Distal Radius Fracture: Clinical Outcome After Conservative Treatment in the Elder Patient (RaDiX)

May 22, 2019 updated by: University Hospital, Basel, Switzerland
This study is performed to evaluate the outcome of conservative treatment after distal radius fractures in patients of 65 years or older at the time of the injury, primarily with respect to the prognostic value of the Adolfsson-score for the functional demands of the patient on his hand.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Department of Orthopaedics and Traumatology, University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with a distal radius fracture who had undergone a conservative treatment at the University Hospital in Basel

Description

Inclusion Criteria:

  • Distal radius fracture with conservative treatment
  • Treated in 2014 or 2015
  • X-ray of injury
  • Informed consent by the patient to participate in the study

Exclusion Criteria:

  • No X-ray
  • No signed informed consent
  • Demented patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adolfsson score
Time Frame: single time point assessment at baseline
Adolfsson-Score quantifies the patient's utility of the Hand; 8-point scale ranging from 1 = no activity done using hand/arm to 8 = professional activity with high physical stress for the arm. Lower scores reflect fewer effort in using arm/Hand; higher scores reflect higher strain in using arm/hand
single time point assessment at baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Suhm Score
Time Frame: single time point assessment at baseline
Suhm Score quantifies the independency of a patient in his daily life. 4-point scale ranging from 1 = living at home, independent to 4 = living in nursing home, dependency. Lower scores reflect high independency of a patient in his daily life; higher scores reflect higher dependency of a patient in his daily life.
single time point assessment at baseline
Quick Disabilities of the Arm, Shoulder and Hand (DASH) score
Time Frame: single time point assessment at baseline
Quick DASH score is a 11-item, self-report questionnaire that measures physical function and symptoms in people with musculoskeletal disorders of the upper limb. The QuickDASH is scored in two components: the disability/symptom section (11 items, scored 1-5) and the optional high performance sport/Music or work modules (4 items, scored 1-5). A higher score indicates greater disability.
single time point assessment at baseline
Range of wrist joint motion (degree)
Time Frame: single time point assessment at baseline
Range of wrist joint motion (degree)
single time point assessment at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Daniel Rikli, PD Dr. med, Department of Orthopaedic Surgery and Traumatology, University Hospital Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 17, 2018

Primary Completion (ACTUAL)

October 18, 2018

Study Completion (ACTUAL)

October 18, 2018

Study Registration Dates

First Submitted

May 22, 2019

First Submitted That Met QC Criteria

May 22, 2019

First Posted (ACTUAL)

May 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 24, 2019

Last Update Submitted That Met QC Criteria

May 22, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-00360; ch19Rikli2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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