Clavicle FracturePlaClaVisNCT05262998
Intramedullary Screw Versus Plate in Displaced Midshaft Clavicle Fractures
A study testing Plate fixation and Intramedullary Screw in people with Clavicle Fracture, run by Bichat Hospital.
Trial summary
This study compares two operative managements of midshaft clavicle fractures: intramedullary screw and plate fixation. In the past ten years, many studies have compared non operative management versus operative fixation and in particular plate fixation which has been well evaluated. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Clavicle Fracture
- What is being tested?
- Plate fixation and Intramedullary Screw
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 1 May 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 yrs
- Midshaft Clavicle fracture
- Completely displaced (one of the criteria)
- Displacement by one bone width
- Angulation exceeding 30°
- Initial shortening of more than 20 mm
- Tenting/compromised skin
Who cannot join
- Open fracture of the clavicle
- Fracture > 3 wks old
- Noncompliance
- Substance abuse
- Not a resident in the area surrounding the hospital
- Pathological fracture
Show all 9Show fewer
- Congenital abnormality/bone disease
- Infectious process around the clavicle area
- Neurovascular injury
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Intramedullary Screw Fixation Versus Plate in Completely Displaced Midshaft Clavicle Fractures ?
This study compares two operative managements of midshaft clavicle fractures: intramedullary screw and plate fixation.
In the past ten years, many studies have compared non operative management versus operative fixation and in particular plate fixation which has been well evaluated. But to date, there are only few retrospective studies that compares plate and intramedullary screw fixation and the knowledge about this last technique and its functional results is poor.
Read more
The main objective of this study is to compare plate and intramedullary screw fixation, in term of functional results and rate of union.
The hypothesis of this study is that there is superiority of plate over intramedullary screw fixation.
The main evaluation criterion is the Constant Score at 3 months postoperatively.
Read the detailed description
Clavicle fractures are common, accounting for about 4% of all fractures, of which 80% occur in the middle third of the bone and occur typically in younger patients, posing a burden for this active population. Traditionally, non-operative treatment with a sling was standard care, however, increasing rates of fixation are now being reported.
Currently, the main procedure for surgical treatment of clavicular fractures is internal fixation with a plate. Plates provide reliable and secure fixation, but require a long incision and usually have to be removed in a second operation. In a meta-analysis of controlled randomized trials conducted by Woltz, the overall rate of secondary intervention in the plate fixation group was elevated at 17.6%, of which 58.9% was for implant removal.
Fuglesang assessed in a randomized controlled trial the functional results of plate fixation versus intramedullary nailing of displaced midshaft clavicle fractures and found that there was no significant difference between the two treatments courses at twelve months and QuickDASH and Constant Score were both excellent in the two groups. They noticed that recovery was faster with plate fixation (QuickDASH significantly better and clinically relevant (inferior by 8.7 points) at 5 weeks of follow-up and QuickDASH and Constant Score significantly better between 6 weeks and 6 months of follow-up).
They highlighted a significant higher rate of complications when a 2mm diameter nail was used for patients with peropertively discovery of narrow medullary canal. Thus, they suggested a conversion to open reduction and internal fixation with a plate when a 2.5 mm nail may not be used. Morever, they showed that degree of comminution was a strong predictor factor of functional results. The more comminution, the higher were the Quick-DASH and DASH scores during the first six months in the intramedullary nailing group. Plating appeared to be able to negate the effect of comminution when bridging the fracture and concluded that in the presence of comminution, plating may be the superior option.
Sun conducted a retrospective study comparing minimally invasive intramedullary fixation with cannulated screws versus plate fixation and showed that time to union was significantly lower in cannulated screw group (13.2 ± 6.9 weeks versus 16.3 ± 8.7 weeks in the plate fixation group) but there was no subsequent significant difference in Neer shoulder activity score between the two groups. Thus, the clinically significance is yet to be assessed.
In the light of the above considerations, we compared the functional results of cannulated screw fixation versus reconstruction plate fixation using a randomized prospective study design.
- Conditions
- Clavicle Fracture
- Being tested
- Plate fixation, Intramedullary Screw
- Keywords
- Clavicle, Fracture, Screw, Intramedullary, Plate, Trauma, Upper limb
- Medical subject headings
- Fractures, Bone, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plate fixationProcedure or surgery
Procedure: plate fixation
Plate fixation was performed by the regular on-call team surgeons and adhered to standard principles of fracture fixation. A standard surgical protocol was used, the approach was moved inferiorly, the fracture was reduced, sometimes with osteosutur and fixed with an antero-superior anatomical plate. 3.5mm Locked and cortical screws were used on both sides of the fracture. Fluoroscopy was used during the procedure. Intradermal suture was used to close the skin
Other: post-intervention All patients were discharged the day after the surgery. Interruption of work was given for 45 days. The same analgesics were administered in both groups for three weeks. Graduated exercises for the shoulder joint with pendular movements in a range of 15°-20° with the protection of a forearm sling were commenced from the postoperative second day. The sling was removed when X-ray films showed growth of callus or an indistinct fracture line.
