Intramedullary Screw Versus Plate in Displaced Midshaft Clavicle Fractures
- Conditions
- Clavicle Fracture
- Interventions
- Procedure: Intramedullary ScrewProcedure: Plate fixation
- Registration Number
- NCT05262998
- Lead Sponsor
- Bichat Hospital
- Brief 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. 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description INTERVENTION Intramedullary Screw Intramedullary Screw CONTROL Plate fixation Plate fixation
- Primary Outcome Measures
Name Time Method The Constant Score 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)
- Secondary Outcome Measures
Name Time Method The Constant Score At 6 weeks, 4 months, 6 months and 12 months Scale from 0 to 100 to evaluate the shoulder function in daily life (0 is no function and 100 is normal function)
Length of incision Peroperatively All incision in cm
The QuickDASH Score At 6 weeks, 3, 4, 6 and 12 months Scale from 0 to 100 to evaluate the shoulder function in daily life (0 is no disability and 100 is maximum disability)
Time to fracture union At 6 weeks, 3, 4, 6 and 12 months From surgery to union (in days)
The duration of surgery Peroperatively From incision to closure (in min)
Numeric Rating Scale (NRS) At 6 weeks, 3, 4, 6 and 12 months Scale from 0 to 10 to evaluate pain (0 is no pain and 10 is worst pain)
Subjective Shoulder Value At 6 weeks, 3, 4, 6 and 12 months Scale from 0 to 100% to evaluate subjective shoulder assessment (0% is no shoulder function and 100% is normal shoulder)
Blood loss during surgery Peroperatively Estimation in mL
Cosmetic result, Numeric Rating Scale At 12 months Scale from 0 to 10 to evaluate cosmetic (0 is worst result and 10 perfect result)
Rated satisfaction At 6 weeks, 3, 4, 6 and 12 months 1: Very Satisfied ; 2: Satisfied ; 3: Ok ; 4: Dissatisfied ; 5: Very dissatisfied
Rate of secondary surgery or complication for non union, mal union, infection of the operative site and implant removal At 12 months Descriptive