Distal Humerus FractureNCT04163172
Elbow Hemiarthroplasty Versus ORIF for Distal Humeral Fractures
A study testing Surgical treatment of distal humeral fracture with elbow hemiarthroplasty and Surgical treatment of distal humeral fracture with double plating. in people with Distal Humerus Fracture and Comminuted Fracture, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial summary
This is a randomized control trial comparing the outcome of ORIF (open reduction and internal fixation) with EHA (elbow hemiarthroplasty) for distal humeral fractures in patients aged 50 years or above. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Distal Humerus Fracture, Comminuted Fracture, Intra-Articular Fractures
- What is being tested?
- Surgical treatment of distal humeral fracture with elbow hemiarthroplasty and Surgical treatment of distal humeral fracture with double plating.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2020to 31 Dec 2032
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Distal humeral fracture AO/OTA type C2 or C3 confirmed by plain radiographs with 2 perpendicular views and CT scan.
- ASA score 1-3 and physically fit for surgery.
- Age of 50 years or above.
Who cannot join
- Patients unable to follow the rehabilitation protocol or answer the Danish questionnaires because of physical or cognitive inabilities as evaluated by the recruiting surgeon.
- Significant elbow osteoarthritis as evaluated by the recruiting surgeon based on plain radiographs and CT scan.
- Fractures that are older than 6 weeks.
- Other associated elbow fractures.
- Pathological fractures or relevant elbow pathology.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Herlev and Gentofte University Hospital
Copenhagen
Ali Al-Hamdani, MD
About this study
Official title: Elbow Hemiarthroplasty Versus Open Reduction and Internal Fixation for AO/OTA Type C2 and C3 Fractures of Distal Humerus in Patients Aged 50 Years or Above; a Randomized Controlled Trial
This is a randomized control trial comparing the outcome of ORIF (open reduction and internal fixation) with EHA (elbow hemiarthroplasty) for distal humeral fractures in patients aged 50 years or above.
Read the detailed description
Intraarticular distal humeral fractures AO/OTA type C2 and C3 pose a surgical challenge despite the evolution of surgical implants and techniques. Open reduction and internal fixation (ORIF) is often preferred as the first choice of treatment, but the results are varying, and sometimes disappointing. Total elbow arthroplasty (TEA) has been widely used for fractures that are not amenable to ORIF in elderly patients, but the mechanical complications remain a challenge, especially in active patients. Elbow hemiarthroplasty (EHA) provides a modern alternative that might avoid the mechanical complications and weight bearing restrictions related to the linked articulation in semiconstrained TEA. There are no studies comparing the results of EHA to that of TEA or ORIF, but case series have reported promising results.
In this study, forty-four patients with AO/OTA type C2 or C3 fractures of distal humerus will be randomized to either ORIF or EHA. The patients will be examined after the operation and at 3 months and 1, 2, 5 and 10 years after the surgery. The main objective of this study is to investigate the best treatment option for distal humeral fractures in patients aged 50 years or above. This can be of value to future patients sustaining these complicated fractures.
- Being tested
- Surgical treatment of distal humeral fracture with elbow hemiarthroplasty, Surgical treatment of distal humeral fracture with double plating.
- Medical subject headings
- Humeral Fractures, Distal, Fractures, Comminuted, Intra-Articular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical treatment of distal humeral fracture with elbow hemiarthroplastyProcedure or surgery
Latitude anatomical elbow hemiarthroplasty (WRIGHT -Memphis, Tennessee)
Surgical treatment of distal humeral fracture with double plating.Procedure or surgery
Double plating (Synthes - Switzerland and West Chester, Pennsylvania, United States)
| Study group | Role | What they receive |
|---|---|---|
| Elbow hemiarthroplasty | Active comparator | The Latitude anatomical hemiarthroplasty (WRIGHT -Memphis, Tennessee) for distal humeral fractures. Receives: Procedure: Surgical treatment of distal humeral fracture with elbow hemiarthroplasty |
| Open reduction and internal fixation | Active comparator | Double plating (Synthes - Switzerland and West Chester, Pennsylvania, United States) for distal humeral fractures. Receives: Procedure: Surgical treatment of distal humeral fracture with double plating. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Elbow Score (OES)
The OES is a 12-item patient-administrated questionnaire that measures the quality of life in patients with elbow disorder. There are three unidimensional domains: Elbow function, pain, and social-psychological status. Each question is answered on a 5-point scale with each question contributing equally to the total score.Thus, the total score ranges from 12-60, with 60 being the worst. For ease of presentation the score is converted to a scale from 0-48 with 48 being the best. The outcome can be interpreted based on a 48-point scale: 0 - 19 - poor; 20-29 - fair; 30-39 - good; and 40-48 - excellent. The Danish version which will be used in this study, has been translated and cultural adapted according to the guidelines by Guillemin, Bombardier and Beaton.
