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CompletedNCT03379935RHAUpdated Dec 20, 2017

Radial Head Arthroplasty A Clinical and Radiological Comparison of Monopolar and Bipolar Radial Head Arthroplasty

An observational study in Radial Head Fracture, Elbow Fracture and Arthroplasty Complications, sponsored by Sundsvall Hospital. Completed. Per ClinicalTrials.gov, last updated 2017-12-20.

Sponsored by Sundsvall Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
27
Sex
All
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Study 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. 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.

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Conditions studied

  • Radial Head Fracture
  • Elbow Fracture
  • Arthroplasty Complications

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In context

Elbow Fractures

47 studies on the registry are indexed under Elbow Fractures; 13 are open to participants now.

This study's enrollment of 27 is below the median of 58 across 16 observational studies indexed under Elbow Fractures.

Browse Elbow Fractures studies →

Lead sponsor

Sundsvall Hospital is the lead sponsor of 22 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients treated with a radial head arthroplasty during the study period.

Exclusion criteria

Exclusion Criteria:

  • None
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
27 participants (actual)
Patient registry
No

Groups and cohorts

  • Bipolar radial head arthroplasty

    Patients treated with bipolar head arthroplasty due to radial head fracture

    Procedure: Type of radial head arthroplasty

  • Unipolar radial head arthroplasty

    Patients treated with unipolar head arthroplasty due to radial head fracture

    Procedure: Type of radial head arthroplasty

Interventions

  • ProcedureType of radial head arthroplasty

    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.

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: 2-16 years postoperatively

Secondary outcomes

  1. Pain

    Visual analogue scale. Range 0-10. Higher value indicate more intensive pain.

    Time frame: 2-16 years postoperatively

  2. Range of motion

    Rang of elbow motion. Measured in grades. Supination, pronation, extension and flexion were measured.

    Time frame: 2-16 years postoperatively

  3. Reoperation

    Number of patients needing revision surgery

    Time frame: 2-16 years postoperatively

  4. Radiographic evaluation

    Radiographic evaluation of the prosthesis. The presence of radiolucent lines, loosening of the prosthesis.

    Time frame: 2-16 years postoperatively

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Study locations

No study locations are listed for this record.

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References and documents

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 27792673 ↗
  • Heijink 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 27521138 ↗
  • Duckworth 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 ↗

Individual participant data

Plan to share: Undecided — Researchers are welcome to ask for data. The corresponding author will provide this.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2017 to primary completion in Jul 2017, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 4, 2017
First posted
Dec 20, 2017
StartActual
Jan 1, 2017
Primary completionActual
Jul 1, 2017
CompletionActual
Oct 1, 2017
Last update
Dec 20, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03379935
Lead sponsor
Sundsvall Hospital
Responsible party
Sponsor
First posted
Dec 20, 2017
Start date
Jan 1, 2017
Primary completion
Jul 1, 2017
Completion
Oct 1, 2017
Last update
Dec 20, 2017

Study contacts

Bakir Kadum, M.D, Ph.D
principal investigator · Umeå University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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