Distal Humerus FractureNCT03596736
Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures
A study testing Elbow Hemiarthroplasty and Total Elbow Arthroplasty in people with Distal Humerus Fracture, run by Linkoeping University at 3 sites in Sweden.
Trial summary
Distal humeral fractures can be difficult to treat, in particular when the joint surface is affected (intra-articular fractures). If rigid internal fixation with plates and screws can be obtained it is considered to be the treatment of choice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Distal Humerus Fracture
- What is being tested?
- Elbow Hemiarthroplasty and Total Elbow Arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesSweden
- Study dates
- 19 Jan 2011to 31 Dec 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Intra-articular distal humeral fracture with two or more displaced joint surface fragments devoid of soft tissue attachment
- Osteopenia
- Fracture deemed unsuitable for internal fixation
- Low-energy trauma
- Closed fracture
- Independent living
Who cannot join
- Comorbidity that affects elbow rehabilitation considerably
- Severe pre-existing elbow disease
- Concurrent injury that affects elbow rehabilitation considerably
- Pathologic fracture
- Vascular injury
- Inability to participate in follow-up
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Sahlgrenska University Hospital
Gothenburg
Linköping University Hospital
Linköping
Varberg Hospital
Varberg
About this study
Official title: Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures. A Multicenter Randomized Controlled Trial
Distal humeral fractures can be difficult to treat, in particular when the joint surface is affected (intra-articular fractures). If rigid internal fixation with plates and screws can be obtained it is considered to be the treatment of choice. In elderly patients, poor bone quality (osteopenia) and fragmentation of the articular surface can make rigid internal fixation non-reliable or even impossible. Total elbow arthroplasty has been shown to be of value in this type of situation. Elbow hemiarthroplasty has been proposed as an alternative to total elbow arthroplasty. The theoretical advantages as opposed to total elbow arthroplasty are: no restriction in the weight allowed to be lifted, complications related to polyethylene wear debris are avoided as there is no polyethylene liner and there is no ulna component that can loosen. Wear of the native ulna and instability are potential complications of elbow hemiarthroplasty.
The aim of this multicenter study is to test the hypothesis that elbow hemiarthroplasty gives better elbow function than total elbow arthroplasty for irreparable distal humeral fractures.
- Conditions
- Distal Humerus Fracture
- Being tested
- Elbow Hemiarthroplasty, Total Elbow Arthroplasty
- Keywords
- Distal Humerus Fracture, Arthroplasty, Replacement, Elbow
- Medical subject headings
- Humeral Fractures, Distal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elbow HemiarthroplastyProcedure or surgery
Total Elbow ArthroplastyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Elbow Hemiarthroplasty | Experimental | Not described Receives: Procedure: Elbow Hemiarthroplasty |
| Total Elbow Arthroplasty | Active comparator | Not described Receives: Procedure: Total Elbow Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
The DASH questionnaire aims to assess symptoms and functional status of the upper extremities. It is a patient reported outcome measure that contains 30 core items. The score ranges from 0 to 100 points with higher scores indicating greater impairment.
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 posted24 Jul 2018
- Study start19 Jan 2011
- Primary completion30 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Humerus FractureStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Göteborg University
- Responsible party
- Principal investigator, Lars Adolfsson, Linkoeping University
- Investigators
- Lars Adolfsson, MD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596736
- Sponsor's protocol ID
- 2010/342-31
- Status last verified
- Mar 2023
- First submitted
- 12 Jul 2018
- Last updated
- 8 Mar 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elbow Hemiarthroplasty Versus Total Elbow Arthroplasty for Irreparable Distal Humeral Fractures. A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03596736
- Acronym / sponsor ID
- 2010/342-31
- Conditions
- Distal Humerus Fracture
- Keywords
- Distal Humerus Fracture, Arthroplasty, Replacement, Elbow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Göteborg University
- Study start
- 19 Jan 2011 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 24 Jul 2018 (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.
Distal humeral fractures can be difficult to treat, in particular when the joint surface is affected (intra-articular fractures). If rigid internal fixation with plates and screws can be obtained it is considered to be the treatment of choice. In elderly patients, poor bone quality (osteopenia) and fragmentation of the articular surface can make rigid internal fixation non-reliable or even impossible. Total elbow arthroplasty has been shown to be of value in this type of situation. Elbow hemiarthroplasty has been proposed as an alternative to total elbow arthroplasty. The theoretical advantages as opposed to total elbow arthroplasty are: no restriction in the weight allowed to be lifted, complications related to polyethylene wear debris are avoided as there is no polyethylene liner and there is no ulna component that can loosen. Wear of the native ulna and instability are potential complications of elbow hemiarthroplasty.
The aim of this multicenter study is to test the hypothesis that elbow hemiarthroplasty gives better elbow function than total elbow arthroplasty for irreparable distal humeral fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elbow Hemiarthroplasty | Experimental | Procedure: Elbow Hemiarthroplasty |
| Total Elbow Arthroplasty | Active comparator | Procedure: Total Elbow Arthroplasty |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Intra-articular distal humeral fracture with two or more displaced joint surface fragments devoid of soft tissue attachment
- Osteopenia
- Fracture deemed unsuitable for internal fixation
- Low-energy trauma
- Closed fracture
Key exclusion criteria (6 listed)
- Comorbidity that affects elbow rehabilitation considerably
- Severe pre-existing elbow disease
- Concurrent injury that affects elbow rehabilitation considerably
- Pathologic fracture
- Vascular injury
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 |
|---|---|---|
| Elbow Hemiarthroplasty | Procedure or surgery | Elbow Hemiarthroplasty |
| Total Elbow Arthroplasty | Procedure or surgery | Total Elbow Arthroplasty |
Primary outcome
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Time frame: 24 months
The DASH questionnaire aims to assess symptoms and functional status of the upper extremities. It is a patient reported outcome measure that contains 30 core items. The score ranges from 0 to 100 points with higher scores indicating greater impairment.
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 8 Mar 2023.
Related trials for Distal Humerus Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
Enrolling by invitation
Comparison of Functional Outcomes Between Triceps Tongue Elevation vs Olecranon Osteotomy in Intra Articular Distal Humerus Fracture (IA-DH) Management
Intra Articular Distal Humerus Fracture
Not yet recruiting
X-BS Ortho Bone Graft Study
Orthopedic Disorder, Trauma Injury
Not yet recruitingObservational study
Clinical Outcomes After Treatment of Distal Humerus Fractures With the LORRAINE 2.5/3.5 mm Distal Humerus System
Intra-Articular or Extra-Articular Distal Humerus Fracture, Distal Humerus Fracture
Recruiting
Clinical Outcomes Study of the Nexel Total Elbow
Elbow Joint Destruction, Post-traumatic Lesions
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.
Lars Adolfsson, MD principal investigator
Linkoeping University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elbow Hemiarthroplasty and Total Elbow Arthroplasty in people with Distal Humerus Fracture, run by Linkoeping University at 3 sites in Sweden.
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 6 inclusion and 6 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 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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?
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire (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 8 Mar 2023.