Study Stopped
Slow enrollment
Safety Study of Femoral Neck Fracture System
CONQUEST FN
A Multicenter, Post Market, Prospective Study Evaluating Safety and Efficacy of CONQUEST FN for the Treatment of Intracapsular Femoral Neck Fractures
1 other identifier
interventional
15
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 10, 2018
CompletedFirst Submitted
Initial submission to the registry
October 19, 2018
CompletedFirst Posted
Study publicly available on registry
October 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 11, 2020
CompletedResults Posted
Study results publicly available
September 25, 2023
CompletedSeptember 25, 2023
February 1, 2021
1.4 years
October 19, 2018
February 16, 2021
September 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reoperation Rate at One Year Post-operation
Reoperation for any reason from time of implantation to one-year post operation
1 year
Secondary Outcomes (8)
Number of Participants With Intraoperative Complications
7 days
Classification of Quality of Fracture Reduction
Operative, 6 weeks, 3 months, 6 months, and 1 year
Visual Analogue Scale (VAS) for Pain
Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 year
Quality of Life - EQ-5D-5L
Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 year
Timed Up and Go (TUG)
6 Weeks, 3 Months, 6 Months, and 1 year
- +3 more secondary outcomes
Study Arms (1)
Control femoral neck fracture system
OTHERThis 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
Interventions
Fracture fixation device consisting of a single plate and three screws
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Orthopaedic Trauma Institute Navicent Health Medical Center
Macon, Georgia, 31201, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157, United States
John Peter Smith Hospital
Fort Worth, Texas, 76104, United States
UT Health Science Center San Antonio
San Antonio, Texas, 78829, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Karlie Morgan
- Organization
- Smith+Nephew, Inc.
Study Officials
- STUDY CHAIR
Karlie Morgan
Smith & Nephew, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2018
First Posted
October 26, 2018
Study Start
September 10, 2018
Primary Completion
February 11, 2020
Study Completion
February 11, 2020
Last Updated
September 25, 2023
Results First Posted
September 25, 2023
Record last verified: 2021-02