Closed Comminuted Oblique Intertrochanteric Fracture of Neck of Right FemurPhase 4NCT01509859
Comparing Weight Bearing After Intramedullary Fixation Devices for the Proximal Femur Fracture
A Phase 4 study testing PFNA proximal femur nail device (Synthes) and INTERTAN proximal femur nail device (Smith&Nephew) in people with Closed Comminuted Oblique Intertrochanteric Fracture of Neck of Right Femur and Closed Comminuted Oblique Intertrochanteric Fracture of Neck of Left Femur, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The purpose of the study is to Compare the stability of the fracture and pain after surgery by measuring the stride length and weight bearing on the operated leg. This study will compare these parameters between two different proximal femur nails used for fixing hip fractures. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Closed Comminuted Oblique Intertrochanteric Fracture of Neck of Right Femur, Closed Comminuted Oblique Intertrochanteric Fracture of Neck of Left Femur
- What is being tested?
- PFNA proximal femur nail device (Synthes) and INTERTAN proximal femur nail device (Smith&Nephew)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2011to Sep 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pertrochanteric fracture ao 2.2 and above
- ambulatory patient, without support prior to the fall
- minor trauma mechanism
- without other injuries
- operated 3 days from the injury
Who cannot join
- dementia
- s/p hip or knee arthroplasty
- known osteoarthritis
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva, 49100
eliezer sidon, MD, 972-3523-896169, elisid@clalit.org.il
yona kosashvili, MD
About this study
Official title: Prospective Randomized Trial Comparing the Weight Bearing After Fixation of Proximal Femur Fractures With Two Different Proximal Intramedullary Devices
The purpose of the study is to Compare the stability of the fracture and pain after surgery by measuring the stride length and weight bearing on the operated leg. This study will compare these parameters between two different proximal femur nails used for fixing hip fractures.
Read the detailed description
Fractures of the proximal femur and hip are relatively common injuries in adults.
According to the Evans and the AO Classification systems, the fracture can be described as stable after reduction or not according to the direction of the fracture lines and the comminution of the medial cortex or the lateral wall of the proximal femur.
Biomechanically, nails allow for stable anatomical fixation of more comminuted fractures without shortening the abductor moment arm or changing the proximal femoral anatomy. These devices provide fracture stability by virtue of allowing the lateral aspect of the head and neck to come to rest against the nail in the medullary canal.
For fractures with comminuted medial cortex or involvement of the lateral cortex (AO 2.2 - AO 3.3) it is advisable to fixate with a more stable fixation device such as intramedullary proximal femur nail Several intramedullary devices are currently in use for the treatment of the intertrochanteric fractures. In our institution, for the unstable fracture we use either one of the intramedullary devices manufactured by Synthes (Proximal femoral nail - anti-rotation = PFNA) or by Smith\&Nephew (Trochanteric Antegrade Nail = InterTan).
Each of these nails allow compression over the Nail\Blade with the intramedullary stability.
There are 3 main complications in the treatment of intramedullary devices : (1) varus collapse of the head/neck, (2) uncontrolled shortening of the neck, and (3)femoral shaft fractures at the tip of the nail The InterTan, unlike other devices, allows for immediate intraoperative compression of the principal fracture fragments through linear compression combined with rotational stability secondary to its unique geometry and mechanism of action.
The mechanical stability of the fracture after the fixation is reflected by the weight bearing the patient can hold . In order to find weather there is a mechanical difference between the two devices we would like to perform a test measuring the weight bearing after fixation of intertrochanteric fractures comparing the pain and impression of mechanical stability in the two devices.
The method to test the amount of weight bearing would be using the "SmartStep gait system" TM (Andante Medical Devices Ltd), an innovative biofeedback and monitoring system that records and analyzes key gait parameters and provides instantaneous and accurate audio and visual feedback.
- Conditions
- Closed Comminuted Oblique Intertrochanteric Fracture of Neck of Right Femur, Closed Comminuted Oblique Intertrochanteric Fracture of Neck of Left Femur
- Being tested
- PFNA proximal femur nail device (Synthes), INTERTAN proximal femur nail device (Smith&Nephew)
- Keywords
- proximal femur nail, pfna, intertan, weight bearing, pertrochanteric fracture, femur neck fracture
- 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.
