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Intracapsular Femoral Neck Fractures Fixation With a Dynamic Locking Plate and Screw System, Targon FN
This study is not yet open for participant recruitment.
Verified by Sheba Medical Center, January 2009
First Received: January 25, 2009   Last Updated: January 27, 2009   History of Changes
Sponsored by: Sheba Medical Center
Information provided by: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00830687
  Purpose

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.


Condition
Femoral Neck Fractures

MedlinePlus related topics: Fractures
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort
Official Title: Intracapsular Femoral Neck Fractures Fixation With a Dynamic Locking Plate and Screw System, Targon FN. Prospective and Retrospective Cohort Study.

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • overall survival, fixation survival and a composite end-point combining the two [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • length of surgery, bleeding, ambulation [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 100
Study Start Date: January 2009
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Targon FN
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients over the age of 18 with subcapital femoral fractures or transcervical femoral fractures.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830687

Locations
Israel
Sheba medical center
Tel-Hashomer, Israel
Assaf-Harofeh Medical Center
ZRIFIN, Israel
Meir Medical Center
KFAR SABA, Israel
Sponsors and Collaborators
Sheba Medical Center
  More Information

Publications:
Garden RS: Low-angle fixation in fractures of the femoral neck. J Bone Joint Surg 43B:647-663, 1961.
Bartonícek J. Pauwels' classification of femoral neck fractures: correct interpretation of the original. J Orthop Trauma. 2001 Jun-Jul;15(5):358-60. Review.
Protzman RR, Burkhalter WE. Femoral-neck fractures in young adults. J Bone Joint Surg Am. 1976 Jul;58(5):689-95.
Dedrick DK, Mackenzie JR, Burney RE. Complications of femoral neck fracture in young adults. J Trauma. 1986 Oct;26(10):932-7.
Zetterberg CH, Irstam L, Andersson GB. Femoral neck fractures in young adults. Acta Orthop Scand. 1982 Jun;53(3):427-35.
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.
Kofoed H. Femoral neck fractures in young adults. Injury. 1982 Sep;14(2):146-50.
Shih CH, Wang KC. Femoral neck fractures. 121 cases treated by Knowles pinning. Clin Orthop Relat Res. 1991 Oct;(271):195-200.
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. Epub 2003 Sep 2.
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.
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-A(8):1711-6.
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.
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.
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.
Askin SR, Bryan RS. Femoral neck fractures in young adults. Clin Orthop Relat Res. 1976 Jan-Feb;(114):259-64.
Parker MJ, Stockton G. Internal fixation implants for intracapsular proximal femoral fractures in adults. Cochrane Database Syst Rev. 2001;(4):CD001467. Review.

Responsible Party: Sheba Medical Center ( Nahshon Shazar MD. Head trauma unite )
Study ID Numbers: SHEBA-09-5582-NS-CTIL
Study First Received: January 25, 2009
Last Updated: January 27, 2009
ClinicalTrials.gov Identifier: NCT00830687     History of Changes
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
subcapital femoral fractures
transcervical femoral fractures
TARGON FN

Study placed in the following topic categories:
Femoral Neck Fractures
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries

Additional relevant MeSH terms:
Femoral Neck Fractures
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries

ClinicalTrials.gov processed this record on May 06, 2009