Radial Head FractureRHANCT03379935
Radial Head Arthroplasty A Clinical and Radiological Comparison of Monopolar and Bipolar Radial Head Arthroplasty
An observational study of Radial Head Fracture and Elbow Fracture, run by Sundsvall Hospital.
Trial summary
Fractures of the radial head are among the most common fractures in the elbow and represent one-third of all elbow fractures.This retrospective cohort study was performed between 2004 and 2014 at Sundsvall and Umeå University hospital, Sweden. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Radial Head Fracture, Elbow Fracture, Arthroplasty Complications
- What is being tested?
- Type of radial head arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Oct 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients treated with a radial head arthroplasty are included in the study. All patients were asked to participate in the follow-up during 2017.
Who may be able to join
- All patients treated with a radial head arthroplasty during the study period.
Who cannot join
- None
About this study
Official title: Radial Head Arthroplasty: A Clinical and Radiological Comparison of Monopolar and Bipolar Radial Head Arthroplasty
Fractures of the radial head are among the most common fractures in the elbow and represent one-third of all elbow fractures.This retrospective cohort study was performed between 2004 and 2014 at Sundsvall and Umeå University hospital, Sweden. All patients who were operated on between 2004 and 2014 with a radial head arthroplasty for an acute or sequelae due to a caput radii fracture.The aim of this study is to evaluate clinical or radiological differences between patients treated with a unipolar or bipolar radial head arthroplasty.
- Being tested
- Type of radial head arthroplasty
- Medical subject headings
- Radial Head and Neck Fractures, Elbow Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of radial head arthroplastyProcedure or surgery
Patiens are either treated with a unipolar or a bipolar radial head arthroplasty. At Sundsvall hospital all patients were treated with a unipolar and at Umeå university hospital all patients were treated with a bipolar arthroplasty.
| Study group | Role | What they receive |
|---|---|---|
| Bipolar radial head arthroplasty | Patients treated with bipolar head arthroplasty due to radial head fracture Receives: Procedure: Type of radial head arthroplasty | |
| Unipolar radial head arthroplasty | Patients treated with unipolar head arthroplasty due to radial head fracture Receives: Procedure: Type of radial head arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
QuickDASH
Patients reported outcome measure. An abbreviated version of the Disabilities the Arm, Shoulder and Hand (DASH) questionnaire. Higher score indicate a greater level of disability, lower scores indicate a lower level of disability. The score ranges from 0 (no disability) to 100 (most severe disability).
Measured: 2-16 years postoperatively
Secondary outcomes (4)
Pain
Visual analogue scale. Range 0-10. Higher value indicate more intensive pain.
Measured: 2-16 years postoperatively
Range of motion
Rang of elbow motion. Measured in grades. Supination, pronation, extension and flexion were measured.
Measured: 2-16 years postoperatively
Reoperation
Number of patients needing revision surgery
Measured: 2-16 years postoperatively
Radiographic evaluation
Radiographic evaluation of the prosthesis. The presence of radiolucent lines, loosening of the prosthesis.
Measured: 2-16 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start1 Jan 2017
- Primary completion1 Jul 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Radial Head 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sundsvall Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bakir Kadum, M.D, Ph.D, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379935
- Sponsor's protocol ID
- Radial head arthrplasty
- Acronym
- RHA
- Status last verified
- Dec 2017
- First submitted
- 4 Dec 2017
- Last updated
- 20 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Researchers are welcome to ask for data. The corresponding author will provide this.
Publications
Heijink A, Kodde IF, Mulder PGH, Veltman ES, Kaas L, van den Bekerom MPJ, Eygendaal D. Radial Head Arthroplasty: A Systematic Review. JBJS Rev. 2016 Oct 18;4(10):e3. doi: 10.2106/JBJS.RVW.15.00095.
PubMed 27792673Heijink A, Kodde IF, Mulder PGH, Van Dijk CN, Eygendaal D. Cemented bipolar radial head arthroplasty: midterm follow-up results. J Shoulder Elbow Surg. 2016 Nov;25(11):1829-1838. doi: 10.1016/j.jse.2016.05.017. Epub 2016 Aug 9.
PubMed 27521138Duckworth AD, Wickramasinghe NR, Clement ND, Court-Brown CM, McQueen MM. Radial head replacement for acute complex fractures: what are the rate and risks factors for revision or removal? Clin Orthop Relat Res. 2014 Jul;472(7):2136-43. doi: 10.1007/s11999-014-3516-y.
