Intramedullary Screw Versus Plate in Displaced Midshaft Clavicle Fractures (PlaClaVis)

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Clavicle Fracture
• Intervention / Treatment: Procedure: Plate fixation; Procedure: Intramedullary Screw

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jules DESCAMPS, MD; Phone Number: 0698270789; Email: dr.jdescamps@gmail.com
• Study Contact Backup: Name: Alma Sarfati, MD; Phone Number: 0610982683; Email: alma.sarfati@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: CONTROL; Plate fixation	Procedure: Plate fixation; 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.
EXPERIMENTAL: INTERVENTION; Intramedullary Screw	Procedure: Intramedullary Screw; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bichat Hospital
• Investigators: Study Chair: Patrick Boyer, PhD, Bichat hospital

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2022
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): May 1, 2024

Study Registration Dates

• First Submitted: February 20, 2022
• First Submitted That Met QC Criteria: February 20, 2022
• First Posted (ACTUAL): March 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Clavicle; Upper limb; Trauma; Fracture; Intramedullary; Plate; Screw
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 2022-0901-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No