PFNA proximal femur nail device (Synthes)Device
synthes "PFNA" proximal femur nail device
INTERTAN proximal femur nail device (Smith&Nephew)Device
Smith\&Nephew "INTERTAN" proximal femur nail device
| Study group | Role | What they receive |
|---|---|---|
| PFNA | Active comparator | these patients will be treated with "synthes" PFNA" device Receives: Device: PFNA proximal femur nail device (Synthes) |
| INTERTAN | Active comparator | these patients will be treated with Smith\&Nephew "INTERTAN" device Receives: Device: INTERTAN proximal femur nail device (Smith&Nephew) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionJul 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Closed Comminuted Oblique Intertrochanteric Fracture of Neck of Right FemurStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yona kosashvili, Rabin Medical Center
- Investigators
- yona kosashvili, MD, Principal investigator, Rabin Medical Centereliezer sidon, MD, Study director, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509859
- Sponsor's protocol ID
- 0333-11-RMC
- Status last verified
- Jan 2012
- First submitted
- 5 Jan 2012
- Last updated
- 13 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zlowodzki M, Zelle BA, Cole PA, Jeray K, McKee MD; Evidence-Based Orthopaedic Trauma Working Group. Treatment of acute midshaft clavicle fractures: systematic review of 2144 fractures: on behalf of the Evidence-Based Orthopaedic Trauma Working Group. J Orthop Trauma. 2005 Aug;19(7):504-7. doi: 10.1097/01.bot.0000172287.44278.ef.
PubMed 16056089Sadowski C, Lubbeke A, Saudan M, Riand N, Stern R, Hoffmeyer P. Treatment of reverse oblique and transverse intertrochanteric fractures with use of an intramedullary nail or a 95 degrees screw-plate: a prospective, randomized study. J Bone Joint Surg Am. 2002 Mar;84(3):372-81.
PubMed 11886906Cummings SR, Rubin SM, Black D. The future of hip fractures in the United States. Numbers, costs, and potential effects of postmenopausal estrogen. Clin Orthop Relat Res. 1990 Mar;(252):163-6.
PubMed 2302881Gullberg B, Duppe H, Nilsson B, Redlund-Johnell I, Sernbo I, Obrant K, Johnell O. Incidence of hip fractures in Malmo, Sweden (1950-1991). Bone. 1993;14 Suppl 1:S23-9. doi: 10.1016/8756-3282(93)90345-b.
PubMed 8110516Williams WW, Parker BC. Complications associated with the use of the gamma nail. Injury. 1992;23(5):291-2. doi: 10.1016/0020-1383(92)90169-s.
PubMed 1644453Koval KJ, Sala DA, Kummer FJ, Zuckerman JD. Postoperative weight-bearing after a fracture of the femoral neck or an intertrochanteric fracture. J Bone Joint Surg Am. 1998 Mar;80(3):352-6. doi: 10.2106/00004623-199803000-00007.
PubMed 9531202
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial Comparing the Weight Bearing After Fixation of Proximal Femur Fractures With Two Different Proximal Intramedullary Devices
- ClinicalTrials.gov ID
- NCT01509859
- Acronym / sponsor ID
- 0333-11-RMC
- Conditions
- Closed Comminuted Oblique Intertrochanteric Fracture of Neck of Right Femur, Closed Comminuted Oblique Intertrochanteric Fracture of Neck of Left Femur
- Keywords
- proximal femur nail, pfna, intertan, weight bearing, pertrochanteric fracture, femur neck fracture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 13 Jan 2012 (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 the study is to Compare the stability of the fracture and pain after surgery by measuring the stride length and weight bearing on the operated leg. This study will compare these parameters between two different proximal femur nails used for fixing hip fractures.
Detailed description
Fractures of the proximal femur and hip are relatively common injuries in adults.
According to the Evans and the AO Classification systems, the fracture can be described as stable after reduction or not according to the direction of the fracture lines and the comminution of the medial cortex or the lateral wall of the proximal femur.
Biomechanically, nails allow for stable anatomical fixation of more comminuted fractures without shortening the abductor moment arm or changing the proximal femoral anatomy. These devices provide fracture stability by virtue of allowing the lateral aspect of the head and neck to come to rest against the nail in the medullary canal.
For fractures with comminuted medial cortex or involvement of the lateral cortex (AO 2.2 - AO 3.3) it is advisable to fixate with a more stable fixation device such as intramedullary proximal femur nail Several intramedullary devices are currently in use for the treatment of the intertrochanteric fractures. In our institution, for the unstable fracture we use either one of the intramedullary devices manufactured by Synthes (Proximal femoral nail - anti-rotation = PFNA) or by Smith\&Nephew (Trochanteric Antegrade Nail = InterTan).