Intramedullary ScrewProcedure or surgery
Procedure: Intramedullary screw fixation
Intramedullary screw fixation was performed by the regular on-call team surgeons and adhered to standard principles of fracture fixation. Intramedullary screw fixation was performed by using a 1.6 or 2.8 mm-diameter threaded guide pin and a 85-100 mm long, 4.5 or 6.5 mm-diameter cannulated screw tapped in along the guide pin. Fluoroscopy was used during the procedure. Intradermal suture was used to close the skin.
Other: post-intervention All patients were discharged the day after the surgery. Interruption of work was given for 45 days. The same analgesics were administered in both groups for three weeks. Graduated exercises for the shoulder joint with pendular movements in a range of 15°-20° with the protection of a forearm sling were commenced from the postoperative second day. The sling was removed when X-ray films showed growth of callus or an indistinct fracture line.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | Active comparator | Plate fixation Receives: Procedure: Plate fixation |
| INTERVENTION | Experimental | Intramedullary Screw Receives: Procedure: Intramedullary Screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Constant Score
Scale from 0 to 100 to evaluate the shoulder function in daily life (0 is no function and 100 is normal function)
Measured: At 3 months
Secondary outcomes (11)
The Constant Score
Scale from 0 to 100 to evaluate the shoulder function in daily life (0 is no function and 100 is normal function)
Measured: At 6 weeks, 4 months, 6 months and 12 months
The QuickDASH Score
Scale from 0 to 100 to evaluate the shoulder function in daily life (0 is no disability and 100 is maximum disability)
Measured: At 6 weeks, 3, 4, 6 and 12 months
Numeric Rating Scale (NRS)
Scale from 0 to 10 to evaluate pain (0 is no pain and 10 is worst pain)
Measured: At 6 weeks, 3, 4, 6 and 12 months
Subjective Shoulder Value
Scale from 0 to 100% to evaluate subjective shoulder assessment (0% is no shoulder function and 100% is normal shoulder)
Measured: At 6 weeks, 3, 4, 6 and 12 months
Time to fracture union
From surgery to union (in days)
Measured: At 6 weeks, 3, 4, 6 and 12 months
Length of incision
All incision in cm
Measured: Peroperatively
The duration of surgery
From incision to closure (in min)
Measured: Peroperatively
Blood loss during surgery
Estimation in mL
Measured: Peroperatively
Cosmetic result, Numeric Rating Scale
Scale from 0 to 10 to evaluate cosmetic (0 is worst result and 10 perfect result)
Measured: At 12 months
Rated satisfaction
1: Very Satisfied ; 2: Satisfied ; 3: Ok ; 4: Dissatisfied ; 5: Very dissatisfied
Measured: At 6 weeks, 3, 4, 6 and 12 months
Rate of secondary surgery or complication for non union, mal union, infection of the operative site and implant removal
Descriptive
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Nov 2022 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Clavicle 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bichat Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jules Descamps, Bichat Hospital
- Investigators
- Patrick Boyer, PhD, Study chair, Bichat Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262998
- Sponsor's protocol ID
- 2022-0901-01
- Acronym
- PlaClaVis
- Status last verified
- Mar 2022
- First submitted
- 20 Feb 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun JZ, Zheng GH, Zhao KY. Minimally invasive treatment of clavicular fractures with cannulated screw. Orthop Surg. 2014 May;6(2):121-7. doi: 10.1111/os.12108.
PubMed 24890294Fuglesang HFS, Flugsrud GB, Randsborg PH, Oord P, Benth JS, Utvag SE. Plate fixation versus intramedullary nailing of completely displaced midshaft fractures of the clavicle: a prospective randomised controlled trial. Bone Joint J. 2017 Aug;99-B(8):1095-1101. doi: 10.1302/0301-620X.99B8.BJJ-2016-1318.R1.
PubMed 28768788Khalil A. Intramedullary screw fixation for midshaft fractures of the clavicle. Int Orthop. 2009 Oct;33(5):1421-4. doi: 10.1007/s00264-009-0724-2. Epub 2009 Feb 19.
