Randomized controlled trial to compare functional outcomes between LOcking compression Plates and Retrograde Intramedullary Nails in distal femur fractures

Not Applicable

Recruiting

• Conditions: Simple extra-articular Distal femur fracture (AO classification type 33A2/3); Injuries and Accidents - Fractures

• Registration Number: ACTRN12622000229774
• Lead Sponsor: Syed Imran Bukhari

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-09
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

•Patients equal to or more than 18 years
•ASA grade 1-3
•Diagnosis of closed extra-articular distal femur fracture type 33A2/3
•Fracture requiring operative treatment amenable to either Retrograde Intramedullary nail (RIMN) or Locking compression plate (LCP)
•Surgical treatment within 7 days after injury
•Informed consent obtained, i.e.:
oAbility to understand the content of the patient information/ informed consent form (ICF)
oWillingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
oSigned and dated ethics committee (EC)/ institutional review board (IRB) approved written informed consent

Exclusion Criteria

•Pathological fractures
•Peri-prosthetic fractures
•Poor skin condition overlying skin incision
•Pre-existing knee arthritis
•Unfit for anesthesia
•Fractures with vascular injury requiring repair
•Retained hardware or existing deformity in the affected limb that would complicate IM nailing or plating
•Soft tissue injuries compromising treatment method with either nail or plate
•Diagnosed metabolic bone disease
•Mentally incompetent patients (a person who cannot make or carry out important decisions regarding his or her affairs).
•Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment
•Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Study & Design

• Study Type: Interventional
• Study Design: Not specified