Radius FracturesNCT02348437
Repair vs Non-repair of the Pronator Quadratus Muscle in Distal Radius Fractures. RCT.
A study testing Repair and Non-repair in people with Radius Fractures and Colles' Fracture, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to determine the functional outcome of repairing the pronator quadratus (PQ) muscle in subjects operated for a distal radius fracture (DRF) with volar locked plating. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radius Fractures, Colles' Fracture, Rupture of Muscle
- What is being tested?
- Repair and Non-repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2015to Jun 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 18 years.
- patients with an unstable DRF AO type 23 A2, A3, C1, C2 or C3 elected for surgery with volar plating. Unstable is defined as one of the following: 1) More than 10 degrees dorsal angulation of radius' joint surface in lateral plane measured from an orthogonal axis through radius. 2) Ulnar variance more than 2 mm. 3) Fracture line involving joint surface with more than 2 mm dislocation. 4) Incongruence of the DRJ.
- patients that can undergo the surgery in plexus brachialis block (so the operation can be performed in the outpatient department).
- patients with the ability to read and understand Danish.
Who cannot join
- patients with an open fracture.
- patients with a neurologic disorder affecting the fractured upper extremity.
- patients with a history of fracture to the same wrist.
- patients with dementia, substance abuse or severe psychiatric disorder.
- patients who do not agree to be randomised.
- patients unable to continue follow-up.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Nordsjaellands Hospital Hilleroed, Unit of Orthopaedic Surgery
Hilleroed, 3400
About this study
Official title: Clinical Outcome After Repair of the Pronator Quadratus Muscle in Volar Locked Plating of the Distal Radius. A Randomised Clinical Trial.
The purpose of this study is to determine the functional outcome of repairing the pronator quadratus (PQ) muscle in subjects operated for a distal radius fracture (DRF) with volar locked plating.
Read the detailed description
Fractures of the distal radius are common in the elderly. A frequent treatment of an unstable DRF is surgery with volar plating using the modified Henry's approach. In some cases the fracture mechanism has injured the PQ muscle and subsequent reconstruction of the muscle can be difficult. When the PQ muscle is not injured the plate is fixated through a radial and distal release of the PQ muscle and resuture/repair of the PQ muscle is attempted by most surgeons.
The clinical relevance of repairing the PQ muscle has not previously been investigated in a randomised clinical trial and we hypothesise that there is no difference in functional outcome whether the PQ muscle is repaired or not.
- Conditions
- Radius Fractures, Colles' Fracture, Rupture of Muscle, Arm Injuries
- Being tested
- Repair, Non-repair
- Keywords
- Pronator quadratus, Distal radius fracture, Repair, Volar plating, PRWE
- Medical subject headings
- Radius Fractures, Colles' Fracture, Arm Injuries, Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RepairProcedure or surgery
An on-going suture technique with minimum four stitches.
Non-repairProcedure or surgery
The PQ muscle will be placed so it covers the volar plate. No suture.
| Study group | Role | What they receive |
|---|---|---|
| Repair | Experimental | Repair of the pronator quadratus muscle Receives: Procedure: Repair |
| Non-repair | Active comparator | Non-repair of the pronator quadratus muscle Receives: Procedure: Non-repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Rated Wrist Evaluation (PRWE)
Measured: 12 months
Secondary outcomes (8)
Patient Rated Wrist Evaluation (PRWE)
Measured: 2 weeks, 5 weeks, 3 months, 6 months
Disabilities of the Arm, Shoulder and Hand (DASH)
Measured: 2 weeks, 5 weeks, 3 months, 6 months, 12 months
Pronation strength
Measured: 5 weeks, 3 months, 6 months, 12 months
Grip strength
Measured: 5 weeks, 3 months, 6 months, 12 months
Range of motion: supination/pronation
Measured: 2 weeks, 5 weeks, 3 months, 6 months, 12 months
Operation time
Measured: day 0
Ultra sonic examination (Examination of tendons and PQ muscle)
Examination of tendons and PQ muscle
Measured: 3 months
Complications (Tendon rupture and Tendinitis)
Tendon rupture and Tendinitis
Measured: 2 weeks, 5 weeks, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radius FracturesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesper Sonntag, Nordsjaellands Hospital
- Investigators
- Jesper Sonntag, MD, Principal investigator, Nordsjaellands Hospital Hilleroed, Unit of Orthopaedic Surgery, Dyrehavevej 29, 3400 Hilleroed. Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348437
- Sponsor's protocol ID
- PQ Project
- Status last verified
- Aug 2017
- First submitted
- 22 Jan 2015
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome After Repair of the Pronator Quadratus Muscle in Volar Locked Plating of the Distal Radius. A Randomised Clinical Trial.
