Femoral Neck FracturesINSITENCT01380444
Intramedullary Nail Versus Sliding Hip Screw Inter-Trochanteric Evaluation
A study testing Gamma3 Intramedullary Nails (Stryker) and Sliding Hip Screws in people with Femoral Neck Fractures and Intertrochanteric Fracture, run by Stryker Trauma and Extremities at 26 sites in 12 countries.
Trial summary
The purpose of this study is to assess the impact of Gamma3 intramedullary nails versus sliding hip screws on health-related quality of life as measured by the EuroQuol-5D at 52 weeks in individuals with trochanteric fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Neck Fractures, Intertrochanteric Fracture
- What is being tested?
- Gamma3 Intramedullary Nails (Stryker) and Sliding Hip Screws
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 880 participants
- Where
- 26 sitesin 12 countries
- Study dates
- Dec 2011to Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men or women aged 18 years and older (with no upper age limit).
- An intertrochanteric fracture (stable or unstable), AO Type 31-A1 or 31-A2, confirmed with anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
- Low energy fracture (defined as a fall from standing height).
- No other major trauma.
- Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker.
- Anticipated medical optimization of the patient for operative fixation of the proximal femur.
- Operative treatment within 7 days after the trauma.(Operative treatment should take place as soon as possible as permitted by each institution's standard of care.)
- Provision of informed consent by patient or proxy.
Who cannot join
- Associated major injuries of the lower extremity (i.e., ipsilateral and/or contralateral fractures of the foot, ankle, tibia, fibula, or knee; dislocations of the ankle, knee, or hip).
- Retained hardware around the affected proximal femur.
- Infection around the proximal femur (i.e., soft tissue or bone).
- Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget's disease, renal osteodystrophy, or osteomalacia).
- Patients with Parkinson's disease severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation.
- Patients with a subtrochanteric fracture.
Show all 14Show fewer
- Patients with a pathologic fracture.
- Patients with a reverse oblique fracture pattern, fracture AO Type 31-A3.
- Obesity in the judgment of the attending surgeon.
- Off-label use of the implant.
- Patients with a previous history of frank dementia that would interfere with assessment of the primary outcome (i.e., EQ-5D at 1 year).
- Likely problems, in the judgment of the Site Investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.
- Patient is enrolled in another ongoing drug or surgical intervention trial.
- If the attending surgeon believes that there is another reason to exclude this patient from INSITE. This reason will be documented on the case report forms (CRFs).
Trial locations and contacts
26 sites in 12 countries.
26 sites in 12 countries
United States7 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Lahey Clinic
Burlington, Massachusetts, 01805
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Community Regional Medical Center
Fresno, California, 93721
Temple University Hospital
Philadelphia, Pennsylvania, 19140
San Francisco General Hospital
San Francisco, California, 94110
Scott&White Memorial Hospital
Temple, Texas, 76508
United Kingdom4 sites
Frenchay Hospital
Bristol, BS16 1LE
The Royal Liverpool University Hospital
Liverpool, L7 8XP
The Royal Berkshire Hospital
Reading, RG1 5AN
Southampton General Hospital
Southampton, SO16 6YD
China3 sites
Chaoyang Hospital
Beijing, Beijing Municipality, 100020
2nd Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310009
Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Canada2 sites
St. Michael's Hospital
Toronto, Ontario, M5C 1R6
Health Sciences Centre Winnipeg
Winnipeg, Manitoba, R3A 1R9
Colombia2 sites
Hospital Universitario Santa Clara
Bogotá, Cundinamarca
Clinica El Rosario Sede El Tesoro
Medellín, Antioquia
Germany2 sites
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, 23538
Robert-Bosch-Krankenhaus
Stuttgart, 70376
South Africa1 site
Charlotte Maxeke Johannesburg Academic Hospital
Parktown, 2193
About this study
Official title: A Multi-Center Randomized Controlled Trial of Intramedullary Nails Versus Sliding Hip Screws in the Management of Intertrochanteric Fractures of the Hip
The purpose of this study is to assess the impact of Gamma3 intramedullary nails versus sliding hip screws on health-related quality of life as measured by the EuroQuol-5D at 52 weeks in individuals with trochanteric fractures. Secondary outcomes include revision surgery rates, fracture healing rates, fracture related adverse events, and health-related quality of life, including the Parker mobility score and Harris Hip Score.
