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

Distal Radius Fracture Clinical Trial

— RaDiX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03962946
• Other study ID #: 2018-00360; ch19Rikli2
• Status: Completed
• Start date: April 17, 2018
• Est. completion date: October 18, 2018

Study information

• Verified date: May 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 18, 2018
• Est. primary completion date: October 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Other:
• Questionnaires to assess Patient reported Outcomes
Adolfsson-Score questionnaire quantifies the patient`s utility of the hand. Suhm Score questionnaire quantifies the independency of a patient in his daily life.
• wrist function test
wrist function assessed by the range of motion (ROM) for both the affected and the unaffected side.

Locations

Country	Name	City	State
Switzerland	Department of Orthopaedics and Traumatology, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adolfsson score	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	Suhm Score	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
Secondary	Quick Disabilities of the Arm, Shoulder and Hand (DASH) score	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
Secondary	Range of wrist joint motion (degree)	Range of wrist joint motion (degree)	single time point assessment at baseline