Retrograde Nail vs Double Plating for Distal Femoral Extra and Simple Articular Fractures With Metaphyseal Comminution

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Intramedullary; Distal Femoral Fractures; Extra-articular Distal Radius Malunions
• Intervention / Treatment: Procedure: Retrograde nail; Procedure: Double plating

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Banhā, Egypt
    • Benha University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Skeletally immature patients
• Pathological fractures
• Open fractures
• Periprosthetic fractures
• Medically unfit patients
• Patients with pre-existing knee pathology
• Neuro-vascular ipsilateral lower limb injuries

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: will be treated by retrograde nail	Procedure: Retrograde nail; 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.
Experimental: Group B :will be treated by double plating	Procedure: Double plating; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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	before surgery and 6 months postoperative

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: distal femur fractures; Intramedullary nail; double plating; metaphyseal comminution
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures; Femoral Fractures, Distal
• Other Study ID Numbers: MD.1.3.2.26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It will be available when it needed
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No