Trochanteric FracturesPhase 2NCT05677191
PFNA vs Dual Mobility in Treatment of Unstable Trochanteric Fractures
A Phase 2 study testing Proximal Femoral Nail and Dual Mobility Arthroplasty in people with Trochanteric Fractures, run by Cairo University.
Trial summary
Proximal femoral nail [PFNA] versus dual mobility arthroplasty in treatment of unstable trochanteric fractures Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Trochanteric Fractures
- What is being tested?
- Proximal Femoral Nail and Dual Mobility Arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 31 Dec 2024
- Phase
- Phase 2
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with trochanteric unstable fractures.
- age 60 or above
- recent fracture time within 2 weeks time period
- trochanteric starting point in pfna
- patients medical condition is stable
Who cannot join
- stable trochanteric fractures
- delayed or neglected fractures
- unstable patients medical conditions
- pirformis fossa starting point in pfna
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Usage Of Proximal Femoral Nail Versus Dual Mobility Arthroplasty In Treatment Of Unstable Trochanteric Fractures
Proximal femoral nail [PFNA] versus dual mobility arthroplasty in treatment of unstable trochanteric fractures
Read the detailed description
compare clinial outcome between two different procdures either using pfna or arthroplasty in the treatment of unstable trochaneric fractures
- Conditions
- Trochanteric Fractures
- Being tested
- Proximal Femoral Nail, Dual Mobility Arthroplasty
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal Femoral NailDevice
Also called PFNA
open reduction
Dual Mobility ArthroplastyCombination product
Also called THA
Hip Arthroplasty Surgery
| Study group | Role | What they receive |
|---|---|---|
| proximal femoral nail | Experimental | 20 patient with trochanteric fractures , unstable type will use proximal femoral nail Receives: Device: Proximal Femoral Nail |
| Dual Mobility Arthroplasty | Active comparator | 20 patient with trochanteric fractures , unstable type will use dual mobility arthroplasty Receives: Combination Product: Dual Mobility Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip score
compare between hip score in first group of pfna versus hip score in second group of THA
Measured: Through study completion, an average of 1 year"
Operation time
compartive operative time between first group of pfna versus second group of THA
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trochanteric FracturesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcos Hanna Morris, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677191
- Sponsor's protocol ID
- Orthopedic
- Status last verified
- Jan 2023
- First submitted
- 23 Nov 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usage Of Proximal Femoral Nail Versus Dual Mobility Arthroplasty In Treatment Of Unstable Trochanteric Fractures
- ClinicalTrials.gov ID
- NCT05677191
- Acronym / sponsor ID
- Orthopedic
- Conditions
- Trochanteric Fractures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Jan 2023 (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.
Proximal femoral nail [PFNA] versus dual mobility arthroplasty in treatment of unstable trochanteric fractures
Detailed description
compare clinial outcome between two different procdures either using pfna or arthroplasty in the treatment of unstable trochaneric fractures
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| proximal femoral nail | Experimental | Device: Proximal Femoral Nail20 patient with trochanteric fractures , unstable type will use proximal femoral nail |
| Dual Mobility Arthroplasty | Active comparator | Combination Product: Dual Mobility Arthroplasty20 patient with trochanteric fractures , unstable type will use dual mobility arthroplasty |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients with trochanteric unstable fractures.
- age 60 or above
- recent fracture time within 2 weeks time period
- trochanteric starting point in pfna
- patients medical condition is stable
Key exclusion criteria (4 listed)
- stable trochanteric fractures
- delayed or neglected fractures
- unstable patients medical conditions
- pirformis fossa starting point in pfna
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 |
|---|---|---|
| Proximal Femoral NailAlso: PFNAopen reduction | Device | proximal femoral nail |
| Dual Mobility ArthroplastyAlso: THAHip Arthroplasty Surgery | Combination product | Dual Mobility Arthroplasty |
Primary outcome
Hip score
Time frame: Through study completion, an average of 1 year"
compare between hip score in first group of pfna versus hip score in second group of THA
Operation time
Time frame: During surgery
compartive operative time between first group of pfna versus second group of THA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Proximal Femoral Nail and Dual Mobility Arthroplasty in people with Trochanteric Fractures, run by Cairo University.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcos Ha Morris (1287076751 ext. 0020, marcos.hanna.morris@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip score (time frame: Through study completion, an average of 1 year"). The study lists 2 primary outcomes in all. 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 11 Jan 2023.