Femoral Neck FracturesCONQUEST FNNCT03721835
Safety Study of Femoral Neck Fracture System
A study testing CONQUEST FN Femoral Neck Fracture System in people with Femoral Neck Fractures, run by Smith & Nephew, Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to assess the reoperation rate of fractures that have occurred at the neck of the femur that are treated with the CONQUEST FN Femoral Neck Fracture System. The CONQUEST FN Femoral Neck Fracture System is approved for use by the United States Food and Drug Administration (FDA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- CONQUEST FN Femoral Neck Fracture System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesUnited States
- Study dates
- 10 Sep 2018to 11 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Must be 18 years of age or older
- Must provide written informed consent
- Willing to make all required study visits for one year post-operation
- Subject has experienced a displaced or non-displaced intracapsular femoral neck fracture and is scheduled for repair using the CONQUEST FN Femoral Neck Fracture System.
Who cannot join
- Subject with known sensitivity or allergies to stainless steel
- Subject with fracture occurring more than 7 days prior to surgery
- Subject has more than one fracture on the hip requiring surgery
- Subject is considered obese by a Body Mass Index > 40 at the time of surgery
- Therapy with another investigational agent within thirty 30 days of screening
- Subject has emotional or neurological condition that precludes cooperation and compliance
Show all 10Show fewer
- Subject has undergone previous surgery on hip.
- Subject has severe bow of the target hip or gross distortion of the femur.
- Current systemic therapy with cytotoxic drugs
- Subject has a physical condition that would preclude adequate implant support or impede healing (e.g. blood supply impairment, insufficient bone quality or quantity, or an active local or systemic infection).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
John Peter Smith Hospital
Fort Worth, Texas, 76104
Orthopaedic Trauma Institute Navicent Health Medical Center
Macon, Georgia, 31201
UT Health Science Center San Antonio
San Antonio, Texas, 78829
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of CONQUEST FN for the Treatment of Intracapsular Femoral Neck Fractures
The purpose of this study is to assess the reoperation rate of fractures that have occurred at the neck of the femur that are treated with the CONQUEST FN Femoral Neck Fracture System. The CONQUEST FN Femoral Neck Fracture System is approved for use by the United States Food and Drug Administration (FDA). It consists of a stainless steel plate and up to three (3) screws intended to treat both non-displaced and displaced fractures to the femoral neck.
Read the detailed description
The CONQUEST FN™ represents the next generation femoral neck fracture system designed to offer better intra-operative reduction control with the assurance of eliminating device failure modes. This system is dedicated to treating both non-displaced and displaced intracapsular fractures of the femoral neck. It is a dynamic locked implant system that provides multiple points of fixed angle support with continuous compression across the fracture site, ensuring bone-on-bone contact during the fracture union process. The continuous fracture site compression and post-operative reduction maintenance is accomplished with the incorporation of telescoping compression screw technology. The novel system empowers surgeons to address the current surgical challenges and often unfavorable patient outcomes and high re-operation rate associated with the current treatment options for intracapsular femoral neck fractures.
This study will evaluate the re-operation rate for any reason of displaced and non-displaced femoral neck fractures treated with the CONQUEST FN Femoral Neck Fracture System at one year post-operation.
- Conditions
- Femoral Neck Fractures
- Being tested
- CONQUEST FN Femoral Neck Fracture System
- Keywords
- Femoral Neck Fracture, Hip, Broken hip, CONQUEST FN, Hip Fracture
- 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.
CONQUEST FN Femoral Neck Fracture SystemDevice
Fracture fixation device consisting of a single plate and three screws
| Study group | Role | What they receive |
|---|---|---|
| Control femoral neck fracture system | Other | This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture Receives: Device: CONQUEST FN Femoral Neck Fracture System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation Rate at One Year Post-operation
Reoperation for any reason from time of implantation to one-year post operation
Measured: 1 year
Secondary outcomes (8)
Number of Participants With Intraoperative Complications
Documentation of any complications related to the implantation of the device
Measured: 7 days
Classification of Quality of Fracture Reduction
Appropriate reduction was defined as the principal compressive trabeculae measuring >160° in the AP view and <5° of posterior angulation in the lateral view. Fractures were then classified as:
- Grade I
- Grade II
- Grade III
If reduction was acceptable in both views, it was classified as Grade I. Grade II was indicative of one plane of malreduction, and Grade III was indicative of malreduction in both radiographic views.
Measured: Operative, 6 weeks, 3 months, 6 months, and 1 year
Visual Analogue Scale (VAS) for Pain
The Visual Analogue Scale was simply a line of fixed length, on which the subject marked their experience of pain with a single stroke of a pen. At each specified visit, the participant was asked to indicate their average level of pain from the operated hip over the prior 24 hours using a visual analog scale (VAS). The participant recorded their level of pain on a 100 millimeter visual analog scale with scores ranging from 0 to 100. The scale marked 'no pain' (score of 0) on the left side of the scale and 'severe pain' (score of 100) at the right end of the scale. The participant was instructed to place a vertical mark on the scale, using an ink pen.
The Investigator, or designee, measured the distance (in millimeters) from the left end of the VAS scale to the vertical line drawn by the participant. This value was entered in the participant's Case Report Form (CRF) as a measure of the pain associated with the operated hip.
Measured: Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 year
Quality of Life - EQ-5D-5L
The EuroQol Five Dimensions (EQ-5D-5L) Questionnaire descriptive system consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), which are each assigned 5 levels:
- 1= no problems
- 2= slight problems
- 3= moderate problems
- 4= severe problems
- 5= extreme problems
The respondent is asked to indicate his/her health using the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for the five dimensions are combined in a 5-digit code describing the respondent's health state with scores ranging from -0.109 to 1 where higher scores indicate a better health state.
Measured: Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 year
Timed Up and Go (TUG)
The Timed Up and Go Test assesses mobility, balance, walking ability, and fall risk in adults by measuring time, in seconds, that it takes the individual to stand from a chair, walk a distance of 10 feet, walk back to the chair, and sit down. The subject will perform the test in their everyday footwear with their walking aid (cane, walker), if applicable. The site will follow the guidelines provided by the Centers for Disease Control and Prevention recording the results on the form provided by the Sponsor.
Measured: 6 Weeks, 3 Months, 6 Months, and 1 year
Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
The ASLR assessment provides information about the ability of load transfer and motor control strategies in the lumbo/pelvic/hip complex. ASLR will be performed with the subject in a relaxed supine position with legs straight and feet apart. Participants will be instructed to raise their operated leg 20cm above the examination table without bending the knee and without pelvic movement relative to the trunk. A score will be provided by the participant for the operated limb on a six-point Likert scale (0 = not difficult at all, 1 = minimally difficult; 2 = somewhat able to do, 3 = fairly difficult, 4 = very difficult, 5 = unable to do).
Measured: 6 Weeks, 3 Months, 6 Months, and 1 year
Number of Participants With Construct Failure
Construct failure past typical femoral neck fracture healing period (past 6 months) indicated by reported device deficiencies.
Measured: 6 months post-operative
Length of Hospital Stay
Time spent in hospital measured by the number of days
Measured: During hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start10 Sep 2018
- Primary completion11 Feb 2020
- Study completion11 Feb 2020
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karlie Morgan, Study chair, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721835
- Sponsor's protocol ID
- 18-3047-02
- Acronym
- CONQUEST FN
- Status last verified
- Feb 2021
- First submitted
- 19 Oct 2018
- Last updated
- 25 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of CONQUEST FN for the Treatment of Intracapsular Femoral Neck Fractures
- ClinicalTrials.gov ID
- NCT03721835
- Acronym / sponsor ID
- CONQUEST FN / 18-3047-02
- Conditions
- Femoral Neck Fractures
- Keywords
- Femoral Neck Fracture, Hip, Broken hip, CONQUEST FN, Hip Fracture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 11 Feb 2020 (actual)
- Study completion
- 11 Feb 2020 (actual)
- First posted
- 26 Oct 2018 (actual)
- Results
- Posted 25 Sep 2023
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 reoperation rate of fractures that have occurred at the neck of the femur that are treated with the CONQUEST FN Femoral Neck Fracture System. The CONQUEST FN Femoral Neck Fracture System is approved for use by the United States Food and Drug Administration (FDA). It consists of a stainless steel plate and up to three (3) screws intended to treat both non-displaced and displaced fractures to the femoral neck.
Detailed description
The CONQUEST FN™ represents the next generation femoral neck fracture system designed to offer better intra-operative reduction control with the assurance of eliminating device failure modes. This system is dedicated to treating both non-displaced and displaced intracapsular fractures of the femoral neck. It is a dynamic locked implant system that provides multiple points of fixed angle support with continuous compression across the fracture site, ensuring bone-on-bone contact during the fracture union process. The continuous fracture site compression and post-operative reduction maintenance is accomplished with the incorporation of telescoping compression screw technology. The novel system empowers surgeons to address the current surgical challenges and often unfavorable patient outcomes and high re-operation rate associated with the current treatment options for intracapsular femoral neck fractures.
This study will evaluate the re-operation rate for any reason of displaced and non-displaced femoral neck fractures treated with the CONQUEST FN Femoral Neck Fracture System at one year post-operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control femoral neck fracture system | Other | Device: CONQUEST FN Femoral Neck Fracture SystemThis is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be 18 years of age or older
- Must provide written informed consent
- Willing to make all required study visits for one year post-operation
- Subject has experienced a displaced or non-displaced intracapsular femoral neck fracture and is scheduled for repair using the CONQUEST FN Femoral Neck Fracture System.
Key exclusion criteria (10 listed)
- Subject with known sensitivity or allergies to stainless steel
- Subject with fracture occurring more than 7 days prior to surgery
- Subject has more than one fracture on the hip requiring surgery
- Subject is considered obese by a Body Mass Index > 40 at the time of surgery
- Therapy with another investigational agent within thirty 30 days of screening
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 |
|---|---|---|
| CONQUEST FN Femoral Neck Fracture SystemFracture fixation device consisting of a single plate and three screws | Device | Control femoral neck fracture system |
Primary outcome
Reoperation Rate at One Year Post-operation
Time frame: 1 year
Reoperation for any reason from time of implantation to one-year post operation
8 secondary outcomes
Number of Participants With Intraoperative Complications
Time frame: 7 days
Classification of Quality of Fracture Reduction
Time frame: Operative, 6 weeks, 3 months, 6 months, and 1 year
Visual Analogue Scale (VAS) for Pain
Time frame: Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 year
Quality of Life - EQ-5D-5L
Time frame: Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 year
Timed Up and Go (TUG)
Time frame: 6 Weeks, 3 Months, 6 Months, and 1 year
Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
Time frame: 6 Weeks, 3 Months, 6 Months, and 1 year
Number of Participants With Construct Failure
Time frame: 6 months post-operative
Length of Hospital Stay
Time frame: During hospitalization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Karlie Morgan study chair
Smith & Nephew, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CONQUEST FN Femoral Neck Fracture System in people with Femoral Neck Fractures, run by Smith & Nephew, Inc. at 4 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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Yes. Results are posted in the registry (first posted 25 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Reoperation Rate at One Year Post-operation (time frame: 1 year). 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 25 Sep 2023.