Intramedullary Screw Versus Plate in Displaced Midshaft Clavicle Fractures

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intramedullary Screw Fixation Versus Plate in Completely Displaced Midshaft Clavicle Fractures ?

Conditions
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Clavicle Fracture

Intervention / Treatment
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* Procedure: Plate fixation
* Procedure: Intramedullary Screw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Open fracture of the clavicle Fracture > 3 wks old Noncompliance Substance abuse Not a resident in the area surrounding the hospital Pathological fracture Congenital abnormality/bone disease Infectious process around the clavicle area Neurovascular injury

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CONTROL<br>Plate fixation | Procedure: Plate fixation<br>* 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.<br>|
| Experimental: INTERVENTION<br>Intramedullary Screw | Procedure: Intramedullary Screw<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | At 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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) | At 6 weeks, 3, 4, 6 and 12 months | 
| Time to fracture union | From surgery to union (in days) | At 6 weeks, 3, 4, 6 and 12 months | 
| Length of incision | All incision in cm | Peroperatively | 
| The duration of surgery | From incision to closure (in min) | Peroperatively | 
| Blood loss during surgery | Estimation in mL | Peroperatively | 
| Cosmetic result, Numeric Rating Scale | Scale from 0 to 10 to evaluate cosmetic (0 is worst result and 10 perfect result) | At 12 months | 
| Rated satisfaction | 1: Very Satisfied ; 2: Satisfied ; 3: Ok ; 4: Dissatisfied ; 5: Very dissatisfied | 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 | At 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clavicle, Fracture, Screw, Intramedullary, Plate, Trauma, Upper limb