Intertrochanteric FracturesLIMITNCT05094791
Lateralization After IntraMedullary Nailing of InterTrochanteric Hip Fractures, Clinical and Radiographic Outcomes
An observational study of Intertrochanteric Fractures, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
Intertrochanteric fractures are commonly stabilized using an intramedullary nail with a lag screw that enters the lateral cortex of the femur. This lag screw commonly protrudes during the healing process and may cause implant related pain. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Intertrochanteric Fractures
- What is being tested?
- Telescoping Lag Screw, Standard lag Screw and Standard lag screw with addition of worm screw
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2021to 23 Feb 2024
- Phase
- Observational
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients sustaining an intertrochantic hip fracture
Who may be able to join
- Patients greater than or equal to 22 years of age who undergo treatment of an intertrochanteric hip fracture with an intramedullary nail.
- Fluoroscopic views of the final fixation construct or a post-operative radiograph taken within 24 hours must be available.
Who cannot join
- Non-ambulatory prior to injury (patient must do more than only transfers)
- Cognitive deficiencies that prevent the patient from providing their own informed consent
- Inability to follow-up at the discretion of the investigator (incarceration, moving out of area, no permanent housing)
- Prior fracture to injured hip
- Prior surgery to injured hip
- Basi-cervical fracture pattern (fracture that begins above the lesser trochanter and exits medial to the greater trochanter)
Show all 11Show fewer
- Patients not treated within 48 hours of admission
- Chronic or acute infection at site of surgery
- Language barrier preventing completion of study forms in English
- Open fracture
- Fracture related to neoplasm
Trial locations and contacts
1 site in 1 country.
United States1 site
Greenville Memorial Hosptial
Greenville, South Carolina, 29605
About this study
Intertrochanteric fractures are commonly stabilized using an intramedullary nail with a lag screw that enters the lateral cortex of the femur. This lag screw commonly protrudes during the healing process and may cause implant related pain. This study will help determine if implant related pain is different depending to the lag screw design.
Read the detailed description
This study compares cephalomedullary fixation of intertrochanteric femur fractures using the Arthrex Hip Nail System with a telescoping lag screw compared to the Zimmer Natural Nail and the Smith and Nephew InterTan. This pilot study will evaluate radiographic outcomes and lateral sided hip pain related to different lag screw designs used for patients with intertrochanteric femur fractures by comparing outcomes of patients receiving 3 different lag screws The primary objective of this study is to compare pain at the level of the lag screw of patients with collapsible lag screws compared to patient who received a standard lag screw using a numeric rating scale on a 0-100 scale.
- Conditions
- Intertrochanteric Fractures
- Being tested
- Telescoping Lag Screw, Standard lag Screw, Standard lag screw with addition of worm 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.
Telescoping Lag ScrewDevice
Also called Arthrex Hip Nail
Intertrochanteric fracture fixation using Arthrex Hip Nail with Telescoping Lag Screw
Standard lag ScrewDevice
Also called Zimmer Natural Nail
Intertrochanteric fracture fixation using Zimmer Natural Nail Cephalomedullary Nail using standard lag screw
Standard lag screw with addition of worm screwDevice
Also called Smith and Nephew TRIGEN INTERTAN
Intertrochanteric fracture fixation using Smith and Nephew TRIGEN INTERTAN with addition of worm screw
| Study group | Role | What they receive |
|---|---|---|
| Telescoping Lag Screw | Intertrochanteric fractures treated with Arthrex Hip Nail with Telescoping Screw Receives: Device: Telescoping Lag Screw | |
| Standard lag Screw | Intertrochanteric fractures treated with Zimmer Natural Nail Cephalomedullary Nail Receives: Device: Standard lag Screw | |
| Standard lag screw with addition of worm screw | Intertrochanteric fractures treated with Smith and Nephew TRIGEN INTERTAN Receives: Device: Standard lag screw with addition of worm screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at lag screw
Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100)
Measured: 6 weeks
Pain at lag screw
Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100)
Measured: 12 weeks
Pain at lag screw
Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100)
Measured: 21 weeks
Pain at lag screw
Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100)
Measured: 52 weeks
Secondary outcomes (3)
Radiographic lateralization of lag screw
Change in the lateralization of the lag screw measured in mm
Measured: 52 weeks
Incidence of lag screw injections
Incidence of patients requiring injections at the location of the lag screw due to pain
Measured: 52 weeks
Reoperation rate
Reoperations to the location in the intertrochanteric fractue
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start4 Oct 2021
- Primary completion23 Feb 2024
- Study completion23 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intertrochanteric FracturesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Collaborators
- Arthrex, Inc.
