Trials Sponsors Conditions Drugs Pricing

Conditions

Garden Grade I Subcapital Fracture of Femoral Neck Garden Grade II Subcapital Fracture of Femoral Neck Intracapsular Proximal Femur Fracture

Keywords

Cannulated ScrewsAugmentation

Outcome Measures

Primary Outcomes (1)

Number of Participants With a Reoperation
Reoperation after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function.
12 months

Secondary Outcomes (8)

Number of Participants With Radiographic Fracture Healing of the Intracapsular Femur (RUSH)
6 weeks, 3 months, 6 months, and 12 months
Participant Steinberg Classification at 12 Months
12 months

Study Arms (1)

N-Force Screws

OTHER

N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures.

Device: N-Force Screws Augmented with N-Force Blue

Interventions

N-Force Screws Augmented with N-Force BlueDevice

N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)

N-Force Screws

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient has primary Garden I or II intracapsular proximal femur fracture requiring surgical intervention and is eligible for fixation by three cannulated screws augmented with N-Force Blue.
Patient receives operative treatment within 7 days of injury.

Sponsors & Collaborators

Zimmer Biomet
Industrylead

Study Sites (4)

Stanford University

Stanford, California, 94305, United States

Washington University

St Louis, Missouri, 63130, United States

Donald B Slocum Research and Education Foundation

Eugene, Oregon, 97401, United States

University of Utah

Salt Lake City, Utah, 84108, United States

Results Point of Contact

Title: Ryan Boylan, Clinical Affairs Manager
Organization: Zimmer Biomet

Study Officials

Ryan Boylan, MBA
Zimmer Biomet
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

12 participants (actual enrollment reported by the registry).

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

January 8, 2019

First Posted

January 16, 2019

Study Start

February 21, 2019

Actual (reported)

Study Stopped

N-Force Screws Augmented With N-Force Blue in Hip Fractures

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (1)

N-Force Screws

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (1)

N-Force Screws

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations