Intertrochanteric FractureNCT02627040
Intertrochanteric Femoral Fracture Fixation Trial
A study testing InterTan Intertrochanteric Nail and Gamma 3 Intertrochanteric Nail in people with Intertrochanteric Fracture and Hip Fracture, run by Florida Orthopaedic Institute at 2 sites in United States.
Trial summary
The main goal of the study is to determine which cephalomedullary nail results in a better functional outcome for the patient with an unstable intertrochanteric hip fracture. Subjects will be randomized to fixation with either a Gamma3 cephalomedullary nail or an InterTan cephalomedullary nail. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Intertrochanteric Fracture, Hip Fracture
- What is being tested?
- InterTan Intertrochanteric Nail and Gamma 3 Intertrochanteric Nail
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Nov 2015to Sep 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients surgically treated for an intertrochanteric femur fracture at Tampa General Hospital.
- Skeletally mature patients over the age of 60; both genders.
- Community ambulators.
Who cannot join
- Patients with ipsilateral lower extremity injury
- Patients under age 60
- Co-existent, severe knee or back problems
- Muscle contracture around the knee or hip joint
- Individuals who have had TKA within 6 months
- Body mass index (BMI; kg/m2) >40
Show all 11Show fewer
- Suspicious of pathologic fracture (tumor in origin)
- Pre-op mobility: Non ambulatory; ambulatory indoors with living support
- Cognitive impairment or dementia
- Prisoners or impending incarceration
- Homeless or no stable address.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brandon Regional Hospital
Brandon, Florida, 33511
Tampa General Hospital
Tampa, Florida, 33606
About this study
Official title: A Prospective Randomized Trial of Intertrochanteric Femoral Fractures Treated With a Single Screw Versus a Two-integrated Screw Cephalo-medullary Nail.
The main goal of the study is to determine which cephalomedullary nail results in a better functional outcome for the patient with an unstable intertrochanteric hip fracture. Subjects will be randomized to fixation with either a Gamma3 cephalomedullary nail or an InterTan cephalomedullary nail. Outcomes will be reviewed over a 12 month follow-up period.
Read the detailed description
Primary Hypotheses:
Patients who maintain their initial fracture reduction and subsequent position over time with minimal femoral neck shortening and varus will demonstrate significantly improved functional abilities, including gait and abductor function.
Secondary Objective:
- Whether radiographic differences in femoral neck shortening and varus collapse translate into a worse functional outcome to the patient.
- Whether there are differences in mortality between treatments
- Whether there is a time frame follow up after which there is no difference in outcomes.
- Evaluate the device used for fracture stabilization as a potentially contributing factor for maintenance of normal or near-normal abductor function and gait.
Primary Outcome:
The primary outcome will be functional abilities at 3, 6 and 12 months after injury. The following measures of functional ability will be utilized:
Methods:
This is a prospective, randomized non-blinded study. Patients will be identified as they present to the orthopaedic trauma service of Tampa General Hospital with a qualifying injury to determine their interest in participating in the study. Written informed consent will be obtained prior to initiation of any study procedures.
Group A will undergo cephalomedullary nail-based single screw intertrochanteric hip fracture fixation device (Gamma 3 nail). Group B will receive the integrated dual screw intertrochanteric hip fracture fixation device (Intertan nail). Patient outcomes will be analyzed using intention to treat principles. Following randomization assignment, surgeons will all follow the identical described surgical technique, with the only variable being the implant used. Post-operative immobilization and time to weight bearing and rehabilitation protocols will be again identical for all patients regardless of fixation technique.
- Conditions
- Intertrochanteric Fracture, Hip Fracture
- Being tested
- InterTan Intertrochanteric Nail, Gamma 3 Intertrochanteric 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.
InterTan Intertrochanteric NailDevice
Cephalomedullary fixation of intertrochanteric fracture with an InterTan Intertrochanteric Nail
Gamma 3 Intertrochanteric NailDevice
Cephalomedullary fixation of intertrochanteric fracture with an Gamma 3 Intertrochanteric Nail
| Study group | Role | What they receive |
|---|---|---|
| InterTan Intertrochanteric Nail | Active comparator | 'Surgical fixation' of intertrochanteric fracture with a cephalomedullary nail with an InterTan device (two-integrated screws) Receives: Device: InterTan Intertrochanteric Nail |
| Gamma 3 Intertrochanteric Nail | Active comparator | 'Surgical fixation' of intertrochanteric fracture with a cephalomedullary nail and Gamma 3 locking nail (single screw) Receives: Device: Gamma 3 Intertrochanteric Nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip Function
Hip Function measured with Harris Hip Score.
Measured: 6 months post-operatively
Secondary outcomes (4)
Functional outcome
Functional outcome will be measured using the following outcome measurement: Gait analysis using MiniSun's IDEEA® LifeGait System, a portable device for assessment of functional gait outcomes.
