Distal Femur FractureNCT06806839
Early Weight Bearing in Distal Femur Fractures
A study testing dual plating and single plating in people with Distal Femur Fracture, run by Assiut University.
Trial summary
Assessment of the effect of double plating and single lateral plating on early weight bearing as a primary outcome and improving union and decreasing complications as secondary outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distal Femur Fracture
- What is being tested?
- dual plating and single plating
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 1 Mar 2027
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Skeletally mature patients.
- Distal femur fracture type A2, A3, C1, C2 by X-ray (Arbeitsgemeinschaft für Osteosynthesefragen classification).
- Injury Severity Score below 15.
- Controlled comorbidities.
- Fresh fractures: within 3 weeks of trauma.
Who cannot join
- Distal femur fractures type A1, B, C3 and A2 if there is a medial wedge.
- Open fracture grade 3 Gustilo Anderson Classification.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Early Weight Bearing in Distal Femoral Fractures, Dual Plating Versus Single Lateral Plating: a Randomized Controlled Study
Assessment of the effect of double plating and single lateral plating on early weight bearing as a primary outcome and improving union and decreasing complications as secondary outcomes.
- Conditions
- Distal Femur Fracture
- Being tested
- dual plating, single 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.
dual platingProcedure or surgery
surgical fixation of the distal femur using two plates to enhance stability and fracture healing.
single platingProcedure or surgery
surgical fixation of the distal femur using a single plate according to standard fixation protocols.
| Study group | Role | What they receive |
|---|---|---|
| Dual plating | Experimental | Participants in this group will undergo dual plating fixation for distal femur fractures. Receives: Procedure: dual plating |
| single plating | Active comparator | Participants in this group will undergo single plate fixation for distal femur fractures. Receives: Procedure: single plating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sander's scale.
A scale of 40 points with 0 as the minimum value and 40 as the maximum value. A higher score means a better outcome. The scale is used as a functional outcome following distal femur fractures fixation using questionaire about the pain, walking ability and return of work and using x rays to measure angulation in degrees and shortening in centimeters and examining the range of motion of the knee joint in degrees.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Distal Femur FractureStudies of the same condition, open and under way.
- More trials run by Assiut 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Tarek Mahmoud Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806839
- Sponsor's protocol ID
- Early weight-bearing.
- Status last verified
- Jan 2025
- First submitted
- 18 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elsoe R, Ceccotti AA, Larsen P. Population-based epidemiology and incidence of distal femur fractures. Int Orthop. 2018 Jan;42(1):191-196. doi: 10.1007/s00264-017-3665-1. Epub 2017 Nov 7.
PubMed 29116356Myers P, Laboe P, Johnson KJ, Fredericks PD, Crichlow RJ, Maar DC, Weber TG. Patient Mortality in Geriatric Distal Femur Fractures. J Orthop Trauma. 2018 Mar;32(3):111-115. doi: 10.1097/BOT.0000000000001078.
PubMed 29462121Merino-Rueda LR, Rubio-Saez I, Mills S, Rubio-Suarez JC. Mortality after distal femur fractures in the elderly. Injury. 2021 Jul;52 Suppl 4:S71-S75. doi: 10.1016/j.injury.2021.03.066. Epub 2021 May 5.
PubMed 33992422Mubark I, Abouelela A, Genena A, Al Ghunimat A, Sarhan I, Ashwood N. Mortality Following Distal Femur Fractures Versus Proximal Femur Fractures in Elderly Population: The Impact of Best Practice Tariff. Cureus. 2020 Sep 30;12(9):e10744. doi: 10.7759/cureus.10744.
PubMed 33150119Larsen P, Ceccotti AA, Elsoe R. High mortality following distal femur fractures: a cohort study including three hundred and two distal femur fractures. Int Orthop. 2020 Jan;44(1):173-177. doi: 10.1007/s00264-019-04343-9. Epub 2019 May 12.
PubMed 31081515Poole WEC, Wilson DGG, Guthrie HC, Bellringer SF, Freeman R, Guryel E, Nicol SG. 'Modern' distal femoral locking plates allow safe, early weight-bearing with a high rate of union and low rate of failure: five-year experience from a United Kingdom major trauma centre. Bone Joint J. 2017 Jul;99-B(7):951-957. doi: 10.1302/0301-620X.99B7.BJJ-2016-0585.R1.
