Distal Radius FractureNCT05558306
Radiological vs Clinical Outcome in DRF
A study testing Surgery of distal radius fracture and Reduction and cast treatment of distal radius fracture in people with Distal Radius Fracture, run by Sundsvall Hospital.
Trial summary
Background: Several studies have investigated the degree of final displacement and its association with clinical outcome. There is still no consensus on the importance of radiological outcome and published studies do not use the same criteria for an acceptable alignment. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Surgery of distal radius fracture and Reduction and cast treatment of distal radius fracture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 451 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Sep 2011
- Phase
- Interventional
- 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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with distal radius fracture between 15 and 74 years, with closed physes of the distal radius and ulna.
Who cannot join
- Dementia
- Previous fracture to the ipsilateral wrist
- Open fracture
- Other concomitant or existing damage or injury to the wrist
- Galeazzi fracture
- Rheumatoid arthritis
- Alcohol or drug abuse
- Neurologic impairment
About this study
Official title: Association Between Radiographic and Clinical Outcome in Distal Radius Fractures: A Prospective Cohort Study With a 1-year Follow-up in 368 Patients
Background: Several studies have investigated the degree of final displacement and its association with clinical outcome. There is still no consensus on the importance of radiological outcome and published studies do not use the same criteria for an acceptable alignment. Previous reports have used a linear or a dichotomized exposure in the statistical analysis, but no study has investigated a nonlinear association.
Methods: We included 438 patients treated for a distal radius fracture (DRF) with either reduction and cast immobilization or surgery. Radiographic outcomes were determined by radiographs 3 months after the injury. Clinical outcome was determined by QuickDASH (qDASH), ROM and grip strength at 1-year after the injury. Nonlinear correlations were analysed with cubic splines.
- Conditions
- Distal Radius Fracture
- Being tested
- Surgery of distal radius fracture, Reduction and cast treatment of distal radius fracture
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery of distal radius fractureProcedure or surgery
Surgery of distal radius fracture for displaced fractures
Reduction and cast treatment of distal radius fractureProcedure or surgery
Reduction and cast treatment of distal radius fracture for minimally displaced fractures
| Study group | Role | What they receive |
|---|---|---|
| Treatment protocol | Other | All patients were treated according to the treatment protocol with cast for minimally displaced fractures and surgery for displaced fractures. Receives: Procedure: Surgery of distal radius fracture; Procedure: Reduction and cast treatment of distal radius fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
quickDASH
The DASH is a 30-item PROM questionnaire that evaluates the upper extremity [115]. The qDASH is a shortened version with 11 questions that can be used instead of the full 30-item questionnaire [114]. Both are validated for use in upper extremity disorders [114,115]. Neither is specific for wrist function and both yield scores from 0 to 100, where lower scores indicate a better outcome.
Measured: 12 months
Range of motion
The active ROM of the radiocarpal joint and the radioulnar joints were measured in both hands using a standard goniometer. The arcs of flexion-extension, pronation-supination and radial-ulnar deviation were recorded. Total ROM was calculated as the sum of these three arcs. The loss of ROM in the fractured wrist was expressed in angular degrees compared to the contralateral uninjured wrist [126].
Independent occupational therapists, blinded to the radiological outcome, measured objective function, including grip strength and active ROM.
Measured: 12 months
Grip strength
Grip strength was measured in a sitting position with the elbow in 90° of flexion, neutral rotation and wrist 0°-30° extension using a JAMAR dynamometer [122]. To prevent it from falling, the examiner may support the JAMAR dynamometer. Both hands are examined, starting with the uninjured hand. Three strength tests were conducted during the assessment of grip strength, with the mean score of the three tests recorded for analysis. Grip strength was adjusted by 10% for the non-dominant hand [123]. The contralateral wrist was used as an internal control. Grip strength was expressed as a percentage (the ratio to the uninjured wrist) and the absolute loss in kilograms comparing the fractured wrist to the uninjured wrist.
Independent occupational therapists, blinded to the radiological outcome, measured objective function, including grip strength and active ROM.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study startOct 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sundsvall Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558306
- Sponsor's protocol ID
- VS_DRF_Outcome
- Status last verified
- Sep 2022
- First submitted
- 21 Sep 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schmidt V, Gordon M, Tagil M, Sayed-Noor A, Mukka S, Wadsten M. Association Between Radiographic and Clinical Outcomes Following Distal Radial Fractures: A Prospective Cohort Study with 1-Year Follow-up in 366 Patients. J Bone Joint Surg Am. 2023 Aug 2;105(15):1156-1167. doi: 10.2106/JBJS.22.01096. Epub 2023 May 12.
PubMed 37172109
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Radiographic and Clinical Outcome in Distal Radius Fractures: A Prospective Cohort Study With a 1-year Follow-up in 368 Patients
- ClinicalTrials.gov ID
- NCT05558306
- Acronym / sponsor ID
- VS_DRF_Outcome
- Conditions
- Distal Radius Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Sundsvall HospitalUniversity, hospital or other
- Study start
- Oct 2009 (actual)
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 28 Sep 2022 (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.
Background: Several studies have investigated the degree of final displacement and its association with clinical outcome. There is still no consensus on the importance of radiological outcome and published studies do not use the same criteria for an acceptable alignment. Previous reports have used a linear or a dichotomized exposure in the statistical analysis, but no study has investigated a nonlinear association.
Methods: We included 438 patients treated for a distal radius fracture (DRF) with either reduction and cast immobilization or surgery. Radiographic outcomes were determined by radiographs 3 months after the injury. Clinical outcome was determined by QuickDASH (qDASH), ROM and grip strength at 1-year after the injury. Nonlinear correlations were analysed with cubic splines.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment protocol | Other | Procedure: Surgery of distal radius fracture, Procedure: Reduction and cast treatment of distal radius fractureAll patients were treated according to the treatment protocol with cast for minimally displaced fractures and surgery for displaced fractures. |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with distal radius fracture between 15 and 74 years, with closed physes of the distal radius and ulna.
Key exclusion criteria (8 listed)
- Dementia
- Previous fracture to the ipsilateral wrist
- Open fracture
- Other concomitant or existing damage or injury to the wrist
- Galeazzi fracture
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 |
|---|---|---|
| Surgery of distal radius fractureSurgery of distal radius fracture for displaced fractures | Procedure or surgery | Treatment protocol |
| Reduction and cast treatment of distal radius fractureReduction and cast treatment of distal radius fracture for minimally displaced fractures | Procedure or surgery | Treatment protocol |
Primary outcome
quickDASH
Time frame: 12 months
The DASH is a 30-item PROM questionnaire that evaluates the upper extremity [115]. The qDASH is a shortened version with 11 questions that can be used instead of the full 30-item questionnaire [114]. Both are validated for use in upper extremity disorders [114,115]. Neither is specific for wrist function and both yield scores from 0 to 100, where lower scores indicate a better outcome.
Range of motion
Time frame: 12 months
The active ROM of the radiocarpal joint and the radioulnar joints were measured in both hands using a standard goniometer. The arcs of flexion-extension, pronation-supination and radial-ulnar deviation were recorded. Total ROM was calculated as the sum of these three arcs. The loss of ROM in the fractured wrist was expressed in angular degrees compared to the contralateral uninjured wrist [126]. Independent occupational therapists, blinded to the radiological outcome, measured objective function, including grip strength and active ROM.
Grip strength
Time frame: 12 months
Grip strength was measured in a sitting position with the elbow in 90° of flexion, neutral rotation and wrist 0°-30° extension using a JAMAR dynamometer [122]. To prevent it from falling, the examiner may support the JAMAR dynamometer. Both hands are examined, starting with the uninjured hand. Three strength tests were conducted during the assessment of grip strength, with the mean score of the three tests recorded for analysis. Grip strength was adjusted by 10% for the non-dominant hand [123]. The contralateral wrist was used as an internal control. Grip strength was expressed as a percentage (the ratio to the uninjured wrist) and the absolute loss in kilograms comparing the fractured wrist to the uninjured wrist. Independent occupational therapists, blinded to the radiological outcome, measured objective function, including grip strength and active ROM.
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 28 Sep 2022.
- Derived from this study: PubMed 37172109Schmidt V, Gordon M, Tagil M, Sayed-Noor A, Mukka S, Wadsten M. Association Between Radiographic and Clinical Outcomes Following Distal Radial Fractures: A Prospective Cohort Study with 1-Year Follow-up in 366 Patients. J Bone Joint Surg Am. 2023 Aug 2;105(15):1156-1167. doi: 10.2106/JBJS.22.01096. Epub 2023 May 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery of distal radius fracture and Reduction and cast treatment of distal radius fracture in people with Distal Radius Fracture, run by Sundsvall Hospital.
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 1 inclusion and 8 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 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
quickDASH (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05558306, which also lists 1 linked publication.
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 28 Sep 2022.