Early Weight Bearing in Distal Femur Fractures

NCT ID: NCT06806839

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2027-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Distal Femur Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dual plating

Participants in this group will undergo dual plating fixation for distal femur fractures.

Group Type EXPERIMENTAL

dual plating

Intervention Type PROCEDURE

surgical fixation of the distal femur using two plates to enhance stability and fracture healing.

single plating

Participants in this group will undergo single plate fixation for distal femur fractures.

Group Type ACTIVE_COMPARATOR

single plating

Intervention Type PROCEDURE

surgical fixation of the distal femur using a single plate according to standard fixation protocols.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

dual plating

surgical fixation of the distal femur using two plates to enhance stability and fracture healing.

Intervention Type PROCEDURE

single plating

surgical fixation of the distal femur using a single plate according to standard fixation protocols.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* Distal femur fractures type A1, B, C3 and A2 if there is a medial wedge.
* Open fracture grade 3 Gustilo Anderson Classification.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohamed Tarek Mahmoud Ahmed

Resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

mohamed TM Ahmed, MBBCh

Role: CONTACT

+0201065442587

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29116356 (View on PubMed)

Myers 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.

Reference Type BACKGROUND
PMID: 29462121 (View on PubMed)

Merino-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.

Reference Type BACKGROUND
PMID: 33992422 (View on PubMed)

Mubark 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.

Reference Type BACKGROUND
PMID: 33150119 (View on PubMed)

Larsen 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.

Reference Type BACKGROUND
PMID: 31081515 (View on PubMed)

Poole 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.

Reference Type BACKGROUND
PMID: 28663403 (View on PubMed)

Schatzker 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.

Reference Type BACKGROUND
PMID: 4443073 (View on PubMed)

Gangavalli 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.

Reference Type BACKGROUND
PMID: 26614924 (View on PubMed)

Atalay 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.

Reference Type BACKGROUND
PMID: 34966488 (View on PubMed)

Virk 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.

Reference Type BACKGROUND
PMID: 27891409 (View on PubMed)

Smith 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.

Reference Type BACKGROUND
PMID: 27980675 (View on PubMed)

Striano 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.

Reference Type BACKGROUND
PMID: 35111355 (View on PubMed)

Imam 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.

Reference Type BACKGROUND
PMID: 28710534 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Early weight-bearing.

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dual Implant Versus Single Implant Distal End of Femur
NCT05292313 ENROLLING_BY_INVITATION NA