Back to resultsSafety Study of Femoral Neck Fracture System (CONQUEST FN)
Primary Purpose
Femoral Neck Fractures
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CONQUEST FN Femoral Neck Fracture System
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Neck Fractures focused on measuring Femoral Neck Fracture, Hip, Broken hip, CONQUEST FN, Hip Fracture
Eligibility Criteria
Inclusion Criteria:
- 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 CONQUET FN Femoral Neck Fracture System.
Exclusion Criteria:
- 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
- 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).
Sites / Locations
- Orthopaedic Trauma Institute Navicent Health Medical Center
- Wake Forest School of Medicine
- John Peter Smith Hospital
- UT Health Science Center San Antonio
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Control femoral neck fracture system
Arm Description
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
Outcomes
Primary Outcome Measures
Reoperation Rate at One Year Post-operation
Reoperation for any reason from time of implantation to one-year post operation
Secondary Outcome Measures
Number of Participants With Intraoperative Complications
Documentation of any complications related to the implantation of the device
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.
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.
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.
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.
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).
Number of Participants With Construct Failure
Construct failure past typical femoral neck fracture healing period (past 6 months) indicated by reported device deficiencies.
Length of Hospital Stay
Time spent in hospital measured by the number of days
Full Information
NCT ID
NCT03721835
First Posted
October 19, 2018
Last Updated
September 22, 2023
Sponsor
Smith & Nephew, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03721835
Brief Title
Safety Study of Femoral Neck Fracture System
Acronym
CONQUEST FN
Official Title
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of CONQUEST FN for the Treatment of Intracapsular Femoral Neck Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
February 11, 2020 (Actual)
Study Completion Date
February 11, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith & Nephew, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures
Keywords
Femoral Neck Fracture, Hip, Broken hip, CONQUEST FN, Hip Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control femoral neck fracture system
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
CONQUEST FN Femoral Neck Fracture System
Intervention Description
Fracture fixation device consisting of a single plate and three screws
Primary Outcome Measure Information:
Title
Reoperation Rate at One Year Post-operation
Description
Reoperation for any reason from time of implantation to one-year post operation
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of Participants With Intraoperative Complications
Description
Documentation of any complications related to the implantation of the device
Time Frame
7 days
Title
Classification of Quality of Fracture Reduction
Description
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.
Time Frame
Operative, 6 weeks, 3 months, 6 months, and 1 year
Title
Visual Analogue Scale (VAS) for Pain
Description
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.
Time Frame
Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 year
Title
Quality of Life - EQ-5D-5L
Description
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.
Time Frame
Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 year
Title
Timed Up and Go (TUG)
Description
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.
Time Frame
6 Weeks, 3 Months, 6 Months, and 1 year
Title
Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
Description
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).
Time Frame
6 Weeks, 3 Months, 6 Months, and 1 year
Title
Number of Participants With Construct Failure
Description
Construct failure past typical femoral neck fracture healing period (past 6 months) indicated by reported device deficiencies.
Time Frame
6 months post-operative
Title
Length of Hospital Stay
Description
Time spent in hospital measured by the number of days
Time Frame
During hospitalization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karlie Morgan
Organizational Affiliation
Smith & Nephew, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Orthopaedic Trauma Institute Navicent Health Medical Center
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Wake Forest School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
John Peter Smith Hospital
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
UT Health Science Center San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78829
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety Study of Femoral Neck Fracture System
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