Read the detailed description
Hip fractures are becoming a more prevalent issue worldwide, leading to profound morbidity, and in some cases, mortality. Currently the most common method of surgical treatment includes the use of a sliding hip screw over a Gamma intramedullary nail, but there is conflicting evidence regarding which device has a lower revision surgery rate and complication rate. Recent improvements in implant design of the Gamma3 nail, demonstrating decreased rates of femoral shaft fractures and improved function, provide compelling rationale for the conduct of a large, definitive trial.
This trial is a definitive, multi-center, concealed randomized controlled trial. Surgeons will use one of the two surgical strategies in patients who have sustained a trochanteric fracture; the Gamma3 intramedullary nail or the sliding hip screw. Clinical assessments will occur at the time of hospital admission, post-surgery, 13 weeks, 26 weeks, 52 weeks, and 104 weeks.
- Conditions
- Femoral Neck Fractures, Intertrochanteric Fracture
- Being tested
- Gamma3 Intramedullary Nails (Stryker), Sliding Hip Screws
- Keywords
- Intertrochanteric fracture, Gamma3 intramedullary nail, Sliding hip screw
- Medical subject headings
- Femoral Neck Fractures, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma3 Intramedullary Nails (Stryker)Procedure or surgery
Also called Gamma Nail, Gamma3 Nail, Intramedullary Nail (IM Nail)
The Gamma3 nail is cannulated for Guide-Wire-controlled insertion, and features a conical tip for optimal alignment with the inner part of the cortical bone. A single distal Locking Screw is provided to stabilize the nail in the medullary canal and to help to prevent rotation in complex fractures.
Sliding Hip ScrewsProcedure or surgery
Also called Sliding Hip Screw (SHS), Dynamic Hip Screw (DHS), Compression Screw and Side Plate
The sliding hip screw is a single larger diameter partially threaded screw, which is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixation.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Gamma3 Intramedullary Nails Receives: Procedure: Gamma3 Intramedullary Nails (Stryker) |
| 2 | Active comparator | Sliding Hip Screws Receives: Procedure: Sliding Hip Screws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Related Quality of Life
To assess the impact of Gamma3 intramedullary nails versus sliding hip screws on health-related quality of life as measured by the EuroQol-5D at 52 weeks in individuals with trochanteric fractures.
Measured: Up to 104 weeks
Secondary outcomes (4)
Health Related Quality of Life
To assess the impact of Gamma3 intramedullary nails versus sliding hip screws on health-related quality of life as measured with the Parker mobility score and the Harris Hip Score.
Measured: Up to 104 weeks
Fracture healing rates
A fracture is to be considered healed when there is obliteration of the fracture lines by newly formed bone along the cortices and within the trabecular bone on anteroposterior and lateral (or oblique) radiographs.
Measured: Up to 104 weeks
Fracture-related adverse events
Including mortality, femoral shaft fracture, avascular necrosis (although rare in trochanteric fractures), nonunion, malunion (shortening, varus deformity, valgus deformity and rotational malunion), implant breakage or failure, and infection (i.e., superficial and deep).
Measured: Up to 104 weeks
Revision surgery rates
Any unplanned surgery after the initial fixation to promote fracture healing (non-union), relieve pain (avascular necrosis, early or late implant failure), treat infection, or improve function will be considered a study event.
