NCT03371030

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 13, 2017

Completed
22 days until next milestone

Study Start

First participant enrolled

January 4, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

4.8 years

First QC Date

November 29, 2017

Last Update Submit

March 6, 2023

Conditions

Keywords

distal radius fracturespronator quadratusosteosynthesis

Outcome Measures

Primary Outcomes (1)

  • Fracture consolidation

    X-Ray radius union

    3 months

Secondary Outcomes (2)

  • Clinical stability

    3 months

  • Radiological stability

    3 months

Study Arms (2)

Pronator quadratus reparation

EXPERIMENTAL

Surgical Intervention: Radius fracture teated with plate and pronator quadratus muscle repair.

Procedure: Pronatus quadratus reparation

No pronator quadratus reparation

ACTIVE COMPARATOR

Surgical Intervention: Radius fracture with plate without pronator quadratus muscle repair.

Procedure: Pronatus quadratus reparation

Interventions

Displaced and intra-articular distal radius fractures treated with volar approach and plate fixation. Pronator Quadratus muscle repair.

No pronator quadratus reparationPronator quadratus reparation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Related Publications (7)

  • 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.

    PMID: 12631484BACKGROUND
  • 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.

    PMID: 8764707BACKGROUND
  • 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.

    PMID: 16518106BACKGROUND
  • 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.

    PMID: 8583061BACKGROUND
  • 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.

    PMID: 29101976BACKGROUND
  • 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.

    PMID: 19475457BACKGROUND
  • Lamas C, Arenas J, Almenara M, Rojas R, Fa-Binefa M, Toro-Aguilera A. Is pronator quadratus muscle repair required after anterior plate fixation for distal radial fractures? A prospective randomized comparative study. J Hand Surg Eur Vol. 2024 Mar;49(3):334-340. doi: 10.1177/17531934231192337. Epub 2023 Sep 8.

MeSH Terms

Conditions

Fractures, BoneWrist Fractures

Condition Hierarchy (Ancestors)

Wounds and InjuriesWrist InjuriesArm Injuries

Study Officials

  • Claudia Lamas, MD, Ph D

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2017

First Posted

December 13, 2017

Study Start

January 4, 2018

Primary Completion

October 28, 2022

Study Completion

November 30, 2022

Last Updated

March 8, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations