NCT06806839

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Feb 2025

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Feb 2025Mar 2027

First Submitted

Initial submission to the registry

January 18, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

February 4, 2025

Status Verified

January 1, 2025

Enrollment Period

2 years

First QC Date

January 18, 2025

Last Update Submit

January 28, 2025

Conditions

Distal Femur Fracture

Outcome Measures

Primary Outcomes (1)

  • 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.

    one year

Study Arms (2)

Dual plating

EXPERIMENTAL

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

Procedure: dual plating

single plating

ACTIVE COMPARATOR

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

Procedure: single plating

Interventions

dual platingPROCEDURE

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

Dual plating
single platingPROCEDURE

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

single plating

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • 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.

    PMID: 29116356BACKGROUND

  • 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.

    PMID: 29462121BACKGROUND

  • 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.

    PMID: 33992422BACKGROUND

  • 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.

    PMID: 33150119BACKGROUND

  • 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.

    PMID: 31081515BACKGROUND

  • 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.

    PMID: 28663403BACKGROUND

  • 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.

    PMID: 4443073BACKGROUND

  • 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.

    PMID: 26614924BACKGROUND

  • 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.

    PMID: 34966488BACKGROUND

  • 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.

    PMID: 27891409BACKGROUND

  • 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.

    PMID: 27980675BACKGROUND

  • 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.

    PMID: 35111355BACKGROUND

  • 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.

    PMID: 28710534BACKGROUND

MeSH Terms

Conditions

Femoral Fractures, Distal

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesLeg Injuries

Central Study Contacts

mohamed TM Ahmed, MBBCh

CONTACT

+0201065442587mohamed.16266135@med.aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

January 18, 2025

First Posted

February 4, 2025

Study Start

February 1, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

February 4, 2025

Record last verified: 2025-01