Distal Femoral FracturesNCT07542249
Retrograde Nail vs Double Plating for Distal Femoral Extra and Simple Articular Fractures With Metaphyseal Comminution
A study testing Retrograde nail and Double plating in people with Distal Femoral Fractures and Extra-articular Distal Radius Malunions, run by Benha University at 1 site in Egypt.
Trial summary
The objective of this study is to compare the short term functional clinical and radiological outcomes of retrograde nail versus double plating for distal femoral extra-articular and simple articular fractures with metaphyseal comminution. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Distal Femoral Fractures, Extra-articular Distal Radius Malunions, Intramedullary
- What is being tested?
- Retrograde nail and Double plating
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2025to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Male patients aged more than 18 years old and females more than 16 years old.
- Both genders
- Extra-articular fracture with metaphyseal comminution
- Simple articular fractures with metaphyseal comminution
Who cannot join
- Skeletally immature patients
- Pathological fractures
- Open fractures
- Periprosthetic fractures
- Medically unfit patients
- Patients with pre-existing knee pathology
- Neuro-vascular ipsilateral lower limb injuries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrograde Nail Versus Double Plating for Distal Femoral Extra-articular and Simple Articular Fractures With Metaphyseal Comminution
The objective of this study is to compare the short term functional clinical and radiological outcomes of retrograde nail versus double plating for distal femoral extra-articular and simple articular fractures with metaphyseal comminution.
Read the detailed description
Fractures of the distal femur are complex injuries that constitute a challenge to the orthopedic surgeon. It represents about 7% of all the femoral fractures. It usually occurs during high energy trauma in younger patients and frequently is associated with concomitant injuries. In elderly patients with severe osteopenia might sustain solitary distal femoral fractures from minor trauma such as simple fall.
The challenge for the surgeons remains in the balance of providing stable fixation to support physiological loading until union while allowing necessary micro motion for callus formation. So, significant advances have been made in treatment of these fractures in the past few decades. It is recognized that operative fixation with the ability to maintain anatomical reduction of the joint surface, restoring axial ligament and early range of motion presents clear advantages over closed means of treatment.
There are principles that have been proposed for the treatment of these fractures which include anatomical reduction of distal femoral articular surface, stable internal fixation, minimal soft tissue stripping and early active mobilization.
Comminuted distal femur fractures are associated with extensive soft tissue injuries like injuries to Ligaments of the knee, injuries to the surrounding muscles additional challenges like extensive bone loss, loss of soft tissue coating and these fractures produce very unfavorable conditions for fracture union. As the long list of challenges a surgeon has to face while treating such injuries, the functional outcomes are usually not satisfactory. These fractures are associated with high rates of malunion, nonunion and infection.
Intramedullary (IM) nail offers a potential biomechanical advantage over side plates and screws because the Intramedullary location results in less stress over the implant and better stress distribution than with eccentric side plate and screws. They have the potential for load shearing. Their use involves minimal soft tissue injury, short operative time, limited perioperative blood loss, and ability to mobilize patients early.
Retrograde intramedullary nail fixation is an accepted and often preferred alternative to distal locking plates for the treatment of distal femur fractures and fractures with simple intra-articular involvement, with metaphyseal and/or epiphyseal comminution with reliable union rates , less revision procedures and reducing the tendency to place varus movement at the fracture site. The reduced bending movement of an intramedullary device has substantially reduced the fixation failure in osteoporotic bone. The anatomical alignment, stable internal fixation, rapid mobilization, and early functional rehabilitation of the knee are effective ways of managing distal femoral fractures, which can be achieved by Intramedullary nail. Another technique described by Liporace and Yoon for treatment of comminuted intra-articular fractures is the combination of nail and plate fixation.
The rationale of adding another locking plate is that fixation with a single lateral plate in complex distal femoral fractures could create an unstable environment that contributes to non-union or hardware failure. More rigid fixation like double plating provides better stability for a sufficient period of time to allow bone healing in distal femoral fractures with extensive metaphyseal comminution, fractures in osteoporotic bone, and in high energy.
The objective of this study is to compare the short term functional clinical and radiological outcomes of retrograde nail versus double plating for distal femoral extra-articular and simple articular fractures with metaphyseal comminution.
- Being tested
- Retrograde nail, Double plating
- Keywords
- double plating, Intramedullary nail, distal femur fractures, metaphyseal comminution
- Medical subject headings
- Femoral Fractures, Distal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde nailProcedure or surgery
Group A (20 patients) will be treated by retrograde nail Retrograde intramedullary nailing: The surgical approach will depend on the fracture type, either closed 'percutaneous trans-patellar approach,' or open 'medial Para-patellar approach,' which may be used in intra-articular fractures. After nail insertion, the knee will be taken through a full range of motion to ensure articular function.
Double platingProcedure or surgery
Group B (20 patients) will be treated double plating Double plating technique: It will be done through dual separate approach (medial and lateral) and fixation will be done using lateral locked distal femoral plate and medial buttress plate.
| Study group | Role | What they receive |
|---|---|---|
| Group A: will be treated by retrograde nail | Experimental | Not described Receives: Procedure: Retrograde nail |
| Group B :will be treated by double plating | Experimental | Not described Receives: Procedure: Double plating |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Oxford Knee Score
The Oxford Knee Score (OKS) is a 12-item patient-reported specifically designed and developed to assess function and pain after around knee surgeries. It is short, reproducible, valid and sensitive to clinically important changes. Scores range from 0 to 48, with lower scores indicating severe arthritis (0-19) and higher scores representing better joint function (40-48).
