Viewing Study NCT06972550


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Ignite Modification Date: 2025-12-27 @ 1:02 PM
Study NCT ID: NCT06972550
Status: COMPLETED
Last Update Posted: 2025-05-15
First Post: 2025-05-03
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Volar Locked Plating for Distal Radius Fractures: Should the Pronator Quadratus Be Spared?
Sponsor: Kasr El Aini Hospital
Organization:

Study Overview

Official Title: Volar Locked Plating for Distal Radius Fractures: Should the Pronator Quadratus Be Spared?
Status: COMPLETED
Status Verified Date: 2025-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Volar locked plates for the distal radius fractures (DRFs) are applied through the Henry approach and it's modification, this approach entails a routine step to disinsert the pronator quadratus from it's radial and distal attachment. This muscle insertion is mostly fleshy with minimal tendinous tissue and surgeons find it difficult to reattach at the end of the surgery, the hardware come in direct contact with the flexor tendons.
Detailed Description: Distal radius fractures (DRFs) account for about 17.5% of all adult fractures and represent the most common fracture of the upper extremity. For severely displaced or unstable fractures, open reduction and internal fixation (ORIF) is often indicated. Volar locking plate fixation through the flexor carpi radialis (FCR) approach is widely used and considered a standard technique for distal radius fixation. Classically, the pronator quadratus (PQ) muscle is released from the radial side of the distal radius to expose the fracture and is later repaired after plate fixation. However, this repair is often not feasible or reliable. Some authors have suggested that failure to restore the PQ may leave the plate exposed to the flexor tendons, increasing the risk of tendon irritation or rupture.

To address these concerns, minimally invasive PQ-sparing approaches have been developed. Imatani et al. first described a technique for volar plating without detaching the PQ, and Dos Remedios et al. reported a similar approach. Theoretically, preserving the PQ creates a cushion between the plate and the flexor tendons and maintains the muscle's function. Several studies have reported better early functional outcomes and less pain post-operatively with PQ-sparing than the traditional approach.

In this prospective case series at a Level I trauma center with a dedicated hand surgery service, the PQ-sparing volar plating technique for distal radius fractures is evaluated. The study's main objectives were to determine whether the PQ can be preserved without compromising fracture reduction, to describe how a volar locking plate can be applied without releasing the PQ, to identify potential benefits of PQ preservation, and to assess any drawbacks of this approach.

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: