Recruiting

Dual Mini-fragment & Single Precontoured

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT05231343

Conditions

Clavicle Fracture

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Dual Mini-fragment Plating

Single Precontoured Plating

Study Details

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.

Conditions

Clavicle Fracture

Study ID

NCT05231343

Start date

Apr 4, 2022

Status verified date

May, 2023

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dual mini-fragment plating

active comparator: Single precontoured plating

Interventions

Dual Mini-fragment Plating

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.

Single Precontoured Plating

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

Primary outcome measure

  • Removal of hardware at two years of follow-up [ Time Frame: 24 months postop ]

Central Contacts and Locations

Central contacts

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Principal Investigator:

Ujash Sheth, MD MSc FRCSC

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

May 24, 2023

Last verified

May, 2023

Keywords

  • Orthogonal plating
  • Hardware removal
  • Reoperation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2023-05-24.