Radius FracturesNCT06738693
External Fixation Vs. Volar Plate for Distal Radius Fractures: Functional Outcomes
A study testing External Fixation and Open Reduction and Internal Fixation (ORIF) with Volar Locking Plate in people with Radius Fractures, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
Trial summary
The goal of this prospective comparative clinical trial is to evaluate the effectiveness of external fixation versus volar locking plates in the management of unstable intra-articular distal radius fractures in adults over 18 years old. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radius Fractures
- What is being tested?
- External Fixation and Open Reduction and Internal Fixation (ORIF) with Volar Locking Plate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteNepal
- Study dates
- 23 Dec 2019to 14 Nov 2020
- 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 aged 18 years or older.
- Diagnosed with recent (<1 week) intra-articular distal end radius fractures.
- Willing and able to provide informed consent.
Who cannot join
- Open fractures classified as Gustilo grade II or higher.
- Fracture avulsion or dislocation.
- Vascular injury associated with the fracture.
- Extra-articular fractures of the distal radius.
- Preexisting joint or carpal bone disease affecting rehabilitation.
- Patients unwilling to provide consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: External Fixation Versus Volar Locking Plate for Unstable Intraarticular Distal Radius Fractures: a Prospective Comparative Study of the Functional Outcomes
The goal of this prospective comparative clinical trial is to evaluate the effectiveness of external fixation versus volar locking plates in the management of unstable intra-articular distal radius fractures in adults over 18 years old. The main questions it aims to answer are:
Does the use of a volar locking plate result in better functional outcomes, as measured by the Green and O'Brien scoring system modified by Cooney, compared to external fixation? What are the differences in intraoperative and postoperative parameters, including complications, between the two methods? Researchers will compare outcomes in two groups: one receiving external fixation and the other undergoing open reduction and internal fixation with volar locking plates.
Read more
Participants will:
Undergo surgical intervention (external fixation or ORIF with volar plates) performed by experienced orthopedic surgeons.
Follow a postoperative rehabilitation plan, including active and passive range of motion exercises.
Attend follow-ups at 6, 12, and 24 weeks to assess pain, range of motion, fracture union, and complications.
- Conditions
- Radius Fractures
- Being tested
- External Fixation, Open Reduction and Internal Fixation (ORIF) with Volar Locking Plate
- Medical subject headings
- Radius Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External FixationProcedure or surgery
External fixation involves the stabilization of unstable intra-articular distal radius fractures using an external fixator. The procedure is performed under anesthesia, with fixator pins placed percutaneously into the proximal and distal fragments of the radius. Postoperative care includes regular cleaning of pin tracts, early mobilization exercises for adjacent joints, and fixator removal upon radiological confirmation of fracture healing, typically between 6 to 8 weeks post-surgery.
Open Reduction and Internal Fixation (ORIF) with Volar Locking PlateProcedure or surgery
ORIF using a volar locking plate is performed to anatomically reduce and stabilize unstable intra-articular distal radius fractures. The procedure is conducted under anesthesia, involving an open approach through the volar aspect of the wrist. The volar locking plate is secured with screws to provide rigid fixation, enabling early mobilization. Postoperative follow-up includes evaluation of functional outcomes, union rates, and potential complications.
| Study group | Role | What they receive |
|---|---|---|
| External Fixation | Experimental | Patients in this arm will undergo external fixation for unstable intra-articular distal radius fractures. The procedure involves the placement of an external fixator to stabilize the fracture, followed by postoperative care including pin tract cleaning and removal of the fixator after radiological confirmation of bone healing (6-8 weeks). Functional outcomes, fracture union, and complications will be assessed at regular intervals. Receives: Procedure: External Fixation |
| Volar Locking Plate | Experimental | Patients in this arm will undergo open reduction and internal fixation (ORIF) using a volar locking plate for unstable intra-articular distal radius fractures. This method provides stable fixation, allowing early mobilization. Postoperative outcomes, including functional scores, union rates, and complications, will be evaluated at follow-up visits. Receives: Procedure: Open Reduction and Internal Fixation (ORIF) with Volar Locking Plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Outcomes Assessed by the Green and O'Brien Scoring System Modified by Cooney
The primary outcome will be the functional outcome of the wrist assessed using the Green and O'Brien scoring system modified by Cooney. This scoring system evaluates four components: pain, function, range of motion, and grip strength, each weighted appropriately to provide a composite score. Scores will be compared between the external fixation and volar plating groups to determine the superiority of either intervention in restoring wrist function.
Measured: 24 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start23 Dec 2019
- Primary completion12 Sep 2020
- Study completion14 Nov 2020
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
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabir Kumar Khadka, B.P. Koirala Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738693
- Sponsor's protocol ID
- IRC/1656/019
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data (IPD) will be shared with other researchers upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Fixation Versus Volar Locking Plate for Unstable Intraarticular Distal Radius Fractures: a Prospective Comparative Study of the Functional Outcomes
- ClinicalTrials.gov ID
- NCT06738693
- Acronym / sponsor ID
- IRC/1656/019
- Conditions
- Radius Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 12 Sep 2020 (actual)
- Study completion
- 14 Nov 2020 (actual)
- First posted
- 18 Dec 2024 (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 goal of this prospective comparative clinical trial is to evaluate the effectiveness of external fixation versus volar locking plates in the management of unstable intra-articular distal radius fractures in adults over 18 years old. The main questions it aims to answer are:
Does the use of a volar locking plate result in better functional outcomes, as measured by the Green and O'Brien scoring system modified by Cooney, compared to external fixation? What are the differences in intraoperative and postoperative parameters, including complications, between the two methods? Researchers will compare outcomes in two groups: one receiving external fixation and the other undergoing open reduction and internal fixation with volar locking plates.
Participants will:
Undergo surgical intervention (external fixation or ORIF with volar plates) performed by experienced orthopedic surgeons.
Follow a postoperative rehabilitation plan, including active and passive range of motion exercises.
Attend follow-ups at 6, 12, and 24 weeks to assess pain, range of motion, fracture union, and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External Fixation | Experimental | Procedure: External FixationPatients in this arm will undergo external fixation for unstable intra-articular distal radius fractures. The procedure involves the placement of an external fixator to stabilize the fracture, followed by postoperative care including pin tract cleaning and removal of the fixator after radiological confirmation of bone healing (6-8 weeks). Functional outcomes, fracture union, and complications will be assessed at regular intervals. |
| Volar Locking Plate | Experimental | Procedure: Open Reduction and Internal Fixation (ORIF) with Volar Locking PlatePatients in this arm will undergo open reduction and internal fixation (ORIF) using a volar locking plate for unstable intra-articular distal radius fractures. This method provides stable fixation, allowing early mobilization. Postoperative outcomes, including functional scores, union rates, and complications, will be evaluated at follow-up visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 years or older.
- Diagnosed with recent (<1 week) intra-articular distal end radius fractures.
- Willing and able to provide informed consent.
Key exclusion criteria (6 listed)
- Open fractures classified as Gustilo grade II or higher.
- Fracture avulsion or dislocation.
- Vascular injury associated with the fracture.
- Extra-articular fractures of the distal radius.
- Preexisting joint or carpal bone disease affecting rehabilitation.
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 |
|---|---|---|
| External FixationExternal fixation involves the stabilization of unstable intra-articular distal radius fractures using an external fixator. The procedure is performed under anesthesia, with fixator pins placed percutaneously into the proximal and distal fragments of the radius. Postoperative care includes regular cleaning of pin tracts, early mobilization exercises for adjacent joints, and fixator removal upon radiological confirmation of fracture healing, typically between 6 to 8 weeks post-surgery. | Procedure or surgery | External Fixation |
| Open Reduction and Internal Fixation (ORIF) with Volar Locking PlateORIF using a volar locking plate is performed to anatomically reduce and stabilize unstable intra-articular distal radius fractures. The procedure is conducted under anesthesia, involving an open approach through the volar aspect of the wrist. The volar locking plate is secured with screws to provide rigid fixation, enabling early mobilization. Postoperative follow-up includes evaluation of functional outcomes, union rates, and potential complications. | Procedure or surgery | Volar Locking Plate |
Primary outcome
Functional Outcomes Assessed by the Green and O'Brien Scoring System Modified by Cooney
Time frame: 24 weeks post-surgery
The primary outcome will be the functional outcome of the wrist assessed using the Green and O'Brien scoring system modified by Cooney. This scoring system evaluates four components: pain, function, range of motion, and grip strength, each weighted appropriately to provide a composite score. Scores will be compared between the external fixation and volar plating groups to determine the superiority of either intervention in restoring wrist function.
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 18 Dec 2024.
- Individual participant dataSharing planned: Yes. Individual Participant Data (IPD) will be shared with other researchers upon reasonable request.
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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 External Fixation and Open Reduction and Internal Fixation (ORIF) with Volar Locking Plate in people with Radius Fractures, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
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 3 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 18 Dec 2024. 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 Nepal. 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?
Functional Outcomes Assessed by the Green and O'Brien Scoring System Modified by Cooney (time frame: 24 weeks post-surgery). 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 18 Dec 2024.