Intertrochanteric FractureNCT03000972
PFN-A Augmentation for Intertrochanteric Femoral Fractures
A study testing Cement augmentation and PFN-A Nail in people with Intertrochanteric Fracture, run by Uppsala University at 1 site in Sweden.
Trial summary
This study evaluates the potential negative effect of cement augmentation in the femoral head on viability of the head. Half of the participants will have the standard intramedullary nail (PFN-A; Proximal Femoral Nail Augmentation), while the other half will get the standard nail plus cement augmentation. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Intertrochanteric Fracture
- What is being tested?
- Cement augmentation and PFN-A Nail
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2014to Oct 2017
- 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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Intertrochanteric Hip Fracture AO (Arbeitsgemeinschaft für Osteosynthesefragen) 31-A1 or AO 31-A2
- Healthy contralateral hip
- ASA (American Society of Anesthesiologists) Physical Status Class I or II
Who cannot join
- Dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PFN-A Intramedullary Nail and Intertrochanteric Hip Fracture. Augmentation of the Femoral Head Assessed by PET-CT (Positron Emission Tomography - Computed Tomography)- a Randomized Trial
This study evaluates the potential negative effect of cement augmentation in the femoral head on viability of the head. Half of the participants will have the standard intramedullary nail (PFN-A; Proximal Femoral Nail Augmentation), while the other half will get the standard nail plus cement augmentation.
Read the detailed description
Cement augmentation is believed to increase the bone implant interface and therefore decrease the risk of implant cut-out of the femoral head. The cement used in previous studies has produced heat and thermal necrosis on bone cells. The cement used in this study (TraumaCemV+) is manufactured specially for this implant and for the augmentation of this implant. TraumaCemV sets under low temperature (40 degrees Celsius) and we do not anticipate any heat necrosis. The volume effect of the cement could theoretically also damage the blood flow in the femoral head. There have been no negative effects in big series of patients operated with this technique.
The aim of this study is to quantify the viability of the femoral head with the use PET-CT (Positron Emission Tomography with simultaneous Computed Tomography) including a radioactive isotope (Fluorine-18) and the use of threedimensional computed tomography.
- Conditions
- Intertrochanteric Fracture
- Being tested
- Cement augmentation, PFN-A Nail
- Keywords
- Augmentation, PET-CT, Positron Emission Tomography, Fluorine-18
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cement augmentationProcedure or surgery
PFN-A NailProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Standard Nail | Active comparator | Hip fracture surgery with a PFN-A Nail (Proximal Femoral Nail Augmentation). Receives: Procedure: PFN-A Nail |
| Augmented Nail | Experimental | Hip fracture surgery with a PFN-A Nail with Cement augmentation with TraumaCemV+ Receives: Procedure: Cement augmentation; Procedure: PFN-A Nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viability of the femoral head as assessed by fluoride uptake using PET-CT
The primary endpoint is the level of fluoride uptake (standardized uptake values: SUVs) representing bone metabolism. PET-CT enables us to quantify this tridimensionally.
Measured: 4 months postoperatively
Secondary outcomes (4)
Viability of the femoral head as assessed by fluoride uptake using PET-CT
Measured: Within 1 week postoperatively
Viability of the femoral head as assessed by fluoride uptake using PET-CT
Measured: 1 year postoperatively
Harris Hip Score
Measured: 4 months
Harris Hip Score
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 posted22 Dec 2016 (estimated)
- Study startJan 2014
- Primary completionOct 2017
- Study completionOct 2017
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.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olof Wolf, MD PhD, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000972
- Sponsor's protocol ID
- PFNA
- Status last verified
- May 2018
- First submitted
- 10 Nov 2016
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PFN-A Intramedullary Nail and Intertrochanteric Hip Fracture. Augmentation of the Femoral Head Assessed by PET-CT (Positron Emission Tomography - Computed Tomography)- a Randomized Trial
- ClinicalTrials.gov ID
- NCT03000972
- Acronym / sponsor ID
- PFNA
- Conditions
- Intertrochanteric Fracture
- Keywords
- Augmentation, PET-CT, Positron Emission Tomography, Fluorine-18
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 22 Dec 2016 (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.
