---
title: Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly
nct_id: NCT01268397
overall_status: UNKNOWN
phase: NA
sponsor: Danderyd Hospital
study_type: INTERVENTIONAL
primary_condition: Fracture of the Distal Radius
countries: Sweden
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01268397.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01268397"
ct_last_update_post_date: 2019-02-08
last_seen_at: "2026-05-12T06:07:14.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly

**Official Title:** Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly. A Randomized Comparison Between Operative Fixation and Plaster Cast Treatment.

**NCT ID:** [NCT01268397](https://clinicaltrials.gov/study/NCT01268397)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 80
- **Lead Sponsor:** Danderyd Hospital
- **Collaborators:** Stockholm South General Hospital
- **Conditions:** Fracture of the Distal Radius, Wrist Fracture
- **Start Date:** 2009-12
- **Completion Date:** 2019-12
- **CT.gov Last Update:** 2019-02-08

## Brief Summary

The purpose of this study is to examine whether operation and fixation with a metal plate gives better result from the patient's perspective than plaster treatment in elderly patients with a displaced wrist fracture.

## Detailed Description

We will perform a prospective randomized clinical trial comparing open reduction and internal fixation with a volar plate with closed reduction and plaster treatment in elderly patients with a displaced Colles' fracture in order to test the null hypothesis that the patient-perceived result is equal after conservative or operative treatment. Secondary outcomes are objective physical measurements.

## Eligibility

- **Minimum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Unilateral unstable dislocated dorsally angulated fracture of the distal radius (radial shortening ≥4 mm and/or dorsal angulation ≥20°).

Exclusion Criteria:

* Previous displaced fracture of the distal radius.
* Additional fractures of the upper extremities, an open fracture, terminal disease, patient not fit for surgery, unwilling or unable to co-operate with follow-up (advanced dementia (SPMSQ\<5), psychiatric illness, alcohol abuse).
```

## Arms

- **ORIF** (ACTIVE_COMPARATOR) — Open reduction and internal fixation with a volar plate
- **plaster treatment** (ACTIVE_COMPARATOR) — Closed reduction and plaster treatment

## Interventions

- **open reduction and internal fixation with a volar plate** (PROCEDURE) — flexor carpi radialis approach, open reduction, fixed-angle volar plate, plaster cast 2 weeks at the surgeon's discretion
- **closed reduction and plaster treatment** (PROCEDURE) — closed reduction, below elbow plaster cast, semicircular for 5 week

## Primary Outcomes

- **patient-perceived disability measured by the PRWE and DASH questionnaires** _(time frame: one year after wrist fracture)_

## Secondary Outcomes

- **impairments (grip strength and range of motion compared with the uninjured wrist)** _(time frame: one year after wrist fracture)_

## Locations (1)

- Division of Orthopaedics Danderyd Hospital, Stockholm, Sweden

## 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.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — 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)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.division of orthopaedics danderyd hospital|stockholm||sweden` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01268397.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01268397*  
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