NCT00830687

Brief Summary

The purpose of this study is to evaluate our experience in internal fixation of intracapsular femoral neck fractures with the Targon FN implant prospectively and retrospectively in terms of the outcomes and complications associated with the treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

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

January 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

September 8, 2010

Status Verified

September 1, 2010

Enrollment Period

2 years

First QC Date

January 25, 2009

Last Update Submit

September 5, 2010

Conditions

Femoral Neck Fractures

Keywords

subcapital femoral fracturestranscervical femoral fracturesTARGON FN

Outcome Measures

Primary Outcomes (1)

  • overall survival, fixation survival and a composite end-point combining the two

    1 year

Secondary Outcomes (1)

  • length of surgery, bleeding, ambulation

    1 year

Study Arms (1)

Targon FN

OTHER

The Targon FN implant consists of a small side plate with six locking screw ports. The two distal holes are used to fix the plate to the lateral cortex of the femur with angle stable 4.5 mm cortical screws. The proximal holes allow the implementation of up to four "TeleScrews" which cross the fracture site. These 6.5 mm screws are dynamic and allow therewith the collapse of the fracture at the femoral neck. The sliding during the collapse occurs within these screws so that a protrusion of the screws in the lateral soft tissue is prevented

Device: TARGON FN

Interventions

TARGON FNDEVICE

The Targon FN implant consists of a small side plate with six locking screw ports

Targon FN

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subcapital femoral fracture
  • transcervical femoral fractures
  • Fractures operated within 7 days
  • ASA score 1-3

You may not qualify if:

  • prior hip surgery
  • pathological fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Meir Medical Center

Kfar Saba, Israel

NOT YET RECRUITING

Sheba medical center

Tel Litwinsky, Israel

RECRUITING

Assaf-Harofeh Medical Center

Zrifin, Israel

NOT YET RECRUITING

Related Publications (16)

  • Garden RS: Low-angle fixation in fractures of the femoral neck. J Bone Joint Surg 43B:647-663, 1961.

    BACKGROUND

  • Bartonicek J. Pauwels' classification of femoral neck fractures: correct interpretation of the original. J Orthop Trauma. 2001 Jun-Jul;15(5):358-60. doi: 10.1097/00005131-200106000-00009.

    PMID: 11433141BACKGROUND

  • Protzman RR, Burkhalter WE. Femoral-neck fractures in young adults. J Bone Joint Surg Am. 1976 Jul;58(5):689-95.

    PMID: 932067BACKGROUND

  • Dedrick DK, Mackenzie JR, Burney RE. Complications of femoral neck fracture in young adults. J Trauma. 1986 Oct;26(10):932-7. doi: 10.1097/00005373-198610000-00013.

    PMID: 3773004BACKGROUND

  • Zetterberg CH, Irstam L, Andersson GB. Femoral neck fractures in young adults. Acta Orthop Scand. 1982 Jun;53(3):427-35. doi: 10.3109/17453678208992237.

    PMID: 7090765BACKGROUND

  • Swiontkowski MF, Winquist RA, Hansen ST Jr. Fractures of the femoral neck in patients between the ages of twelve and forty-nine years. J Bone Joint Surg Am. 1984 Jul;66(6):837-46. doi: 10.2106/00004623-198466060-00003.

    PMID: 6736085BACKGROUND

  • Kofoed H. Femoral neck fractures in young adults. Injury. 1982 Sep;14(2):146-50. doi: 10.1016/0020-1383(82)90049-3.

    PMID: 7141676BACKGROUND

  • Shih CH, Wang KC. Femoral neck fractures. 121 cases treated by Knowles pinning. Clin Orthop Relat Res. 1991 Oct;(271):195-200.

    PMID: 1914295BACKGROUND

  • Lee CH, Huang GS, Chao KH, Jean JL, Wu SS. Surgical treatment of displaced stress fractures of the femoral neck in military recruits: a report of 42 cases. Arch Orthop Trauma Surg. 2003 Dec;123(10):527-33. doi: 10.1007/s00402-003-0579-8. Epub 2003 Sep 2.

    PMID: 12955538BACKGROUND

  • Visuri T, Vara A, Meurman KO. Displaced stress fractures of the femoral neck in young male adults: a report of twelve operative cases. J Trauma. 1988 Nov;28(11):1562-9. doi: 10.1097/00005373-198811000-00007.

    PMID: 3184218BACKGROUND

  • Haidukewych GJ, Rothwell WS, Jacofsky DJ, Torchia ME, Berry DJ. Operative treatment of femoral neck fractures in patients between the ages of fifteen and fifty years. J Bone Joint Surg Am. 2004 Aug;86(8):1711-6. doi: 10.2106/00004623-200408000-00015.

    PMID: 15292419BACKGROUND

  • Upadhyay A, Jain P, Mishra P, Maini L, Gautum VK, Dhaon BK. Delayed internal fixation of fractures of the neck of the femur in young adults. A prospective, randomised study comparing closed and open reduction. J Bone Joint Surg Br. 2004 Sep;86(7):1035-40. doi: 10.1302/0301-620x.86b7.15047.

    PMID: 15446534BACKGROUND

  • Tooke SM, Favero KJ. Femoral neck fractures in skeletally mature patients, fifty years old or less. J Bone Joint Surg Am. 1985 Oct;67(8):1255-60.

    PMID: 4055851BACKGROUND

  • Gautam VK, Anand S, Dhaon BK. Management of displaced femoral neck fractures in young adults (a group at risk). Injury. 1998 Apr;29(3):215-8. doi: 10.1016/s0020-1383(97)00184-8.

    PMID: 9709424BACKGROUND

  • Askin SR, Bryan RS. Femoral neck fractures in young adults. Clin Orthop Relat Res. 1976 Jan-Feb;(114):259-64.

    PMID: 1261119BACKGROUND

  • Parker MJ, Stockton G. Internal fixation implants for intracapsular proximal femoral fractures in adults. Cochrane Database Syst Rev. 2001;2001(4):CD001467. doi: 10.1002/14651858.CD001467.

    PMID: 11687113BACKGROUND

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 25, 2009

First Posted

January 28, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2012

Last Updated

September 8, 2010

Record last verified: 2010-09

Locations

IL(3)