Safety Study of Femoral Neck Fracture System

Femoral Neck Fractures Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03721835
• Other study ID #: 18-3047-02
• Status: Terminated
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: February 11, 2020

Study information

• Verified date: February 2021
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: February 11, 2020
• Est. primary completion date: February 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fractures, Bone

Intervention

Device:
• CONQUEST FN Femoral Neck Fracture System
Fracture fixation device consisting of a single plate and three screws

Locations

Country	Name	City	State
United States	John Peter Smith Hospital	Fort Worth	Texas
United States	Orthopaedic Trauma Institute Navicent Health Medical Center	Macon	Georgia
United States	UT Health Science Center San Antonio	San Antonio	Texas
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reoperation Rate at One Year Post-operation	Reoperation for any reason from time of implantation to one-year post operation	1 year
Secondary	Number of Participants With Intraoperative Complications	Documentation of any complications related to the implantation of the device	7 days
Secondary	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.	Operative, 6 weeks, 3 months, 6 months, and 1 year
Secondary	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.	Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 year
Secondary	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.	Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 year
Secondary	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.	6 Weeks, 3 Months, 6 Months, and 1 year
Secondary	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).	6 Weeks, 3 Months, 6 Months, and 1 year
Secondary	Number of Participants With Construct Failure	Construct failure past typical femoral neck fracture healing period (past 6 months) indicated by reported device deficiencies.	6 months post-operative
Secondary	Length of Hospital Stay	Time spent in hospital measured by the number of days	During hospitalization