FracturesNCT02074969
Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures
A study testing Gamma Nail 3 and PFNA in people with Fractures, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The purpose of this study is to assess the differences between two different types of devices for the treatment of unstable pertrochanteric hip fractures. The hypothesis of this study is, that patients who are treated with the proximal femoral Nail Antirotation (PFNA) have a better outcome and lower complication rates… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fractures
- What is being tested?
- Gamma Nail 3 and PFNA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2007to May 2012
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- AO/OTA 31-A2 fractures
- age between 18 - 100 years
- Signed written informed consent and agreement to attend the planned FUs
- Able to understand and read country national language at an elementary level
Who cannot join
- missing informed consent form
- pathological fracture
- incomplete patient record
- death within one month of intervention (surgery)
- prior surgery to the hip
- polytrauma
Show all 9Show fewer
- any additional fracture
- any implant at the same hip
- infection
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Trauma, Medical University of Vienna
Vienna, Austria, 1090
About this study
Official title: Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures - Epidemiological Data and Rates of Complications
The purpose of this study is to assess the differences between two different types of devices for the treatment of unstable pertrochanteric hip fractures. The hypothesis of this study is, that patients who are treated with the proximal femoral Nail Antirotation (PFNA) have a better outcome and lower complication rates than patients treated with the Gamma Nail (GN3).
Read the detailed description
This trial is a prospective randomized controlled study including the treatment of AO/OTA 31-A2 fractures in 200 patients with 2 different surgical devices. 100 patients are treated with a Gamma Nail 3 (GN3) (Stryker) the other 100 patients with a Proximal Femoral Nail Antirotation (PFNA) (Synthes).
All surgeries are performed by trauma surgeons at a Level 1 University Hospital. One hundred patients are randomized to the gamma nail and 100 are randomized to the proximal femoral nail for treatment fixation. A 1:1 randomization is performed using sealed envelopes (200 in total), which are opened by the surgeon immediately before the operation.
Patients missing an informed consent form, incomplete chart, or showing a pathologic fracture are getting excluded from final comparisons.
Patients anthropometric data as well as pre-injury mobility assessments, and ASA will be documented. Furthermore the time from admission to going to surgery, surgery length, length of stay and mobility assessment at dischargement are recorded.
After surgery the stay in the hospital is documented precisely and patients are scheduled for next appointments 2 weeks, 6 weeks, 3 months, 6 months and 1 year after surgery.
Postoperative X-rays are measured precisely to determine the Tip-Apex Distance (TAD), the Parkers-Ratio, the Singh-Score and the Neck-Shaft-Angle of the injured and contralateral side. Rates of complications as cut-out and reoperation-rates are evaluated. All intra-operative complications are noted and included in the chart.
- Conditions
- Fractures
- Being tested
- Gamma Nail 3, PFNA
- Keywords
- re-operation rate, pertrochanteric fractures, GammaNail, PFNA, Tip-Apex-Distance, Parkers-Ratio
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma Nail 3Device
Also called Gamma Nail 3 Stryker
Patients who have sustained an unstable pertrochanteric hip fracture are getting treated by Gamma Nail 3.
PFNADevice
Also called PFNA Antirotation Synthes
Patients who have sustained an unstable pertrochanteric hip fracture are getting treated by PFNA.
| Study group | Role | What they receive |
|---|---|---|
| Gamma Nail 3 | Active comparator | Gamma Nail 3 Stryker. Receives: Device: Gamma Nail 3 |
| PFNA | Active comparator | PFNA Antirotation Synthes Receives: Device: PFNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
re-operation rate
Measured: time between intervention and one year after
Secondary outcomes (1)
Screw-Cut Out
evaluation of sliding movements of the hip screw in the sense of a cut-out
Measured: time between intervention and one year after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startOct 2007
- Primary completionDec 2010
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FracturesStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harry Widhalm, Medical University of Vienna
- Investigators
- Harald K. Widhalm, M.D., Principal investigator, Department of Trauma, Medical University of Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074969
- Sponsor's protocol ID
- 2007406
- Status last verified
- Feb 2014
- First submitted
- 27 Feb 2014
- Last updated
- 3 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barton TM, Gleeson R, Topliss C, Greenwood R, Harries WJ, Chesser TJ. A comparison of the long gamma nail with the sliding hip screw for the treatment of AO/OTA 31-A2 fractures of the proximal part of the femur: a prospective randomized trial. J Bone Joint Surg Am. 2010 Apr;92(4):792-8. doi: 10.2106/JBJS.I.00508.