This study evaluates the potential negative effect of cement augmentation in the femoral head on viability of the head. Half of the participants will have the standard intramedullary nail (PFN-A; Proximal Femoral Nail Augmentation), while the other half will get the standard nail plus cement augmentation.
Detailed description
Cement augmentation is believed to increase the bone implant interface and therefore decrease the risk of implant cut-out of the femoral head. The cement used in previous studies has produced heat and thermal necrosis on bone cells. The cement used in this study (TraumaCemV+) is manufactured specially for this implant and for the augmentation of this implant. TraumaCemV sets under low temperature (40 degrees Celsius) and we do not anticipate any heat necrosis. The volume effect of the cement could theoretically also damage the blood flow in the femoral head. There have been no negative effects in big series of patients operated with this technique.
The aim of this study is to quantify the viability of the femoral head with the use PET-CT (Positron Emission Tomography with simultaneous Computed Tomography) including a radioactive isotope (Fluorine-18) and the use of threedimensional computed tomography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Nail | Active comparator | Procedure: PFN-A NailHip fracture surgery with a PFN-A Nail (Proximal Femoral Nail Augmentation). |
| Augmented Nail | Experimental | Procedure: Cement augmentation, Procedure: PFN-A NailHip fracture surgery with a PFN-A Nail with Cement augmentation with TraumaCemV+ |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Intertrochanteric Hip Fracture AO (Arbeitsgemeinschaft für Osteosynthesefragen) 31-A1 or AO 31-A2
- Healthy contralateral hip
- ASA (American Society of Anesthesiologists) Physical Status Class I or II
Key exclusion criteria (1 listed)
- Dementia
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 |
|---|---|---|
| Cement augmentation | Procedure or surgery | Augmented Nail |
| PFN-A Nail | Procedure or surgery | Augmented Nail, Standard Nail |
Primary outcome
Viability of the femoral head as assessed by fluoride uptake using PET-CT
Time frame: 4 months postoperatively
The primary endpoint is the level of fluoride uptake (standardized uptake values: SUVs) representing bone metabolism. PET-CT enables us to quantify this tridimensionally.
4 secondary outcomes
Viability of the femoral head as assessed by fluoride uptake using PET-CT
Time frame: Within 1 week postoperatively
Viability of the femoral head as assessed by fluoride uptake using PET-CT
Time frame: 1 year postoperatively
Harris Hip Score
Time frame: 4 months
Harris Hip Score
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Individual participant dataSharing planned: No
Related trials for Intertrochanteric Fracture
Recruiting
Monitored Anesthesia Care and Soft Tissue Infiltration With Local Anesthesia Feasibility Trial
Hip Fracture Surgeries, Intertrochanteric Fracture
RecruitingObservational study
Cohort Study on the Prognosis and Influencing Factors in Elderly Patients With Hip Fractures in Multicenter of China
Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)
Recruiting
Influence of Cemented Cephalic Augmentation on the Outcome of Intramedullary Nailing in Pertrochanteric Hip Fractures
Hip Fracture of Intertrochanteric Type
Not yet recruiting
FICB for Hip Fracture Pain in Elderly
Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures), Postoperative Pain
Recruiting
Robot-Assisted Closed Reduction and Internal Fixation for Intertrochanteric Femoral Fractures
Intertrochanteric Fractures, Intertrochanteric Fractures of the Hip
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.
Olof Wolf, MD PhD principal investigator
Uppsala University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cement augmentation and PFN-A Nail in people with Intertrochanteric Fracture, run by Uppsala University at 1 site in Sweden.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 9 May 2018. 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 Sweden. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viability of the femoral head as assessed by fluoride uptake using PET-CT (time frame: 4 months postoperatively). 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 9 May 2018.