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Role of the Pronator Quadratus in Distal Radius Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03371030
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : February 18, 2020
Sponsor:
Collaborator:
Spanish Clinical Research Network - CAIBER
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

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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 : January 15, 2021
Estimated Study Completion Date : January 15, 2021

Resource links provided by the National Library of Medicine


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.




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371030


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

Locations
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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         
Claudia Lamas Recruiting
Barcelona, Spain, 08035
Contact: Claudia Lamas, MD, Ph D    34935537031    clamasg@santpau.cat   
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Spanish Clinical Research Network - CAIBER
Publications:
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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    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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