PubMed 20360500
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures - Epidemiological Data and Rates of Complications
- ClinicalTrials.gov ID
- NCT02074969
- Acronym / sponsor ID
- 2007406
- Conditions
- Fractures
- Keywords
- re-operation rate, pertrochanteric fractures, GammaNail, PFNA, Tip-Apex-Distance, Parkers-Ratio
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 3 Mar 2014 (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 assess the differences between two different types of devices for the treatment of unstable pertrochanteric hip fractures. The hypothesis of this study is, that patients who are treated with the proximal femoral Nail Antirotation (PFNA) have a better outcome and lower complication rates than patients treated with the Gamma Nail (GN3).
Detailed description
This trial is a prospective randomized controlled study including the treatment of AO/OTA 31-A2 fractures in 200 patients with 2 different surgical devices. 100 patients are treated with a Gamma Nail 3 (GN3) (Stryker) the other 100 patients with a Proximal Femoral Nail Antirotation (PFNA) (Synthes).
All surgeries are performed by trauma surgeons at a Level 1 University Hospital. One hundred patients are randomized to the gamma nail and 100 are randomized to the proximal femoral nail for treatment fixation. A 1:1 randomization is performed using sealed envelopes (200 in total), which are opened by the surgeon immediately before the operation.
Patients missing an informed consent form, incomplete chart, or showing a pathologic fracture are getting excluded from final comparisons.
Patients anthropometric data as well as pre-injury mobility assessments, and ASA will be documented. Furthermore the time from admission to going to surgery, surgery length, length of stay and mobility assessment at dischargement are recorded.
After surgery the stay in the hospital is documented precisely and patients are scheduled for next appointments 2 weeks, 6 weeks, 3 months, 6 months and 1 year after surgery.
Postoperative X-rays are measured precisely to determine the Tip-Apex Distance (TAD), the Parkers-Ratio, the Singh-Score and the Neck-Shaft-Angle of the injured and contralateral side. Rates of complications as cut-out and reoperation-rates are evaluated. All intra-operative complications are noted and included in the chart.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gamma Nail 3 | Active comparator | Device: Gamma Nail 3Gamma Nail 3 Stryker. |
| PFNA | Active comparator | Device: PFNAPFNA Antirotation Synthes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- AO/OTA 31-A2 fractures
- age between 18 - 100 years
- Signed written informed consent and agreement to attend the planned FUs
- Able to understand and read country national language at an elementary level
Key exclusion criteria (9 listed)
- missing informed consent form
- pathological fracture
- incomplete patient record
- death within one month of intervention (surgery)
- prior surgery to 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 |
|---|---|---|
| Gamma Nail 3Also: Gamma Nail 3 StrykerPatients who have sustained an unstable pertrochanteric hip fracture are getting treated by Gamma Nail 3. | Device | Gamma Nail 3 |
| PFNAAlso: PFNA Antirotation SynthesPatients who have sustained an unstable pertrochanteric hip fracture are getting treated by PFNA. | Device | PFNA |
Primary outcome
re-operation rate
Time frame: time between intervention and one year after
1 secondary outcome
Screw-Cut Out
Time frame: time between intervention and one year after
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 3 Mar 2014.
- Results publication: PubMed 20360500Barton TM, Gleeson R, Topliss C, Greenwood R, Harries WJ, Chesser TJ. A comparison of the long gamma nail with the sliding hip screw for the treatment of AO/OTA 31-A2 fractures of the proximal part of the femur: a prospective randomized trial. J Bone Joint Surg Am. 2010 Apr;92(4):792-8. doi: 10.2106/JBJS.I.00508.
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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.
Harald K. Widhalm, M.D. principal investigator
Department of Trauma, Medical University of Vienna, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamma Nail 3 and PFNA in people with Fractures, run by Medical University of Vienna at 1 site in Austria.
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 9 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 3 Mar 2014. 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 Austria. 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?
re-operation rate (time frame: time between intervention and one year after). 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 NCT02074969, which also lists 1 linked publication.
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 3 Mar 2014.