Measured: 6 months
Secondary outcomes (1)
Radiographic evaluation: The standard antero-anterior and the lateral radiograph views and oblique views will be evaluated both pre- and post-operatively for assessment of union and alignment and/or CT when necessary
Measured: before surgery and 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start30 Sep 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Femoral 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elsayed Abdellah Elwarwary, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542249
- Sponsor's protocol ID
- MD.1.3.2.26
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be available when it needed
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrograde Nail Versus Double Plating for Distal Femoral Extra-articular and Simple Articular Fractures With Metaphyseal Comminution
- ClinicalTrials.gov ID
- NCT07542249
- Acronym / sponsor ID
- MD.1.3.2.26
- Keywords
- double plating, Intramedullary nail, distal femur fractures, metaphyseal comminution
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 21 Apr 2026 (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 objective of this study is to compare the short term functional clinical and radiological outcomes of retrograde nail versus double plating for distal femoral extra-articular and simple articular fractures with metaphyseal comminution.
Detailed description
Fractures of the distal femur are complex injuries that constitute a challenge to the orthopedic surgeon. It represents about 7% of all the femoral fractures. It usually occurs during high energy trauma in younger patients and frequently is associated with concomitant injuries. In elderly patients with severe osteopenia might sustain solitary distal femoral fractures from minor trauma such as simple fall.
The challenge for the surgeons remains in the balance of providing stable fixation to support physiological loading until union while allowing necessary micro motion for callus formation. So, significant advances have been made in treatment of these fractures in the past few decades. It is recognized that operative fixation with the ability to maintain anatomical reduction of the joint surface, restoring axial ligament and early range of motion presents clear advantages over closed means of treatment.
There are principles that have been proposed for the treatment of these fractures which include anatomical reduction of distal femoral articular surface, stable internal fixation, minimal soft tissue stripping and early active mobilization.
Comminuted distal femur fractures are associated with extensive soft tissue injuries like injuries to Ligaments of the knee, injuries to the surrounding muscles additional challenges like extensive bone loss, loss of soft tissue coating and these fractures produce very unfavorable conditions for fracture union. As the long list of challenges a surgeon has to face while treating such injuries, the functional outcomes are usually not satisfactory. These fractures are associated with high rates of malunion, nonunion and infection.
Intramedullary (IM) nail offers a potential biomechanical advantage over side plates and screws because the Intramedullary location results in less stress over the implant and better stress distribution than with eccentric side plate and screws. They have the potential for load shearing. Their use involves minimal soft tissue injury, short operative time, limited perioperative blood loss, and ability to mobilize patients early.
Retrograde intramedullary nail fixation is an accepted and often preferred alternative to distal locking plates for the treatment of distal femur fractures and fractures with simple intra-articular involvement, with metaphyseal and/or epiphyseal comminution with reliable union rates , less revision procedures and reducing the tendency to place varus movement at the fracture site. The reduced bending movement of an intramedullary device has substantially reduced the fixation failure in osteoporotic bone. The anatomical alignment, stable internal fixation, rapid mobilization, and early functional rehabilitation of the knee are effective ways of managing distal femoral fractures, which can be achieved by Intramedullary nail. Another technique described by Liporace and Yoon for treatment of comminuted intra-articular fractures is the combination of nail and plate fixation.
The rationale of adding another locking plate is that fixation with a single lateral plate in complex distal femoral fractures could create an unstable environment that contributes to non-union or hardware failure. More rigid fixation like double plating provides better stability for a sufficient period of time to allow bone healing in distal femoral fractures with extensive metaphyseal comminution, fractures in osteoporotic bone, and in high energy.
The objective of this study is to compare the short term functional clinical and radiological outcomes of retrograde nail versus double plating for distal femoral extra-articular and simple articular fractures with metaphyseal comminution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: will be treated by retrograde nail | Experimental | Procedure: Retrograde nail |
| Group B :will be treated by double plating | Experimental | Procedure: Double plating |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male patients aged more than 18 years old and females more than 16 years old.
- Both genders
- Extra-articular fracture with metaphyseal comminution
- Simple articular fractures with metaphyseal comminution
Key exclusion criteria (7 listed)
- Skeletally immature patients
- Pathological fractures
- Open fractures
- Periprosthetic fractures
- Medically unfit patients
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 |
|---|---|---|
| Retrograde nailGroup A (20 patients) will be treated by retrograde nail Retrograde intramedullary nailing: The surgical approach will depend on the fracture type, either closed 'percutaneous trans-patellar approach,' or open 'medial Para-patellar approach,' which may be used in intra-articular fractures. After nail insertion, the knee will be taken through a full range of motion to ensure articular function. | Procedure or surgery | Group A: will be treated by retrograde nail |
| Double platingGroup B (20 patients) will be treated double plating Double plating technique: It will be done through dual separate approach (medial and lateral) and fixation will be done using lateral locked distal femoral plate and medial buttress plate. | Procedure or surgery | Group B :will be treated by double plating |
Primary outcome
The Oxford Knee Score
Time frame: 6 months
The Oxford Knee Score (OKS) is a 12-item patient-reported specifically designed and developed to assess function and pain after around knee surgeries. It is short, reproducible, valid and sensitive to clinically important changes. Scores range from 0 to 48, with lower scores indicating severe arthritis (0-19) and higher scores representing better joint function (40-48).
1 secondary outcome
Radiographic evaluation: The standard antero-anterior and the lateral radiograph views and oblique views will be evaluated both pre- and post-operatively for assessment of union and alignment and/or CT when necessary
Time frame: before surgery and 6 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: Yes. It will be available when it needed
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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 Retrograde nail and Double plating in people with Distal Femoral Fractures and Extra-articular Distal Radius Malunions, run by Benha University 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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
The Oxford Knee Score (time frame: 6 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 22 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.