Pertrochanteric FractureHeracles PFNNCT03911180
Pertrochanteric Fracture Fixation In Elderly Adults Using Proximal Femoral Nail Anti-rotation (HERACLES) With a T-shaped Parallel Blade: A New Design
A study testing Proximal femoral nail with straight parallel blade in people with Pertrochanteric Fracture and Intertrochanteric Fractures, run by Ilocos Training and Regional Medical Center.
Trial summary
This is a prospective case series of elderly adult patients sustaining pertrochanteric fractures who will be treated by a proximal femoral nail with a non-helical (straight) blade. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pertrochanteric Fracture, Intertrochanteric Fractures, Pertrochanteric Fracture of Femur, Closed
- What is being tested?
- Proximal femoral nail with straight parallel blade
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2019to 1 May 2022
- Phase
- Interventional
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who sustained stable pertrochanteric fracture (AO31A.1)
- Patients who sustained unstable pertrochanteric fracture (AO31A.2 or AO31A.)
Who cannot join
- Patients who are bedridden
- Patients with a neurologic/psychiatric disorder (previous or present)
- Patients with severe dementia/Alzheimer's disease
- Patient with a history of hip dislocation (whether reduced or unreduced)
- Patient who underwent previous operation on the hip
- Patient with amputation of one or both legs
Show all 10Show fewer
- Patient with segmental fractures involving the ipsilateral femoral shaft/metaphysis
- Patient with pathologic fractures, e.g. secondary to metastatic bone disease/ metabolic bone disease
- Patient presenting with an infection
- Patient who sustained multiple injuries from other body systems
Trial locations and contacts
No sites are listed yet.
About this study
This is a prospective case series of elderly adult patients sustaining pertrochanteric fractures who will be treated by a proximal femoral nail with a non-helical (straight) blade. This study seeks to observe and evaluate the outcomes, advantages and complication rates in using the HERACLES PFN with a non-helical (T-shaped parallel) blade.
Read the detailed description
The trochanteric area is defined by AO as the area bordered by the tip of the greater trochanter, extracapsular portion of the femoral neck extending to a line parallel to the inferior most border of the lesser trochanter.
Pertrochanteric fracture is a fracture is of the trochanteric area which is usually reducible. Unstable pertrochanteric fracture is defined as AO-31A2 or AO-31A3. Instability arises from the degree of comminution, the presence, and comminution of the posteromedial fragment and lastly, lateral wall involvement The ideal implant for fixation of this kind of fractures is still under debate, but intramedullary implants are preferred than extramedullary implants in these unstable fractures. On the other hand, unique fracture configurations predispose to instability such as reverse obliquity fractures and fractures extending to the subtrochanteric area.
Proximal femoral locking plate as used in unstable pertrochanteric fracture has a high complication rate. In one study in 2014, there is up to 41.4% failure rate due to the proud plate, screw malposition, too rigid construct when used as a bridge plate.
Intramedullary implants specifically cephalomedullary nails has been the mainstay of treatment in unstable pertrochanteric fractures primarily because of the short moment arm and load-sharing properties. It employs relative stability and can be applied in a minimally invasive manner.
In 1997, the AO/ASIF group developed the proximal femoral nail. The proximal femoral nail has two proximal screws that traverse the neck to the femoral head. The inferior screw is the load-bearing screw, and the superior screw is the anti-rotation screw. Good to excellent results were observed using this implant compared to previous implant designs, but complications still exist.
These complications are related to the position of the two screws. There is difficulty attaining the ideal placement of proximal locking screws. As a result, the early medial cutout of one screw and lateral migration of the second screw occurs which is the so-called Z-effect. To address these disadvantages, the AO/ASIF group in 2004 developed a new implant design wherein the two proximal locking screws are replaced by a single helical blade. This improvement in design maximizes bone purchase and bone contact in cancellous bone hereby improving cutout rates.
Even with the new PFNA implant is not exempted from complications. Zhou and Chang in 2012 identified 12 cases of helical blade protrusion in 6 papers. Biomechanically, the helical blade migrates axially through the porotic bone in the geriatric population.
The new design of the blade includes a T-shaped anchor for stable fixation in osteoporotic bone. The nail also features a flat lateral design with a smooth radius transition from proximal to distal portion of the nail compared to the bulky profile of conventional nail resulting in easier insertion. Locking mechanism inherent to the nail and blade limits gliding and rotation of the blade. One of the advantages of the system is the use of a radiolucent arm with targeting options for an anti-rotation pin and determination of the superior most aspect of the femoral head for reference.
