Femoral Neck FracturesPhase 4NCT00829725
Comparison Study of 3-4-screws-internal Fixation With Multi-screw-system Targon FN for Femoral Neck Fracture
A Phase 4 study testing screws-internal fixation and TARGON FN in people with Femoral Neck Fractures, run by Sheba Medical Center at 3 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- screws-internal fixation and TARGON FN
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesIsrael
- Study dates
- Jan 2009to Jan 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- nondisplaced subcapital femoral fracture (gARDEN 1-2)
- transcervical femoral fractures(Pauwells 1 \& 2).
- Fractures operated within 7 days
- ASA score 1-3
Who cannot join
- prior hip surgery
- pathological fractures
Trial locations and contacts
3 sites in 1 country.
Israel3 sites, 3 recruiting
- Not yet recruiting
Meir Medical Center
Kfar Saba
Benjamin KISH, MD, +972545855125
Chayim Yehuda, MD, dochaim@gmail.com
- Recruiting
Sheba medical center
Tel HaShomer
Ran Thein, MD, +972544310305, ranthein@gmail.com
Nahshon Shazar, MD
- Not yet recruiting
Assaf-Harofeh Medical Center
Zrifin
About this study
Official title: Randomized, Prospective, Multi-center, Comparison Study of 3-4-screws-internal Fixation With Multi-screw-system Targon FN for Femoral Neck Fracture
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.
Read the 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.
- Conditions
- Femoral Neck Fractures
- Being tested
- screws-internal fixation, TARGON FN
- Keywords
- subcapital femoral fractures, transcervical femoral fractures, TARGON FN
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screws-internal fixationDevice
3-4-screws-internal fixation
TARGON FNDevice
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
| Study group | Role | What they receive |
|---|---|---|
| screws-internal fixation | Active comparator | 3-4-screws-internal fixation Receives: Device: screws-internal fixation |
| TARGON FN | Experimental | 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 Receives: Device: TARGON FN |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival, fixation survival and a composite end-point combining the two
Measured: 1 year
Secondary outcomes (1)
length of surgery, bleeding, ambulation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2011 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829725
- Sponsor's protocol ID
- SHEBA-09-5569-NS-CTIL
- Status last verified
- Sep 2010
- First submitted
- 25 Jan 2009
- Last updated
- 8 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 7983113Tanaka 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.
PubMed 11995876Conn KS, Parker MJ. Undisplaced intracapsular hip fractures: results of internal fixation in 375 patients. Clin Orthop Relat Res. 2004 Apr;(421):249-54.
PubMed 15123955Protzman RR, Burkhalter WE. Femoral-neck fractures in young adults. J Bone Joint Surg Am. 1976 Jul;58(5):689-95.
PubMed 932067Dedrick 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.
PubMed 3773004Zetterberg CH, Irstam L, Andersson GB. Femoral neck fractures in young adults. Acta Orthop Scand. 1982 Jun;53(3):427-35. doi: 10.3109/17453678208992237.
PubMed 7090765Swiontkowski 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.
PubMed 6736085Kofoed H. Femoral neck fractures in young adults. Injury. 1982 Sep;14(2):146-50. doi: 10.1016/0020-1383(82)90049-3.
PubMed 7141676Shih CH, Wang KC. Femoral neck fractures. 121 cases treated by Knowles pinning. Clin Orthop Relat Res. 1991 Oct;(271):195-200.
PubMed 1914295Lee 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.
PubMed 12955538Visuri 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.
PubMed 3184218Haidukewych 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.
PubMed 15292419Upadhyay 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.
PubMed 15446534Tooke 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.
PubMed 4055851Gautam 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.
PubMed 9709424
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Prospective, Multi-center, Comparison Study of 3-4-screws-internal Fixation With Multi-screw-system Targon FN for Femoral Neck Fracture
- ClinicalTrials.gov ID
- NCT00829725
- Acronym / sponsor ID
- SHEBA-09-5569-NS-CTIL
- Conditions
- Femoral Neck Fractures
- Keywords
- subcapital femoral fractures, transcervical femoral fractures, TARGON FN
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 27 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| screws-internal fixation | Active comparator | Device: screws-internal fixation3-4-screws-internal fixation |
| TARGON FN | Experimental | Device: TARGON FNThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- nondisplaced subcapital femoral fracture (gARDEN 1-2)
- transcervical femoral fractures(Pauwells 1 \& 2).
- Fractures operated within 7 days
- ASA score 1-3
Key exclusion criteria (2 listed)
- prior hip surgery
- pathological fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| screws-internal fixation3-4-screws-internal fixation | Device | screws-internal fixation |
| TARGON FNThe 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 |
Primary outcome
overall survival, fixation survival and a composite end-point combining the two
Time frame: 1 year
1 secondary outcome
length of surgery, bleeding, ambulation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2010.
- Background: PubMed 7983113Hui 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.
- Background: PubMed 11995876Tanaka 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.
- Background: PubMed 15123955Conn KS, Parker MJ. Undisplaced intracapsular hip fractures: results of internal fixation in 375 patients. Clin Orthop Relat Res. 2004 Apr;(421):249-54.
- Background: PubMed 932067Protzman RR, Burkhalter WE. Femoral-neck fractures in young adults. J Bone Joint Surg Am. 1976 Jul;58(5):689-95.
- Background: PubMed 3773004Dedrick 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.
- Background: PubMed 7090765Zetterberg CH, Irstam L, Andersson GB. Femoral neck fractures in young adults. Acta Orthop Scand. 1982 Jun;53(3):427-35. doi: 10.3109/17453678208992237.
- Background: PubMed 6736085Swiontkowski 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.
- Background: PubMed 7141676Kofoed H. Femoral neck fractures in young adults. Injury. 1982 Sep;14(2):146-50. doi: 10.1016/0020-1383(82)90049-3.
- Background: PubMed 1914295Shih CH, Wang KC. Femoral neck fractures. 121 cases treated by Knowles pinning. Clin Orthop Relat Res. 1991 Oct;(271):195-200.
- Background: PubMed 12955538Lee 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.
- Background: PubMed 3184218Visuri 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.
- Background: PubMed 15292419Haidukewych 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing screws-internal fixation and TARGON FN in people with Femoral Neck Fractures, run by Sheba Medical Center at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ran Thein, MD (+972544310305, ranthein@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival, fixation survival and a composite end-point combining the two (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00829725, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2010.