Single Lateral PlateNCT07381725
Single Lateral Plate Versus Double Plating for the Fixation of Distal Femoral Fractures
A study testing Single lateral distal femoral locking compression plate and Double Plating in people with Single Lateral Plate and Double Plating, run by Beni-Suef University at 1 site in Egypt.
Trial summary
This trial aimed to provide Level I evidence on the comparative effectiveness, safety, and functional outcomes of single versus double plating for distal femoral fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Single Lateral Plate, Double Plating, Fixation
- What is being tested?
- Single lateral distal femoral locking compression plate and Double Plating
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Oct 2024to 2 Oct 2025
- 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
- Age ≥ 18 years.
- Acute, displaced, closed or Gustilo-Anderson Type I open distal femoral fracture (AO/OTA types 33-A1, A2, A3, C1, C2, C3).
- Presentation within 7 days of injury.
- Provision of written informed consent.
Who cannot join
- Pathological fractures.
- Associated ipsilateral lower extremity trauma (floating knee).
- Associated neurovascular injury requiring repair.
- Pre-existing symptomatic knee arthritis or prior major knee surgery.
- Active local or systemic infection.
- Medical comorbidities precluding surgery or anesthesia [American Society of Anesthesiologists (ASA) class IV/V].
- Cognitive impairment or inability to comply with follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Analysis of Single Lateral Plate Versus Double Plating for the Fixation of Distal Femoral Fractures: A Randomized Clinical Trial
This trial aimed to provide Level I evidence on the comparative effectiveness, safety, and functional outcomes of single versus double plating for distal femoral fractures.
Read the detailed description
Distal femoral fractures, particularly those with metaphyseal comminution, present a significant surgical challenge with high risks of nonunion, malalignment, and functional impairment.
The single lateral locking plate (SLP) is a common fixation method but may lack sufficient stability in complex fractures, leading to varus collapse.
Dual plating (lateral and medial plates) offers enhanced biomechanical stability but involves greater surgical invasiveness.
- Being tested
- Single lateral distal femoral locking compression plate, Double Plating
- 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.
Single lateral distal femoral locking compression plateProcedure or surgery
Patients underwent open Reduction and Internal Fixation (ORIF) using a single pre-contoured lateral distal femoral locking compression plate via a standard lateral approach.
Double PlatingProcedure or surgery
Patients underwent open Reduction and Internal Fixation (ORIF) using a lateral distal femoral locking plate combined with a medial buttress plate (3.5mm reconstruction plate) via an anterolateral approach with subvastus medial dissection.
| Study group | Role | What they receive |
|---|---|---|
| Group I (Single Plate): | Experimental | Patients underwent open Reduction and Internal Fixation (ORIF) using a single pre-contoured lateral distal femoral locking compression plate via a standard lateral approach. Receives: Procedure: Single lateral distal femoral locking compression plate |
| Group II (Double Plate) | Experimental | Patients underwent open Reduction and Internal Fixation (ORIF) using a lateral distal femoral locking plate combined with a medial buttress plate (3.5mm reconstruction plate) via an anterolateral approach with subvastus medial dissection. Receives: Procedure: Double Plating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Score (KSS)
The Knee Society Score (KSS) contains questions in 2 sections: knee joint (pain, range of motion, stability) and function (walking distance, ability to climb stairs). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
Measured: 6 months post-surgery
Secondary outcomes (5)
Radiological Union
Radiological Union (defined as bridging callus in 3/4 cortices) was recorded. It was assessed at 2, 6, 12, 24, and 52 weeks post-surgery.
Measured: 52 weeks post-surgery
Active Range of Motion
Active Range of Motion was measured with a goniometer assesses the joint angle achieved through a patient's voluntary muscle contraction, without external assistance. It was assessed at 2, 6, 12, 24, and 52 weeks post-surgery.
Measured: 52 weeks post-surgery
Degree of pain
Degree of pain was assessed using Visual Analogue Scale (VAS). 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'). It was assessed at 2, 6, 12, 24, and 52 weeks post-surgery.