This case-series introduces a modification in implant design of the PFNA and aims to observe outcomes, advantages, and complications related to its use.
- Conditions
- Pertrochanteric Fracture, Intertrochanteric Fractures, Pertrochanteric Fracture of Femur, Closed, Pertrochanteric Fracture of Femur, Open
- Being tested
- Proximal femoral nail with straight parallel blade
- Keywords
- Pertrochanteric fracture, Intertrochanteric fracture, subtrochanteric extension, Proximal femoral nail, Proximal locking screw, Distal locking screw
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal femoral nail with straight parallel bladeDevice
Also called Heracles proximal femoral nail
Petrochanteric fixation with Heracles proximal femoral nail
| Study group | Role | What they receive |
|---|---|---|
| PFN straight parallel blade | Experimental | All patients with pertrochanteric fracture that is eligible will undergo PFNA with straight parallel blade. Receives: Device: Proximal femoral nail with straight parallel blade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Clinical Union
Weeks until Union
Clinical Union - fracture site becomes stable and pain-free
Measured: 2 months to 4 months
Time to full weightbearing
weeks until full weight bearing without pain
Measured: 4-6 months
Secondary outcomes (9)
Quality and Maintenance of Reduction
Acceptable reduction was defined as:
- Range of neck angle between 5° varus and 20° valgus.
- <20 deg angulation on lateral
- No fragment greater than 4 mm displaced
Reduction is defined as good (3/3), adequate (2/3) and poor (0-1/3)
Measured: up to 2 years
Tip-Apex Distance
expressed in millimetres, is the sum of the distance from the tip of the blade to the apex of the femoral head on both AP and lateral radiographic views
Measured: up to 2 years
Blood Loss
Blood loss during the procedure in milliliters
Measured: Taken immediately postop
Fluoroscopy time
Total time of exposure during the procedure starting from identification of starting point to insertion of distal locking screw
Measured: Intraoperative measurement
Mobility scale
Mobility scoring modified for use in patients who sustained a hip fracture (Bowers and Parker 2016). 1 is best and 10 is worst.
- Never uses any walking aid, no restriction in walking distance
- Never uses any walking aid, can walk less than one kilometer
- Occasionally uses a walking aid
- Normally uses one walking stick or needs to hold on to furniture
- Normally uses two sticks or crutches
- Mobilizes with a frame alone, without the need for assistance
- Mobilizes with a frame and the assistance of one other person
- Mobilizes with a frame and the assistance of two people
- Bed-to-chair, or wheelchair-bound
- Bedbound most or all of the day.
Measured: up to 2 years
Social dependence scale
Modified to apply for hip fractures; includes determination of independence to ADLs and advanced ADLs (Bowers and Parker 2016) 1 is best and 8 is worst
- Completely independent
- Minimal assistance
- Moderate assistance
- Regular assistance
- Dependent
- Severely dependent
- Fully dependent
- Patient temporarily resident in hospital
Measured: up to 2 years
Pain scale
Pain scale adapted for hip fractures (Bowers and Parker 2016) 1 is best and 8 is worst
- Unable to answer
- No pain at all in the hip
- Occasional and slight pain
- Some pain when starting to walk, no rest pain.
- None or minimal pain at rest, some pain with activities
- Regular pain with activities which limits walking distance.
- Frequent rest pain and pain at night. Pain on walking.
- Constant pain presents around the hip.
- Constant and severe pain in the hip requires regular strong analgesia such as opiates.
Measured: Postop up to 2 years
Radiographic Union Score for the Hip
is a validated outcome instrument designed to improve intra and interobserver reliability when describing the radiographic healing of proximal femur fractures
Based on grading of the anterior cortex, posterior cortex, lateral cortex and medial cortex bridging
- - No cortical bridging
- - Some cortical bridging
- - Complete Cortical Bridging
In addition, disappearance of the fracture line in the anterior cortex, posterior cortex, medial cortex, lateral cortex
- - Fully visible fracture line
- - Some evidence of the fracture line
- - No evidence of fracture line
Add all component scores to get the total score
Measured: up to 2 years
Radiation load
Amount of radiation during the procedure as measured by a Dosimeter
Measured: Intraoperative measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start1 May 2019 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pertrochanteric 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ilocos Training and Regional Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lou Mervyn Tec, Ilocos Training and Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911180
- Sponsor's protocol ID
- ITRMCOrthoCS0001
- Acronym
- Heracles PFN
- Status last verified
- Apr 2019
- First submitted
- 6 Apr 2019
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meinberg EG, Agel J, Roberts CS, Karam MD, Kellam JF. Fracture and Dislocation Classification Compendium-2018. J Orthop Trauma. 2018 Jan;32 Suppl 1:S1-S170. doi: 10.1097/BOT.0000000000001063. No abstract available.
