Role of the Pronator Quadratus in Distal Radius Fractures

Role of the Pronator Quadratus in Vascularity and Stabilisation in Distal Radius Fractures After Osteosynthesis: Clinical and Anatomical Experimental Study

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.

Study Overview

Status

Recruiting

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Contact:
        • Principal Investigator:
          • Claudia Lamas, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pronator quadratus reparation
Surgical Intervention: Radius fracture teated with plate and pronator quadratus muscle repair.
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.
Displaced and intra-articular distal radius fractures treated with volar approach and plate fixation. Pronator Quadratus muscle repair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fracture consolidation
Time Frame: 3 months
X-Ray radius union
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical stability
Time Frame: 3 months
Clinical stability of the distal radioulnar joint
3 months
Radiological stability
Time Frame: 3 months
Radiological stability of the distal radioulnar joint
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2018

Primary Completion (Anticipated)

October 28, 2022

Study Completion (Anticipated)

November 30, 2022

Study Registration Dates

First Submitted

November 29, 2017

First Submitted That Met QC Criteria

December 7, 2017

First Posted (Actual)

December 13, 2017

Study Record Updates

Last Update Posted (Actual)

September 1, 2022

Last Update Submitted That Met QC Criteria

August 31, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • IIBSP-QUA-2017-36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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