search
Back to results

Intracapsular Femoral Neck Fractures Fixation With a Dynamic Locking Plate and Screw System, Targon FN

Primary Purpose

Femoral Neck Fractures

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
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:

  • subcapital femoral fracture
  • transcervical femoral fractures
  • 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 Type

Other

Arm Label

Targon FN

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

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
search

1. Study Identification

Unique Protocol Identification Number
NCT00830687
Brief Title
Intracapsular Femoral Neck Fractures Fixation With a Dynamic Locking Plate and Screw System, Targon FN
Official Title
Intracapsular Femoral Neck Fractures Fixation With a Dynamic Locking Plate and Screw System, Targon FN. Prospective and Retrospective Cohort Study.
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 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.
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. Management of those fractures is based on few factors related to the patient, such as preinjury ambulatory status, age, cognitive function, and co morbidities, and on factors related to the fracture like the type of the fracture and the degree of displacement. Treatment options include nonsurgical management, fixation (percoutan, CRIF, ORIF) or arthroplasty (hemiarthroplasty, THR). 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. In displaced intracapsular femoral neck fractures like Garden type 3 and 4 or in unstable transcervcal fractures like Pauwel type 3 which are subjected to increased shear loads [2], the goals, for a physiologically young and active adult, are to preserve the femoral head, avoid osteonecrosis, and achieve union in order to avoid arthroplasty. Femoral neck fractures in young adults are associated with higher incidences of femoral head osteonecrosis [3-11] and nonunion [3, 4, 7, 12]. The reported rate of osteonecrosis after a femoral neck fracture in young patients ranges from 12% to 86% [3, 6-15]. 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. A review of the Cochrane database revealed 28 randomized or quasirandomized trials of 5,547 patients with femoral neck fractures treated with 19 different pin and/or screw constructs in a variety of configurations. [16] None of the implants had significantly superior results for outcomes related to fracture healing, osteonecrosis, wound infection, pain scores, reoperation rate, use of walking aids, periprosthetic fracture, or mortality. Recently the Targon FN a new implant for fixation of femoral neck fracture has become available. 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 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.

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
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Targon FN
Arm Type
Other
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)
TARGON FN
Intervention Description
The Targon FN implant consists of a small side plate with six locking screw ports
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: subcapital femoral fracture transcervical femoral fractures Fractures operated within 7 days ASA score 1-3 Exclusion Criteria: prior hip surgery pathological fractures
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:
Citation
Garden RS: Low-angle fixation in fractures of the femoral neck. J Bone Joint Surg 43B:647-663, 1961.
Results Reference
background
PubMed Identifier
11433141
Citation
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.
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
background
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
background
PubMed Identifier
7090765
Citation
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.
Results Reference
background
PubMed Identifier
6736085
Citation
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.
Results Reference
background
PubMed Identifier
7141676
Citation
Kofoed H. Femoral neck fractures in young adults. Injury. 1982 Sep;14(2):146-50. doi: 10.1016/0020-1383(82)90049-3.
Results Reference
background
PubMed Identifier
1914295
Citation
Shih CH, Wang KC. Femoral neck fractures. 121 cases treated by Knowles pinning. Clin Orthop Relat Res. 1991 Oct;(271):195-200.
Results Reference
background
PubMed Identifier
12955538
Citation
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.
Results Reference
background
PubMed Identifier
3184218
Citation
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.
Results Reference
background
PubMed Identifier
15292419
Citation
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.
Results Reference
background
PubMed Identifier
15446534
Citation
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.
Results Reference
background
PubMed Identifier
4055851
Citation
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.
Results Reference
background
PubMed Identifier
9709424
Citation
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.
Results Reference
background
PubMed Identifier
1261119
Citation
Askin SR, Bryan RS. Femoral neck fractures in young adults. Clin Orthop Relat Res. 1976 Jan-Feb;(114):259-64.
Results Reference
background
PubMed Identifier
11687113
Citation
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.
Results Reference
background

Learn more about this trial

Intracapsular Femoral Neck Fractures Fixation With a Dynamic Locking Plate and Screw System, Targon FN

We'll reach out to this number within 24 hrs