Role of the Pronator Quadratus in Distal Radius Fractures
Primary Purpose
Radius; Fracture, Lower or Distal End
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pronatus quadratus reparation
Sponsored by
About this trial
This is an interventional treatment trial for Radius; Fracture, Lower or Distal End focused on measuring distal radius fractures, pronator quadratus, osteosynthesis
Eligibility 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
Sites / Locations
- Hospital de la Santa Creu i Sant Pau
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pronator quadratus reparation
No pronator quadratus reparation
Arm Description
Surgical Intervention: Radius fracture teated with plate and pronator quadratus muscle repair.
Surgical Intervention: Radius fracture with plate without pronator quadratus muscle repair.
Outcomes
Primary Outcome Measures
Fracture consolidation
X-Ray radius union
Secondary Outcome Measures
Clinical stability
Clinical stability of the distal radioulnar joint
Radiological stability
Radiological stability of the distal radioulnar joint
Full Information
NCT ID
NCT03371030
First Posted
November 29, 2017
Last Updated
March 6, 2023
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Spanish Clinical Research Network - SCReN
1. Study Identification
Unique Protocol Identification Number
NCT03371030
Brief Title
Role of the Pronator Quadratus in Distal Radius Fractures
Official Title
Role of the Pronator Quadratus in Vascularity and Stabilisation in Distal Radius Fractures After Osteosynthesis: Clinical and Anatomical Experimental Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 4, 2018 (Actual)
Primary Completion Date
October 28, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators
Spanish Clinical Research Network - SCReN
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radius; Fracture, Lower or Distal End
Keywords
distal radius fractures, pronator quadratus, osteosynthesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pronator quadratus reparation
Arm Type
Experimental
Arm Description
Surgical Intervention: Radius fracture teated with plate and pronator quadratus muscle repair.
Arm Title
No pronator quadratus reparation
Arm Type
Active Comparator
Arm Description
Surgical Intervention: Radius fracture with plate without pronator quadratus muscle repair.
Intervention Type
Procedure
Intervention Name(s)
Pronatus quadratus reparation
Intervention Description
Displaced and intra-articular distal radius fractures treated with volar approach and plate fixation. Pronator Quadratus muscle repair.
Primary Outcome Measure Information:
Title
Fracture consolidation
Description
X-Ray radius union
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Clinical stability
Description
Clinical stability of the distal radioulnar joint
Time Frame
3 months
Title
Radiological stability
Description
Radiological stability of the distal radioulnar joint
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Lamas, MD, Ph D
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12631484
Citation
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. doi: 10.1016/s0266-7681(02)00279-6.
Results Reference
background
PubMed Identifier
8764707
Citation
Inoue Y, Taylor GI. The angiosomes of the forearm: anatomic study and clinical implications. Plast Reconstr Surg. 1996 Aug;98(2):195-210. doi: 10.1097/00006534-199608000-00001.
Results Reference
background
PubMed Identifier
16518106
Citation
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. doi: 10.1097/01.bth.0000126570.82826.0a.
Results Reference
background
PubMed Identifier
8583061
Citation
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. doi: 10.1016/S0363-5023(05)80136-4.
Results Reference
background
PubMed Identifier
29101976
Citation
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.
Results Reference
background
PubMed Identifier
19475457
Citation
Lamas C, Llusa M, Mendez 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.
Results Reference
background
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Role of the Pronator Quadratus in Distal Radius Fractures
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