FractureNCT01242982
Subcapital and Shaft Fractures of the 5. Metacarpal
A study testing Closed reduction and fixation with 2 pins and Reduction and Plaster of Paris in people with Fracture, run by St. Olavs Hospital at 5 sites in Norway.
Trial summary
The purpose of this study is to find out the best treatment for subcapital and shaft fractures of the 5. metacarpal. It is a prospective randomized multicenter study. Comparing only fractures dislocated more than 30 degrees. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Fracture
- What is being tested?
- Closed reduction and fixation with 2 pins and Reduction and Plaster of Paris
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 5 sitesNorway
- Study dates
- Jan 2011to May 2012
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- voluntarily, only isolated subcapital og shaft fracture of the 5. metacarpal,operated/reduction within 10 days of injury,not intoxicated,degree of fracture dislocation minimum 30 degrees measured on the X-ray.
Who cannot join
- open fractures, fractures of the head of 5. metacarpal/intraarticular fractures, patients who wants to be followed up at Hospitals outside the study area, earlier injury of the hand that might have influence on function.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Norway5 sites
Ålesund sjukehus, Helse Sunmøre
Ålesund, Møre og Romsdal, 6026
Kristiansund sykehus, Helse Nord Møre og Romsdal
Kristiansund-N, Møre og Romsdal, 6508
Molde sykehus, Helse Nordmøre og Romsdal
Molde, Møre og Romsdal, 6412
Sykehuset Namsos, Helse Nord-Trøndelag
Namsos, Nord -Trøndelag, 7801
Sykehuset i Vestfold-Tønsberg
Tønsberg, 3103
About this study
Official title: Prospective Randomised Study of Subcapital and Shaft Fractures of the 5. Metacarpal. Comparison Conservative Treatment and Operation
The purpose of this study is to find out the best treatment for subcapital and shaft fractures of the 5. metacarpal.
It is a prospective randomized multicenter study. Comparing only fractures dislocated more than 30 degrees.
One group will be operated with intramedullary pins and one group will be treated conservatively with reduction and then Plaster of Paris for 3 weeks.
All patients will be followed up after 3, 6 and 12 months.
Read the detailed description
See above
- Conditions
- Fracture
- Being tested
- Closed reduction and fixation with 2 pins, Reduction and Plaster of Paris
- Keywords
- 5. metacarpal fracture/fractures, subcapital, shaft, closed
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed reduction and fixation with 2 pinsProcedure or surgery
Closed reduction and fixation with 2 antegrade intramedullary Kirschner wires. Cast for 2 weeks. Control after 2 and 5 weeks. Thereafter a control after 3,6 and 12 months
Reduction and Plaster of ParisProcedure or surgery
Closed reduction in local anesthesia and a Plaster of Paris for max. 3 weeks. Control after 1 and 3 weeks, thereafter control after 3,6 and 12 months
| Study group | Role | What they receive |
|---|---|---|
| Operation | Experimental | Closed reduction and operated for fixation with 2 antegrade intramedullary Kirschner wires. Receives: Procedure: Closed reduction and fixation with 2 pins |
| Conservative treatment | Active comparator | Treated conservatively with reduction and then Plaster of Paris. Receives: Procedure: Reduction and Plaster of Paris |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome comparing conservative and operative treatment of subcapital and shaft fractures of the 5. metacarpal
The goal is 200 patients with shaft and subcapital fractures of the 5.metacarpal. In each group the goal is 100 patients there 50 patients will be operated (2 intramedullary pins) and 50 patients undergo conservative treatment. The follow up is 1 year.
Measured: 2 -3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: problems to include patients, patients not showing up at check-up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FractureStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Ivar Rossvoll, dr. med., Study director, St. Olavs Hospital, orthopedic department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242982
- Sponsor's protocol ID
- TOSL-2010
- Status last verified
- Apr 2015
- First submitted
- 16 Nov 2010
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Study of Subcapital and Shaft Fractures of the 5. Metacarpal. Comparison Conservative Treatment and Operation
- ClinicalTrials.gov ID
- NCT01242982
- Acronym / sponsor ID
- TOSL-2010
- Conditions
- Fracture
- Keywords
- 5. metacarpal fracture/fractures, subcapital, shaft, closed
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: problems to include patients, patients not showing up at check-up
- Enrolment
- 39 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- Jan 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 17 Nov 2010 (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 find out the best treatment for subcapital and shaft fractures of the 5. metacarpal.
It is a prospective randomized multicenter study. Comparing only fractures dislocated more than 30 degrees.
One group will be operated with intramedullary pins and one group will be treated conservatively with reduction and then Plaster of Paris for 3 weeks.
All patients will be followed up after 3, 6 and 12 months.
Detailed description
See above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operation | Experimental | Procedure: Closed reduction and fixation with 2 pinsClosed reduction and operated for fixation with 2 antegrade intramedullary Kirschner wires. |
| Conservative treatment | Active comparator | Procedure: Reduction and Plaster of ParisTreated conservatively with reduction and then Plaster of Paris. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- voluntarily, only isolated subcapital og shaft fracture of the 5. metacarpal,operated/reduction within 10 days of injury,not intoxicated,degree of fracture dislocation minimum 30 degrees measured on the X-ray.
Key exclusion criteria (1 listed)
- open fractures, fractures of the head of 5. metacarpal/intraarticular fractures, patients who wants to be followed up at Hospitals outside the study area, earlier injury of the hand that might have influence on function.
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 |
|---|---|---|
| Closed reduction and fixation with 2 pinsClosed reduction and fixation with 2 antegrade intramedullary Kirschner wires. Cast for 2 weeks. Control after 2 and 5 weeks. Thereafter a control after 3,6 and 12 months | Procedure or surgery | Operation |
| Reduction and Plaster of ParisClosed reduction in local anesthesia and a Plaster of Paris for max. 3 weeks. Control after 1 and 3 weeks, thereafter control after 3,6 and 12 months | Procedure or surgery | Conservative treatment |
Primary outcome
Clinical outcome comparing conservative and operative treatment of subcapital and shaft fractures of the 5. metacarpal
Time frame: 2 -3 years
The goal is 200 patients with shaft and subcapital fractures of the 5.metacarpal. In each group the goal is 100 patients there 50 patients will be operated (2 intramedullary pins) and 50 patients undergo conservative treatment. The follow up is 1 year.
Results and safety
The study was stopped early (reason given: problems to include patients, patients not showing up at check-up). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
Related trials for Fracture
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
Active, not recruitingObservational study
The Developmental Origins of Suicide Mortality
Suicide Mortality
RecruitingObservational study
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
Proximal Humeral Fracture, Reverse Total Shoulder Arthroplasty
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
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.
Ivar Rossvoll, dr. med. study director
St. Olavs Hospital, orthopedic department
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed reduction and fixation with 2 pins and Reduction and Plaster of Paris in people with Fracture, run by St. Olavs Hospital at 5 sites in Norway.
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 1 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 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Norway. 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 stopped early (reason given: problems to include patients, patients not showing up at check-up). 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?
Clinical outcome comparing conservative and operative treatment of subcapital and shaft fractures of the 5. metacarpal (time frame: 2 -3 years). 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 8 Apr 2015.