Measured: Up to 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startDec 2011
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- More trials run by Stryker Trauma and ExtremitiesThe 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
- Outcomes assessor
- Enrolment
- 880 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Global Research Solutions
- Responsible party
- Sponsor
- Investigators
- Mohit Bhandari, MD, PhD, FRCSC, Principal investigator, Global Research SolutionsGeorgia Mitchell, Study director, Stryker Trauma and Extremities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380444
- Sponsor's protocol ID
- 14032012_INSITE_v2.0
- Other IDs
- 96308751
- Acronym
- INSITE
- Status last verified
- Mar 2019
- First submitted
- 20 Jun 2011
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ahrengart L, Tornkvist H, Fornander P, Thorngren KG, Pasanen L, Wahlstrom P, Honkonen S, Lindgren U. A randomized study of the compression hip screw and Gamma nail in 426 fractures. Clin Orthop Relat Res. 2002 Aug;(401):209-22. doi: 10.1097/00003086-200208000-00024.
PubMed 12151898Bhandari M, Schemitsch E, Jonsson A, Zlowodzki M, Haidukewych GJ. Gamma nails revisited: gamma nails versus compression hip screws in the management of intertrochanteric fractures of the hip: a meta-analysis. J Orthop Trauma. 2009 Jul;23(6):460-4. doi: 10.1097/BOT.0b013e318162f67f.
PubMed 19550235Parker MJ, Handoll HH. Gamma and other cephalocondylic intramedullary nails versus extramedullary implants for extracapsular hip fractures in adults. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD000093. doi: 10.1002/14651858.CD000093.pub4.
PubMed 18646058Schemitsch EH, Nowak LL, Schulz AP, Brink O, Poolman RW, Mehta S, Stengel D, Zhang CQ, Martinez S, Kinner B, Chesser TJS, Bhandari M; INSITE Investigators. Intramedullary Nailing vs Sliding Hip Screw in Trochanteric Fracture Management: The INSITE Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2317164. doi: 10.1001/jamanetworkopen.2023.17164.
PubMed 37278998
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Randomized Controlled Trial of Intramedullary Nails Versus Sliding Hip Screws in the Management of Intertrochanteric Fractures of the Hip
- ClinicalTrials.gov ID
- NCT01380444
- Acronym / sponsor ID
- INSITE / 14032012_INSITE_v2.0
- Conditions
- Femoral Neck Fractures, Intertrochanteric Fracture
- Keywords
- Intertrochanteric fracture, Gamma3 intramedullary nail, Sliding hip screw
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 880 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Collaborators
- Global Research Solutions
- Study start
- Dec 2011 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 27 Jun 2011 (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 impact of Gamma3 intramedullary nails versus sliding hip screws on health-related quality of life as measured by the EuroQuol-5D at 52 weeks in individuals with trochanteric fractures. Secondary outcomes include revision surgery rates, fracture healing rates, fracture related adverse events, and health-related quality of life, including the Parker mobility score and Harris Hip Score.
Detailed description
Hip fractures are becoming a more prevalent issue worldwide, leading to profound morbidity, and in some cases, mortality. Currently the most common method of surgical treatment includes the use of a sliding hip screw over a Gamma intramedullary nail, but there is conflicting evidence regarding which device has a lower revision surgery rate and complication rate. Recent improvements in implant design of the Gamma3 nail, demonstrating decreased rates of femoral shaft fractures and improved function, provide compelling rationale for the conduct of a large, definitive trial.
This trial is a definitive, multi-center, concealed randomized controlled trial. Surgeons will use one of the two surgical strategies in patients who have sustained a trochanteric fracture; the Gamma3 intramedullary nail or the sliding hip screw. Clinical assessments will occur at the time of hospital admission, post-surgery, 13 weeks, 26 weeks, 52 weeks, and 104 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Gamma3 Intramedullary Nails (Stryker)Gamma3 Intramedullary Nails |
| 2 | Active comparator | Procedure: Sliding Hip ScrewsSliding Hip Screws |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult men or women aged 18 years and older (with no upper age limit).
- An intertrochanteric fracture (stable or unstable), AO Type 31-A1 or 31-A2, confirmed with anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
- Low energy fracture (defined as a fall from standing height).
