๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2023-05-22

Comparing Dual Mini-fragment Plating to Single Precontoured Plating of Acute Midshaft Clavicle Fractures Trial (NCT05231343)

A Prospective Randomized Trial Comparing Dual Mini-Fragment Plating to Single Precontoured Plating of Acute Midshaft Clavicle Fractures: A Pilot Study

๐ŸŸข Recruiting Observational / Diagnostic ๐Ÿฉบ Clinical Procedure Protocol Sponsor: Sunnybrook Health Sciences Centre

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Sunnybrook Health Sciences Centre โ€” Toronto, Ontario

Age range: 18 Years to 65 Years

๐Ÿงช Interventions in This Study

  • Dual Mini-fragment Plating (PROCEDURE)
  • Single Precontoured Plating (PROCEDURE)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Sunnybrook Health Sciences Centre โ€” Toronto, Ontario

๐Ÿ“ž Contact the Study Coordinator

Phone: (416) 480-4285

Email: orthores@sunnybrook.ca

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Clavicle Fracture

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—