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

NCT07542249 | Active Not Recruiting

• 1 other identifier: MD.1.3.2.26
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Distal Femoral Fractures; Extra-articular Distal Radius Malunions; Intramedullary

Keywords

double plating; Intramedullary nail; distal femur fractures; metaphyseal comminution

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Group A: will be treated by retrograde nail

EXPERIMENTAL

Procedure: Retrograde nail

Group B :will be treated by double plating

EXPERIMENTAL

Procedure: Double plating

Interventions

Retrograde nail PROCEDURE

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.

Group A: will be treated by retrograde nail

Double plating PROCEDURE

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.

Group B :will be treated by double plating

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha university

Banhā, Egypt

Location

MeSH Terms

Conditions

Femoral Fractures, Distal

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Leg Injuries

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 at Orthopedic surgery Ain Shams University

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: September 30, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

EG (1)