Each of these nails allow compression over the Nail\Blade with the intramedullary stability.
There are 3 main complications in the treatment of intramedullary devices : (1) varus collapse of the head/neck, (2) uncontrolled shortening of the neck, and (3)femoral shaft fractures at the tip of the nail The InterTan, unlike other devices, allows for immediate intraoperative compression of the principal fracture fragments through linear compression combined with rotational stability secondary to its unique geometry and mechanism of action.
The mechanical stability of the fracture after the fixation is reflected by the weight bearing the patient can hold . In order to find weather there is a mechanical difference between the two devices we would like to perform a test measuring the weight bearing after fixation of intertrochanteric fractures comparing the pain and impression of mechanical stability in the two devices.
The method to test the amount of weight bearing would be using the "SmartStep gait system" TM (Andante Medical Devices Ltd), an innovative biofeedback and monitoring system that records and analyzes key gait parameters and provides instantaneous and accurate audio and visual feedback.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFNA | Active comparator | Device: PFNA proximal femur nail device (Synthes)these patients will be treated with "synthes" PFNA" device |
| INTERTAN | Active comparator | Device: INTERTAN proximal femur nail device (Smith&Nephew)these patients will be treated with Smith\&Nephew "INTERTAN" device |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- pertrochanteric fracture ao 2.2 and above
- ambulatory patient, without support prior to the fall
- minor trauma mechanism
- without other injuries
- operated 3 days from the injury
Key exclusion criteria (3 listed)
- dementia
- s/p hip or knee arthroplasty
- known osteoarthritis
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 |
|---|---|---|
| PFNA proximal femur nail device (Synthes)synthes "PFNA" proximal femur nail device | Device | PFNA |
| INTERTAN proximal femur nail device (Smith&Nephew)Smith\&Nephew "INTERTAN" proximal femur nail device | Device | INTERTAN |
Primary outcome
Not reported in the source record.
1 secondary outcome
complication
Time frame: the patients will be measured during the hospital stay (average of 1 week) and at 6 weeks after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2012.
- Background: PubMed 16056089Zlowodzki M, Zelle BA, Cole PA, Jeray K, McKee MD; Evidence-Based Orthopaedic Trauma Working Group. Treatment of acute midshaft clavicle fractures: systematic review of 2144 fractures: on behalf of the Evidence-Based Orthopaedic Trauma Working Group. J Orthop Trauma. 2005 Aug;19(7):504-7. doi: 10.1097/01.bot.0000172287.44278.ef.
- Background: PubMed 11886906Sadowski C, Lubbeke A, Saudan M, Riand N, Stern R, Hoffmeyer P. Treatment of reverse oblique and transverse intertrochanteric fractures with use of an intramedullary nail or a 95 degrees screw-plate: a prospective, randomized study. J Bone Joint Surg Am. 2002 Mar;84(3):372-81.
- Background: PubMed 2302881Cummings SR, Rubin SM, Black D. The future of hip fractures in the United States. Numbers, costs, and potential effects of postmenopausal estrogen. Clin Orthop Relat Res. 1990 Mar;(252):163-6.
- Background: PubMed 8110516Gullberg B, Duppe H, Nilsson B, Redlund-Johnell I, Sernbo I, Obrant K, Johnell O. Incidence of hip fractures in Malmo, Sweden (1950-1991). Bone. 1993;14 Suppl 1:S23-9. doi: 10.1016/8756-3282(93)90345-b.
- Background: PubMed 1644453Williams WW, Parker BC. Complications associated with the use of the gamma nail. Injury. 1992;23(5):291-2. doi: 10.1016/0020-1383(92)90169-s.
- Background: PubMed 9531202Koval KJ, Sala DA, Kummer FJ, Zuckerman JD. Postoperative weight-bearing after a fracture of the femoral neck or an intertrochanteric fracture. J Bone Joint Surg Am. 1998 Mar;80(3):352-6. doi: 10.2106/00004623-199803000-00007.
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.
yona kosashvili, MD principal investigator
Rabin Medical Center
eliezer sidon, MD study director
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PFNA proximal femur nail device (Synthes) and INTERTAN proximal femur nail device (Smith&Nephew) in people with Closed Comminuted Oblique Intertrochanteric Fracture of Neck of Right Femur and Closed Comminuted Oblique Intertrochanteric Fracture of Neck of Left Femur, run by Rabin Medical Center at 1 site 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 5 inclusion and 3 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 13 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 eliezer sidon, MD (972-523-896169, elisid@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01509859, which also lists 6 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 13 Jan 2012.