Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the performance of Dynamic Locking Screws (DLS) used to stabilize the shaft component of distal femur fractures in comparison to standard locking screws (SLS). The hypothesis is that DLS will lead to better functional outcomes (WOMAC score) due to increased and more symmetrical callus formation and fewer non-unions.

Official Title
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A Multi-Center Randomized Controlled Pilot Study of Dynamic Locking Screws 5.0 vs. Standard Locking Screws in Fracture of Distal Femur Treated With Locked Plate Fixation

Conditions
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Distal Femur Fractures

Intervention / Treatment
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* Device: DLS 5.0 (Dynamic locking screws)
* Device: SLS (Standard locking screw)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21 years and older Closed or open distal femur fracture (AO 33 A1-3, 33 C1-3) including distal femur fractures above a total knee arthroplasty Ability to walk independently prior to injury Eligible for treatment with ORIF of the distal femur with a large fragment locking plate (LISS, LCP) Willing and able to comply with post-operative protocol and return for follow-up. Ability to understand the content of the patient information / informed consent form and participate in the clinical investigation Signed informed consent Exclusion Criteria: Additional ipsi- or contralateral lower extremity fracture Any kind of implant at the ipsilateral proximal femur Pre-existing malunion or nonunion of the ipsilateral lower extremity Segmental bone defect requiring bone grafting More than 4 weeks between injury and surgery Pathologic fracture due to a disease other than osteoporosis (eg, tumor, metastasis) Polytrauma Active malignancy Any not medically managed severe systemic disease Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment Pregnancy or women planning to conceive within the study period Prisoner Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DLS 5.0 (Dynamic Locking Screws)<br>ORIF with DLS 5.0 (Dynamic Locking Screws) | Device: DLS 5.0 (Dynamic locking screws)<br>* Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0<br>|
| Active Comparator: SLS (Standard locking screw)<br>ORIF with SLS (Standard locking screw) | Device: SLS (Standard locking screw)<br>* Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Index (WOMAC) | To assess pain, stiffness, and physical function | 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up-and-go Test (TUG) | The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command ready - go and stopped when the seated position is reached again. | 12 weeks ± 7 days, 6 months ± 30 days | 
| Quality of Life (EuroQol-5D) |  | Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery | 
| Range of Motion (ROM) | Assessment of passive ROM of the knee (flexion - extension) | 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery | 
| Full Weight-bearing Status | Assessment of the timepoint when the patient : can bear the whole body weight on the affected leg at single-leg-stance for 3 seconds can walk without walking aid has no intake of analgesics has a pain level experienced at the fracture site during weight bearing over two consecutive measurements with a value of ≤ 3 as measured on a 0-10 numeric rating scale (NRS), where 0 = no pain and 10 = worst pain imaginable | weekly measurement at home | 
| WOMAC | To assess pain, stiffness, and physical function | Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WOMAC, Femoral fracture, Periprosthetic fracture, Fracture fixation, internal, Distal femur fractures, Dynamic Locking Screw