Distal Radius FracturesNCT00788190
Treatment of Distal Radius Fractures in Elderly Patients
A study testing Distal Radius Fracture Reduction and Conservative Management in people with Distal Radius Fractures, run by Hand and Upper Limb Clinic, Canada at 2 sites in Canada.
Trial summary
The purpose of this study is to create and test a treatment algorithm to guide the treatment of distal radius fractures in patients 65 and older and to obtain level-one evidence to determine the best method of treating distal radius fractures in this growing population demographic. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Distal Radius Fractures
- What is being tested?
- Distal Radius Fracture Reduction and Conservative Management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2008to not given
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Distal Radius Fracture
- Between 10 and 20 degrees of dorsal angulation
- Between 3 and 5mm of Ulnar positive variance
- Between 1 and 2mm intra Articular Step deformity
- Age 65 and older
Who cannot join
- Pre-Morbid medical conditions which preclude surgical intervention
- Patients who do not live independently.
- Patients with an open fracture
- Associated soft tissue or skeletal injury to the same limb.
- Pre-existing wrist arthrosis or disability
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Hand and Upper Limb Centre
London, Ontario, N6A4L6
Hand and upper Limb Centre
London, Ontario, N6A5L8
About this study
Official title: Treatment of Distal Radius Fractures in Elderly Patients, a Randomized Controlled Trial
The purpose of this study is to create and test a treatment algorithm to guide the treatment of distal radius fractures in patients 65 and older and to obtain level-one evidence to determine the best method of treating distal radius fractures in this growing population demographic.
Read the detailed description
- Distal radius fractures with borderline alignment will be randomized to surgical intervention or conservative treatment.
- Patients will fill out subjective questionnaires at 0, 6weeks, 3months, 6 months, and 1 year.
- Patients will perform objective strength tests, dexterity tests and have their range of motion tested at 12 weeks, 6 months and 12 months.
- Conditions
- Distal Radius Fractures
- Being tested
- Distal Radius Fracture Reduction, Conservative Management
- Keywords
- Distal Radius Fracture, Elderly, Prospective randomized trial, Outcomes, Pain and Function, Surgical Vs. conservative management, Fractures with borderline alignment
- Medical subject headings
- Wrist Fractures, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal Radius Fracture ReductionProcedure or surgery
Also called Distal Radius Reduction
Surgical Intervention to Reduce Distal Radius Fracture
Conservative ManagementOther
Conservative management of Distal Radius Fractures
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Other | Surgical intervention to reduce Distal Radius Fracture Receives: Procedure: Distal Radius Fracture Reduction |
| Conservative Treatment | Other | Conservative treatment of Distal Radius Fractures Receives: Other: Conservative Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary: Patient pain and disability. Will be quantified with Disabilities of the Arm and Shoulder (DASH) and Patient Rated Wrist Evaluation (PRWE).
Measured: 0-1 year
Secondary outcomes (3)
Secondary: To determine if other baseline factors influence outcome. For example, baseline activity levels (RAPA), home supports, hand dominance, and general mental health will be analyzed.
Measured: over 1 year
Secondary: To stratify results by age. (65-75, 77-80, and >80)
Measured: 0-1 year
Grip strength, Range of Motion and Dexterity testing of wrists
Measured: 3 months to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2008 (estimated)
- Study startNov 2008
Why it stopped: The inclusion/Exclusion criteria was too strict which restricted recruitment
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hand and Upper Limb Clinic, Canada
- Sponsor type
- Research network
- Collaborators
- LHRI- Lawson Health Research Institute
- Investigators
- Joy C MacDermid, PhD, Principal investigator, Hand and Upper Limb Centre, St. Joseph's Health CareRuby Grewal, MD, FRCSC, Principal investigator, Hand and Upper Limb Centre, St Joseph's Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788190
- Sponsor's protocol ID
- LHRI 001
- Status last verified
- Nov 2008
- First submitted
- 7 Nov 2008
- Last updated
- 11 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Distal Radius Fractures in Elderly Patients, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00788190
- Acronym / sponsor ID
- LHRI 001
- Conditions
- Distal Radius Fractures
- Keywords
- Distal Radius Fracture, Elderly, Prospective randomized trial, Outcomes, Pain and Function, Surgical Vs. conservative management, Fractures with borderline alignment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The inclusion/Exclusion criteria was too strict which restricted recruitment
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Hand and Upper Limb Clinic, CanadaResearch network
- Collaborators
- LHRI- Lawson Health Research Institute
- Study start
- Nov 2008
- First posted
- 10 Nov 2008 (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.
The purpose of this study is to create and test a treatment algorithm to guide the treatment of distal radius fractures in patients 65 and older and to obtain level-one evidence to determine the best method of treating distal radius fractures in this growing population demographic.
Detailed description
- Distal radius fractures with borderline alignment will be randomized to surgical intervention or conservative treatment.
- Patients will fill out subjective questionnaires at 0, 6weeks, 3months, 6 months, and 1 year.
- Patients will perform objective strength tests, dexterity tests and have their range of motion tested at 12 weeks, 6 months and 12 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Other | Procedure: Distal Radius Fracture ReductionSurgical intervention to reduce Distal Radius Fracture |
| Conservative Treatment | Other | Other: Conservative ManagementConservative treatment of Distal Radius Fractures |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Distal Radius Fracture
- Between 10 and 20 degrees of dorsal angulation
- Between 3 and 5mm of Ulnar positive variance
- Between 1 and 2mm intra Articular Step deformity
- Age 65 and older
Key exclusion criteria (5 listed)
- Pre-Morbid medical conditions which preclude surgical intervention
- Patients who do not live independently.
- Patients with an open fracture
- Associated soft tissue or skeletal injury to the same limb.
- Pre-existing wrist arthrosis or disability
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 |
|---|---|---|
| Distal Radius Fracture ReductionAlso: Distal Radius ReductionSurgical Intervention to Reduce Distal Radius Fracture | Procedure or surgery | Surgery |
| Conservative ManagementConservative management of Distal Radius Fractures | Other | Conservative Treatment |
Primary outcome
Primary: Patient pain and disability. Will be quantified with Disabilities of the Arm and Shoulder (DASH) and Patient Rated Wrist Evaluation (PRWE).
Time frame: 0-1 year
3 secondary outcomes
Secondary: To determine if other baseline factors influence outcome. For example, baseline activity levels (RAPA), home supports, hand dominance, and general mental health will be analyzed.
Time frame: over 1 year
Secondary: To stratify results by age. (65-75, 77-80, and >80)
Time frame: 0-1 year
Grip strength, Range of Motion and Dexterity testing of wrists
Time frame: 3 months to 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 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.
Joy C MacDermid, PhD principal investigator
Hand and Upper Limb Centre, St. Joseph's Health Care
Ruby Grewal, MD, FRCSC principal investigator
Hand and Upper Limb Centre, St Joseph's Health Care
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distal Radius Fracture Reduction and Conservative Management in people with Distal Radius Fractures, run by Hand and Upper Limb Clinic, Canada at 2 sites in Canada.
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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 11 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
Primary: Patient pain and disability. Will be quantified with Disabilities of the Arm and Shoulder (DASH) and Patient Rated Wrist Evaluation (PRWE). (time frame: 0-1 year). 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 11 Apr 2011.