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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00829725
First received: January 25, 2009
Last updated: September 5, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Femoral Neck Fractures
Device: screws-internal fixation
Device: TARGON FN
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Prospective, Multi-center, Comparison Study of 3-4-screws-internal Fixation With Multi-screw-system Targon FN for Femoral Neck Fracture

Resource links provided by NLM:


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 ]

Estimated Enrollment: 300
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)
Arms Assigned Interventions
Active Comparator: screws-internal fixation
3-4-screws-internal fixation
Device: screws-internal fixation
3-4-screws-internal fixation
Experimental: 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
Device: 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. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829725

Contacts
Contact: Ran Thein, MD +972544310305 ranthein@gmail.com

Locations
Israel
Meir Medical Center Not yet recruiting
Kfar Saba, Israel
Contact: Benjamin KISH, MD    +972545855125      
Contact: Chayim Yehuda, MD       dochaim@gmail.com   
Principal Investigator: Benjamin Kish, MD         
Sheba medical center Recruiting
Tel-Hashomer, Israel
Contact: Ran Thein, MD    +972544310305    ranthein@gmail.com   
Principal Investigator: Nahshon Shazar, MD         
Assaf-Harofeh Medical Center Not yet recruiting
Zrifin, Israel
Sponsors and Collaborators
Sheba Medical Center
  More Information

Publications:

Responsible Party: Nahshon Shazar MD. Head Trauma Unit, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00829725     History of Changes
Other Study ID Numbers: SHEBA-09-5569-NS-CTIL
Study First Received: January 25, 2009
Last Updated: September 5, 2010
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Femoral Neck Fractures
Fractures, Bone
Femoral Fractures
Hip Fractures
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 21, 2014