PubMed 24549774
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radial Head Arthroplasty: A Clinical and Radiological Comparison of Monopolar and Bipolar Radial Head Arthroplasty
- ClinicalTrials.gov ID
- NCT03379935
- Acronym / sponsor ID
- RHA / Radial head arthrplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Sundsvall HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 20 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.
Fractures of the radial head are among the most common fractures in the elbow and represent one-third of all elbow fractures.This retrospective cohort study was performed between 2004 and 2014 at Sundsvall and Umeå University hospital, Sweden. All patients who were operated on between 2004 and 2014 with a radial head arthroplasty for an acute or sequelae due to a caput radii fracture.The aim of this study is to evaluate clinical or radiological differences between patients treated with a unipolar or bipolar radial head arthroplasty.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar radial head arthroplasty | – | Procedure: Type of radial head arthroplastyPatients treated with bipolar head arthroplasty due to radial head fracture |
| Unipolar radial head arthroplasty | – | Procedure: Type of radial head arthroplastyPatients treated with unipolar head arthroplasty due to radial head fracture |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients treated with a radial head arthroplasty are included in the study. All patients were asked to participate in the follow-up during 2017.
Key inclusion criteria (1 listed)
- All patients treated with a radial head arthroplasty during the study period.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Type of radial head arthroplastyPatiens are either treated with a unipolar or a bipolar radial head arthroplasty. At Sundsvall hospital all patients were treated with a unipolar and at Umeå university hospital all patients were treated with a bipolar arthroplasty. | Procedure or surgery | Bipolar radial head arthroplasty, Unipolar radial head arthroplasty |
Primary outcome
QuickDASH
Time frame: 2-16 years postoperatively
Patients reported outcome measure. An abbreviated version of the Disabilities the Arm, Shoulder and Hand (DASH) questionnaire. Higher score indicate a greater level of disability, lower scores indicate a lower level of disability. The score ranges from 0 (no disability) to 100 (most severe disability).
4 secondary outcomes
Pain
Time frame: 2-16 years postoperatively
Range of motion
Time frame: 2-16 years postoperatively
Reoperation
Time frame: 2-16 years postoperatively
Radiographic evaluation
Time frame: 2-16 years postoperatively
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 20 Dec 2017.
- Background: PubMed 27792673Heijink A, Kodde IF, Mulder PGH, Veltman ES, Kaas L, van den Bekerom MPJ, Eygendaal D. Radial Head Arthroplasty: A Systematic Review. JBJS Rev. 2016 Oct 18;4(10):e3. doi: 10.2106/JBJS.RVW.15.00095.
- Background: PubMed 27521138Heijink A, Kodde IF, Mulder PGH, Van Dijk CN, Eygendaal D. Cemented bipolar radial head arthroplasty: midterm follow-up results. J Shoulder Elbow Surg. 2016 Nov;25(11):1829-1838. doi: 10.1016/j.jse.2016.05.017. Epub 2016 Aug 9.
- Background: PubMed 24549774Duckworth AD, Wickramasinghe NR, Clement ND, Court-Brown CM, McQueen MM. Radial head replacement for acute complex fractures: what are the rate and risks factors for revision or removal? Clin Orthop Relat Res. 2014 Jul;472(7):2136-43. doi: 10.1007/s11999-014-3516-y.
- Individual participant dataSharing planned: Undecided. Researchers are welcome to ask for data. The corresponding author will provide this.
Related trials for Radial Head Fracture
Active, not recruiting
RHEVOLUTION Clinical Trial: Use of Two Radial Head Arthroplasty Designs for the Treatment of Elbow Instability
Elbow Arthropathy, Elbow Dislocation
Recruiting
The Utilization of Ultrasound to Diagnose Pediatric Elbow Fractures
Elbow Pain, Supracondylar Humerus Fracture
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.
Bakir Kadum, M.D, Ph.D principal investigator
Umeå University
Questions about this trial
What is this clinical trial studying?
An observational study of Radial Head Fracture and Elbow Fracture, run by Sundsvall 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 1 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 20 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?
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?
QuickDASH (time frame: 2-16 years postoperatively). 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 NCT03379935, which also lists 3 linked publications.
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 20 Dec 2017.