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Completed

NCT Number: NCT03962946

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

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.

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Key information

Conditions

Distal Radius Fracture Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Orthopaedics and Traumatology, University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaires to assess Patient reported Outcomes

Other

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

Other

wrist function assessed by the range of motion (ROM) for both the affected and the unaffected side.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. Range of wrist joint motion (degree)

    Time frame: single time point assessment at baseline

    Range of wrist joint motion (degree)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Acronym: RaDiX

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 24, 2019
Registry last updated
May 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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