Clavicle FracturesPhase 2/3NCT01015924
Plate Osteosynthesis Versus ESIN of Displaced Midclavicular Fractures
A Phase 2/3 study testing plate osteosynthesis and ESIN in people with Clavicle Fractures, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
The purpose of this study is to compare two widely used operative techniques on displaced midshaft clavicular fractures. The hypothesis is that there is no difference in functional outcome. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Clavicle Fractures
- What is being tested?
- plate osteosynthesis and ESIN
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteNorway
- Study dates
- Jul 2009to Sep 2013
- Phase
- Phase 2/3
- 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 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 16 - 60 years of age
- Dislplaced midshaft clavicular fractures with no cortical bone contact or shortening over 15 mm
- Tenting/compromised skin
- Axial malalignment over 30 degrees
Who cannot join
- More than 4 weeks old fracture
- Ipsilateral damage that will influence the recovery and scoring systems, ie. Rotator cuff injury/fracture
- Pathological fracture
- Neurovascular injury
- Open fracture
- Noncompliance
- Congenital anomaly or bone disease
- Ongoing infectious process around the incision site for plate osteosynthesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intramedullary Nailing Compared With Plate Fixation of Displaced Mid-clavicular Fractures. A Prospective Randomized Controlled Trial
The purpose of this study is to compare two widely used operative techniques on displaced midshaft clavicular fractures. The hypothesis is that there is no difference in functional outcome.
Read the detailed description
Clavicular fracture is one of the most common fractures, accounting for about 4 % of all fractures. Midshaft fractures account for approximately 80%. Traditionally, midshaft fractures have been thought to have a good prognosis even when substantially displaced, and most have been treated nonoperatively with a sling or a figure of eight bandage. Early studies by Neer and Rowe in the 60´s demonstrated a very low non-union rate, with av prevalence of 4 in a series of 566 patients, and 3 nonunions in 2235 in another. On this basis, the general view has been that the vast majority of even severely displaced midshaft fractures healed uneventfully, with a very low nonunion rate and a good functional result. Operative results reported on the other hand bad results, especially concerning the risk of infection. Recent studies, however, conclude differently, and suggest the outcomes of displaced fractures might not be as favourable as once thought. Hill showed in a series of 52 completely displaced midclavicular fractures a nonunion rate of 15% (8 of 52 patients) and 31% (16 of 52) of patients were not satisfied with the end result. This correlated with a shortening of more than 2 cm. In a prospective study of 222 patients by Nowak, 42% (93 of 222) were found to have persisting symptoms after 6 months wheras 15% were found to have nonunion. These symptoms seem to persist even after 9 - 10 years reporting 29 % of 208 patients having pain during activity and 9% pain at rest. 46% did not consider themselves fully recovered.
Similar result were found in a systemic review of 2144 fractures. 15.1 % (24 of 159) of nonoperative treated dislocated fractures resulted in nonuion, whereas 2,2% (10 of 460) and 2% (5 of 152) nonunions were found in fractures treated operatively with either plate or intramedullary pins. On this basis, it is becoming more evident that conservative treatment gives much inferior results compared to earlier reported results.
The operative approach to midclavicular fractures have traditionally been plate osteosynthesis or intramedullary nailing. Poigenfürst in 1992 showed in a series of 122 patients a low nonunion rate and good functional results after plating. Likewise, intramedullary nailing has been described as an alternative technique with good results. Kettler demonstrated en a series of 87 patients a good functional results union in 97,7 % ( 85 of 87) and no infections. Similar results were fond by Rehm in 2004, with one nonunion of 136 fractures treated and a constant score one year after implant removal of 97.
Operative treatment of displaced midclavicular fracture thus shows reliable good results compared to earlier reported results. In 2007, the Canadian Orthopedic Trauma Society published a prospective randomised controlled trial of 132 patients, randomised to either conservative treatment with a sling, or plate fixation. The operative group showed clear superiority in Constant and DASH scores, reduction in risk of developing non-union, earlier return to work. With intramedullary nailing using ESIN technique, Smekal et al demonstrated superior results in the operative group in a prospective randomised controlled trial of 60 patients. 30 patients were opereated with elastic stable intramedullary nailing, and 30 patients were randomised to conservative treatment with a sling. The operative group had fewer complications, shorter time to union and a better functional outcome.
