NCT05262998

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

July 20, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

February 20, 2022

Last Update Submit

July 18, 2022

Conditions

Clavicle Fracture

Keywords

ClavicleFractureScrewIntramedullaryPlateTraumaUpper limb

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • The Constant Score

    At 6 weeks, 4 months, 6 months and 12 months

  • The QuickDASH Score

    At 6 weeks, 3, 4, 6 and 12 months

  • Numeric Rating Scale (NRS)

    At 6 weeks, 3, 4, 6 and 12 months

  • Subjective Shoulder Value

    At 6 weeks, 3, 4, 6 and 12 months

  • Time to fracture union

    At 6 weeks, 3, 4, 6 and 12 months

  • +6 more secondary outcomes

Study Arms (2)

CONTROL

ACTIVE COMPARATOR

Plate fixation

Procedure: Plate fixation

INTERVENTION

EXPERIMENTAL

Intramedullary Screw

Procedure: Intramedullary Screw

Interventions

Plate fixationPROCEDURE

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.

CONTROL
Intramedullary ScrewPROCEDURE

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.

INTERVENTION

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 24890294RESULT

  • 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.

    PMID: 28768788RESULT

  • 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.

    PMID: 19225778RESULT

  • 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.

    PMID: 23370985RESULT

  • 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.

    PMID: 29129131RESULT

MeSH Terms

Conditions

Fractures, BoneWounds and Injuries

Study Officials

  • Patrick Boyer, PhD

    Bichat Hospital

    STUDY CHAIR

Central Study Contacts

Jules Descamps, MD

CONTACT

0698270789dr.jdescamps@gmail.com

Alma Sarfati, MD

CONTACT

0610982683alma.sarfati@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

February 20, 2022

First Posted

March 2, 2022

Study Start

November 1, 2022

Primary Completion

May 1, 2023

Study Completion

May 1, 2024

Last Updated

July 20, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share