PubMed 29256945Chang SM, Zhang YQ, Ma Z, Li Q, Dargel J, Eysel P. Fracture reduction with positive medial cortical support: a key element in stability reconstruction for the unstable pertrochanteric hip fractures. Arch Orthop Trauma Surg. 2015 Jun;135(6):811-8. doi: 10.1007/s00402-015-2206-x. Epub 2015 Apr 4.
PubMed 25840887Palm H, Jacobsen S, Sonne-Holm S, Gebuhr P; Hip Fracture Study Group. Integrity of the lateral femoral wall in intertrochanteric hip fractures: an important predictor of a reoperation. J Bone Joint Surg Am. 2007 Mar;89(3):470-5. doi: 10.2106/JBJS.F.00679.
PubMed 17332094Sharma G, kumar G N K, Yadav S, Lakhotia D, Singh R, Gamanagatti S, Sharma V. Pertrochanteric fractures (AO/OTA 31-A1 and A2) not amenable to closed reduction: causes of irreducibility. Injury. 2014 Dec;45(12):1950-7. doi: 10.1016/j.injury.2014.10.007.
PubMed 25458060Jones HW, Johnston P, Parker M. Are short femoral nails superior to the sliding hip screw? A meta-analysis of 24 studies involving 3,279 fractures. Int Orthop. 2006 Apr;30(2):69-78. doi: 10.1007/s00264-005-0028-0. Epub 2006 Feb 22.
PubMed 16496147Johnson B, Stevenson J, Chamma R, Patel A, Rhee SJ, Lever C, Starks I, Roberts PJ. Short-term follow-up of pertrochanteric fractures treated using the proximal femoral locking plate. J Orthop Trauma. 2014 May;28(5):283-7. doi: 10.1097/01.bot.0000435629.86640.6f.
PubMed 24751607Radaideh AM, Qudah HA, Audat ZA, Jahmani RA, Yousef IR, Saleh AAA. Functional and Radiological Results of Proximal Femoral Nail Antirotation (PFNA) Osteosynthesis in the Treatment of Unstable Pertrochanteric Fractures. J Clin Med. 2018 Apr 12;7(4):78. doi: 10.3390/jcm7040078.
PubMed 29649099Al-yassari G, Langstaff RJ, Jones JW, Al-Lami M. The AO/ASIF proximal femoral nail (PFN) for the treatment of unstable trochanteric femoral fracture. Injury. 2002 Jun;33(5):395-9. doi: 10.1016/s0020-1383(02)00008-6.
PubMed 12095718Simmermacher RK, Bosch AM, Van der Werken C. The AO/ASIF-proximal femoral nail (PFN): a new device for the treatment of unstable proximal femoral fractures. Injury. 1999 Jun;30(5):327-32. doi: 10.1016/s0020-1383(99)00091-1.
PubMed 10505125Gardenbroek TJ, Segers MJ, Simmermacher RK, Hammacher ER. The proximal femur nail antirotation: an identifiable improvement in the treatment of unstable pertrochanteric fractures? J Trauma. 2011 Jul;71(1):169-74. doi: 10.1097/TA.0b013e3182213c6e.
PubMed 21818023Zhou JQ, Chang SM. Failure of PFNA: helical blade perforation and tip-apex distance. Injury. 2012 Jul;43(7):1227-8. doi: 10.1016/j.injury.2011.10.024. Epub 2011 Nov 12. No abstract available.
PubMed 22079147
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pertrochanteric Fracture Fixation In Elderly Adults Using Proximal Femoral Nail Anti-rotation (HERACLES) With a T-shaped Parallel Blade: A New Design
- ClinicalTrials.gov ID
- NCT03911180
- Acronym / sponsor ID
- Heracles PFN / ITRMCOrthoCS0001
- Conditions
- Pertrochanteric Fracture, Intertrochanteric Fractures, Pertrochanteric Fracture of Femur, Closed, Pertrochanteric Fracture of Femur, Open
- Keywords
- Pertrochanteric fracture, Intertrochanteric fracture, subtrochanteric extension, Proximal femoral nail, Proximal locking screw, Distal locking screw
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ilocos Training and Regional Medical CenterOther government
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 11 Apr 2019 (actual)
- 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.