It seems from the above, that it is reasonable to offer operative treatment to active adults with displaced fractures of the middle third of the clavicle due to the risk of developing a symptomatic non- or malunion. Both plate fixation and intramedullary nailing of displaced fractures are described as safe methods of operative treatment. To our knowledge, there has never been conducted a prospective randomised controlled trial that compares different forms of the former mentioned operative alternatives.
On this basis, we plan to contuct a prospective randomised controlled trial comparing operative plate fixation and intramedullary nailing with TEN.
- Conditions
- Clavicle Fractures
- Being tested
- plate osteosynthesis, ESIN
- Keywords
- clavicle, TEN, Plate osteosynthesis, displaced, ESIN, displaced midshaft clavicular fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plate osteosynthesisProcedure or surgery
Also called The standard plate i a precontoured LCP clavicle plate by Synthes
Patients are operated upon within 3 w of the fracture
ESINProcedure or surgery
Also called TEN, synthes
Elastiv stable intramedullary nailing
| Study group | Role | What they receive |
|---|---|---|
| Elastic Stable Intramedullary Nailing | Active comparator | Operative intervention with closed or open reduction and intramedullary stabilization of midshaft clavicle fractures Receives: Procedure: plate osteosynthesis; Procedure: ESIN |
| Plate osteosynthesis | Active comparator | Open reduction and plate fixation of midshaft clavicle fractures Receives: Procedure: plate osteosynthesis; Procedure: ESIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome using DASH score
Measured: quick dash w 1 thru 6. DASH at 6, 12, 26, 52
Secondary outcomes (3)
At each control, complication such as infection, thoracic outlet syndrome is evaluated
Measured: continuously, as well as w 6, 12, 26, 52
Constant score
Measured: evaluated 6w, 12w, 26w 52 w
SF 36
Measured: 26 w and 52 w
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startJul 2009
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clavicle 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hendrik Frolich Fuglesang, University Hospital, Akershus
- Investigators
- Stein Erik Utvag, MD PhD, Study director, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015924
- Sponsor's protocol ID
- rek 1.2009.1196
- Status last verified
- Jan 2014
- First submitted
- 17 Nov 2009
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramedullary Nailing Compared With Plate Fixation of Displaced Mid-clavicular Fractures. A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01015924
- Acronym / sponsor ID
- rek 1.2009.1196
- Conditions
- Clavicle Fractures
- Keywords
- clavicle, TEN, Plate osteosynthesis, displaced, ESIN, displaced midshaft clavicular fractures
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 18 Nov 2009 (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 compare two widely used operative techniques on displaced midshaft clavicular fractures. The hypothesis is that there is no difference in functional outcome.
Detailed description
Clavicular fracture is one of the most common fractures, accounting for about 4 % of all fractures. Midshaft fractures account for approximately 80%. Traditionally, midshaft fractures have been thought to have a good prognosis even when substantially displaced, and most have been treated nonoperatively with a sling or a figure of eight bandage. Early studies by Neer and Rowe in the 60´s demonstrated a very low non-union rate, with av prevalence of 4 in a series of 566 patients, and 3 nonunions in 2235 in another. On this basis, the general view has been that the vast majority of even severely displaced midshaft fractures healed uneventfully, with a very low nonunion rate and a good functional result. Operative results reported on the other hand bad results, especially concerning the risk of infection. Recent studies, however, conclude differently, and suggest the outcomes of displaced fractures might not be as favourable as once thought. Hill showed in a series of 52 completely displaced midclavicular fractures a nonunion rate of 15% (8 of 52 patients) and 31% (16 of 52) of patients were not satisfied with the end result. This correlated with a shortening of more than 2 cm. In a prospective study of 222 patients by Nowak, 42% (93 of 222) were found to have persisting symptoms after 6 months wheras 15% were found to have nonunion. These symptoms seem to persist even after 9 - 10 years reporting 29 % of 208 patients having pain during activity and 9% pain at rest. 46% did not consider themselves fully recovered.
