NCT05231343

Brief Summary

The rate of surgical fixation of fractures of the collarbone (i.e., midshaft clavicle) has exponentially increased in recent years; however, the rate of repeat procedures for removal of these implants (i.e., plates) due to irritation remains high. Despite technological advances in implant design, nearly one in four patients with a surgically fixed collarbone ultimately undergoes removal of their implant. More recently, there has been a growing body of literature demonstrating the effectiveness of using two smaller caliber plates, which have been found to have similar rates of implant removal. As such, the proposed randomized clinical trial seeks to be the first level I study to directly compare dual mini-fragment plating of acute displaced midshaft clavicle fractures to single precontoured plating. The investigators hypothesize that dual mini-fragment plating will result in lower rates of reoperation with similar rates of union and complication.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress71%
Apr 2022Jan 2028

First Submitted

Initial submission to the registry

January 13, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 9, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 4, 2022

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

4.7 years

First QC Date

January 13, 2022

Last Update Submit

May 22, 2023

Conditions

Clavicle Fracture

Keywords

Orthogonal platingHardware removalReoperation

Outcome Measures

Primary Outcomes (1)

  • Removal of hardware at two years of follow-up

    The proportion of people that had their clavicle hardware removed by the two year follow-up.

    24 months postop

Secondary Outcomes (11)

  • Radiographic union

    6 weeks, 3 months, 6 months, 12 months and 24 months postop

  • Reoperation causes other than hardware removal

    6 weeks, 3 months, 6 months, 12 months and 24 months postop

  • Adverse events/complications

    6 weeks, 3 months, 6 months, 12 months and 24 months postop

  • Operative duration

    Immediately after skin closure

  • Pain as measured by the Numeric Pain Rating Scale (NPRS)

    6 weeks, 3 months, 6 months, 12 months and 24 months postop

  • +6 more secondary outcomes

Study Arms (2)

Dual mini-fragment plating

EXPERIMENTAL
Procedure: Dual Mini-fragment Plating

Single precontoured plating

ACTIVE COMPARATOR
Procedure: Single Precontoured Plating

Interventions

Dual Mini-fragment PlatingPROCEDURE

Patients randomized to dual mini-fragment plating will undergo clavicle fixation using any configuration of 2.0-mm, 2.4-mm and 2.7-mm limited contact dynamic compression (LC-DCP), locking compression (LCP) or reconstruction plates (i.e., 2.4-mm superior and 2.7-mm anteroinferior). One of the two plates used must be a LC-DCP or LCP plate. Surgeons will contour the mini-fragment plate intraoperatively to fit each patient's anatomy.

Dual mini-fragment plating
Single Precontoured PlatingPROCEDURE

Patients randomized to a single plate construct will undergo fixation using an anatomically precontoured (superior or anterior-inferior) clavicle plate.

Single precontoured plating

Eligibility Criteria

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

You may qualify if:

  • Between 18 and 65 years of age
  • A completely displaced midshaft fracture of the clavicle (no cortical contact between the main proximal and distal fragments (AO/OTA 15.2A/B/C)
  • Fracture amenable to plate fixation with a minimum of three screws in each proximal and distal fragment

You may not qualify if:

  • Open fracture
  • Pathological fracture
  • Fracture seen \> 28 days after injury
  • Associated neurovascular injury
  • Associated head injury (Glasgow Coma Scale \< 12)
  • Concomitant ipsilateral upper extremity fracture
  • Significant medical comorbidities (i.e., ASA grade IV and V)
  • Inability to comply with follow-up and
  • Lack of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Study Officials

  • Ujash Sheth, MD MSc FRCSC

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Aman, BSc

CONTACT

416-480-4285orthores@sunnybrook.ca

Katrine Milner, BSc

CONTACT

katrine.milner@sunnybrook.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Surgeon

Study Record Dates

First Submitted

January 13, 2022

First Posted

February 9, 2022

Study Start

April 4, 2022

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

May 24, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)