This is a prospective case series of elderly adult patients sustaining pertrochanteric fractures who will be treated by a proximal femoral nail with a non-helical (straight) blade. This study seeks to observe and evaluate the outcomes, advantages and complication rates in using the HERACLES PFN with a non-helical (T-shaped parallel) blade.
Detailed description
The trochanteric area is defined by AO as the area bordered by the tip of the greater trochanter, extracapsular portion of the femoral neck extending to a line parallel to the inferior most border of the lesser trochanter.
Pertrochanteric fracture is a fracture is of the trochanteric area which is usually reducible. Unstable pertrochanteric fracture is defined as AO-31A2 or AO-31A3. Instability arises from the degree of comminution, the presence, and comminution of the posteromedial fragment and lastly, lateral wall involvement The ideal implant for fixation of this kind of fractures is still under debate, but intramedullary implants are preferred than extramedullary implants in these unstable fractures. On the other hand, unique fracture configurations predispose to instability such as reverse obliquity fractures and fractures extending to the subtrochanteric area.
Proximal femoral locking plate as used in unstable pertrochanteric fracture has a high complication rate. In one study in 2014, there is up to 41.4% failure rate due to the proud plate, screw malposition, too rigid construct when used as a bridge plate.
Intramedullary implants specifically cephalomedullary nails has been the mainstay of treatment in unstable pertrochanteric fractures primarily because of the short moment arm and load-sharing properties. It employs relative stability and can be applied in a minimally invasive manner.
In 1997, the AO/ASIF group developed the proximal femoral nail. The proximal femoral nail has two proximal screws that traverse the neck to the femoral head. The inferior screw is the load-bearing screw, and the superior screw is the anti-rotation screw. Good to excellent results were observed using this implant compared to previous implant designs, but complications still exist.
These complications are related to the position of the two screws. There is difficulty attaining the ideal placement of proximal locking screws. As a result, the early medial cutout of one screw and lateral migration of the second screw occurs which is the so-called Z-effect. To address these disadvantages, the AO/ASIF group in 2004 developed a new implant design wherein the two proximal locking screws are replaced by a single helical blade. This improvement in design maximizes bone purchase and bone contact in cancellous bone hereby improving cutout rates.
Even with the new PFNA implant is not exempted from complications. Zhou and Chang in 2012 identified 12 cases of helical blade protrusion in 6 papers. Biomechanically, the helical blade migrates axially through the porotic bone in the geriatric population.
The new design of the blade includes a T-shaped anchor for stable fixation in osteoporotic bone. The nail also features a flat lateral design with a smooth radius transition from proximal to distal portion of the nail compared to the bulky profile of conventional nail resulting in easier insertion. Locking mechanism inherent to the nail and blade limits gliding and rotation of the blade. One of the advantages of the system is the use of a radiolucent arm with targeting options for an anti-rotation pin and determination of the superior most aspect of the femoral head for reference.
This case-series introduces a modification in implant design of the PFNA and aims to observe outcomes, advantages, and complications related to its use.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PFN straight parallel blade | Experimental | Device: Proximal femoral nail with straight parallel bladeAll patients with pertrochanteric fracture that is eligible will undergo PFNA with straight parallel blade. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who sustained stable pertrochanteric fracture (AO31A.1)
- Patients who sustained unstable pertrochanteric fracture (AO31A.2 or AO31A.)
Key exclusion criteria (10 listed)
- Patients who are bedridden
- Patients with a neurologic/psychiatric disorder (previous or present)
- Patients with severe dementia/Alzheimer's disease
- Patient with a history of hip dislocation (whether reduced or unreduced)
- Patient who underwent previous operation on the hip
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 |
|---|---|---|
| Proximal femoral nail with straight parallel bladeAlso: Heracles proximal femoral nailPetrochanteric fixation with Heracles proximal femoral nail | Device | PFN straight parallel blade |
Primary outcome
Time to Clinical Union
Time frame: 2 months to 4 months
Weeks until Union Clinical Union - fracture site becomes stable and pain-free
Time to full weightbearing
Time frame: 4-6 months
weeks until full weight bearing without pain
9 secondary outcomes
Quality and Maintenance of Reduction
Time frame: up to 2 years
Tip-Apex Distance
Time frame: up to 2 years
Blood Loss
Time frame: Taken immediately postop
Fluoroscopy time
Time frame: Intraoperative measurement
Mobility scale
Time frame: up to 2 years
Social dependence scale
Time frame: up to 2 years
Pain scale
Time frame: Postop up to 2 years
Radiographic Union Score for the Hip
Time frame: up to 2 years
Radiation load
Time frame: Intraoperative measurement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Background: PubMed 29256945Meinberg EG, Agel J, Roberts CS, Karam MD, Kellam JF. Fracture and Dislocation Classification Compendium-2018. J Orthop Trauma. 2018 Jan;32 Suppl 1:S1-S170. doi: 10.1097/BOT.0000000000001063. No abstract available.