- ClinicalTrials.gov ID
- NCT02348437
- Acronym / sponsor ID
- PQ Project
- Conditions
- Radius Fractures, Colles' Fracture, Rupture of Muscle, Arm Injuries
- Keywords
- Pronator quadratus, Distal radius fracture, Repair, Volar plating, PRWE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 28 Jan 2015 (estimated)
- 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 purpose of this study is to determine the functional outcome of repairing the pronator quadratus (PQ) muscle in subjects operated for a distal radius fracture (DRF) with volar locked plating.
Detailed description
Fractures of the distal radius are common in the elderly. A frequent treatment of an unstable DRF is surgery with volar plating using the modified Henry's approach. In some cases the fracture mechanism has injured the PQ muscle and subsequent reconstruction of the muscle can be difficult. When the PQ muscle is not injured the plate is fixated through a radial and distal release of the PQ muscle and resuture/repair of the PQ muscle is attempted by most surgeons.
The clinical relevance of repairing the PQ muscle has not previously been investigated in a randomised clinical trial and we hypothesise that there is no difference in functional outcome whether the PQ muscle is repaired or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repair | Experimental | Procedure: RepairRepair of the pronator quadratus muscle |
| Non-repair | Active comparator | Procedure: Non-repairNon-repair of the pronator quadratus muscle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients over 18 years.
- patients with an unstable DRF AO type 23 A2, A3, C1, C2 or C3 elected for surgery with volar plating. Unstable is defined as one of the following: 1) More than 10 degrees dorsal angulation of radius' joint surface in lateral plane measured from an orthogonal axis through radius. 2) Ulnar variance more than 2 mm. 3) Fracture line involving joint surface with more than 2 mm dislocation. 4) Incongruence of the DRJ.
- patients that can undergo the surgery in plexus brachialis block (so the operation can be performed in the outpatient department).
- patients with the ability to read and understand Danish.
Key exclusion criteria (6 listed)
- patients with an open fracture.
- patients with a neurologic disorder affecting the fractured upper extremity.
- patients with a history of fracture to the same wrist.
- patients with dementia, substance abuse or severe psychiatric disorder.
- patients who do not agree to be randomised.
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 |
|---|---|---|
| RepairAn on-going suture technique with minimum four stitches. | Procedure or surgery | Repair |
| Non-repairThe PQ muscle will be placed so it covers the volar plate. No suture. | Procedure or surgery | Non-repair |
Primary outcome
Patient Rated Wrist Evaluation (PRWE)
Time frame: 12 months
8 secondary outcomes
Patient Rated Wrist Evaluation (PRWE)
Time frame: 2 weeks, 5 weeks, 3 months, 6 months
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: 2 weeks, 5 weeks, 3 months, 6 months, 12 months
Pronation strength
Time frame: 5 weeks, 3 months, 6 months, 12 months
Grip strength
Time frame: 5 weeks, 3 months, 6 months, 12 months
Range of motion: supination/pronation
Time frame: 2 weeks, 5 weeks, 3 months, 6 months, 12 months
Operation time
Time frame: day 0
Ultra sonic examination (Examination of tendons and PQ muscle)
Time frame: 3 months
Complications (Tendon rupture and Tendinitis)
Time frame: 2 weeks, 5 weeks, 3 months, 6 months, 12 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 1 Sep 2017.
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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.
Jesper Sonntag, MD principal investigator
Nordsjaellands Hospital Hilleroed, Unit of Orthopaedic Surgery, Dyrehavevej 29, 3400 Hilleroed. Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repair and Non-repair in people with Radius Fractures and Colles' Fracture, run by Nordsjaellands Hospital at 1 site in Denmark.
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 4 inclusion and 6 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 1 Sep 2017. 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 Denmark. 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?
Patient Rated Wrist Evaluation (PRWE) (time frame: 12 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 1 Sep 2017.