PubMed 28663403Schatzker J, Home G, Waddell J. The Toronto experience with the supracondylar fracture of the femur, 1966-72. Injury. 1974 Nov;6(2):113-28. doi: 10.1016/0020-1383(74)90005-9. No abstract available.
PubMed 4443073Gangavalli AK, Nwachuku CO. Management of Distal Femur Fractures in Adults: An Overview of Options. Orthop Clin North Am. 2016 Jan;47(1):85-96. doi: 10.1016/j.ocl.2015.08.011.
PubMed 26614924Atalay IB, Ozturk R, Yapar A, Karakoc Y, Eksioglu MF. Outcomes of the Surgical Treatment of Periprosthetic Fractures Around the Knee with Locking Plates: A Single Centre Experience. Malays Orthop J. 2021 Nov;15(3):1-7. doi: 10.5704/MOJ.2111.001.
PubMed 34966488Virk JS, Garg SK, Gupta P, Jangira V, Singh J, Rana S. Distal Femur Locking Plate: The Answer to All Distal Femoral Fractures. J Clin Diagn Res. 2016 Oct;10(10):RC01-RC05. doi: 10.7860/JCDR/2016/22071.8759. Epub 2016 Oct 1.
PubMed 27891409Smith WR, Stoneback JW, Morgan SJ, Stahel PF. Is immediate weight bearing safe for periprosthetic distal femur fractures treated by locked plating? A feasibility study in 52 consecutive patients. Patient Saf Surg. 2016 Dec 7;10:26. doi: 10.1186/s13037-016-0114-9. eCollection 2016.
PubMed 27980675Striano BM, Grisdela PT Jr, Shapira S, Heng M. Early Weight Bearing after Distal Femur Fracture Fixation. Geriatr Orthop Surg Rehabil. 2022 Jan 27;13:21514593211070128. doi: 10.1177/21514593211070128. eCollection 2022.
PubMed 35111355Imam MA, Torieh A, Matthana A. Double plating of intra-articular multifragmentary C3-type distal femoral fractures through the anterior approach. Eur J Orthop Surg Traumatol. 2018 Jan;28(1):121-130. doi: 10.1007/s00590-017-2014-9. Epub 2017 Jul 14.
PubMed 28710534
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Weight Bearing in Distal Femoral Fractures, Dual Plating Versus Single Lateral Plating: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06806839
- Acronym / sponsor ID
- Early weight-bearing.
- Conditions
- Distal Femur Fracture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 4 Feb 2025 (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.
Assessment of the effect of double plating and single lateral plating on early weight bearing as a primary outcome and improving union and decreasing complications as secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual plating | Experimental | Procedure: dual platingParticipants in this group will undergo dual plating fixation for distal femur fractures. |
| single plating | Active comparator | Procedure: single platingParticipants in this group will undergo single plate fixation for distal femur fractures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Skeletally mature patients.
- Distal femur fracture type A2, A3, C1, C2 by X-ray (Arbeitsgemeinschaft für Osteosynthesefragen classification).
- Injury Severity Score below 15.
- Controlled comorbidities.
- Fresh fractures: within 3 weeks of trauma.
Key exclusion criteria (2 listed)
- Distal femur fractures type A1, B, C3 and A2 if there is a medial wedge.
- Open fracture grade 3 Gustilo Anderson Classification.
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 |
|---|---|---|
| dual platingsurgical fixation of the distal femur using two plates to enhance stability and fracture healing. | Procedure or surgery | Dual plating |
| single platingsurgical fixation of the distal femur using a single plate according to standard fixation protocols. | Procedure or surgery | single plating |
Primary outcome
Sander's scale.
Time frame: one year
A scale of 40 points with 0 as the minimum value and 40 as the maximum value. A higher score means a better outcome. The scale is used as a functional outcome following distal femur fractures fixation using questionaire about the pain, walking ability and return of work and using x rays to measure angulation in degrees and shortening in centimeters and examining the range of motion of the knee joint in degrees.
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 4 Feb 2025.
