Intertrochanteric FracturePhase 4NCT01797237
Outcome Comparison Between PFNA and InterTAN
A Phase 4 study testing PFNA and InterTAN in people with Intertrochanteric Fracture, run by Peifu Tang at 1 site in China.
Trial summary
The purpose of this study is to determine whether this two intramedullary fixations are effectively in the treatment of intertrochanteric fracture. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Intertrochanteric Fracture
- What is being tested?
- PFNA and InterTAN
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to Oct 2015
- 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
- Adult men or women aged 18 years and older (with no upper age limit).
- Fracture of the intertrochanteric fracture confirmed with either anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
- Operative treatment of fractures within 14 days of presenting to the emergency room.
- Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker.
- Anticipated medical optimalization for operative fixation of the hip.
- Provision of informed consent by patient or legal guardian.
- No other major trauma.
Who cannot join
- Patients not suitable for internal fixation (i.e., severe osteoarthritis, rheumatoid arthritis, or pathologic fracture).
- Associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture).
- Retained hardware around the affected hip.
- Infection around the hip (i.e., soft tissue or bone).
- Patients with disorders of bone metabolism except osteoporosis (i.e., Paget's disease, renal osteodystrophy, osteomalacia).
- Moderate or severe cognitively impaired patients (i.e., Six Item Screener with 3 or more errors).
- Patients with Parkinson's disease (or dementia) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation. Likely problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The General Hospital of the People's Liberation Army
Beijing, Beijing Municipality, 100853
Peifu Tang, MD, 861099638101, pftang301@126.com
Lihai Zhang, MD
About this study
Official title: Outcome Comparison Between PFNA and InterTAN in Intertrochanteric Fractures
The purpose of this study is to determine whether this two intramedullary fixations are effectively in the treatment of intertrochanteric fracture.
Read the detailed description
With the progress of aging society, elderly patients with intertrochanteric fractures were occurred more and more. The best recommend treatment is surgical treatment of intramedullary fixation. However, existing methods of intramedullary fixation could not be restored the integrated interior support, and it will occur early hip varus. Meanwhile, the varus deformity will no longer develop if the two ends contact with wach other. This new intramedullary fixation device can overcome the existing shortage of intramedullary fixation devices and supporting the inside of the problem. It can prompting the fracture site to obtain a stronger initial stability, improve fracture healing rate, reduce the incidence of varus and allow patients with early weight-bearing walking.
- Conditions
- Intertrochanteric Fracture
- Being tested
- PFNA, InterTAN
- Keywords
- surgery, fixation, intramedullary nail
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFNADevice
Also called Proximal Femoral Nail Antirotation (Synthes)
InterTANDevice
Also called InterTAN Femoral Nail (Smith&Nephew)
| Study group | Role | What they receive |
|---|---|---|
| Stable intertrochanteric fracture | Experimental | The type of intertrochanteric fracture was below A2.1 (with A2.1) according to the AO/ATO classification. Receives: Device: PFNA; Device: InterTAN |
| Unstable intertrochanteric fracture | Experimental | The type of intertrochanteric fracture was above A2.1 (without A2.1) according to the AO/ATO classification. Receives: Device: PFNA; Device: InterTAN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Assessment the quality of life by SF-36 (The Short Form Health Survey), ADL (Activities of Daily Living), FIM (Functional Independence Measure).
Measured: six months
Secondary outcomes (1)
Bone healing condition
Bone healing condition was checked by radiological examination.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionSep 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intertrochanteric FractureStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peifu Tang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peifu Tang, Chinese PLA General Hospital
- Investigators
- Peifu Tang, MD, Study chair, Chinese PLA General HospitalLihai Zhang, MD, Study director, Chinese PLA General HospitalQi Yao, MD, Principal investigator, Beijing Shijitan Hospital, Capital Medical UniversityWen Zhao, MD, Principal investigator, Beijing Aerospace General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797237
- Sponsor's protocol ID
- PLAGH OD 14
- Status last verified
- Feb 2015
- First submitted
- 20 Feb 2013
- Last updated
- 6 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Comparison Between PFNA and InterTAN in Intertrochanteric Fractures
- ClinicalTrials.gov ID
- NCT01797237
- Acronym / sponsor ID
- PLAGH OD 14
- Conditions
- Intertrochanteric Fracture
- Keywords
- surgery, fixation, intramedullary nail
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peifu TangUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 22 Feb 2013 (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 determine whether this two intramedullary fixations are effectively in the treatment of intertrochanteric fracture.
Detailed description
With the progress of aging society, elderly patients with intertrochanteric fractures were occurred more and more. The best recommend treatment is surgical treatment of intramedullary fixation. However, existing methods of intramedullary fixation could not be restored the integrated interior support, and it will occur early hip varus. Meanwhile, the varus deformity will no longer develop if the two ends contact with wach other. This new intramedullary fixation device can overcome the existing shortage of intramedullary fixation devices and supporting the inside of the problem. It can prompting the fracture site to obtain a stronger initial stability, improve fracture healing rate, reduce the incidence of varus and allow patients with early weight-bearing walking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stable intertrochanteric fracture | Experimental | Device: PFNA, Device: InterTANThe type of intertrochanteric fracture was below A2.1 (with A2.1) according to the AO/ATO classification. |
| Unstable intertrochanteric fracture | Experimental | Device: PFNA, Device: InterTANThe type of intertrochanteric fracture was above A2.1 (without A2.1) according to the AO/ATO classification. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult men or women aged 18 years and older (with no upper age limit).
- Fracture of the intertrochanteric fracture confirmed with either anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
- Operative treatment of fractures within 14 days of presenting to the emergency room.
- Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker.
- Anticipated medical optimalization for operative fixation of the hip.
Key exclusion criteria (7 listed)
- Patients not suitable for internal fixation (i.e., severe osteoarthritis, rheumatoid arthritis, or pathologic fracture).
- Associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture).
- Retained hardware around the affected hip.
- Infection around the hip (i.e., soft tissue or bone).
- Patients with disorders of bone metabolism except osteoporosis (i.e., Paget's disease, renal osteodystrophy, osteomalacia).
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 |
|---|---|---|
| PFNAAlso: Proximal Femoral Nail Antirotation (Synthes) | Device | Stable intertrochanteric fracture, Unstable intertrochanteric fracture |
| InterTANAlso: InterTAN Femoral Nail (Smith&Nephew) | Device | Stable intertrochanteric fracture, Unstable intertrochanteric fracture |
Primary outcome
Quality of life
Time frame: six months
Assessment the quality of life by SF-36 (The Short Form Health Survey), ADL (Activities of Daily Living), FIM (Functional Independence Measure).
1 secondary outcome
Bone healing condition
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2015.
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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.
Peifu Tang, MD study chair
Chinese PLA General Hospital
Lihai Zhang, MD study director
Chinese PLA General Hospital
Qi Yao, MD principal investigator
Beijing Shijitan Hospital, Capital Medical University
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 and InterTAN in people with Intertrochanteric Fracture, run by Peifu Tang at 1 site in China.
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 7 inclusion and 7 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 6 Feb 2015. 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 China. 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 Peifu Tang, MD (861099638101, pftang301@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2015.