Intraarticular Distal Radius Fractures, X-fix or Volar Fixation

NCT ID: NCT01035359

Last Updated: 2014-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2014-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Distal radius fractures are treated surgically if severely displaced. This study aims to investigate the outcome after surgery. The investigators will randomize patients to either external fixation with optional addition of k-wires or open reduction and fixation with a volar plate.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study has been merged with NCT 01034943 and a new permit has been issued by the Swedish National board on Ethical Permits

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dorsally Displaced Intraarticular Distal Radius Fractures Age 50 - 74 for Females or 60-74 for Males Low Energy Trauma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

external fixation

Operation with external fixation and optional addition of k-wire

Group Type ACTIVE_COMPARATOR

External fixation

Intervention Type PROCEDURE

Bridging external fixation of a distal radius fracture with an optional addition of k-wire(s)

Volar plate

Operation with a Synthes volar two column plate (TCP)

Group Type EXPERIMENTAL

Volar plate

Intervention Type PROCEDURE

Operation of distal radius fracture with open reduction and fixation with a plate from the volar side of the wrist.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

External fixation

Bridging external fixation of a distal radius fracture with an optional addition of k-wire(s)

Intervention Type PROCEDURE

Volar plate

Operation of distal radius fracture with open reduction and fixation with a plate from the volar side of the wrist.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Stryker's Hoffman external fixation Synthes Two Column Plate (TCP)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Female 50-74 years or male 60-74 years
* Dorsally displaced intraarticular distal radius fracture
* Dorsal angulation \>20 degrees measured from the plane perpendicular to the radius axis
* Low energy trauma
* Injury \<72 hours when diagnosed
* Patient independent of help for ADL

Exclusion Criteria

* Earlier dysfunction in any wrist
* Other major injuries
* Rheumatoid arthritis or other systemic joint disease
* Dementia or severe psychiatric disease
* Severe medical condition making general anesthesia a major risk
Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sari Ponzer

Professor, MD, Senior consultant orthopaedic surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stockholm South Hospital Department of Orthopeadic Surgery

Stockholm, Stockholm County, Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DRF intra

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.