Role of the Pronator Quadratus in Distal Radius Fractures

• ClinicalTrials.gov Identifier: NCT03371030
• Recruitment Status: Recruiting
• First Posted: December 13, 2017
• Last Update Posted: October 26, 2021
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborator: Spanish Clinical Research Network - SCReN
• Information provided by (Responsible Party): Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Description

Brief Summary:

The skin, the bones, and most muscles received branches from the source arteries of at least two angiosomes, thus revealing one of the important anastomotic pathways by which the circulation is reconstituted in those cases where a source artery is interrupted by disease or trauma.

There are numerous metaphyseal-epiphyseal branches arise within the pronator quadratus and the anterior interosseous artery and course towards the distal radius. These branches may be fundamental to the healing of the distal radius fractures and make nonunion a rare complication. The aim of this study is the evaluation of the role of the pronator quadratus muscle and its repair in volar approach in distal radius fractures treated with plate fixation.

Condition or disease	Intervention/treatment	Phase
Radius; Fracture, Lower or Distal End	Procedure: Pronatus quadratus reparation	Not Applicable

Detailed Description:

Nonunion is an extremely rare complication in distal radius fractures and is most likely to occur in patients with conditions such as diabetes, peripheral vascular disease, or alcoholism. Diagnosis of nonunion is based on the absence of radiographic signs of union at 6 months. Treatment should be individualized but options are reconstructive procedures or wrist arthrodesis. In volar plating and often by the fracture injury itself, the complete pronator quadratus is stripped off the volar radius. Thus, the intraosseous collateral circulation must be sufficient for clinical healing. Any operative approach to the distal radius fracture should not compromise both volar radial and the dorsoulnar arteries.

While the branches to the pronator quadratus must be sacrificed in a palmar approach, the distal perforator can and should be spared. This is true even in the flexor carpi radialis extended approach. In distal radius fractures, when the normal outward flow of blood through the cortex is blocked, the periosteal arterioles have more ability than medullary arterioles to function and proliferate.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Role of the Pronator Quadratus in Vascularity and Stabilisation in Distal Radius Fractures After Osteosynthesis: Clinical and Anatomical Experimental Study
• Actual Study Start Date: January 4, 2018
• Estimated Primary Completion Date: March 31, 2022
• Estimated Study Completion Date: May 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Pronator quadratus reparation; Surgical Intervention: Radius fracture teated with plate and pronator quadratus muscle repair.	Procedure: Pronatus quadratus reparation; Displaced and intra-articular distal radius fractures treated with volar approach and plate fixation. Pronator Quadratus muscle repair.
Active Comparator: No pronator quadratus reparation; Surgical Intervention: Radius fracture with plate without pronator quadratus muscle repair.	Procedure: Pronatus quadratus reparation; Displaced and intra-articular distal radius fractures treated with volar approach and plate fixation. Pronator Quadratus muscle repair.

Outcome Measures

Primary Outcome Measures :

1. Fracture consolidation [ Time Frame: 3 months ]
   X-Ray radius union

Secondary Outcome Measures :

1. Clinical stability [ Time Frame: 3 months ]
   Clinical stability of the distal radioulnar joint
2. Radiological stability [ Time Frame: 3 months ]
   Radiological stability of the distal radioulnar joint

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Distal radius fractures with intra-articular fragment, comminuted or displaced fracture
• Adults between 18- 90 years old

Exclusion Criteria:

• Children
• Non displaced distal radius fractures treated with immobilization.
• Adults older than 90 years old

Contacts and Locations

Contacts

Contact: Claudia Lamas, MD PhD; +34935537031; clamasg@santpau.cat

Locations

Spain

Hospital de la Santa Creu i Sant Pau; Recruiting

Barcelona, Spain, 08025

Contact: Claudia Lamas, MD PhD +34935537031 clamasg@santpau.cat

Principal Investigator: Claudia Lamas, MD PhD

Sponsors and Collaborators

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Spanish Clinical Research Network - SCReN

Investigators

• Principal Investigator: Claudia Lamas, MD, Ph D; Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

More Information

Publications:

Haerle M, Schaller HE, Mathoulin C. Vascular anatomy of the palmar surfaces of the distal radius and ulna: its relevance to pedicled bone grafts at the distal palmar forearm. J Hand Surg Br. 2003 Apr;28(2):131-6.

Inoue Y, Taylor GI. The angiosomes of the forearm: anatomic study and clinical implications. Plast Reconstr Surg. 1996 Aug;98(2):195-210.

Orbay J, Badia A, Khoury RK, Gonzalez E, Indriago I. Volar fixed-angle fixation of distal radius fractures: the DVR plate. Tech Hand Up Extrem Surg. 2004 Sep;8(3):142-8.

Sheetz KK, Bishop AT, Berger RA. The arterial blood supply of the distal radius and ulna and its potential use in vascularized pedicled bone grafts. J Hand Surg Am. 1995 Nov;20(6):902-14.

Huang HK, Wang JP, Chang MC. Repair of Pronator Quadratus With Partial Muscle Split and Distal Transfer for Volar Plating of Distal Radius Fractures. J Hand Surg Am. 2017 Nov;42(11):935.e1-935.e5. doi: 10.1016/j.jhsa.2017.08.018. Review.

Lamas C, Llusà M, Méndez A, Proubasta I, Carrera A, Forcada P. Intraosseous vascularity of the distal radius: anatomy and clinical implications in distal radius fractures. Hand (N Y). 2009 Dec;4(4):418-23. doi: 10.1007/s11552-009-9204-9. Epub 2009 May 28.

• Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• ClinicalTrials.gov Identifier: NCT03371030
• Other Study ID Numbers: IIBSP-QUA-2017-36
• First Posted: December 13, 2017
• Last Update Posted: October 26, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

distal radius fractures; pronator quadratus; osteosynthesis

Additional relevant MeSH terms:

Fractures, Bone; Radius Fractures; Wounds and Injuries; Forearm Injuries; Arm Injuries