Acute, Displaced Midshaft Clavicle FracturesNCT01483482
Treatment of Displaced, Midshaft Clavicle Fractures. Sling or Plate?
A study testing Conservative Treatment and Surgical treatment in people with Acute, Displaced Midshaft Clavicle Fractures, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Clavicle fractures are frequent and represent somewhere between 5 and 10% of all fractures seen in orthopedics. There is no consensus concerning the best treatment of acute, displaced, midshaft clavicle fractures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute, Displaced Midshaft Clavicle Fractures
- What is being tested?
- Conservative Treatment and Surgical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2011to Sep 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- The patient can not have any medical untreated illness : only ASA 1-2
- The patient must be able to speak and understand Danish.
- The patient must be able to give informed consent.
- The patient is expected to be able to follow the postoperative controls.
Who cannot join
- Multitrauma patient
- Other simultaneous fractures
- Former surgery of the shoulder or clavicular.
- Former chronic illness of the shoulder
- Pathological or open fractures
- Associated nerve or vessel damage of the affected arm.
- Fractures older than 3 weeks (21 days)
- Patients with drug(alcohol abuse where it is not expected that the patient i able to complete the follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neither Operative Nor Non-operative Approach is Superior Treating Displaced Midshaft Clavicle Fractures: a Randomised Clinical Trial
Clavicle fractures are frequent and represent somewhere between 5 and 10% of all fractures seen in orthopedics.
There is no consensus concerning the best treatment of acute, displaced, midshaft clavicle fractures. Conservative treatment has, traditionally, been the preferred treatment but recent studies have shown higher incidences of non-union and symptomatic malunion associated with conservative treatment. Primary surgery has in several studies been associated with high success rates and few complications but there is no compelling evidence towards superior results after primary surgery.
The objective of this randomized study is to compare conservative treatment (sling) with primary surgery (locking plate) of acute, displaced, midshaft clavicle fractures.
Read the detailed description
Conservative treatment has been the preferred treatment for midshaft clavicle fractures, whether the fracture is displaced or undisplaced. The background for this comes from two large studies done in the 60s. C. Neer (2235 patients) and C. R Rowe (566 patients) showed respectively in 1960 and 1968 that patients with a clavicle fracture, even with larger fracture displacements, had few symptoms when the fracture is healed and that the incidence of non-union is below 1%. Both studies have been criticized for including children and adolescents where the healing potential is significantly larger than in adults and that their results are based purely on surgical and radiologic endpoints and no patient-reported outcome measurements were used.
Clavicle fractures are frequent and represent somewhere between 5 and 10% of all fractures seen in orthopedics. The incidence of clavicle fracture is somewhere between 29 and 64 per 100000 per year. Fracture of the clavicle most frequently occurs in young men and the male-to-female distribution is 2.6:1. Between 70 and 80% of all clavicle fractures are localized to the middle part of the clavicle and of these, most fractures are displaced. Midshaft clavicle fracture is defined as a fracture in the middle 3/5 parts of the clavicle (lateral boundary is a vertical line from the base of processus coracoideus and medial border is a vertical line from the middle of the first rib).
Recent studies have shown higher incidences of non-union, especially when the fracture is displaced and a shortening of two cm or more occurs. Malunion, that was previously not considered clinically important, appears in several resent studies to be associated with profound symptomatic shoulder problems. One study reported that up to 30% of the displaced clavicle fractures that healed with malunion results in profound symptoms and discomfort of the shoulder.
Surgery, with plate osteosynthesis of the displaced clavicle fracture, has in several studies been associated with a high success rate and few complications. To date only one randomized trial comparing conservative treatment with plate osteosynthesis of the displaced midshaft fracture has been done. This Canadian multi-center study from 2007, where 132 patients were randomized (111 patients completing), concludes that there is a small significant improvement in functional outcome in patients where the fracture has been osteosynthesised compared with conservative treatment. This study recommends surgery of displaced fractures in active patients.
Recently two review articles have questioned the results from the Canadian study because it is unclear whether the poorer functional outcome in the conservatively treated group is due to the non-unions in this group (14.2%). They both conclude that there is an estimated risk of overtreatment as a numbers-needed-to-treat analysis estimates the 9 operations is needed to prevent 1 non-union.
Though the evidence for surgical intervention over conservative treatment for displaced midshaft clavicle fractures still is controversial it seems that more and more patients are treated with primary operative intervention.
Because of this tendency there is a need to validate whether operative intervention with a clavicle plate is superior or not compared to the conservative treatment for displaced midshaft clavicle fractures.
- Being tested
- Conservative Treatment, Surgical treatment
- Keywords
- clavicle fractures, midshaft clavicle fractures, conservative treatment, surgical treatment, functional outcome, clinical assessment, adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative TreatmentProcedure or surgery
Simple Sling
Surgical treatmentProcedure or surgery
Superior Locking plate
| Study group | Role | What they receive |
|---|---|---|
| Conservative treatment | Other | The group allocated to conservative treatment is treated with a simple sling. The sling is removed when the patient is pain free.
The first 6 weeks max 1 kg of weight-bearing is allowed and the patient is instructed to restrict movement of the arm to the level of the shoulder. Receives: Procedure: Conservative Treatment |
| Surgical treatment | Other | Patients allocated to surgical treatment are operated with a superior locking plate.
The first 6 weeks max 1 kg of weight-bearing is allowed and the patient is instructed to restrict movement of the arm to the level of the shoulder. Receives: Procedure: Surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome
Constant score and DASH score is used to evaluate the functional score at 6 weeks, 6 months and 12 months.
Measured: 12 month follow-up
Secondary outcomes (1)
Clinical assessment
Clinical and radiological assessment is done at 6 weeks, 6 months and 12 months of follow-up. Non-union, symptomatic manlunion,surgical complication (infection, hardware failure) is registered.
Measured: 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute, Displaced Midshaft 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilija Ban, Hvidovre University Hospital
- Investigators
- Ilija Ban, MD, Principal investigator, University Hospital of HvidovreAnders Troelsen, MD, PhD, Study director, University Hospital of Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483482
- Sponsor's protocol ID
- CORH-IB-0001
- Status last verified
- Jun 2019
- First submitted
- 29 Nov 2011
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neither Operative Nor Non-operative Approach is Superior Treating Displaced Midshaft Clavicle Fractures: a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT01483482
- Acronym / sponsor ID
- CORH-IB-0001
- Keywords
- clavicle fractures, midshaft clavicle fractures, conservative treatment, surgical treatment, functional outcome, clinical assessment, adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Apr 2011 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 1 Dec 2011 (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.
Clavicle fractures are frequent and represent somewhere between 5 and 10% of all fractures seen in orthopedics.
There is no consensus concerning the best treatment of acute, displaced, midshaft clavicle fractures. Conservative treatment has, traditionally, been the preferred treatment but recent studies have shown higher incidences of non-union and symptomatic malunion associated with conservative treatment. Primary surgery has in several studies been associated with high success rates and few complications but there is no compelling evidence towards superior results after primary surgery.
The objective of this randomized study is to compare conservative treatment (sling) with primary surgery (locking plate) of acute, displaced, midshaft clavicle fractures.
Detailed description
Conservative treatment has been the preferred treatment for midshaft clavicle fractures, whether the fracture is displaced or undisplaced. The background for this comes from two large studies done in the 60s. C. Neer (2235 patients) and C. R Rowe (566 patients) showed respectively in 1960 and 1968 that patients with a clavicle fracture, even with larger fracture displacements, had few symptoms when the fracture is healed and that the incidence of non-union is below 1%. Both studies have been criticized for including children and adolescents where the healing potential is significantly larger than in adults and that their results are based purely on surgical and radiologic endpoints and no patient-reported outcome measurements were used.
