NCT01693367.

Trial name or title	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
Methods	Interventional, randomised, efficacy study. Single blinded (participant)
Participants	Inclusion criteria: men and women ≥ 21 years 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 (Less Invasive Stabilisation System (LISS), LCP) willing and able to comply with postoperative protocol and return for follow‐up ability to understand the content of the participant information/informed consent form and participate in the clinical investigation signed informed consent Exclusion criteria: additional ipsi‐ or contralateral lower extremity fracture any type of implant at the ipsilateral proximal femur pre‐existing malunion or non‐union of the ipsilateral lower extremity segmental bone defect requiring bone grafting > 4 weeks between injury and surgery pathological fracture due to a disease other than osteoporosis (e.g. tumour, metastasis) polytrauma active malignancy any not medically managed severe systemic disease recent history of substance abuse (i.e. 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
Interventions	DLS 5.0 (dynamic locking screws) SLS (standard locking screw)
Outcomes	Timed up‐and‐go test (TUG) (time frame: 12 weeks ± 7 days, 6 months ± 30 days) Quality of life (EuroQol‐5D) (time frame: preoperative, 6 weeks ± 7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery) Range of motion (time frame: 6 weeks ± 7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery) Full weight‐bearing status (time frame: weekly measurement at home). Assessment of the time point when the participant 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 Western Ontario and McMaster Universities Arthritis Index (WOMAC) (time frame: preoperative, 6 weeks ± 7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery)
Starting date	September 2102
Contact information	Michael J Gardner, MD, Washington University School of Medicine
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