---
title: Radial Head Arthroplasty A Clinical and Radiological Comparison of Monopolar and Bipolar Radial Head Arthroplasty
nct_id: NCT03379935
overall_status: COMPLETED
sponsor: Sundsvall Hospital
study_type: OBSERVATIONAL
primary_condition: Radial Head Fracture
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03379935.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03379935"
ct_last_update_post_date: 2017-12-20
last_seen_at: "2026-05-12T06:47:25.413Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Radial Head Arthroplasty A Clinical and Radiological Comparison of Monopolar and Bipolar Radial Head Arthroplasty

**Official Title:** Radial Head Arthroplasty: A Clinical and Radiological Comparison of Monopolar and Bipolar Radial Head Arthroplasty

**NCT ID:** [NCT03379935](https://clinicaltrials.gov/study/NCT03379935)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 27
- **Lead Sponsor:** Sundsvall Hospital
- **Conditions:** Radial Head Fracture, Elbow Fracture, Arthroplasty Complications
- **Start Date:** 2017-01-01
- **Completion Date:** 2017-10-01
- **CT.gov Last Update:** 2017-12-20

## Brief 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.

## Eligibility

- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

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

Exclusion Criteria:

* None
```

## Arms

- **Bipolar radial head arthroplasty** — Patients treated with bipolar head arthroplasty due to radial head fracture
- **Unipolar radial head arthroplasty** — Patients treated with unipolar head arthroplasty due to radial head fracture

## Interventions

- **Type of radial head arthroplasty** (PROCEDURE) — 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.

## Primary Outcomes

- **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).

## 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)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03379935.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03379935*  
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