Clavicle fractures are frequent and represent somewhere between 5 and 10% of all fractures seen in orthopedics. The incidence of clavicle fracture is somewhere between 29 and 64 per 100000 per year. Fracture of the clavicle most frequently occurs in young men and the male-to-female distribution is 2.6:1. Between 70 and 80% of all clavicle fractures are localized to the middle part of the clavicle and of these, most fractures are displaced. Midshaft clavicle fracture is defined as a fracture in the middle 3/5 parts of the clavicle (lateral boundary is a vertical line from the base of processus coracoideus and medial border is a vertical line from the middle of the first rib).
Recent studies have shown higher incidences of non-union, especially when the fracture is displaced and a shortening of two cm or more occurs. Malunion, that was previously not considered clinically important, appears in several resent studies to be associated with profound symptomatic shoulder problems. One study reported that up to 30% of the displaced clavicle fractures that healed with malunion results in profound symptoms and discomfort of the shoulder.
Surgery, with plate osteosynthesis of the displaced clavicle fracture, has in several studies been associated with a high success rate and few complications. To date only one randomized trial comparing conservative treatment with plate osteosynthesis of the displaced midshaft fracture has been done. This Canadian multi-center study from 2007, where 132 patients were randomized (111 patients completing), concludes that there is a small significant improvement in functional outcome in patients where the fracture has been osteosynthesised compared with conservative treatment. This study recommends surgery of displaced fractures in active patients.
Recently two review articles have questioned the results from the Canadian study because it is unclear whether the poorer functional outcome in the conservatively treated group is due to the non-unions in this group (14.2%). They both conclude that there is an estimated risk of overtreatment as a numbers-needed-to-treat analysis estimates the 9 operations is needed to prevent 1 non-union.
Though the evidence for surgical intervention over conservative treatment for displaced midshaft clavicle fractures still is controversial it seems that more and more patients are treated with primary operative intervention.
Because of this tendency there is a need to validate whether operative intervention with a clavicle plate is superior or not compared to the conservative treatment for displaced midshaft clavicle fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative treatment | Other | Procedure: Conservative TreatmentThe group allocated to conservative treatment is treated with a simple sling. The sling is removed when the patient is pain free. The first 6 weeks max 1 kg of weight-bearing is allowed and the patient is instructed to restrict movement of the arm to the level of the shoulder. |
| Surgical treatment | Other | Procedure: Surgical treatmentPatients allocated to surgical treatment are operated with a superior locking plate. The first 6 weeks max 1 kg of weight-bearing is allowed and the patient is instructed to restrict movement of the arm to the level of the shoulder. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65 years
- The patient can not have any medical untreated illness : only ASA 1-2
- The patient must be able to speak and understand Danish.
- The patient must be able to give informed consent.
- The patient is expected to be able to follow the postoperative controls.
Key exclusion criteria (8 listed)
- Multitrauma patient
- Other simultaneous fractures
- Former surgery of the shoulder or clavicular.
- Former chronic illness of the shoulder
- Pathological or open fractures
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 |
|---|---|---|
| Conservative TreatmentSimple Sling | Procedure or surgery | Conservative treatment |
| Surgical treatmentSuperior Locking plate | Procedure or surgery | Surgical treatment |
Primary outcome
Functional outcome
Time frame: 12 month follow-up
Constant score and DASH score is used to evaluate the functional score at 6 weeks, 6 months and 12 months.
1 secondary outcome
Clinical assessment
Time frame: 12 month follow-up
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 26 Jun 2019.
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.
Ilija Ban, MD principal investigator
University Hospital of Hvidovre
Anders Troelsen, MD, PhD study director
University Hospital of Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative Treatment and Surgical treatment in people with Acute, Displaced Midshaft Clavicle Fractures, run by Hvidovre University Hospital at 1 site in Denmark.
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 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 26 Jun 2019. 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 Denmark. 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 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 (time frame: 12 month follow-up). 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 26 Jun 2019.