exclusion criteria (4 listed)
- Not eligible to surgical treatment
- Non-compliant
- Former shoulder fracture or symptomatic shoulder illness
- 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 |
|---|---|---|
| Open reduction internal fixation (ORIF) with an angular stable plateOperative treatment of proximal humeral fracture | Device | Group A: ALPS-PHP device, Group B: Philos device |
Primary outcome
Peg penetration into glenohumeral joint
Time frame: 12 months
Radiographic or CT verified peg penetration
Screw penetration into glenohumeral joint
Time frame: 12 months
Radiographic or CT verified screw penetration
4 secondary outcomes
Humeral head deformation
Time frame: 12 months
Shoulder function
Time frame: 12 months
Self reported shoulder function
Time frame: 12 months
Quality of life
Time frame: 12 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 14 Sep 2021.
- Derived from this study: PubMed 35109905Bones I, Karlberg AC, Liljeholm M, Fraser AN, Madsen JE, Fjalestad T. Pegs not superior to screws for fixation of fractures of the proximal humerus. J Orthop Surg Res. 2022 Feb 2;17(1):66. doi: 10.1186/s13018-022-02947-3.
- Individual participant dataSharing planned: Undecided. No plan has been decided
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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.
Tore Fjalestad, MD, PhD. principal investigator
Oslo University Hospital, Ortophaedic Dept.
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 Implant Complication and Proximal Humeral Fracture, run by Oslo University Hospital 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 2 inclusion and 4 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 14 Sep 2021. 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?
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?
Peg penetration into glenohumeral joint (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT04622852, 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 14 Sep 2021.