PubMed 19225778Smith SD, Wijdicks CA, Jansson KS, Boykin RE, Martetschlaeger F, de Meijer PP, Millett PJ, Hackett TR. Stability of mid-shaft clavicle fractures after plate fixation versus intramedullary repair and after hardware removal. Knee Surg Sports Traumatol Arthrosc. 2014 Feb;22(2):448-55. doi: 10.1007/s00167-013-2411-5. Epub 2013 Jan 31.
PubMed 23370985Domos P, Tytherleigh-Strong G, Van Rensburg L. Increased wound complication with intramedullary screw fixation of clavicle fractures: Is it thermal necrosis? J Orthop Surg (Hong Kong). 2017 Sep-Dec;25(3):2309499017739482. doi: 10.1177/2309499017739482.
PubMed 29129131
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramedullary Screw Fixation Versus Plate in Completely Displaced Midshaft Clavicle Fractures ?
- ClinicalTrials.gov ID
- NCT05262998
- Acronym / sponsor ID
- PlaClaVis / 2022-0901-01
- Conditions
- Clavicle Fracture
- Keywords
- Clavicle, Fracture, Screw, Intramedullary, Plate, Trauma, Upper limb
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bichat HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 2 Mar 2022 (actual)
- 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.
This study compares two operative managements of midshaft clavicle fractures: intramedullary screw and plate fixation.
In the past ten years, many studies have compared non operative management versus operative fixation and in particular plate fixation which has been well evaluated. But to date, there are only few retrospective studies that compares plate and intramedullary screw fixation and the knowledge about this last technique and its functional results is poor.
The main objective of this study is to compare plate and intramedullary screw fixation, in term of functional results and rate of union.
The hypothesis of this study is that there is superiority of plate over intramedullary screw fixation.
The main evaluation criterion is the Constant Score at 3 months postoperatively.
Detailed description
Clavicle fractures are common, accounting for about 4% of all fractures, of which 80% occur in the middle third of the bone and occur typically in younger patients, posing a burden for this active population. Traditionally, non-operative treatment with a sling was standard care, however, increasing rates of fixation are now being reported.
Currently, the main procedure for surgical treatment of clavicular fractures is internal fixation with a plate. Plates provide reliable and secure fixation, but require a long incision and usually have to be removed in a second operation. In a meta-analysis of controlled randomized trials conducted by Woltz, the overall rate of secondary intervention in the plate fixation group was elevated at 17.6%, of which 58.9% was for implant removal.
Fuglesang assessed in a randomized controlled trial the functional results of plate fixation versus intramedullary nailing of displaced midshaft clavicle fractures and found that there was no significant difference between the two treatments courses at twelve months and QuickDASH and Constant Score were both excellent in the two groups. They noticed that recovery was faster with plate fixation (QuickDASH significantly better and clinically relevant (inferior by 8.7 points) at 5 weeks of follow-up and QuickDASH and Constant Score significantly better between 6 weeks and 6 months of follow-up).
They highlighted a significant higher rate of complications when a 2mm diameter nail was used for patients with peropertively discovery of narrow medullary canal. Thus, they suggested a conversion to open reduction and internal fixation with a plate when a 2.5 mm nail may not be used. Morever, they showed that degree of comminution was a strong predictor factor of functional results. The more comminution, the higher were the Quick-DASH and DASH scores during the first six months in the intramedullary nailing group. Plating appeared to be able to negate the effect of comminution when bridging the fracture and concluded that in the presence of comminution, plating may be the superior option.
Sun conducted a retrospective study comparing minimally invasive intramedullary fixation with cannulated screws versus plate fixation and showed that time to union was significantly lower in cannulated screw group (13.2 ± 6.9 weeks versus 16.3 ± 8.7 weeks in the plate fixation group) but there was no subsequent significant difference in Neer shoulder activity score between the two groups. Thus, the clinically significance is yet to be assessed.
