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NCT Number: NCT07542249

Retrograde Nail vs Double Plating for Distal Femoral Extra 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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha university

Banhā, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. The Oxford Knee Score

    Time frame: 6 months

    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).

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

    Time frame: before surgery and 6 months postoperative

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Retrograde Nail Versus Double Plating for Distal Femoral Extra-articular and Simple Articular Fractures With Metaphyseal Comminution

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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