Similar result were found in a systemic review of 2144 fractures. 15.1 % (24 of 159) of nonoperative treated dislocated fractures resulted in nonuion, whereas 2,2% (10 of 460) and 2% (5 of 152) nonunions were found in fractures treated operatively with either plate or intramedullary pins. On this basis, it is becoming more evident that conservative treatment gives much inferior results compared to earlier reported results.
The operative approach to midclavicular fractures have traditionally been plate osteosynthesis or intramedullary nailing. Poigenfürst in 1992 showed in a series of 122 patients a low nonunion rate and good functional results after plating. Likewise, intramedullary nailing has been described as an alternative technique with good results. Kettler demonstrated en a series of 87 patients a good functional results union in 97,7 % ( 85 of 87) and no infections. Similar results were fond by Rehm in 2004, with one nonunion of 136 fractures treated and a constant score one year after implant removal of 97.
Operative treatment of displaced midclavicular fracture thus shows reliable good results compared to earlier reported results. In 2007, the Canadian Orthopedic Trauma Society published a prospective randomised controlled trial of 132 patients, randomised to either conservative treatment with a sling, or plate fixation. The operative group showed clear superiority in Constant and DASH scores, reduction in risk of developing non-union, earlier return to work. With intramedullary nailing using ESIN technique, Smekal et al demonstrated superior results in the operative group in a prospective randomised controlled trial of 60 patients. 30 patients were opereated with elastic stable intramedullary nailing, and 30 patients were randomised to conservative treatment with a sling. The operative group had fewer complications, shorter time to union and a better functional outcome.
It seems from the above, that it is reasonable to offer operative treatment to active adults with displaced fractures of the middle third of the clavicle due to the risk of developing a symptomatic non- or malunion. Both plate fixation and intramedullary nailing of displaced fractures are described as safe methods of operative treatment. To our knowledge, there has never been conducted a prospective randomised controlled trial that compares different forms of the former mentioned operative alternatives.
On this basis, we plan to contuct a prospective randomised controlled trial comparing operative plate fixation and intramedullary nailing with TEN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elastic Stable Intramedullary Nailing | Active comparator | Procedure: plate osteosynthesis, Procedure: ESINOperative intervention with closed or open reduction and intramedullary stabilization of midshaft clavicle fractures |
| Plate osteosynthesis | Active comparator | Procedure: plate osteosynthesis, Procedure: ESINOpen reduction and plate fixation of midshaft clavicle fractures |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 16 - 60 years of age
- Dislplaced midshaft clavicular fractures with no cortical bone contact or shortening over 15 mm
- Tenting/compromised skin
- Axial malalignment over 30 degrees
Key exclusion criteria (8 listed)
- More than 4 weeks old fracture
- Ipsilateral damage that will influence the recovery and scoring systems, ie. Rotator cuff injury/fracture
- Pathological fracture
- Neurovascular injury
- Open 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 |
|---|---|---|
| plate osteosynthesisAlso: The standard plate i a precontoured LCP clavicle plate by SynthesPatients are operated upon within 3 w of the fracture | Procedure or surgery | Elastic Stable Intramedullary Nailing, Plate osteosynthesis |
| ESINAlso: TEN, synthesElastiv stable intramedullary nailing | Procedure or surgery | Elastic Stable Intramedullary Nailing, Plate osteosynthesis |
Primary outcome
Functional outcome using DASH score
Time frame: quick dash w 1 thru 6. DASH at 6, 12, 26, 52
3 secondary outcomes
At each control, complication such as infection, thoracic outlet syndrome is evaluated
Time frame: continuously, as well as w 6, 12, 26, 52
Constant score
Time frame: evaluated 6w, 12w, 26w 52 w
SF 36
Time frame: 26 w and 52 w
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2014.
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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.
Stein Erik Utvag, MD PhD study director
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing plate osteosynthesis and ESIN in people with Clavicle Fractures, run by University Hospital, Akershus at 1 site 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 4 inclusion and 8 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 31 Jan 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 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional outcome using DASH score (time frame: quick dash w 1 thru 6. DASH at 6, 12, 26, 52). 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 31 Jan 2014.