Distal Radius FractureRaDiXNCT03962946
Distal Radius Fracture: Clinical Outcome After Conservative Treatment in the Elder Patient
An observational study of Distal Radius Fracture, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Questionnaires to assess Patient reported Outcomes and wrist function test
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Apr 2018to 18 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients with a distal radius fracture who had undergone a conservative treatment at the University Hospital in Basel
Who may be able to join
- 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
Who cannot join
- No X-ray
- No signed informed consent
- Demented patients
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Orthopaedics and Traumatology, University Hospital Basel
Basel, 4031
About this study
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.
- Conditions
- Distal Radius Fracture
- Being tested
- Questionnaires to assess Patient reported Outcomes, wrist function test
- Keywords
- Adolfsson-score, Suhm Score
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires to assess Patient reported OutcomesOther
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 testOther
wrist function assessed by the range of motion (ROM) for both the affected and the unaffected side.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: single time point assessment at baseline
Secondary outcomes (3)
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.
Measured: single time point assessment at baseline
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.
Measured: single time point assessment at baseline
Range of wrist joint motion (degree)
Range of wrist joint motion (degree)
Measured: single time point assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start17 Apr 2018
- Primary completion18 Oct 2018
- Study completion18 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Rikli, PD Dr. med, Principal investigator, Department of Orthopaedic Surgery and Traumatology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962946
- Sponsor's protocol ID
- 2018-00360; ch19Rikli2
- Other IDs
- 2018
- Acronym
- RaDiX
- Status last verified
- May 2019
- First submitted
- 22 May 2019
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distal Radius Fracture: Clinical Outcome After Conservative Treatment in the Elder Patient
- ClinicalTrials.gov ID
- NCT03962946
- Acronym / sponsor ID
- RaDiX / 2018-00360; ch19Rikli2
- Conditions
- Distal Radius Fracture
- Keywords
- Adolfsson-score, Suhm Score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 18 Oct 2018 (actual)
- Study completion
- 18 Oct 2018 (actual)
- First posted
- 24 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients with a distal radius fracture who had undergone a conservative treatment at the University Hospital in Basel
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- No X-ray
- No signed informed consent
- Demented patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires to assess Patient reported OutcomesAdolfsson-Score questionnaire quantifies the patient's utility of the hand. Suhm Score questionnaire quantifies the independency of a patient in his daily life. | Other | – |
| wrist function testwrist function assessed by the range of motion (ROM) for both the affected and the unaffected side. | Other | – |
Primary outcome
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
3 secondary outcomes
Suhm Score
Time frame: single time point assessment at baseline
Quick Disabilities of the Arm, Shoulder and Hand (DASH) score
Time frame: single time point assessment at baseline
Range of wrist joint motion (degree)
Time frame: single time point assessment at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Rikli, PD Dr. med principal investigator
Department of Orthopaedic Surgery and Traumatology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Radius Fracture, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adolfsson score (time frame: single time point assessment at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2019.