Colles' FractureCoNCReTeNCT00631267
CoNCReTe-trial: Colles Fractures, Determining the Norm in Closed Reduction Techniques
A study testing Manual Manipulation and Finger Trap Traction in people with Colles' Fracture, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
Rationale: Many different closed techniques are used to reduce a dorsally dislocated distal radius fracture (Colles' fracture). One trial to compare two main techniques (finger-trap traction and manual manipulation) did not find significant difference in radiological and clinical outcome (Earnshaw 2002). Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colles' Fracture
- What is being tested?
- Manual Manipulation and Finger Trap Traction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2008to 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients of 16 years and older visiting our EMD with newly diagnosed closed distal radius fractures:
- within 2cm of the radiocarpal joint
- with dorsoradial dislocation (Colles' fractures),
- AO-type 23.A2 and 23.A3 (extra-articular) and 23-C1 and 23-C2 (intra-articular)
- which are in need for reduction. I.e. Colles' fractures:
- with loss of ≥2mm of radial height (RH),
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- change of ≥5º of radial inclination (RI),
- loss of ≥10º volar tilt (VT),
- loss of reduction of the distal radioulnar (DRU) joint and/or
- fractures with >1mm intra-articular step-off
Who cannot join
- Patients who will not have their follow-up in our hospital
- Patients <16 year old
- Greenstick fractures
- Additional fractures of carpalia or elbow joint
- Patients suffering a High Energy Trauma (HET)
- Fractures that do not need reduction (see 4.2 for definition)
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- Patients with pre-existent wrist-trauma or pathological bone except for osteoporosis (cyst, metastasis)
- Patients who cannot give informed consent or do not understand the Dutch language
- Patients with bilateral fractures
- Open fractures
- Fractures >48h old
- (Smith, Barton, reversed Barton or Chauffeurs fractures)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Colles Fractures, Determining the Norm in Closed Reduction Techniques
Rationale:
Many different closed techniques are used to reduce a dorsally dislocated distal radius fracture (Colles' fracture). One trial to compare two main techniques (finger-trap traction and manual manipulation) did not find significant difference in radiological and clinical outcome (Earnshaw 2002). This trial aims to investigate patient and medical satisfaction between both techniques
Read more
Objective:
To demonstrate patient satisfaction (pain, duration, general) and medical satisfaction (difficulty of reposition). It is suggested that finger-trap traction causes less pain for patients and is more easy than manual manipulation but have the same radiological and clinical outcome.
Study design:
Randomised controlled intervention study
Study population:
300 Patients with newly diagnosed closed distal radius fractures with dorsal angulation (Colles' fracture) older than 16years coming to the Emergency Medical Department.
Intervention:
One group is put in finger-trap traction (digitus 1-3) for 10minutes with 4-5kg of ballast on their upper arm followed by reduction by dorsal pressure. The other group is manually reduced according to Charnley with traction and "hooking over" of the fracture elements.
Main study parameters/endpoints:
Visual analogue scale of patient and medical satisfaction, percentage of successful primary reductions. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Apart for the regular follow-up of patients with distal radius fractures,one extra out-patient visit is necessary to assess functional outcome after three months.Finger-trap traction has a (theoretical) risk of causing traumatic damage to ligaments of the fingers, but this risk is in our opinion not higher than in the manual manipulation. It is expected that the finger-trap traction group is more satisfied because this technique seems less traumatic than but as successful as the manual manipulation group.
- Conditions
- Colles' Fracture
- Being tested
- Manual Manipulation, Finger Trap Traction
- Keywords
- reduction, satisfaction, visual-analog scale, complications, functional outcome, radiological outcome
- Medical subject headings
- Colles' Fracture, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual ManipulationProcedure or surgery
The currently used method for reduction: using manual traction to reduce the distal radial fragment by hyperextension followed by hyperflection.
Finger Trap TractionProcedure or surgery
Using a finger trap traction device in vertical suspension. After 10min reduction by dorsal pressure.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Manual Manipulation Receives: Procedure: Manual Manipulation |
| 2 | Active comparator | Finger Trap Traction Receives: Procedure: Finger Trap Traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the difference in satisfaction of both patient and treating doctor between two well-known techniques of fracture reposition provided that both techniques show equal results in clinical and radiological outcome.
Measured: 3 months
Secondary outcomes (1)
To describe the functional outcome after three months, complication rate and osteoporosis rate in an urban community of a level-2 trauma-centre.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startJul 2008
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: Due to poor patient accrual
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 Colles' 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Karel Kolkman, MD, surgeon, Study director, Rijnstate Hospital Arnhem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631267
- Sponsor's protocol ID
- LTC-502-141207
- Acronym
- CoNCReTe
- Status last verified
- Nov 2014
- First submitted
- 27 Feb 2008
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Earnshaw SA, Aladin A, Surendran S, Moran CG. Closed reduction of colles fractures: comparison of manual manipulation and finger-trap traction: a prospective, randomized study. J Bone Joint Surg Am. 2002 Mar;84(3):354-8. doi: 10.2106/00004623-200203000-00004.