- Background: PubMed 25840887Chang SM, Zhang YQ, Ma Z, Li Q, Dargel J, Eysel P. Fracture reduction with positive medial cortical support: a key element in stability reconstruction for the unstable pertrochanteric hip fractures. Arch Orthop Trauma Surg. 2015 Jun;135(6):811-8. doi: 10.1007/s00402-015-2206-x. Epub 2015 Apr 4.
- Background: PubMed 17332094Palm H, Jacobsen S, Sonne-Holm S, Gebuhr P; Hip Fracture Study Group. Integrity of the lateral femoral wall in intertrochanteric hip fractures: an important predictor of a reoperation. J Bone Joint Surg Am. 2007 Mar;89(3):470-5. doi: 10.2106/JBJS.F.00679.
- Background: PubMed 25458060Sharma G, kumar G N K, Yadav S, Lakhotia D, Singh R, Gamanagatti S, Sharma V. Pertrochanteric fractures (AO/OTA 31-A1 and A2) not amenable to closed reduction: causes of irreducibility. Injury. 2014 Dec;45(12):1950-7. doi: 10.1016/j.injury.2014.10.007.
- Background: PubMed 16496147Jones HW, Johnston P, Parker M. Are short femoral nails superior to the sliding hip screw? A meta-analysis of 24 studies involving 3,279 fractures. Int Orthop. 2006 Apr;30(2):69-78. doi: 10.1007/s00264-005-0028-0. Epub 2006 Feb 22.
- Background: PubMed 24751607Johnson B, Stevenson J, Chamma R, Patel A, Rhee SJ, Lever C, Starks I, Roberts PJ. Short-term follow-up of pertrochanteric fractures treated using the proximal femoral locking plate. J Orthop Trauma. 2014 May;28(5):283-7. doi: 10.1097/01.bot.0000435629.86640.6f.
- Background: PubMed 29649099Radaideh AM, Qudah HA, Audat ZA, Jahmani RA, Yousef IR, Saleh AAA. Functional and Radiological Results of Proximal Femoral Nail Antirotation (PFNA) Osteosynthesis in the Treatment of Unstable Pertrochanteric Fractures. J Clin Med. 2018 Apr 12;7(4):78. doi: 10.3390/jcm7040078.
- Background: PubMed 12095718Al-yassari G, Langstaff RJ, Jones JW, Al-Lami M. The AO/ASIF proximal femoral nail (PFN) for the treatment of unstable trochanteric femoral fracture. Injury. 2002 Jun;33(5):395-9. doi: 10.1016/s0020-1383(02)00008-6.
- Background: PubMed 10505125Simmermacher RK, Bosch AM, Van der Werken C. The AO/ASIF-proximal femoral nail (PFN): a new device for the treatment of unstable proximal femoral fractures. Injury. 1999 Jun;30(5):327-32. doi: 10.1016/s0020-1383(99)00091-1.
- Background: PubMed 21818023Gardenbroek TJ, Segers MJ, Simmermacher RK, Hammacher ER. The proximal femur nail antirotation: an identifiable improvement in the treatment of unstable pertrochanteric fractures? J Trauma. 2011 Jul;71(1):169-74. doi: 10.1097/TA.0b013e3182213c6e.
- Background: PubMed 22079147Zhou JQ, Chang SM. Failure of PFNA: helical blade perforation and tip-apex distance. Injury. 2012 Jul;43(7):1227-8. doi: 10.1016/j.injury.2011.10.024. Epub 2011 Nov 12. No abstract available.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Proximal femoral nail with straight parallel blade in people with Pertrochanteric Fracture and Intertrochanteric Fractures, run by Ilocos Training and Regional Medical Center.
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 2 inclusion and 10 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 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Lou Mervyn A. Tec, MD (+639158467650, loumervyntec@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Clinical Union (time frame: 2 months to 4 months). The study lists 2 primary outcomes in all. 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 NCT03911180, which also lists 11 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 11 Apr 2019.