Measured: 6 months post-operatively
Walking ability
Subjects will wear a pedometer applied in the immediate post-operative period, and will continue to wear it for 3 months. Total walking steps will be measured.
Measured: 3 months post-operatively
Hip range of motion
Range of motion of hip measured with Harris Hip Score.
Measured: 6 months post-operatively
Hip Pain
Pain measured with Harris Hip Score.
Measured: 6 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study start30 Nov 2015
- Primary completion31 Aug 2020 (estimated)
- Study completionSep 2020 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida Orthopaedic Institute
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Hassan R Mir, MD, MBA, Principal investigator, Florida Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627040
- Sponsor's protocol ID
- 00023144
- Status last verified
- Nov 2019
- First submitted
- 25 Nov 2015
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to share data.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Intertrochanteric Femoral Fractures Treated With a Single Screw Versus a Two-integrated Screw Cephalo-medullary Nail.
- ClinicalTrials.gov ID
- NCT02627040
- Acronym / sponsor ID
- 00023144
- Conditions
- Intertrochanteric Fracture, Hip Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Florida Orthopaedic InstituteResearch network
- Study start
- 30 Nov 2015 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 10 Dec 2015 (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 main goal of the study is to determine which cephalomedullary nail results in a better functional outcome for the patient with an unstable intertrochanteric hip fracture. Subjects will be randomized to fixation with either a Gamma3 cephalomedullary nail or an InterTan cephalomedullary nail. Outcomes will be reviewed over a 12 month follow-up period.
Detailed description
Primary Hypotheses:
Patients who maintain their initial fracture reduction and subsequent position over time with minimal femoral neck shortening and varus will demonstrate significantly improved functional abilities, including gait and abductor function.
Secondary Objective:
- Whether radiographic differences in femoral neck shortening and varus collapse translate into a worse functional outcome to the patient.
- Whether there are differences in mortality between treatments
- Whether there is a time frame follow up after which there is no difference in outcomes.
- Evaluate the device used for fracture stabilization as a potentially contributing factor for maintenance of normal or near-normal abductor function and gait.
Primary Outcome:
The primary outcome will be functional abilities at 3, 6 and 12 months after injury. The following measures of functional ability will be utilized:
Methods:
This is a prospective, randomized non-blinded study. Patients will be identified as they present to the orthopaedic trauma service of Tampa General Hospital with a qualifying injury to determine their interest in participating in the study. Written informed consent will be obtained prior to initiation of any study procedures.
Group A will undergo cephalomedullary nail-based single screw intertrochanteric hip fracture fixation device (Gamma 3 nail). Group B will receive the integrated dual screw intertrochanteric hip fracture fixation device (Intertan nail). Patient outcomes will be analyzed using intention to treat principles. Following randomization assignment, surgeons will all follow the identical described surgical technique, with the only variable being the implant used. Post-operative immobilization and time to weight bearing and rehabilitation protocols will be again identical for all patients regardless of fixation technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| InterTan Intertrochanteric Nail | Active comparator | Device: InterTan Intertrochanteric Nail'Surgical fixation' of intertrochanteric fracture with a cephalomedullary nail with an InterTan device (two-integrated screws) |
| Gamma 3 Intertrochanteric Nail | Active comparator | Device: Gamma 3 Intertrochanteric Nail'Surgical fixation' of intertrochanteric fracture with a cephalomedullary nail and Gamma 3 locking nail (single screw) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients surgically treated for an intertrochanteric femur fracture at Tampa General Hospital.
Key exclusion criteria (11 listed)
- Patients with ipsilateral lower extremity injury
- Patients under age 60
- Co-existent, severe knee or back problems
- Muscle contracture around the knee or hip joint
- Individuals who have had TKA within 6 months
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 |
|---|---|---|
| InterTan Intertrochanteric NailCephalomedullary fixation of intertrochanteric fracture with an InterTan Intertrochanteric Nail | Device | InterTan Intertrochanteric Nail |
| Gamma 3 Intertrochanteric NailCephalomedullary fixation of intertrochanteric fracture with an Gamma 3 Intertrochanteric Nail | Device | Gamma 3 Intertrochanteric Nail |
Primary outcome
Hip Function
Time frame: 6 months post-operatively
Hip Function measured with Harris Hip Score.
4 secondary outcomes
Functional outcome
Time frame: 6 months post-operatively
Walking ability
Time frame: 3 months post-operatively
Hip range of motion
Time frame: 6 months post-operatively
Hip Pain
Time frame: 6 months post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Individual participant dataSharing planned: No. There is no plan to share data.
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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.
Hassan R Mir, MD, MBA principal investigator
Florida Orthopaedic Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InterTan Intertrochanteric Nail and Gamma 3 Intertrochanteric Nail in people with Intertrochanteric Fracture and Hip Fracture, run by Florida Orthopaedic Institute at 2 sites in United States.
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 11 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 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Results are not available in the source record.
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?
Hip Function (time frame: 6 months post-operatively). 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 18 Nov 2019.