- Background: PubMed 29116356Elsoe R, Ceccotti AA, Larsen P. Population-based epidemiology and incidence of distal femur fractures. Int Orthop. 2018 Jan;42(1):191-196. doi: 10.1007/s00264-017-3665-1. Epub 2017 Nov 7.
- Background: PubMed 29462121Myers P, Laboe P, Johnson KJ, Fredericks PD, Crichlow RJ, Maar DC, Weber TG. Patient Mortality in Geriatric Distal Femur Fractures. J Orthop Trauma. 2018 Mar;32(3):111-115. doi: 10.1097/BOT.0000000000001078.
- Background: PubMed 33992422Merino-Rueda LR, Rubio-Saez I, Mills S, Rubio-Suarez JC. Mortality after distal femur fractures in the elderly. Injury. 2021 Jul;52 Suppl 4:S71-S75. doi: 10.1016/j.injury.2021.03.066. Epub 2021 May 5.
- Background: PubMed 33150119Mubark I, Abouelela A, Genena A, Al Ghunimat A, Sarhan I, Ashwood N. Mortality Following Distal Femur Fractures Versus Proximal Femur Fractures in Elderly Population: The Impact of Best Practice Tariff. Cureus. 2020 Sep 30;12(9):e10744. doi: 10.7759/cureus.10744.
- Background: PubMed 31081515Larsen P, Ceccotti AA, Elsoe R. High mortality following distal femur fractures: a cohort study including three hundred and two distal femur fractures. Int Orthop. 2020 Jan;44(1):173-177. doi: 10.1007/s00264-019-04343-9. Epub 2019 May 12.
- Background: PubMed 28663403Poole WEC, Wilson DGG, Guthrie HC, Bellringer SF, Freeman R, Guryel E, Nicol SG. 'Modern' distal femoral locking plates allow safe, early weight-bearing with a high rate of union and low rate of failure: five-year experience from a United Kingdom major trauma centre. Bone Joint J. 2017 Jul;99-B(7):951-957. doi: 10.1302/0301-620X.99B7.BJJ-2016-0585.R1.
- Background: PubMed 4443073Schatzker J, Home G, Waddell J. The Toronto experience with the supracondylar fracture of the femur, 1966-72. Injury. 1974 Nov;6(2):113-28. doi: 10.1016/0020-1383(74)90005-9. No abstract available.
- Background: PubMed 26614924Gangavalli AK, Nwachuku CO. Management of Distal Femur Fractures in Adults: An Overview of Options. Orthop Clin North Am. 2016 Jan;47(1):85-96. doi: 10.1016/j.ocl.2015.08.011.
- Background: PubMed 34966488Atalay IB, Ozturk R, Yapar A, Karakoc Y, Eksioglu MF. Outcomes of the Surgical Treatment of Periprosthetic Fractures Around the Knee with Locking Plates: A Single Centre Experience. Malays Orthop J. 2021 Nov;15(3):1-7. doi: 10.5704/MOJ.2111.001.
- Background: PubMed 27891409Virk JS, Garg SK, Gupta P, Jangira V, Singh J, Rana S. Distal Femur Locking Plate: The Answer to All Distal Femoral Fractures. J Clin Diagn Res. 2016 Oct;10(10):RC01-RC05. doi: 10.7860/JCDR/2016/22071.8759. Epub 2016 Oct 1.
- Background: PubMed 27980675Smith WR, Stoneback JW, Morgan SJ, Stahel PF. Is immediate weight bearing safe for periprosthetic distal femur fractures treated by locked plating? A feasibility study in 52 consecutive patients. Patient Saf Surg. 2016 Dec 7;10:26. doi: 10.1186/s13037-016-0114-9. eCollection 2016.
- Background: PubMed 35111355Striano BM, Grisdela PT Jr, Shapira S, Heng M. Early Weight Bearing after Distal Femur Fracture Fixation. Geriatr Orthop Surg Rehabil. 2022 Jan 27;13:21514593211070128. doi: 10.1177/21514593211070128. eCollection 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing dual plating and single plating in people with Distal Femur Fracture, run by Assiut 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 2 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: opening soon, as of the sponsor's last update on 4 Feb 2025. 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.
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?
Contact mohamed TM Ahmed, MBBCh (+0201065442587, mohamed.16266135@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sander's scale. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06806839, which also lists 13 linked publications.
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 4 Feb 2025.