Radius FracturesPhase 3NCT00908895
Non-bridging Fixator Versus Percutaneous Pinning for Distal Radius Fractures
A Phase 3 study testing Radio-radial fixator and Percutaneous pinning in people with Radius Fractures, run by Hopital de l'Enfant-Jesus at 1 site in Canada.
Trial summary
The treatment of extra-articular distal radius fractures is still controversial. In Canada, most patients with unstable fractures are treated with pinning and cast. Results are often associated with shortening and lack of function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radius Fractures
- What is being tested?
- Radio-radial fixator and Percutaneous pinning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2003to May 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Distal radius fracture Frykman I or II
- Unstable fracture according to Lafontaine's criteria
- Fracture line more than 1cm form the joint line
- Closed fracture
- Age > 18 years
- Surgery performed between 72 hours from the trauma
- Monotrauma
- Patient signed the informed consent
Who cannot join
- Distal radius fracture Frykman III-VI (intra-articular fracture)
- Open fracture
- Polytraumatism
- Stable or non-displaced fracture
Trial locations and contacts
1 site in 1 country.
Canada1 site
Département d'orthopédie, CHA-Pavillon Enfant-Jésus
Québec, Quebec, G1J1Z4
About this study
Official title: Non-bridging Radio-radial Fixator Compared to Percutaneous Pinning for Unstable Distal Radius Fracture. A Prospective Randomized Trial.
The treatment of extra-articular distal radius fractures is still controversial. In Canada, most patients with unstable fractures are treated with pinning and cast. Results are often associated with shortening and lack of function.
The purpose of the study is to compare stabilization with a radio-radial fixator to the usual method, suggesting that the radio-radial fixator will provide more strength at 6 months follow-up.
- Conditions
- Radius Fractures
- Being tested
- Radio-radial fixator, Percutaneous pinning
- Keywords
- Radius fractures, Radio-radial fixator, Percutaneous pinning, Grip strength
- Medical subject headings
- Radius Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radio-radial fixatorProcedure or surgery
Using the Distal Radius Fixator from Synthes. A single splint for 5 days.
Percutaneous pinningProcedure or surgery
Insert two K-wires in the distal radius, one in the fracture line dorsally and one from the styloid. A cast for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Radio-radial fixator | Experimental | Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes) Receives: Procedure: Radio-radial fixator |
| Percutaneous pinning | Active comparator | Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks Receives: Procedure: Percutaneous pinning |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Grip Strength
Grip strength measured with Jamar dynamometer in kilograms and adjusted to the opposite side in percentage. Correction made according to dominance.
Measured: 6 months
Secondary outcomes (1)
Range of Movement of Wrist
Range of motion were divided in subgroups: dorsal flexion, volar flexion, pronation, supination, radial inclination, cubital inclination.
Motion is described as a percentage of the opposite side.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study startApr 2003
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital de l'Enfant-Jesus
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908895
- Sponsor's protocol ID
- PEJ-206
- Status last verified
- Nov 2009
- First submitted
- 26 May 2009
- Last updated
- 1 Mar 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-bridging Radio-radial Fixator Compared to Percutaneous Pinning for Unstable Distal Radius Fracture. A Prospective Randomized Trial.
- ClinicalTrials.gov ID
- NCT00908895
- Acronym / sponsor ID
- PEJ-206
- Conditions
- Radius Fractures
- Keywords
- Radius fractures, Radio-radial fixator, Percutaneous pinning, Grip strength
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hopital de l'Enfant-JesusUniversity, hospital or other
- Study start
- Apr 2003
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 27 May 2009 (estimated)
- Results
- Posted 7 Jun 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The treatment of extra-articular distal radius fractures is still controversial. In Canada, most patients with unstable fractures are treated with pinning and cast. Results are often associated with shortening and lack of function.
The purpose of the study is to compare stabilization with a radio-radial fixator to the usual method, suggesting that the radio-radial fixator will provide more strength at 6 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radio-radial fixator | Experimental | Procedure: Radio-radial fixatorPatients are operated on using a radio-radial fixator (Distal radius fixator, Synthes) |
| Percutaneous pinning | Active comparator | Procedure: Percutaneous pinningTwo K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Distal radius fracture Frykman I or II
- Unstable fracture according to Lafontaine's criteria
- Fracture line more than 1cm form the joint line
- Closed fracture
- Age > 18 years
Key exclusion criteria (4 listed)
- Distal radius fracture Frykman III-VI (intra-articular fracture)
- Open fracture
- Polytraumatism
- Stable or non-displaced 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 |
|---|---|---|
| Radio-radial fixatorUsing the Distal Radius Fixator from Synthes. A single splint for 5 days. | Procedure or surgery | Radio-radial fixator |
| Percutaneous pinningInsert two K-wires in the distal radius, one in the fracture line dorsally and one from the styloid. A cast for 6 weeks. | Procedure or surgery | Percutaneous pinning |
Primary outcome
The Grip Strength
Time frame: 6 months
Grip strength measured with Jamar dynamometer in kilograms and adjusted to the opposite side in percentage. Correction made according to dominance.
1 secondary outcome
Range of Movement of Wrist
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radio-radial fixator and Percutaneous pinning in people with Radius Fractures, run by Hopital de l'Enfant-Jesus at 1 site 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 8 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: finished, as of the sponsor's last update on 1 Mar 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Grip Strength (time frame: 6 months). 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 1 Mar 2011.