In the light of the above considerations, we compared the functional results of cannulated screw fixation versus reconstruction plate fixation using a randomized prospective study design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL | Active comparator | Procedure: Plate fixationPlate fixation |
| INTERVENTION | Experimental | Procedure: Intramedullary ScrewIntramedullary Screw |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 75 yrs
- Midshaft Clavicle fracture
- Completely displaced (one of the criteria)
Key exclusion criteria (9 listed)
- Open fracture of the clavicle
- Fracture > 3 wks old
- Noncompliance
- Substance abuse
- Not a resident in the area surrounding the hospital
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 fixationProcedure: plate fixation Plate fixation was performed by the regular on-call team surgeons and adhered to standard principles of fracture fixation. A standard surgical protocol was used, the approach was moved inferiorly, the fracture was reduced, sometimes with osteosutur and fixed with an antero-superior anatomical plate. 3.5mm Locked and cortical screws were used on both sides of the fracture. Fluoroscopy was used during the procedure. Intradermal suture was used to close the skin Other: post-intervention All patients were discharged the day after the surgery. Interruption of work was given for 45 days. The same analgesics were administered in both groups for three weeks. Graduated exercises for the shoulder joint with pendular movements in a range of 15°-20° with the protection of a forearm sling were commenced from the postoperative second day. The sling was removed when X-ray films showed growth of callus or an indistinct fracture line. | Procedure or surgery | CONTROL |
| Intramedullary ScrewProcedure: Intramedullary screw fixation Intramedullary screw fixation was performed by the regular on-call team surgeons and adhered to standard principles of fracture fixation. Intramedullary screw fixation was performed by using a 1.6 or 2.8 mm-diameter threaded guide pin and a 85-100 mm long, 4.5 or 6.5 mm-diameter cannulated screw tapped in along the guide pin. Fluoroscopy was used during the procedure. Intradermal suture was used to close the skin. Other: post-intervention All patients were discharged the day after the surgery. Interruption of work was given for 45 days. The same analgesics were administered in both groups for three weeks. Graduated exercises for the shoulder joint with pendular movements in a range of 15°-20° with the protection of a forearm sling were commenced from the postoperative second day. The sling was removed when X-ray films showed growth of callus or an indistinct fracture line. | Procedure or surgery | INTERVENTION |
Primary outcome
The Constant Score
Time frame: At 3 months
Scale from 0 to 100 to evaluate the shoulder function in daily life (0 is no function and 100 is normal function)
11 secondary outcomes
The Constant Score
Time frame: At 6 weeks, 4 months, 6 months and 12 months
The QuickDASH Score
Time frame: At 6 weeks, 3, 4, 6 and 12 months
Numeric Rating Scale (NRS)
Time frame: At 6 weeks, 3, 4, 6 and 12 months
Subjective Shoulder Value
Time frame: At 6 weeks, 3, 4, 6 and 12 months
Time to fracture union
Time frame: At 6 weeks, 3, 4, 6 and 12 months
Length of incision
Time frame: Peroperatively
The duration of surgery
Time frame: Peroperatively
Blood loss during surgery
Time frame: Peroperatively
Cosmetic result, Numeric Rating Scale
Time frame: At 12 months
Rated satisfaction
Time frame: At 6 weeks, 3, 4, 6 and 12 months
Rate of secondary surgery or complication for non union, mal union, infection of the operative site and implant removal
Time frame: At 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Results publication: PubMed 24890294Sun JZ, Zheng GH, Zhao KY. Minimally invasive treatment of clavicular fractures with cannulated screw. Orthop Surg. 2014 May;6(2):121-7. doi: 10.1111/os.12108.
- Results publication: PubMed 28768788Fuglesang HFS, Flugsrud GB, Randsborg PH, Oord P, Benth JS, Utvag SE. Plate fixation versus intramedullary nailing of completely displaced midshaft fractures of the clavicle: a prospective randomised controlled trial. Bone Joint J. 2017 Aug;99-B(8):1095-1101. doi: 10.1302/0301-620X.99B8.BJJ-2016-1318.R1.
- Results publication: PubMed 19225778Khalil A. Intramedullary screw fixation for midshaft fractures of the clavicle. Int Orthop. 2009 Oct;33(5):1421-4. doi: 10.1007/s00264-009-0724-2. Epub 2009 Feb 19.
- Results publication: PubMed 23370985Smith SD, Wijdicks CA, Jansson KS, Boykin RE, Martetschlaeger F, de Meijer PP, Millett PJ, Hackett TR. Stability of mid-shaft clavicle fractures after plate fixation versus intramedullary repair and after hardware removal. Knee Surg Sports Traumatol Arthrosc. 2014 Feb;22(2):448-55. doi: 10.1007/s00167-013-2411-5. Epub 2013 Jan 31.
- Results publication: PubMed 29129131Domos P, Tytherleigh-Strong G, Van Rensburg L. Increased wound complication with intramedullary screw fixation of clavicle fractures: Is it thermal necrosis? J Orthop Surg (Hong Kong). 2017 Sep-Dec;25(3):2309499017739482. doi: 10.1177/2309499017739482.
- Individual participant dataSharing planned: No
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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.
Patrick Boyer, PhD study chair
Bichat Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Plate fixation and Intramedullary Screw in people with Clavicle Fracture, run by Bichat Hospital.
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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jules Descamps, MD (0698270789, dr.jdescamps@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Constant Score (time frame: At 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 NCT05262998, which also lists 5 linked publications.
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 20 Jul 2022.