- Responsible party
- Sponsor
- Investigators
- John D Adams, MD, Principal investigator, Prisma Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094791
- Sponsor's protocol ID
- Pro00113048
- Acronym
- LIMIT
- Status last verified
- Jul 2024
- First submitted
- 4 Oct 2021
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateralization After IntraMedullary Nailing of InterTrochanteric Hip Fractures, Clinical and Radiographic Outcomes
- ClinicalTrials.gov ID
- NCT05094791
- Acronym / sponsor ID
- LIMIT / Pro00113048
- Conditions
- Intertrochanteric Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Collaborators
- Arthrex, Inc.
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 26 Oct 2021 (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.
Intertrochanteric fractures are commonly stabilized using an intramedullary nail with a lag screw that enters the lateral cortex of the femur. This lag screw commonly protrudes during the healing process and may cause implant related pain. This study will help determine if implant related pain is different depending to the lag screw design.
Detailed description
This study compares cephalomedullary fixation of intertrochanteric femur fractures using the Arthrex Hip Nail System with a telescoping lag screw compared to the Zimmer Natural Nail and the Smith and Nephew InterTan. This pilot study will evaluate radiographic outcomes and lateral sided hip pain related to different lag screw designs used for patients with intertrochanteric femur fractures by comparing outcomes of patients receiving 3 different lag screws The primary objective of this study is to compare pain at the level of the lag screw of patients with collapsible lag screws compared to patient who received a standard lag screw using a numeric rating scale on a 0-100 scale.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Telescoping Lag Screw | – | Device: Telescoping Lag ScrewIntertrochanteric fractures treated with Arthrex Hip Nail with Telescoping Screw |
| Standard lag Screw | – | Device: Standard lag ScrewIntertrochanteric fractures treated with Zimmer Natural Nail Cephalomedullary Nail |
| Standard lag screw with addition of worm screw | – | Device: Standard lag screw with addition of worm screwIntertrochanteric fractures treated with Smith and Nephew TRIGEN INTERTAN |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients sustaining an intertrochantic hip fracture
Key inclusion criteria (2 listed)
- Patients greater than or equal to 22 years of age who undergo treatment of an intertrochanteric hip fracture with an intramedullary nail.
- Fluoroscopic views of the final fixation construct or a post-operative radiograph taken within 24 hours must be available.
Key exclusion criteria (11 listed)
- Non-ambulatory prior to injury (patient must do more than only transfers)
- Cognitive deficiencies that prevent the patient from providing their own informed consent
- Inability to follow-up at the discretion of the investigator (incarceration, moving out of area, no permanent housing)
- Prior fracture to injured hip
- Prior surgery to injured 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 |
|---|---|---|
| Telescoping Lag ScrewAlso: Arthrex Hip NailIntertrochanteric fracture fixation using Arthrex Hip Nail with Telescoping Lag Screw | Device | Telescoping Lag Screw |
| Standard lag ScrewAlso: Zimmer Natural NailIntertrochanteric fracture fixation using Zimmer Natural Nail Cephalomedullary Nail using standard lag screw | Device | Standard lag Screw |
| Standard lag screw with addition of worm screwAlso: Smith and Nephew TRIGEN INTERTANIntertrochanteric fracture fixation using Smith and Nephew TRIGEN INTERTAN with addition of worm screw | Device | Standard lag screw with addition of worm screw |
Primary outcome
Pain at lag screw
Time frame: 6 weeks
Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100)
Pain at lag screw
Time frame: 12 weeks
Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100)
Pain at lag screw
Time frame: 21 weeks
Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100)
Pain at lag screw
Time frame: 52 weeks
Pain will be accessed at the location of the lag screw, pain will be measured by using a Numeric rating scale (0-100)
3 secondary outcomes
Radiographic lateralization of lag screw
Time frame: 52 weeks
Incidence of lag screw injections
Time frame: 52 weeks
Reoperation rate
Time frame: 52 weeks
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 30 Jul 2024.
- 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.
John D Adams, MD principal investigator
Prisma Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intertrochanteric Fractures, run by Prisma Health-Upstate 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 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: finished, as of the sponsor's last update on 30 Jul 2024. 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?
Pain at lag screw (time frame: 6 weeks). The study lists 4 primary outcomes in all. 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 30 Jul 2024.