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This trial aimed to provide Level I evidence on the comparative effectiveness, safety, and functional outcomes of single versus double plating for distal femoral fractures.
Distal femoral fractures, particularly those with metaphyseal comminution, present a significant surgical challenge with high risks of nonunion, malalignment, and functional impairment.
The single lateral locking plate (SLP) is a common fixation method but may lack sufficient stability in complex fractures, leading to varus collapse.
Dual plating (lateral and medial plates) offers enhanced biomechanical stability but involves greater surgical invasiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (Single Plate): | Experimental | Patients underwent open Reduction and Internal Fixation (ORIF) using a single pre-contoured lateral distal femoral locking compression plate via a standard lateral approach. |
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| Group II (Double Plate) | Experimental | Patients underwent open Reduction and Internal Fixation (ORIF) using a lateral distal femoral locking plate combined with a medial buttress plate (3.5mm reconstruction plate) via an anterolateral approach with subvastus medial dissection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single lateral distal femoral locking compression plate | Procedure | Patients underwent open Reduction and Internal Fixation (ORIF) using a single pre-contoured lateral distal femoral locking compression plate via a standard lateral approach. |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Score (KSS) | The Knee Society Score (KSS) contains questions in 2 sections: knee joint (pain, range of motion, stability) and function (walking distance, ability to climb stairs). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions. | 6 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Radiological Union | Radiological Union (defined as bridging callus in 3/4 cortices) was recorded. It was assessed at 2, 6, 12, 24, and 52 weeks post-surgery. | 52 weeks post-surgery |
| Active Range of Motion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni Suef University | Banī Suwayf | Beni Suweif Governorate | 62511 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| ID | Term |
|---|---|
| D000092524 | Femoral Fractures, Distal |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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| Double Plating | Procedure | Patients underwent open Reduction and Internal Fixation (ORIF) using a lateral distal femoral locking plate combined with a medial buttress plate (3.5mm reconstruction plate) via an anterolateral approach with subvastus medial dissection. |
|
Active Range of Motion was measured with a goniometer assesses the joint angle achieved through a patient's voluntary muscle contraction, without external assistance. It was assessed at 2, 6, 12, 24, and 52 weeks post-surgery.
| 52 weeks post-surgery |
| Degree of pain | Degree of pain was assessed using Visual Analogue Scale (VAS). The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). It was assessed at 2, 6, 12, 24, and 52 weeks post-surgery. | 52 weeks post-surgery |
| Fracture Alignment | Fracture Alignment on Anterior Posterior (AP)/Lateral radiographs was recorded. It was assessed at 2, 6, 12, 24, and 52 weeks post-surgery. | 52 weeks post-surgery |
| Assessment of quality of Life | Quality of Life was assessed using EQ-5D-5L questionnaire across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It was assessed at 6 and 12 months post-surgery. | 12 months post-surgery |