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Completed

NCT Number: NCT05363943

DP Vs DFR for Management of Geriatric Distal Femur Fractures.

The aim of this study was to compare the functional and radiological outcomes of fixation by using double plating technique versus replacement using distal femur tumor prothesis as a primary management for the distal femoral fractures in geriatric patients. The hypothesis was that the distal femoral replacement will yield better functional outcome and earlier rehabilitation and return to pre-injury level of activity.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University - Faculty of Medicine

Cairo, 1181, Egypt

About this study

Geriatric distal femoral fractures represent a major challenge for the orthopedic surgeons, to the present days still there is no definite algorithm or specific guidelines that can be used accurately in the management of these fractures. Unlike hip fractures however, there is no widely accepted treatment algorithm or standard of care.

The surgical treatment of distal femoral fractures depends on both patient and fracture characteristics. Options include conservative treatment, open reduction internal fixation, intramedullary nails, or recently distal femoral replacement.

There is currently a move towards distal femoral replacement (DFR) for these complex fractures which has the potential benefit of allowing early weight bearing, and therefore aiming to prevent complications associated with immobility and non-union.

Using distal femoral replacement had yield good results in small case series, as it allows immediate full weightbearing, eliminate the risk of nonunion and may provide greater satisfaction scores. However, DFR has its own risks, most notably deep infection, and loosening. While a DFR is more costly compared with fixation plates and nails, the initial increased cost may be outweighed by faster rehabilitation and return to the patient's usual place of residence.

In the study, the investigators are aiming to compare the functional and radiological outcomes of fixation by using double plating technique versus replacement as a primary management for the geriatric distal femoral fractures.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • AO 33 A3 and 33 C fractures
  • Age group ≥ 60 years
  • Closed fractures
  • Neurovascular intact

Exclusion criteria

  • Open fractures
  • Non ambulant patients
  • Patients with peripheral neurovascular diseases
  • Peri-prosthetic fractures
  • Associated other orthopedic injuries
  • Poly-traumatized patients
  • Pathological fractures

Treatment and study plan

double plating

Procedure

open reduction and internal fixation by using lateral and medial plates.

Distal femoral replacement

Procedure

excision of the distal part of femur and replacement with distal femoral prosthesis

Primary outcomes

  1. change in Knee Society Score

    Time frame: 1 month, 6 month and 12 month

    the score has two-part, knee and function parts. The score is graded from 0 to 100 in each domain with 100 is the best outcome and 0 is the worst. The knee part assesses the range of motion, pain, and alignment of the joint while the function part assesses walking, stairs and usage of walking aids.

Secondary outcomes

  1. change in Knee range of motion

    Time frame: 1 month and 12 month

    Assessment of range of motion of the knee which has normal range from 0 to 135

  2. Postoperative complications

    Time frame: form first day to 12 month

    Assessment of postoperative complications either early or late complications

  3. Reoperation rate

    Time frame: form first day to 12 month

    Recording the need for secondary operation for a cause related to the fracture union, postoperative complications, or prothesis problems.

  4. Operative time

    Time frame: At the operation

    Recording of the operative time from the time of incision to the time of skin closure

Sponsors and collaborators

Lead sponsor

Amr Gamaleldin Mahmoud Khalil Gendya

Other

Registry information

Official study title

Double Plating (DP) Fixation vs Distal Femoral Replacement (DFR) in the Management of Distal Femoral Fractures in Geriatric Patients.

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 6, 2022
Registry last updated
Jul 20, 2023

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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