Radius; Fracture, Lower or Distal EndNCT03371030
Role of the Pronator Quadratus in Distal Radius Fractures
A study testing Pronatus quadratus reparation in people with Radius; Fracture, Lower or Distal End, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Radius; Fracture, Lower or Distal End
- What is being tested?
- Pronatus quadratus reparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 4 Jan 2018to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Distal radius fractures with intra-articular fragment, comminuted or displaced fracture
- Adults between 18- 90 years old
Who cannot join
- Children
- Non displaced distal radius fractures treated with immobilization.
- Adults older than 90 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Radius; Fracture, Lower or Distal End
- Being tested
- Pronatus quadratus reparation
- Keywords
- distal radius fractures, pronator quadratus, osteosynthesis
- Medical subject headings
- Fractures, Bone, Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pronatus quadratus reparationProcedure or surgery
Displaced and intra-articular distal radius fractures treated with volar approach and plate fixation. Pronator Quadratus muscle repair.
| Study group | Role | What they receive |
|---|---|---|
| Pronator quadratus reparation | Experimental | Surgical Intervention: Radius fracture teated with plate and pronator quadratus muscle repair. Receives: Procedure: Pronatus quadratus reparation |
| No pronator quadratus reparation | Active comparator | Surgical Intervention: Radius fracture with plate without pronator quadratus muscle repair. Receives: Procedure: Pronatus quadratus reparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture consolidation
X-Ray radius union
Measured: 3 months
Secondary outcomes (2)
Clinical stability
Clinical stability of the distal radioulnar joint
Measured: 3 months
Radiological stability
Radiological stability of the distal radioulnar joint
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start4 Jan 2018
- Primary completion28 Oct 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Radius; Fracture, Lower or Distal EndStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Clinical Research Network - SCReN
- Responsible party
- Sponsor
- Investigators
- Claudia Lamas, MD, Ph D, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371030
- Sponsor's protocol ID
- IIBSP-QUA-2017-36
- Status last verified
- Mar 2023
- First submitted
- 29 Nov 2017
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. doi: 10.1016/s0266-7681(02)00279-6.
PubMed 12631484Inoue 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.
PubMed 8764707Orbay 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.
PubMed 16518106Sheetz 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.
PubMed 8583061Huang 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.
PubMed 29101976Lamas 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.
PubMed 19475457Lamas 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.
PubMed 37684023
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Pronator Quadratus in Vascularity and Stabilisation in Distal Radius Fractures After Osteosynthesis: Clinical and Anatomical Experimental Study
- ClinicalTrials.gov ID
- NCT03371030
- Acronym / sponsor ID
- IIBSP-QUA-2017-36
- Conditions
- Radius; Fracture, Lower or Distal End
- Keywords
- distal radius fractures, pronator quadratus, osteosynthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Spanish Clinical Research Network - SCReN
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pronator quadratus reparation | Experimental | Procedure: Pronatus quadratus reparationSurgical Intervention: Radius fracture teated with plate and pronator quadratus muscle repair. |
| No pronator quadratus reparation | Active comparator | Procedure: Pronatus quadratus reparationSurgical Intervention: Radius fracture with plate without pronator quadratus muscle repair. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Distal radius fractures with intra-articular fragment, comminuted or displaced fracture
- Adults between 18- 90 years old
Key exclusion criteria (3 listed)
- Children
- Non displaced distal radius fractures treated with immobilization.
- Adults older than 90 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pronatus quadratus reparationDisplaced and intra-articular distal radius fractures treated with volar approach and plate fixation. Pronator Quadratus muscle repair. | Procedure or surgery | No pronator quadratus reparation, Pronator quadratus reparation |
Primary outcome
Fracture consolidation
Time frame: 3 months
X-Ray radius union
2 secondary outcomes
Clinical stability
Time frame: 3 months
Radiological stability
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Background: PubMed 12631484Haerle 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.
- Background: PubMed 8764707Inoue 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.
- Background: PubMed 16518106Orbay 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.
- Background: PubMed 8583061Sheetz 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.
- Background: PubMed 29101976Huang 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.
- Background: PubMed 19475457Lamas 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.
- Derived from this study: PubMed 37684023Lamas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Lamas, MD, Ph D principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pronatus quadratus reparation in people with Radius; Fracture, Lower or Distal End, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture consolidation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03371030, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.