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Comparison Study of 3-4-screws-internal Fixation With Multi-screw-system Targon FN for Femoral Neck Fracture

Primary Purpose

Femoral Neck Fractures

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
screws-internal fixation
TARGON FN
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Neck Fractures focused on measuring subcapital femoral fractures, transcervical femoral fractures, TARGON FN

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • nondisplaced subcapital femoral fracture (gARDEN 1-2)
  • transcervical femoral fractures(Pauwells 1 & 2).
  • Fractures operated within 7 days
  • ASA score 1-3

Exclusion Criteria:

  • prior hip surgery
  • pathological fractures

Sites / Locations

  • Meir Medical Center
  • Sheba medical centerRecruiting
  • Assaf-Harofeh Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

screws-internal fixation

TARGON FN

Arm Description

3-4-screws-internal fixation

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

length of surgery, bleeding, ambulation

Full Information

First Posted
January 25, 2009
Last Updated
September 5, 2010
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00829725
Brief Title
Comparison Study of 3-4-screws-internal Fixation With Multi-screw-system Targon FN for Femoral Neck Fracture
Official Title
Randomized, Prospective, Multi-center, Comparison Study of 3-4-screws-internal Fixation With Multi-screw-system Targon FN for Femoral Neck Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
January 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare between two methods of internal fixation, the 3-4 parallel screws or the Targon FN implant in gardens type 1-2 or Pauwels type 1-2 femoral neck fractures in terms of the outcomes and complications associated with the treatment of these fractures.
Detailed Description
Intracapsular femoral neck fractures include subcapital and transcervical fractures. They typically occur in a bimodal age distribution, with most occurring in the elderly population. The rest are the result of high energy injury in the young. Undisplaced hip fractures are defined as fractures where the inferior cortical buttress is undisplaced on the anteroposterior (AP) radiograph.[1] Undisplaced hip fractures includes fractures impacted in all degrees of valgus regardless of any angulations at the fractures' edges seen on the lateral radiographs. The fractures can be classified using either the Garden or Pauwel classifications for subcapital fracture or transcervical fractures, respectively. The choice of treatment of undisplaced hip fractures is contentious, especially in elderly patients. The options range from nonoperative treatment in younger patients with stable impacted fractures to primary hemiarthroplasty for frail, elderly patients.[2] Although some of those fracture, like impacted valgus fractures have a degree of inherent stability, internal fixation is generally recommended because nonunion rates of up to 39% have been reported with nonsurgical treatment. [3] In one study the authors examined 375 patients with nondisplaced intracapsular fractures treated with internal fixation [cannulated cancellous screws (366 patients), dynamic hip screws (nine patients)]. The authors noted a nonunion rate of 6.4% and an osteonecrosis rate of 4.0%. Age, walking ability, degree of impaction evident on the anteroposterior radiograph, and angulation on the lateral radiograph were determined to be predictive of healing complications. In this study, the conversion rate to arthroplasty was 7.7%. [4] Femoral neck fractures in young adults are associated with higher incidences of femoral head osteonecrosis [5-13] and nonunion [5, 6, 9, 14]. The reported rate of osteonecrosis after a femoral neck fracture in young patients ranges from 12% to 86% [5, 8-17]. This complication may lead to collapse of the femoral head and osteoarthritis. Salvage procedures, such as osteotomy, and other reoperations have high failure rates, and arthroplasty procedures are not ideal, given the patient's young age and higher level of activity. The achievement of an anatomic reduction and stable internal fixation is imperative. 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. The only report was reported by Martyn Parker MD and was released in Jatros Orthopädie 2008. He reported a serial of 50 femoral neck fractures, 27 (54%) of the fractures were undisplaced and 23 (48%) were displaced. There were two cases of fracture non-union, In one patient the plate became detached. One patient with a non-displaced femur neck fracture showed early radiographic signs of a possible avascular necrosis after one year. The implant was removed and the symptoms improved somewhat. The purpose of this study is therefore to compare between two methods of internal fixation, the 3-4 parallel screws or the Targon FN implant in gardens type 1-2 or Pauwels type 1-2 femoral neck fractures in terms of the outcomes and complications associated with the treatment of these fractures. we expect around 5% complications using the Targon FN implant comparing to 11% complications with the screws.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures
Keywords
subcapital femoral fractures, transcervical femoral fractures, TARGON FN

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
screws-internal fixation
Arm Type
Active Comparator
Arm Description
3-4-screws-internal fixation
Arm Title
TARGON FN
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
screws-internal fixation
Intervention Description
3-4-screws-internal fixation
Intervention Type
Device
Intervention Name(s)
TARGON FN
Intervention Description
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
Primary Outcome Measure Information:
Title
overall survival, fixation survival and a composite end-point combining the two
Time Frame
1 year
Secondary Outcome Measure Information:
Title
length of surgery, bleeding, ambulation
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: nondisplaced subcapital femoral fracture (gARDEN 1-2) transcervical femoral fractures(Pauwells 1 & 2). Fractures operated within 7 days ASA score 1-3 Exclusion Criteria: prior hip surgery pathological fractures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ran Thein, MD
Phone
+972544310305
Email
ranthein@gmail.com
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin KISH, MD
Phone
+972545855125
First Name & Middle Initial & Last Name & Degree
Chayim Yehuda, MD
Email
dochaim@gmail.com
First Name & Middle Initial & Last Name & Degree
Benjamin Kish, MD
Facility Name
Sheba medical center
City
Tel-Hashomer
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ran Thein, MD
Phone
+972544310305
Email
ranthein@gmail.com
First Name & Middle Initial & Last Name & Degree
Nahshon Shazar, MD
Facility Name
Assaf-Harofeh Medical Center
City
Zrifin
Country
Israel
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
7983113
Citation
Hui AC, Anderson GH, Choudhry R, Boyle J, Gregg PJ. Internal fixation or hemiarthroplasty for undisplaced fractures of the femoral neck in octogenarians. J Bone Joint Surg Br. 1994 Nov;76(6):891-4.
Results Reference
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11995876
Citation
Tanaka J, Seki N, Tokimura F, Hayashi Y. Conservative treatment of Garden stage I femoral neck fracture in elderly patients. Arch Orthop Trauma Surg. 2002 Feb;122(1):24-8. doi: 10.1007/s004020100318.
Results Reference
background
PubMed Identifier
15123955
Citation
Conn KS, Parker MJ. Undisplaced intracapsular hip fractures: results of internal fixation in 375 patients. Clin Orthop Relat Res. 2004 Apr;(421):249-54.
Results Reference
background
PubMed Identifier
932067
Citation
Protzman RR, Burkhalter WE. Femoral-neck fractures in young adults. J Bone Joint Surg Am. 1976 Jul;58(5):689-95.
Results Reference
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PubMed Identifier
3773004
Citation
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.
Results Reference
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PubMed Identifier
7090765
Citation
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Results Reference
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PubMed Identifier
6736085
Citation
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Citation
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Citation
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12955538
Citation
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Citation
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Comparison Study of 3-4-screws-internal Fixation With Multi-screw-system Targon FN for Femoral Neck Fracture

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