Measured: 52 weeks post-surgery
Fracture Alignment
Fracture Alignment on Anterior Posterior (AP)/Lateral radiographs was recorded. It was assessed at 2, 6, 12, 24, and 52 weeks post-surgery.
Measured: 52 weeks post-surgery
Assessment of quality of Life
Quality of Life was assessed using EQ-5D-5L questionnaire across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It was assessed at 6 and 12 months post-surgery.
Measured: 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start2 Oct 2024
- Primary completion2 Oct 2025
- Study completion2 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single Lateral PlateStudies 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Abdelkader, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381725
- Sponsor's protocol ID
- FMBSUREC/02102022/Ali
- Status last verified
- Jan 2026
- First submitted
- 25 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Analysis of Single Lateral Plate Versus Double Plating for the Fixation of Distal Femoral Fractures: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07381725
- Acronym / sponsor ID
- FMBSUREC/02102022/Ali
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 2 Oct 2025 (actual)
- Study completion
- 2 Oct 2025 (actual)
- First posted
- 2 Feb 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.
This trial aimed to provide Level I evidence on the comparative effectiveness, safety, and functional outcomes of single versus double plating for distal femoral fractures.
Detailed description
Distal femoral fractures, particularly those with metaphyseal comminution, present a significant surgical challenge with high risks of nonunion, malalignment, and functional impairment.
The single lateral locking plate (SLP) is a common fixation method but may lack sufficient stability in complex fractures, leading to varus collapse.
Dual plating (lateral and medial plates) offers enhanced biomechanical stability but involves greater surgical invasiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Single Plate): | Experimental | Procedure: Single lateral distal femoral locking compression platePatients underwent open Reduction and Internal Fixation (ORIF) using a single pre-contoured lateral distal femoral locking compression plate via a standard lateral approach. |
| Group II (Double Plate) | Experimental | Procedure: Double PlatingPatients underwent open Reduction and Internal Fixation (ORIF) using a lateral distal femoral locking plate combined with a medial buttress plate (3.5mm reconstruction plate) via an anterolateral approach with subvastus medial dissection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Acute, displaced, closed or Gustilo-Anderson Type I open distal femoral fracture (AO/OTA types 33-A1, A2, A3, C1, C2, C3).
- Presentation within 7 days of injury.
- Provision of written informed consent.
Key exclusion criteria (7 listed)
- Pathological fractures.
- Associated ipsilateral lower extremity trauma (floating knee).
- Associated neurovascular injury requiring repair.
- Pre-existing symptomatic knee arthritis or prior major knee surgery.
- Active local or systemic infection.
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 |
|---|---|---|
| Single lateral distal femoral locking compression platePatients underwent open Reduction and Internal Fixation (ORIF) using a single pre-contoured lateral distal femoral locking compression plate via a standard lateral approach. | Procedure or surgery | Group I (Single Plate): |
| Double PlatingPatients underwent open Reduction and Internal Fixation (ORIF) using a lateral distal femoral locking plate combined with a medial buttress plate (3.5mm reconstruction plate) via an anterolateral approach with subvastus medial dissection. | Procedure or surgery | Group II (Double Plate) |
Primary outcome
Knee Society Score (KSS)
Time frame: 6 months post-surgery
The Knee Society Score (KSS) contains questions in 2 sections: knee joint (pain, range of motion, stability) and function (walking distance, ability to climb stairs). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
5 secondary outcomes
Radiological Union
Time frame: 52 weeks post-surgery
Active Range of Motion
Time frame: 52 weeks post-surgery
Degree of pain
Time frame: 52 weeks post-surgery
Fracture Alignment
Time frame: 52 weeks post-surgery
Assessment of quality of Life
Time frame: 12 months post-surgery
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 2 Feb 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Single Lateral Plate
Active, not recruiting
Single-Window Versus Two-Window Posterolateral Approach for Malleolar Fractures
Ankle Fractures, Posterior Malleolus Fractures
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 Single lateral distal femoral locking compression plate and Double Plating in people with Single Lateral Plate and Double Plating, run by Beni-Suef 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: finished, as of the sponsor's last update on 2 Feb 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?
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?
Knee Society Score (KSS) (time frame: 6 months 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 2 Feb 2026.