Measured: 2 years after surgery.
Secondary outcomes (4)
Mayo Elbow Performance Score (MEPS)
The MEPS is a surgeon-administrated instrument that evaluates the outcome after elbow surgery. There are four domains including: Pain (0-45 points), range of motion (0-20 points), stability (0-10 points) and difficulties in daily activities (0-25 points).The outcome can be interpreted based on a 100 points scale: 0 - 60 - poor; 60-74 - fair; 75-89 - good; and 90-100 - excellent.
Measured: 3 months after surgery and 1, 2, 5, and 10 years after surgery.
Pain severity score (VAS)
Pain is answered on a visual analogue scale (VAS) ranging from 0 to 10, with 10 being the worst and 0 represents a pain free elbow.
Measured: 3 months after surgery and 1, 2, 5, and 10 years after surgery.
Range of motion
Measuring the flexion/extension and supination/pronation arcs in degrees.
Measured: 3 months after surgery and 1, 2, 5, and 10 years after surgery.
Patients satisfaction
Patients satisfaction of the treatment will be recorded using 5-items score with 1 being the worst and 5 represents a very satisfied patient.
Measured: 3 months after surgery and 1, 2, 5, and 10 years after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start1 Feb 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2032 (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 Distal Humerus FractureStudies 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
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Al-Hamdani, Herlev and Gentofte Hospital
- Investigators
- Ali Al-Hamdani, MD, Principal investigator, Herlev and Gentofte University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163172
- Sponsor's protocol ID
- EVORI
- Status last verified
- Oct 2023
- First submitted
- 31 Oct 2019
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Hamdani A, Rasmussen JV, Holtz K, Olsen BS. Elbow hemiarthroplasty versus open reduction and internal fixation for AO/OTA type 13 C2 and C3 fractures of distal humerus in patients aged 50 years or above: a randomized controlled trial. Trials. 2020 Jun 8;21(1):497. doi: 10.1186/s13063-020-04418-8.
PubMed 32513252
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elbow Hemiarthroplasty Versus Open Reduction and Internal Fixation for AO/OTA Type C2 and C3 Fractures of Distal Humerus in Patients Aged 50 Years or Above; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04163172
- Acronym / sponsor ID
- EVORI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 14 Nov 2019 (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.
This is a randomized control trial comparing the outcome of ORIF (open reduction and internal fixation) with EHA (elbow hemiarthroplasty) for distal humeral fractures in patients aged 50 years or above.
Detailed description
Intraarticular distal humeral fractures AO/OTA type C2 and C3 pose a surgical challenge despite the evolution of surgical implants and techniques. Open reduction and internal fixation (ORIF) is often preferred as the first choice of treatment, but the results are varying, and sometimes disappointing. Total elbow arthroplasty (TEA) has been widely used for fractures that are not amenable to ORIF in elderly patients, but the mechanical complications remain a challenge, especially in active patients. Elbow hemiarthroplasty (EHA) provides a modern alternative that might avoid the mechanical complications and weight bearing restrictions related to the linked articulation in semiconstrained TEA. There are no studies comparing the results of EHA to that of TEA or ORIF, but case series have reported promising results.
