Distal Radius FractureNCT06972550
Volar Locked Plating for Distal Radius Fractures: Should the Pronator Quadratus Be Spared?
A study testing pronator quadratus sparing in people with Distal Radius Fracture, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Volar locked plates for the distal radius fractures (DRFs) are applied through the Henry approach and it's modification, this approach entails a routine step to disinsert the pronator quadratus from it's radial and distal attachment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- pronator quadratus sparing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 1 Dec 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- isolated closed distal radius fractures
Who cannot join
- fractures >3 weeks old,
- age >60 years (reflecting our practice of treating most low-demand elderly patients nonoperatively unless the fracture was highly unstable),
- pathologic fractures (e.g. metastatic lesions).
Trial locations and contacts
1 site in 1 country.
About this study
Volar locked plates for the distal radius fractures (DRFs) are applied through the Henry approach and it's modification, this approach entails a routine step to disinsert the pronator quadratus from it's radial and distal attachment. This muscle insertion is mostly fleshy with minimal tendinous tissue and surgeons find it difficult to reattach at the end of the surgery, the hardware come in direct contact with the flexor tendons.
Read the detailed description
Distal radius fractures (DRFs) account for about 17.5% of all adult fractures and represent the most common fracture of the upper extremity. For severely displaced or unstable fractures, open reduction and internal fixation (ORIF) is often indicated. Volar locking plate fixation through the flexor carpi radialis (FCR) approach is widely used and considered a standard technique for distal radius fixation. Classically, the pronator quadratus (PQ) muscle is released from the radial side of the distal radius to expose the fracture and is later repaired after plate fixation. However, this repair is often not feasible or reliable. Some authors have suggested that failure to restore the PQ may leave the plate exposed to the flexor tendons, increasing the risk of tendon irritation or rupture.
To address these concerns, minimally invasive PQ-sparing approaches have been developed. Imatani et al. first described a technique for volar plating without detaching the PQ, and Dos Remedios et al. reported a similar approach. Theoretically, preserving the PQ creates a cushion between the plate and the flexor tendons and maintains the muscle's function. Several studies have reported better early functional outcomes and less pain post-operatively with PQ-sparing than the traditional approach.
In this prospective case series at a Level I trauma center with a dedicated hand surgery service, the PQ-sparing volar plating technique for distal radius fractures is evaluated. The study's main objectives were to determine whether the PQ can be preserved without compromising fracture reduction, to describe how a volar locking plate can be applied without releasing the PQ, to identify potential benefits of PQ preservation, and to assess any drawbacks of this approach.
- Conditions
- Distal Radius Fracture
- Being tested
- pronator quadratus sparing
- Keywords
- Distal radius fracture
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pronator quadratus sparingProcedure or surgery
the pronator quadratus was spared when doing orif and the plare was slided beneath it
| Study group | Role | What they receive |
|---|---|---|
| Pronator Quadratus sparing | Experimental | The pronator quadratus was spared during ORIF of the fracture Receives: Procedure: pronator quadratus sparing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological bone union
an xray was done to determine if the bone ends had become united.
Measured: 2 months, 4 months
Secondary outcomes (1)
pain postoperatively by the Visual Analogue Scale (VAS) score
pain is measured by a vas score both post operative and throughout the follow up period in a 10 point scale. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Measured: 2 months, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start1 Feb 2018
- Primary completion1 Jun 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Omar Sabry, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972550
- Sponsor's protocol ID
- N-837-2018
- Status last verified
- May 2025
- First submitted
- 3 May 2025
- Last updated
- 15 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volar Locked Plating for Distal Radius Fractures: Should the Pronator Quadratus Be Spared?
- ClinicalTrials.gov ID
- NCT06972550
- Acronym / sponsor ID
- N-837-2018
- Conditions
- Distal Radius Fracture
- Keywords
- Distal radius fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 15 May 2025 (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.
Volar locked plates for the distal radius fractures (DRFs) are applied through the Henry approach and it's modification, this approach entails a routine step to disinsert the pronator quadratus from it's radial and distal attachment. This muscle insertion is mostly fleshy with minimal tendinous tissue and surgeons find it difficult to reattach at the end of the surgery, the hardware come in direct contact with the flexor tendons.
Detailed description
Distal radius fractures (DRFs) account for about 17.5% of all adult fractures and represent the most common fracture of the upper extremity. For severely displaced or unstable fractures, open reduction and internal fixation (ORIF) is often indicated. Volar locking plate fixation through the flexor carpi radialis (FCR) approach is widely used and considered a standard technique for distal radius fixation. Classically, the pronator quadratus (PQ) muscle is released from the radial side of the distal radius to expose the fracture and is later repaired after plate fixation. However, this repair is often not feasible or reliable. Some authors have suggested that failure to restore the PQ may leave the plate exposed to the flexor tendons, increasing the risk of tendon irritation or rupture.
To address these concerns, minimally invasive PQ-sparing approaches have been developed. Imatani et al. first described a technique for volar plating without detaching the PQ, and Dos Remedios et al. reported a similar approach. Theoretically, preserving the PQ creates a cushion between the plate and the flexor tendons and maintains the muscle's function. Several studies have reported better early functional outcomes and less pain post-operatively with PQ-sparing than the traditional approach.
In this prospective case series at a Level I trauma center with a dedicated hand surgery service, the PQ-sparing volar plating technique for distal radius fractures is evaluated. The study's main objectives were to determine whether the PQ can be preserved without compromising fracture reduction, to describe how a volar locking plate can be applied without releasing the PQ, to identify potential benefits of PQ preservation, and to assess any drawbacks of this approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pronator Quadratus sparing | Experimental | Procedure: pronator quadratus sparingThe pronator quadratus was spared during ORIF of the fracture |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- isolated closed distal radius fractures
Key exclusion criteria (3 listed)
- fractures >3 weeks old,
- age >60 years (reflecting our practice of treating most low-demand elderly patients nonoperatively unless the fracture was highly unstable),
- pathologic fractures (e.g. metastatic lesions).
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 |
|---|---|---|
| pronator quadratus sparingthe pronator quadratus was spared when doing orif and the plare was slided beneath it | Procedure or surgery | Pronator Quadratus sparing |
Primary outcome
Radiological bone union
Time frame: 2 months, 4 months
an xray was done to determine if the bone ends had become united.
1 secondary outcome
pain postoperatively by the Visual Analogue Scale (VAS) score
Time frame: 2 months, 4 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 15 May 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pronator quadratus sparing in people with Distal Radius Fracture, run by Kasr El Aini Hospital at 1 site in Egypt.
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 1 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 15 May 2025. 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 Egypt. 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?
Radiological bone union (time frame: 2 months, 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2025.