- No other major trauma.
- Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker.
Key exclusion criteria (14 listed)
- Associated major injuries of the lower extremity (i.e., ipsilateral and/or contralateral fractures of the foot, ankle, tibia, fibula, or knee; dislocations of the ankle, knee, or hip).
- Retained hardware around the affected proximal femur.
- Infection around the proximal femur (i.e., soft tissue or bone).
- Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget's disease, renal osteodystrophy, or osteomalacia).
- Patients with Parkinson's disease severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation.
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 |
|---|---|---|
| Gamma3 Intramedullary Nails (Stryker)Also: Gamma Nail, Gamma3 Nail, Intramedullary Nail (IM Nail)The Gamma3 nail is cannulated for Guide-Wire-controlled insertion, and features a conical tip for optimal alignment with the inner part of the cortical bone. A single distal Locking Screw is provided to stabilize the nail in the medullary canal and to help to prevent rotation in complex fractures. | Procedure or surgery | 1 |
| Sliding Hip ScrewsAlso: Sliding Hip Screw (SHS), Dynamic Hip Screw (DHS), Compression Screw and Side PlateThe sliding hip screw is a single larger diameter partially threaded screw, which is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixation. | Procedure or surgery | 2 |
Primary outcome
Health Related Quality of Life
Time frame: Up to 104 weeks
To assess the impact of Gamma3 intramedullary nails versus sliding hip screws on health-related quality of life as measured by the EuroQol-5D at 52 weeks in individuals with trochanteric fractures.
4 secondary outcomes
Health Related Quality of Life
Time frame: Up to 104 weeks
Fracture healing rates
Time frame: Up to 104 weeks
Fracture-related adverse events
Time frame: Up to 104 weeks
Revision surgery rates
Time frame: Up to 104 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 7 Mar 2019.
- Background: PubMed 12151898Ahrengart L, Tornkvist H, Fornander P, Thorngren KG, Pasanen L, Wahlstrom P, Honkonen S, Lindgren U. A randomized study of the compression hip screw and Gamma nail in 426 fractures. Clin Orthop Relat Res. 2002 Aug;(401):209-22. doi: 10.1097/00003086-200208000-00024.
- Background: PubMed 19550235Bhandari M, Schemitsch E, Jonsson A, Zlowodzki M, Haidukewych GJ. Gamma nails revisited: gamma nails versus compression hip screws in the management of intertrochanteric fractures of the hip: a meta-analysis. J Orthop Trauma. 2009 Jul;23(6):460-4. doi: 10.1097/BOT.0b013e318162f67f.
- Background: PubMed 18646058Parker MJ, Handoll HH. Gamma and other cephalocondylic intramedullary nails versus extramedullary implants for extracapsular hip fractures in adults. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD000093. doi: 10.1002/14651858.CD000093.pub4.
- Derived from this study: PubMed 37278998Schemitsch EH, Nowak LL, Schulz AP, Brink O, Poolman RW, Mehta S, Stengel D, Zhang CQ, Martinez S, Kinner B, Chesser TJS, Bhandari M; INSITE Investigators. Intramedullary Nailing vs Sliding Hip Screw in Trochanteric Fracture Management: The INSITE Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2317164. doi: 10.1001/jamanetworkopen.2023.17164.
- 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.
Mohit Bhandari, MD, PhD, FRCSC principal investigator
Global Research Solutions
Georgia Mitchell study director
Stryker Trauma and Extremities
26 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamma3 Intramedullary Nails (Stryker) and Sliding Hip Screws in people with Femoral Neck Fractures and Intertrochanteric Fracture, run by Stryker Trauma and Extremities at 26 sites in 12 countries.
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 8 inclusion and 14 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 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, United Kingdom, China, Canada, Colombia and 7 more countries. 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?
Health Related Quality of Life (time frame: Up to 104 weeks). 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 NCT01380444, which also lists 4 linked publications.
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 7 Mar 2019.