Pertrochanteric Hip FractureNCT02285127
Short Versus Long Cephalomedullary Nailing of Pertrochanteric Hip Fractures: A Randomized Prospective Study
A study testing Short versus long cephalomedullary Intramedullary nail in people with Pertrochanteric Hip Fracture, run by Mayo Clinic at 1 site in United States.
Trial summary
Is there a functional outcome difference when treating pertrochanteric fractures with a short or long cephalomedullary nail? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pertrochanteric Hip Fracture
- What is being tested?
- Short versus long cephalomedullary Intramedullary nail
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Sep 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AO/OTA fracture classification 31(A-B) (1-3).
- Age greater than 18 years old.
Who cannot join
- -Less than 18 years old.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Is there a functional outcome difference when treating pertrochanteric fractures with a short or long cephalomedullary nail?
- Conditions
- Pertrochanteric Hip Fracture
- Being tested
- Short versus long cephalomedullary Intramedullary nail
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short versus long cephalomedullary Intramedullary nailProcedure or surgery
Biomet Affixus Short and Long hip fracture nail. Stryker Gamma Short and Long hip fracture nail.
| Study group | Role | What they receive |
|---|---|---|
| Short nail implant | Active comparator | used to treat pertrochanteric fractures Receives: Procedure: Short versus long cephalomedullary Intramedullary nail |
| Long nail implant | Active comparator | used to treat pertrochanteric fractures Receives: Procedure: Short versus long cephalomedullary Intramedullary nail |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF (short form)-36
Measured: 3 months
Secondary outcomes (1)
Harris Hip Score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startNov 2014
- Primary completion1 May 2018
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pertrochanteric Hip FractureStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen A. Sems, Mayo Clinic
- Investigators
- Stephen Sems, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285127
- Sponsor's protocol ID
- 14-002490
- Status last verified
- May 2023
- First submitted
- 4 Nov 2014
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Versus Long Cephalomedullary Nailing of Pertrochanteric Hip Fractures: A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT02285127
- Acronym / sponsor ID
- 14-002490
- Conditions
- Pertrochanteric Hip Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 1 May 2018 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 6 Nov 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.
Is there a functional outcome difference when treating pertrochanteric fractures with a short or long cephalomedullary nail?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short nail implant | Active comparator | Procedure: Short versus long cephalomedullary Intramedullary nailused to treat pertrochanteric fractures |
| Long nail implant | Active comparator | Procedure: Short versus long cephalomedullary Intramedullary nailused to treat pertrochanteric fractures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- AO/OTA fracture classification 31(A-B) (1-3).
- Age greater than 18 years old.
Key exclusion criteria (1 listed)
- -Less than 18 years old.
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 |
|---|---|---|
| Short versus long cephalomedullary Intramedullary nailBiomet Affixus Short and Long hip fracture nail. Stryker Gamma Short and Long hip fracture nail. | Procedure or surgery | Long nail implant, Short nail implant |
Primary outcome
SF (short form)-36
Time frame: 3 months
1 secondary outcome
Harris Hip Score
Time frame: 3 months
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 12 May 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Pertrochanteric Hip Fracture
Recruiting
Influence of Cemented Cephalic Augmentation on the Outcome of Intramedullary Nailing in Pertrochanteric Hip Fractures
Hip Fracture of Intertrochanteric Type
Recruiting
One Versus Two Doses of Tranexamic Acid in Surgically Treated Extracapsular Hip Fractures
Hip Fractures
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.
Stephen Sems, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short versus long cephalomedullary Intramedullary nail in people with Pertrochanteric Hip Fracture, run by Mayo Clinic at 1 site 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 2 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 12 May 2023. 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 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?
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?
SF (short form)-36 (time frame: 3 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 12 May 2023.