Clinical trial NCT03721835: Safety Study of Femoral Neck Fracture System
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
Overall status: TERMINATED
Phase: NA
Conditions: Femoral Neck Fractures
Keywords: Femoral Neck Fracture
Hip
Broken hip
CONQUEST FN
Hip Fracture
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Must be 18 years of age or older
2. Must provide written informed consent
3. Willing to make all required study visits for one year post-operation
4. 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:

1. Subject with known sensitivity or allergies to stainless steel
2. Subject with fracture occurring more than 7 days prior to surgery
3. Subject has more than one fracture on the hip requiring surgery
4. Subject is considered obese by a Body Mass Index \> 40 at the time of surgery
5. Therapy with another investigational agent within thirty 30 days of screening
6. Subject has emotional or neurological condition that precludes cooperation and compliance
7. Subject has undergone previous surgery on hip.
8. Subject has severe bow of the target hip or gross distortion of the femur.
9. Current systemic therapy with cytotoxic drugs
10. 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).

Primary outcomes:
measure: Reoperation Rate at One Year Post-operation
timeFrame: 1 year
Secondary outcomes:
measure: Number of Participants With Intraoperative Complications
timeFrame: 7 days
measure: Classification of Quality of Fracture Reduction
timeFrame: Operative, 6 weeks, 3 months, 6 months, and 1 year
measure: Visual Analogue Scale (VAS) for Pain
timeFrame: Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 year
measure: Quality of Life - EQ-5D-5L
timeFrame: Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 year
measure: Timed Up and Go (TUG)
timeFrame: 6 Weeks, 3 Months, 6 Months, and 1 year
measure: Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
timeFrame: 6 Weeks, 3 Months, 6 Months, and 1 year
measure: Number of Participants With Construct Failure
timeFrame: 6 months post-operative
measure: Length of Hospital Stay
timeFrame: During hospitalization
Other outcomes:
Locations:
city: Macon
country: United States
facility: Orthopaedic Trauma Institute Navicent Health Medical Center
state: Georgia
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
city: Fort Worth
country: United States
facility: John Peter Smith Hospital
state: Texas
city: San Antonio
country: United States
facility: UT Health Science Center San Antonio
state: Texas
Study officials:
affiliation: Smith & Nephew, Inc.
name: Karlie Morgan
role: STUDY_CHAIR
References: