Distal Radius FracturesNCT01435070
Functional Outcome Following Fracture of the Distal Radius
An observational study of Distal Radius Fractures, run by University of Warwick at 1 site in United Kingdom.
Trial summary
Patients attending the University Hospital Coventry UK with a broken wrist requiring an operation, will be invited to enter the study. At the first visit, they will have an xray of the wrist and will be asked to complete a number of questionnaires. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fractures
- What is being tested?
- Kirschner wire fixation and Volar Locking Plate fixation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2011to Oct 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients presenting to University Hospital Coventry with an acute fracture of the distal radius requiring operative management
Who may be able to join
- Sustained a dorsally displaced fracture of the distal radius, which is defined as a fracture within 3cm of the radio-carpal joint
- The treating Consultant surgeon believes that they would benefit from operative fixation of the fracture
- Aged over 18years (either sex) and able to give informed consent
Who cannot join
- The fracture extends more than 3 cm from the radio-carpal joint
- The fracture open with a Gustillo grading greater than 1
- There are contra-indications to general anaesthetic
- There is evidence that the patient would be unable to adhere to trial procedures or complete questionnaires
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Warwick Medical School
Coventry, Warwickshire, CV22DX
Juul Achten, PhD, 02476964000 ext. 28614, J.Achten@warwick.ac.uk
Caroline E Plant, MBChB
About this study
Official title: A Correlation of Functional Outcome Measures of Fractures of the Distal Radius Following Operative Management
Patients attending the University Hospital Coventry UK with a broken wrist requiring an operation, will be invited to enter the study. At the first visit, they will have an xray of the wrist and will be asked to complete a number of questionnaires. The questions are to determine if they normally have pain in the wrist and how well they can perform their daily activities. The patient will then have an operation, and the fracture in the wrist will be held in the correct position with either a metal plate and screws or wires.
At 6 weeks following the operation the patient will be reassessed and an xray will be taken. At 3 months, 6 months and 12 months after the operation patients will perform tests to assess the strength of their grip, pinch and movement of their wrist. In addition they will complete the the same questionnaires from their first visit. At the 12 month visit patients will have another xray.
- Conditions
- Distal Radius Fractures
- Being tested
- Kirschner wire fixation, Volar Locking Plate fixation
- Keywords
- Colles' fracture, Radius fracture, grip strength, pinch strength, range of movement, PRWE, DASH, EQ-5D, Kirschner wire, Volar locking plate
- Medical subject headings
- Wrist Fractures, Colles' Fracture, Radius Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kirschner wire fixationProcedure or surgery
Also called K-wire fixation
The wires are passed through the skin over the dorsal aspect of the distal radius and into the bone in order to hold the fracture in the correct (anatomical) position. The size and number of wires, the insertion technique and the configuration of wires will be left entirely to the discretion of the surgeon.
A plaster cast will be applied at the end of the procedure to supplement the wire fixation as per standard surgical practice. This cast holds the wrist still and is left on until the wires are removed at the follow-up appointment.
Volar Locking Plate fixationProcedure or surgery
Also called open reduction and internal fixation, plate and screw fixation
The locking-plate is applied through an incision over the volar (palm) aspect of the wrist. The surgical approach, the type of plate and the number and configuration of screws will be left to the discretion of the surgeon. The screws in the distal portion of the bone will be fixed-angle, i.e. screwed into the plate, but this is standard technique for use of these plates. The type of proximal screw will be left to the discretion of the surgeon; these may be locking or non-locking screws. The use of a cast will left to the discretion of the surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Distal radius fracture | Patients aged 18 years and older with a fracture of the distal radius, within 3 cm of the radiocarpal joint Receives: Procedure: Kirschner wire fixation; Procedure: Volar Locking Plate fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip strength
Maximum grip strength applied to a hand-held dynamometer, measured in kilograms
Measured: 1 year post-operatively
Secondary outcomes (5)
Pinch strength
The force in kilograms of the pinch between the thumb pad and the radial aspect of the middle phalanx of the index finger when applied to a pinch gauge.
Measured: 1 year post-operatively
Wrist arc motion
The range of motion in flexion-extension, radioulnar deviation and supination-pronation of the wrist and forearm.
Measured: 1 year post-operatively
Patient rated wrist evaluation (PRWE)
The PRWE score is a validated self-reported questionnaire. It consists of 15 items specifically related to the function of the wrist.
Measured: 1 year post-operatively
Disabilities of Arm, Shoulder and Hand Score (DASH)
The DASH outcome measure is a 30-item, self-report questionnaire designed to provide a more general measure of physical function and symptoms in people with musculoskeletal disorders of the upper limb
Measured: 1 year post-operatively
EQ-5D
A validated, generalised, quality of life questionnaire consisting of 5 domains related to daily activities with a 3-level answer possibility. The combination of answers leads to the QoL score.
Measured: 1 year post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FracturesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Warwick
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals Coventry and Warwickshire NHS Trust, DePuy International
- Responsible party
- Principal investigator, Caroline Plant, University of Warwick
- Investigators
- Matthew Costa, FRCS, PhD, Study chair, Warwick OrthopaedicsJuul Achten, PhD, Study director, Warwick OrthopaedicsCaroline E Plant, BSc, MBChB, Principal investigator, Warwick Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435070
- Sponsor's protocol ID
- IIS2010025
- Status last verified
- Sep 2011
- First submitted
- 30 Aug 2011
- Last updated
- 15 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Correlation of Functional Outcome Measures of Fractures of the Distal Radius Following Operative Management
- ClinicalTrials.gov ID
- NCT01435070
- Acronym / sponsor ID
- IIS2010025
- Conditions
- Distal Radius Fractures
- Keywords
- Colles' fracture, Radius fracture, grip strength, pinch strength, range of movement, PRWE, DASH, EQ-5D
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of WarwickUniversity, hospital or other
- Collaborators
- University Hospitals Coventry and Warwickshire NHS Trust, DePuy International
- Study start
- Jan 2011
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 15 Sep 2011 (estimated)
- 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.
Patients attending the University Hospital Coventry UK with a broken wrist requiring an operation, will be invited to enter the study. At the first visit, they will have an xray of the wrist and will be asked to complete a number of questionnaires. The questions are to determine if they normally have pain in the wrist and how well they can perform their daily activities. The patient will then have an operation, and the fracture in the wrist will be held in the correct position with either a metal plate and screws or wires.
At 6 weeks following the operation the patient will be reassessed and an xray will be taken. At 3 months, 6 months and 12 months after the operation patients will perform tests to assess the strength of their grip, pinch and movement of their wrist. In addition they will complete the the same questionnaires from their first visit. At the 12 month visit patients will have another xray.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Distal radius fracture | – | Procedure: Kirschner wire fixation, Procedure: Volar Locking Plate fixationPatients aged 18 years and older with a fracture of the distal radius, within 3 cm of the radiocarpal joint |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients presenting to University Hospital Coventry with an acute fracture of the distal radius requiring operative management
Key inclusion criteria (3 listed)
- Sustained a dorsally displaced fracture of the distal radius, which is defined as a fracture within 3cm of the radio-carpal joint
- The treating Consultant surgeon believes that they would benefit from operative fixation of the fracture
- Aged over 18years (either sex) and able to give informed consent
Key exclusion criteria (4 listed)
- The fracture extends more than 3 cm from the radio-carpal joint
- The fracture open with a Gustillo grading greater than 1
- There are contra-indications to general anaesthetic
- There is evidence that the patient would be unable to adhere to trial procedures or complete questionnaires
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 |
|---|---|---|
| Kirschner wire fixationAlso: K-wire fixationThe wires are passed through the skin over the dorsal aspect of the distal radius and into the bone in order to hold the fracture in the correct (anatomical) position. The size and number of wires, the insertion technique and the configuration of wires will be left entirely to the discretion of the surgeon. A plaster cast will be applied at the end of the procedure to supplement the wire fixation as per standard surgical practice. This cast holds the wrist still and is left on until the wires are removed at the follow-up appointment. | Procedure or surgery | Distal radius fracture |
| Volar Locking Plate fixationAlso: open reduction and internal fixation, plate and screw fixationThe locking-plate is applied through an incision over the volar (palm) aspect of the wrist. The surgical approach, the type of plate and the number and configuration of screws will be left to the discretion of the surgeon. The screws in the distal portion of the bone will be fixed-angle, i.e. screwed into the plate, but this is standard technique for use of these plates. The type of proximal screw will be left to the discretion of the surgeon; these may be locking or non-locking screws. The use of a cast will left to the discretion of the surgeon. | Procedure or surgery | Distal radius fracture |
Primary outcome
Grip strength
Time frame: 1 year post-operatively
Maximum grip strength applied to a hand-held dynamometer, measured in kilograms
5 secondary outcomes
Pinch strength
Time frame: 1 year post-operatively
Wrist arc motion
Time frame: 1 year post-operatively
Patient rated wrist evaluation (PRWE)
Time frame: 1 year post-operatively
Disabilities of Arm, Shoulder and Hand Score (DASH)
Time frame: 1 year post-operatively
EQ-5D
Time frame: 1 year post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2011.
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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.
Matthew Costa, FRCS, PhD study chair
Warwick Orthopaedics
Juul Achten, PhD study director
Warwick Orthopaedics
Caroline E Plant, BSc, MBChB principal investigator
Warwick Orthopaedics
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 Fractures, run by University of Warwick at 1 site in United Kingdom.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 Sep 2011. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline E Plant, MBChB (02476964000 ext. 28628, c.e.gaymer@warwick.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip strength (time frame: 1 year post-operatively). 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 15 Sep 2011.