In this study, forty-four patients with AO/OTA type C2 or C3 fractures of distal humerus will be randomized to either ORIF or EHA. The patients will be examined after the operation and at 3 months and 1, 2, 5 and 10 years after the surgery. The main objective of this study is to investigate the best treatment option for distal humeral fractures in patients aged 50 years or above. This can be of value to future patients sustaining these complicated fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elbow hemiarthroplasty | Active comparator | Procedure: Surgical treatment of distal humeral fracture with elbow hemiarthroplastyThe Latitude anatomical hemiarthroplasty (WRIGHT -Memphis, Tennessee) for distal humeral fractures. |
| Open reduction and internal fixation | Active comparator | Procedure: Surgical treatment of distal humeral fracture with double plating.Double plating (Synthes - Switzerland and West Chester, Pennsylvania, United States) for distal humeral fractures. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Distal humeral fracture AO/OTA type C2 or C3 confirmed by plain radiographs with 2 perpendicular views and CT scan.
- ASA score 1-3 and physically fit for surgery.
- Age of 50 years or above.
Key exclusion criteria (5 listed)
- Patients unable to follow the rehabilitation protocol or answer the Danish questionnaires because of physical or cognitive inabilities as evaluated by the recruiting surgeon.
- Significant elbow osteoarthritis as evaluated by the recruiting surgeon based on plain radiographs and CT scan.
- Fractures that are older than 6 weeks.
- Other associated elbow fractures.
- Pathological fractures or relevant elbow pathology.
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 |
|---|---|---|
| Surgical treatment of distal humeral fracture with elbow hemiarthroplastyLatitude anatomical elbow hemiarthroplasty (WRIGHT -Memphis, Tennessee) | Procedure or surgery | Elbow hemiarthroplasty |
| Surgical treatment of distal humeral fracture with double plating.Double plating (Synthes - Switzerland and West Chester, Pennsylvania, United States) | Procedure or surgery | Open reduction and internal fixation |
Primary outcome
Oxford Elbow Score (OES)
Time frame: 2 years after surgery.
The OES is a 12-item patient-administrated questionnaire that measures the quality of life in patients with elbow disorder. There are three unidimensional domains: Elbow function, pain, and social-psychological status. Each question is answered on a 5-point scale with each question contributing equally to the total score.Thus, the total score ranges from 12-60, with 60 being the worst. For ease of presentation the score is converted to a scale from 0-48 with 48 being the best. The outcome can be interpreted based on a 48-point scale: 0 - 19 - poor; 20-29 - fair; 30-39 - good; and 40-48 - excellent. The Danish version which will be used in this study, has been translated and cultural adapted according to the guidelines by Guillemin, Bombardier and Beaton.
4 secondary outcomes
Mayo Elbow Performance Score (MEPS)
Time frame: 3 months after surgery and 1, 2, 5, and 10 years after surgery.
Pain severity score (VAS)
Time frame: 3 months after surgery and 1, 2, 5, and 10 years after surgery.
Range of motion
Time frame: 3 months after surgery and 1, 2, 5, and 10 years after surgery.
Patients satisfaction
Time frame: 3 months after surgery and 1, 2, 5, and 10 years after surgery.
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 6 Oct 2023.
- Derived from this study: PubMed 32513252Al-Hamdani A, Rasmussen JV, Holtz K, Olsen BS. Elbow hemiarthroplasty versus open reduction and internal fixation for AO/OTA type 13 C2 and C3 fractures of distal humerus in patients aged 50 years or above: a randomized controlled trial. Trials. 2020 Jun 8;21(1):497. doi: 10.1186/s13063-020-04418-8.
- 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.
Ali Al-Hamdani, MD principal investigator
Herlev and Gentofte University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical treatment of distal humeral fracture with elbow hemiarthroplasty and Surgical treatment of distal humeral fracture with double plating. in people with Distal Humerus Fracture and Comminuted Fracture, run by Herlev and Gentofte Hospital at 1 site in Denmark.
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 5 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 6 Oct 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 Denmark. 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 Ali Al-Hamdani, MD (004538673276, ali.kuthayer.khalil.al-hamdani@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Elbow Score (OES) (time frame: 2 years after surgery.). 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 NCT04163172, 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 6 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.