NCT00578019

Brief Summary

The purpose of this study is to compare patient outcomes for the Less Invasive Stabilization System (LISS) (Synthes {USA}, Paoli, PA, USA), a minimally invasive plating system used in the treatment of supracondylar femur fractures, with patient outcomes for the Supracondylar Nail (Smith \& Nephew Inc, Memphis, TN, USA), a retrograde intramedullary nail.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1999

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 20, 2007

Completed
Last Updated

October 1, 2013

Status Verified

September 1, 2013

Enrollment Period

5.4 years

First QC Date

December 18, 2007

Last Update Submit

September 28, 2013

Conditions

Supracondylar Femur Fracture

Keywords

ComparativeSupracondylar Femur FractureIntramedullary nailingLess Invasive Stabilization System (LISS) Plating

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure is complete healing of the femur fracture

    Clinical outcomes will be evaluated at weeks 12, 26, and 52

Secondary Outcomes (1)

  • Secondary outcome is to compare the time and quality of healing of the femur fracture

    Will be evaluated at weeks 12, 26 and 52

Study Arms (2)

1, A

ACTIVE COMPARATOR
Procedure: IM Nailing

2, B

EXPERIMENTAL

Group B patients will have their fracture stabilized with the LISS plates (Synthes \[USA\], Paoli, PA, USA).

Procedure: LISS

Interventions

IM NailingPROCEDURE

Patients randomized to Arm 1, A will be treated with a retrograde intramedullary nailing of the femur fracture utilizing the Smith \& Nephew supracondylar nail.

Also known as: Smith & Nephew Supracondylar Nail
1, A
LISSPROCEDURE

Group B patients will have their fracture stabilized with the LISS plates (Synthes \[USA\], Paoli, PA, USA).

Also known as: Synthes LISS
2, B

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type A or C supracondylar femur fracture
  • Adult patients (19 years or older)

You may not qualify if:

  • Patients unable or unwilling to comply with follow-up gait, radiographic, and clinical evaluations necessary to complete the study
  • Patients are not able or willing to give informed consent and/or have no responsible family member willing to give consent
  • Patients with a disease entity or condition that totally precludes the possibility of bony fusion or patients undergoing drug therapy that prevents bony healing
  • Mentally retarded persons
  • Mentally disabled individuals
  • Prisoners
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Alabama at Birmingham, Orthopaedic Trauma

Birmingham, Alabama, 35294, United States

Location

Related Publications (3)

  • Kayali C, Agus H, Turgut A. Successful results of minimally invasive surgery for comminuted supracondylar femoral fractures with LISS: comparative study of multiply injured and isolated femoral fractures. J Orthop Sci. 2007 Sep;12(5):458-65. doi: 10.1007/s00776-007-1156-8. Epub 2007 Sep 28.

    PMID: 17909931BACKGROUND

  • Boldin C, Fankhauser F, Hofer HP, Szyszkowitz R. Three-year results of proximal tibia fractures treated with the LISS. Clin Orthop Relat Res. 2006 Apr;445:222-9. doi: 10.1097/01.blo.0000203467.58431.a0.

    PMID: 16456310BACKGROUND

  • Stannard JP, Wilson TC, Volgas DA, Alonso JE. The less invasive stabilization system in the treatment of complex fractures of the tibial plateau: short-term results. J Orthop Trauma. 2004 Sep;18(8):552-8. doi: 10.1097/00005131-200409000-00012.

    PMID: 15475852BACKGROUND

Study Officials

  • James P Stannard, MD

    The University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 20, 2007

Study Start

December 1, 1999

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

October 1, 2013

Record last verified: 2013-09

Locations

US(1)