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Clinical Trials/NCT01693367
NCT01693367TerminatedPhase 4

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

AO Innovation Translation Center24 sites in 4 countries5 target enrollmentStarted: September 1, 2012Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Terminated
Sponsor
Enrollment
5
Locations
24
Primary Endpoint
Western Ontario and McMaster Universities Index (WOMAC)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
21 Years to 120 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Outcomes

Primary Outcomes

Western Ontario and McMaster Universities Index (WOMAC)

Time Frame: 12 months after surgery

To assess pain, stiffness, and physical function

Secondary Outcomes

  • Timed Up-and-go Test (TUG)(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)(6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery)
  • Full Weight-bearing Status(weekly measurement at home)
  • WOMAC(Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery)

Investigators

Sponsor
AO Innovation Translation Center
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (24)

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