PubMed 11886903
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colles Fractures, Determining the Norm in Closed Reduction Techniques
- ClinicalTrials.gov ID
- NCT00631267
- Acronym / sponsor ID
- CoNCReTe / LTC-502-141207
- Conditions
- Colles' Fracture
- Keywords
- reduction, satisfaction, visual-analog scale, complications, functional outcome, radiological outcome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to poor patient accrual
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 7 Mar 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.
Rationale:
Many different closed techniques are used to reduce a dorsally dislocated distal radius fracture (Colles' fracture). One trial to compare two main techniques (finger-trap traction and manual manipulation) did not find significant difference in radiological and clinical outcome (Earnshaw 2002). This trial aims to investigate patient and medical satisfaction between both techniques
Objective:
To demonstrate patient satisfaction (pain, duration, general) and medical satisfaction (difficulty of reposition). It is suggested that finger-trap traction causes less pain for patients and is more easy than manual manipulation but have the same radiological and clinical outcome.
Study design:
Randomised controlled intervention study
Study population:
300 Patients with newly diagnosed closed distal radius fractures with dorsal angulation (Colles' fracture) older than 16years coming to the Emergency Medical Department.
Intervention:
One group is put in finger-trap traction (digitus 1-3) for 10minutes with 4-5kg of ballast on their upper arm followed by reduction by dorsal pressure. The other group is manually reduced according to Charnley with traction and "hooking over" of the fracture elements.
Main study parameters/endpoints:
Visual analogue scale of patient and medical satisfaction, percentage of successful primary reductions. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Apart for the regular follow-up of patients with distal radius fractures,one extra out-patient visit is necessary to assess functional outcome after three months.Finger-trap traction has a (theoretical) risk of causing traumatic damage to ligaments of the fingers, but this risk is in our opinion not higher than in the manual manipulation. It is expected that the finger-trap traction group is more satisfied because this technique seems less traumatic than but as successful as the manual manipulation group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Procedure: Manual ManipulationManual Manipulation |
| 2 | Active comparator | Procedure: Finger Trap TractionFinger Trap Traction |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patients of 16 years and older visiting our EMD with newly diagnosed closed distal radius fractures:
- within 2cm of the radiocarpal joint
- with dorsoradial dislocation (Colles' fractures),
- AO-type 23.A2 and 23.A3 (extra-articular) and 23-C1 and 23-C2 (intra-articular)
- which are in need for reduction. I.e. Colles' fractures:
Key exclusion criteria (12 listed)
- Patients who will not have their follow-up in our hospital
- Patients <16 year old
- Greenstick fractures
- Additional fractures of carpalia or elbow joint
- Patients suffering a High Energy Trauma (HET)
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 |
|---|---|---|
| Manual ManipulationThe currently used method for reduction: using manual traction to reduce the distal radial fragment by hyperextension followed by hyperflection. | Procedure or surgery | 1 |
| Finger Trap TractionUsing a finger trap traction device in vertical suspension. After 10min reduction by dorsal pressure. | Procedure or surgery | 2 |
Primary outcome
To determine the difference in satisfaction of both patient and treating doctor between two well-known techniques of fracture reposition provided that both techniques show equal results in clinical and radiological outcome.
Time frame: 3 months
1 secondary outcome
To describe the functional outcome after three months, complication rate and osteoporosis rate in an urban community of a level-2 trauma-centre.
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Due to poor patient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
- Background: PubMed 11886903Earnshaw SA, Aladin A, Surendran S, Moran CG. Closed reduction of colles fractures: comparison of manual manipulation and finger-trap traction: a prospective, randomized study. J Bone Joint Surg Am. 2002 Mar;84(3):354-8. doi: 10.2106/00004623-200203000-00004.
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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.
Karel Kolkman, MD, surgeon study director
Rijnstate Hospital Arnhem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Manipulation and Finger Trap Traction in people with Colles' Fracture, run by Rijnstate Hospital at 1 site in Netherlands.
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 10 inclusion and 12 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: stopped early, as of the sponsor's last update on 6 Nov 2014. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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 stopped early (reason given: Due to poor patient accrual). Results are not available in the source record.
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?
To determine the difference in satisfaction of both patient and treating doctor between two well-known techniques of fracture reposition provided that both techniques show equal results in clinical and radiological outcome. (time frame: 3 months). 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 NCT00631267, 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 6 Nov 2014.