Clinical trial NCT05262998: Intramedullary Screw Versus Plate in Displaced Midshaft Clavicle Fractures
Official title: Intramedullary Screw Fixation Versus Plate in Completely Displaced Midshaft Clavicle Fractures ?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Clavicle Fracture
Keywords: Clavicle
Fracture
Screw
Intramedullary
Plate
Trauma
Upper limb
Lead sponsor: Bichat Hospital
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Constant Score
timeFrame: At 3 months
Secondary outcomes:
measure: The Constant Score
timeFrame: At 6 weeks, 4 months, 6 months and 12 months
measure: The QuickDASH Score
timeFrame: At 6 weeks, 3, 4, 6 and 12 months
measure: Numeric Rating Scale (NRS)
timeFrame: At 6 weeks, 3, 4, 6 and 12 months
measure: Subjective Shoulder Value
timeFrame: At 6 weeks, 3, 4, 6 and 12 months
measure: Time to fracture union
timeFrame: At 6 weeks, 3, 4, 6 and 12 months
measure: Length of incision
timeFrame: Peroperatively
measure: The duration of surgery
timeFrame: Peroperatively
measure: Blood loss during surgery
timeFrame: Peroperatively
measure: Cosmetic result, Numeric Rating Scale
timeFrame: At 12 months
measure: Rated satisfaction
timeFrame: At 6 weeks, 3, 4, 6 and 12 months
measure: Rate of secondary surgery or complication for non union, mal union, infection of the operative site and implant removal
timeFrame: At 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Bichat Hospital
name: Patrick Boyer, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: Fuglesang 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.
citation: Khalil 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.
citation: Smith 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.
citation: Domos 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.